SCOTUS in Focus: Amgen v. Sanofi and the Future of Pharma Patents

We’re leading off Season 3 with a close look at a Supreme Court patent case that could have profound impacts on the invention enablement problems we covered heavily in Season 2. SCOTUS is set to hear opening arguments in Amgen v. Sanofi on March 27th. For the first time in over 75 years, the Supreme Court is evaluating the meaning and scope of the enablement requirement. For those who’ve been following along, you’ll know that this has become one of the bigger issues plaguing patenting and especially so in the life sciences.

Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora, leads our discussion today along with our all star patent panel, exploring the scientific background around antibodies necessary to understand the claims, a brief case history of Amgen v. Sanofi, an overview of the enablement factors and tests that have been historically applied in courts and how they might apply to this case, and a discussion around open questions and the potential unintended consequences of the Supreme Court only taking up one-half of the two-sided enablement coin. This ends up being a really great, spirited conversation with panel members coming down strongly on both sides of the case with very compelling arguments – really highlighting the complexities and fundamental issues the court will have to face.

Ashley is joined today by our always exceptional group of IP experts including:

⦿ David Cohen, Principal at Cohen Sciences
⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ David Jackrel, President of Jackrel Consulting
⦿ Ty Davis, Patent Strategy Associate at Aurora

** Aurora is Hiring! **

Join us in the trenches and on this podcast! Aurora is looking for a part-time Biomedical Sciences Patent Agent to help with patent portfolio management, application drafting, prosecution, and strategy. This is a salaried, fully remote position with a flexible work week and benefits. Work where you want, when you want, with a great team, on engaging subject matter, and even get the opportunity to be heard on this Podcast and featured on IPWatchdog! Learn more and apply at https://www.aurorapatents.com/careers.html.

** Resources **

⦿ Show Notes: https://www.aurorapatents.com/blog/scotus-in-focus-amgen-v-sanofi
⦿ Slides: https://www.aurorapatents.com/uploads/9/8/1/1/98119826/amgenvsanofi.pdf
⦿ Apply: https://www.aurorapatents.com/careers.html

** Follow Aurora Consulting **

⦿ Home: https://www.aurorapatents.com/
⦿ Twitter: https://twitter.com/AuroraPatents
⦿ LinkedIn: https://www.linkedin.com/company/aurora-cg/
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⦿ Instagram: https://www.instagram.com/aurorapatents/

And as always, thanks for listening! 

---
Note: The contents of this podcast do not constitute legal advice.

Chapters

• 0:00 Intro
• 11:48 Panel survival skills icebreaker
• 15:27 Strategy tidbits: Inclusion of embodiments section
• 21:12 Strategy tidbits: Slowing prosecution with suspension of action
• 23:28 35 USC 112(a): Written Description and Enablement
• 25:45 Discussion outline
• 26:36 In re Wands
• 27:00 Antibody basics
• 34:10 Antibody design
• 36:42 In re Wands case history
• 38:54 Wands Factors - enablement test
• 39:12 Written description tests
• 40:07 Purpose of Amgen patents
• 42:20 Amgen v. Sanofi case history
• 44:20 Amgen claims analysis
• 1:02:59 Amgen Wands Factors analysis
• 1:07:19 Amgen Written Description Test analysis
• 1:08:58 Separating enablement from written description
• 1:12:19 Panel questions
• 1:22:30 MPEP standard mismatch
• 1:24:39 Outro

Transcript

WEBVTT

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Good day, and welcome to the patently Strategic Podcast, where we discuss all things at

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the intersection of business, technology and patents. This podcast

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is a monthly discussion amongst experts in the field of patenting. It is for inventors,

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founders and IP professionals alike, established or aspiring.

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And in today's episode, we're officially kicking off our third season.

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It's going to be a big year for patents, and we couldn't be more excited

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excited about the lineup we're bringing you. Starting in April, we'll be releasing huge interviews

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with distinguished industry heavyweights delving into much needed meaningful

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solutions for patent reform. Shortly after, we'll be starting

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a series of interviews with some incredibly savvy investors to help better understand what

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investors want in patents. We typically think about the primary

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audiences for patents being the pto in courts, but many inventors

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and startups care more initially anyway. About investors this is a

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very important perspective, since it's taking the innovation world by storm.

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We're also going to take a look at what generative AI like Chat gpt could

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mean for the patent world. Pulling from some of the most frequent questions

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we get from live inventor training events, we'll go even deeper on prior explorations

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into software patenting by looking at the interplay between patents,

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copyrights, and open source. We're also working on a collaborative effort to

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do a tangential dive into the world of copyrights and trademarks in

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the wave of pop culture cases that could have major implications

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for copyright law this year, and for those wanting to better understand the levers

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at the heart of patent law, we have a series planned for further exploration into

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claim types and strategies. But first, in this month's episode,

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we're leading off with a close look at a Supreme Court patent case that could

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have profound impacts on the invention enablement problems we covered

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heavily in season two. scotus is set to hear opening arguments in Amgen

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versus Sanofi on March 27. So we're leading off with this topic

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to help get folks booted up who might want to follow along as the case

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unfolds over the coming months. For the first time in over 75

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years, the Supreme Court is evaluating the meaning and scope of

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the enablement requirement. For those who have been following along, you'll know

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that this has become one of the bigger issues plaguing patenting, and especially so

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in the life sciences. Enablement, like its wicked sibling eligibility,

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have been two grounds for rejection and invalidation that haven't historically

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been all that common, but are becoming increasingly prevalent in

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the less predictable arts like immunology, molecular biology,

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chemistry, and diagnostics. This is in part due to something called

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a genus claim, which has been a critical patent feature for chem,

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biotech, and pharmaceutical industries. Derived from their

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traditional biological definitions. A genus is a group

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defined by common characteristics, and a species is a logical division

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of a genus in chemical, biotech, and pharma patents. A genus

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claim covers a group of structurally and or functionally related

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chemicals, whereas a species claim covers a single compound without

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coverage of analogs derivatives or compounds in the same family.

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Why this particularly matters for pharmaceuticals is that one successful

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drug needs to be able to recoup the massive R and D costs from the

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countless failures that preceded it, and that requires adequate coverage

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and exclusivity over a period of time. A lot of drugs would

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be pretty easy to design around. If a patent only narrowly claims

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a specific chemical species, a competitor would simply have

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to use a different functional group or additive with the same properties,

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and bam. They have a new non infringing therapeutic based

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on an R and D investment they didn't make. It would be impractical,

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if not impossible, to reduce to practice every possible

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applicable species. The broader genus claims have historically been the

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umbrella tool of choice for many innovators in this space.

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Where the genus claims have run into trouble is with the interpretation and court

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based expansion of one of the core statutes that governs patentability.

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This fundamental tenet of patent law is the concept of enablement.

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When a patent publishes, the information contained in the patent becomes part

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of the public record. So enablement requirements aim to ensure that

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society receives something useful in exchange for the exclusive rights

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granted to the inventor. This is the grand bargain of the patent system.

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Codified in section 112 of Us. Code title 35

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are the minimum requirements for the quality and quantity of

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information that must be contained in a patent application to justify the grant

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of a patent. Section 112 basically says that a patent

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application must describe the invention in full, clear,

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concise and exact enough terms to demonstrate that the inventor had

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possession of the invention at the time of filing. This is called the written

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description requirement and to enable those skilled in the art to make and use

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the invention or the enablement requirement. A 1916

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Supreme Court decision further defined the standard for determining whether

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the description meets the enablement requirement by raising the question of

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whether or not the experimentation needed to practice the invention is undue or

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unreasonable. To this day, even though the statute does not use

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the term undo experimentation, it has been interpreted to

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require that the claimed invention be enabled so that any person skilled in the art

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can make and use the invention without undue experimentation. The big

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question this all culminates in is the focus of the upcoming Supreme Court case that

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is the focus of today's conversation. What do genus claims require

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from an enablement perspective? Will the enablement standard be governed

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by the black and white codified section 112 statutory requirement that

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the specification must only teach those skilled in the art how to make

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and use the claimed invention? Or will the Supreme Court lean on court based additions

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to the standard that the specification must enable those skilled in the art to,

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quote, reach the full scope of claimed embodiments? Without undue

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experimentation to get genus level coverage. The latter would

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require the inventor to actually reduce to practice every single species they

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intend the genus to cover. And that brings us to the particulars

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of the case at hand. Amgen v. Sanofi has a long case history

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that goes back nearly a decade, with the involved parties trading turns

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on offense and defense, with two juries coming down on the side of

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Amgen but district and Federal Circuit court judges ultimately

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ruling in favor of Sanofi. The battle centers around competing versions of

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cholesterol lowering drugs produced by the two companies.

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Amgen makes Rapatha and sanofi makes prolulent with us.

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Sales handled by regeneron, the drugs are monoclonal antibodies

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that lower the levels of ldl or low density lipoprotein

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cholesterol, aka. The bad cholesterol. Amgen initially

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sued, arguing that patents protecting ripatha were being infringed

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by Prowulent. regeneron and Sanofi argued that amgen's patents

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weren't valid in the first place. Twice, district court juries found amgen's

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patents valid, concluding that Sanofi failed to prove that the claims lacked

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enablement or written description. Sanofi's subsequent motion for judgment

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as a matter of law for lack of enablement, however, was successful

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at the district court level and was later affirmed on appeal at the Federal

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Circuit, which concluded that amgen's claims were invalid on grounds of

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enablement because, quote, undue experimentation would be required

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to practice the full scope of claims. In a rare move for patent

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law and against the Solicitor general's recommendation, the Supreme Court will

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now hear the case, giving Amgen a final opportunity to resurrect its

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patents and hopefully more broadly, provide clarity for the industry.

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On the enablement standard for genus claims, santa fe is arguing

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that Amgen is asserting a monopoly over an entire genus of functionally

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defined claims that are not enabled since they cover thousands of possible

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antibodies. While the application only highlights a limited number

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of examples, Sanofi's arguments hinge on the Federal circuit's full scope enablement

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standard, where every species in a genus must be reduced to practice.

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Sanofi believes that beyond the lack of enablement, the functional genus claims

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and their overly broad protections stifle innovation by monopolizing entire

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classes of rival drugs. Amgen, on the other hand, is arguing

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that the Federal Circuit has gone off the rails on enablement laws,

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that it's defying more than a century of Supreme Court precedent on the issue,

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invading the jury's role, imposing a full scope requirement that's not

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contained in the patent act, and is frustrating the purpose of patent

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law by invalidating patents for breakthrough inventions. By demanding

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disclosure about theoretical far corners, amgen contends that

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imposing these standards and invalidating genius claims on perceived

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size alone will have a devastating impact on breakthrough innovations

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in biotech and pharmaceutical industries. They state that given the

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significant investments required to discover and develop new innovative

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therapeutics, the patents must provide a meaningful scope of protection

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broader than just the specific examples the inventors disclose.

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In the void of those protections, the system will encourage copies,

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not the next big breakthrough, making it all too easy to

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create MeToo drugs that only require minor changes and not

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the same research investment. amgen's key argument is that their application

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provides the necessary roadmap for someone skilled in the art to make and use

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its drug and all covered species without undue experimentation,

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whether it's five or 5000, and that the law is codified

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does not require the applicant to include examples for every possible permutation.

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Regardless of how this plays out, it's hard to imagine the High Court's ruling not

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having significant consequences for the industry. Their willingness to

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hear the case alone signals that big changes could be on the horizon. With district

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and federal circuit courts ruling one way in, lockstep and the Solicitor

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General recommending that the Supreme Court not even take the case.

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Combined with the fact that the Court takes up few cases on petition and even

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fewer yet for patent law, there's little reason to believe the Supreme Court

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would take the case to simply step in and just rubber stamp prior rulings.

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In any case, the stakes are incredibly high and there truly

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is a very important balance to strike in all of this. While broader protection

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is necessary for life changing pharmaceutical patents to have any real value,

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enablement requirements are the check in the system that prevent massive land grabs

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and exclusive rights for things that applicants didn't actually invent.

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And I can't think of a better person to help break this all down for

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us. Dr. Ashley slote, president and Director of Patent Strategy at aurora,

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leads our discussion today along with our all star patent panel exploring

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the scientific background around antibodies necessary to understand the claims. A Brief

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History of Amgen versus Sanofi an overview of the enablement

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factors and tests that have been historically applied in courts and

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how they might apply to this case and a discussion around open questions

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and the potential unintended consequences of the Supreme Court

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only taking up one half of the two sided enablement coin. This ends

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up being a really great, spirited conversation with panel members

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coming down strongly on both sides of the case, with very compelling arguments

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really highlighting the complexities and fundamental issues the court will have to face.

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The group also leads off with a short brainstorming session around embodiment

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drafting, some dialogue around a lesser known process for strategically

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slowing prosecution, and an icebreaker that shines some revealing light

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into the survival instincts of your beloved hosts and panelists.

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Ashley is joined today by our always exceptional group of IP experts,

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including David Cohen, principal at Cohen Sciences kristen

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hansen, patent strategist here at aurora, david Jackerel, president of

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Jacob Consulting and ty Davis, patent strategy associate at aurora.

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And if you'd like to help us navigate this complex world both before and after

10:51.056 --> 10:54.586
the Supreme Court discussion, I have great news. aurora is now hiring

10:54.618 --> 10:57.886
for a part time biomedical sciences patent agent. This is

10:57.908 --> 11:01.758
a salaried fully remote position with a flexible work week and benefits.

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Work where you want, when you want, with a great team on engaging subject matter,

11:05.928 --> 11:09.794
and even get the opportunity to join us on this podcast. Learn more

11:09.832 --> 11:13.634
and apply at aurorapatants. Comcareers. We'll also

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include that link in the show. Notes if you still haven't had your

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fill of enablement, I do encourage you to check out several related episodes

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from season two, including episode five, fortifying Life Science Patents,

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where we explore both eligibility and enablement issues currently confronting life

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Science patents. Episode eight on Means Plus Function,

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where we discuss enablement standards around the use of functional claim language,

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and episode ten on The Unpredictable Arts, where we cover practical tips

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for getting more predictable results when patenting biological, chemical and

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emerging technologies. Now, without further ado take

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it away, ashley, the icebreaker I have for today was if

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you could take three things to a desert island, what would they be?

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Could we start with one thing? Sure.

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Years ago there was one of these sort of team building exercises

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at a company I was working in, and they

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brought in a trainer and there was a scenario,

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some scenario you were in the wilderness and

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it was like this what what item would you

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take with you? And I said,

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Take a flashlight. And I've never

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forgotten. And this other woman in in,

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you know, our cluster, said, oh, are you afraid of the dark?

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Anyway, when it came time to reveal

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the correct answers, the first thing was a flashlight.

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So I'm sticking with flashlight for my I

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like it. It does seem reasonable. That would be helpful. That's not the thing I

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had been thinking but now I'm reevaluating right

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for the second and third, I would take extra batteries.

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That's what I would do.

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I take a water filter and sunscreen.

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Fair. I don't know about the third. When I first

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read it, I was thinking much less practical.

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A bikini. I was thinking a guitar,

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because endless hours of entertainment,

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what do you do? Something to make fire would probably

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be I think that might it's not quite as good as a

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flashlight, but you can also cook food if you

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happen to catch any fish or anything. So maybe

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a guitar and flint and steel. There you go.

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I like it. I think I

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would cheat, let's say 3d printer,

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but I'm also going to need the computer,

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cad software and electricity,

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of course. Yeah. How do you order more powered

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3d printer? 20 tons of

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filament? Or maybe the ideal

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answer is like a fully charged sat phone.

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Get off of the ice.

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I don't need the other two because I'm getting out of

14:33.128 --> 14:36.386
here. Yeah,

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I was thinking a warm blanket because I am very cold and even

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an island I feel like would be cold at night, so I would

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want a warm blanket. But then the water filter also

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occurred to me, but I was thinking maybe some kind of machete because I don't

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know what's on this island. Kill something to eat or

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I don't know, make a shelter, cut down some branches. I don't

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know. I've seen Survivor. You need some stuff. Right.

15:00.030 --> 15:03.326
Make it in the parade. Exactly.

15:03.428 --> 15:06.350
Right. Duct tape. Yeah, duct tape.

15:07.090 --> 15:08.990
A boat to get off the island.

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Christian. Then a flare, a satellite phone

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and a boat.

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Well, to miss how tropical it is. I mean, if it's like really tropical.

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I don't know. Could be persuaded to stay.

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All right, so strategy, tidbits problems,

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practice issues, technical issues. I have just a random

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thing I learned to share. Does anybody else have any thoughts,

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comments,

15:41.310 --> 15:44.506
insights? I guess I

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wonder, do people put an embodiment

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section typically in their application at

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the very end where you list out all your

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claims and narrative form? Is that standard?

15:59.572 --> 16:03.166
Does everyone do that? We've been doing it more and more,

16:03.268 --> 16:07.022
especially for particular clients. I mean, the summary kind of suffices

16:07.086 --> 16:11.140
that for a while, but now kind of been putting it at the end.

16:11.670 --> 16:15.026
If you're going anywhere outside the Us. You really do want to pay to

16:15.048 --> 16:16.820
have that in there.

16:18.710 --> 16:21.750
There's a lot of software that will auto generate that for you as well.

16:21.900 --> 16:25.842
But it's just becoming more important for European practice,

16:25.906 --> 16:29.450
I think. I've been stuck a handful of times where

16:29.520 --> 16:33.530
I can't get a claim from further down my claim list

16:33.680 --> 16:37.562
because it's from a different embodiment in my spec. Right.

16:37.616 --> 16:40.814
So doing those permutations of embodiments has

16:40.852 --> 16:44.266
been helpful. So another thing I've

16:44.298 --> 16:47.760
noticed is some people, rather than

16:49.170 --> 16:52.962
dependency, rather than going back to a particular

16:53.096 --> 16:56.930
embodiment or claim, they'll say any of the above.

16:59.670 --> 17:03.246
What about that one? I think that holds

17:03.278 --> 17:06.578
less weight. In Europe, we went through an opposition proceeding

17:06.754 --> 17:11.782
with the client and those

17:11.836 --> 17:16.066
kinds of statements, especially early in the spec, for whatever reason, at least, the examining

17:16.178 --> 17:20.460
the opposition division kind of viewed that as almost like

17:21.550 --> 17:25.050
a summary intro section and didn't give it as much weight.

17:26.190 --> 17:30.220
I think there's still value in saying, like, other parts of the spec saying

17:30.830 --> 17:34.078
this could be applied to any of the other devices. For example, any of the

17:34.084 --> 17:37.758
devices of figures one through ten. Because you're

17:37.764 --> 17:41.274
kind of being a little bit more specific there. But at least in my limited

17:41.322 --> 17:44.942
experience of how at least the opposition division views that it's,

17:45.006 --> 17:49.140
for whatever reason, given less weight. I see.

17:49.830 --> 17:53.346
Ashley. Ashley, did we have

17:53.368 --> 17:56.734
a claim that said any of the above

17:56.782 --> 18:00.594
embodiments and in particular the embodiments of examples

18:00.642 --> 18:04.054
two through four and they were kind of more specific in that way?

18:04.252 --> 18:08.086
Yeah, that was in an example embodiment section

18:08.118 --> 18:09.740
at the end. Yeah,

18:12.830 --> 18:14.700
I've seen that happen. Right,

18:16.350 --> 18:20.134
so you would say any of the above, but in particular

18:20.272 --> 18:23.886
this and this and this and sort of have it both ways.

18:24.068 --> 18:27.550
Yeah. I don't know if it works. I haven't

18:28.130 --> 18:29.360
pushed that through.

18:31.490 --> 18:34.746
I think the other thing I've seen from even just a mixing and matching

18:34.778 --> 18:38.420
embodiments again from the same prior opposition proceeding was that

18:39.750 --> 18:43.202
especially in the chemical sciences, you get a whole bunch of lists of things,

18:43.256 --> 18:46.734
right? Like the first polymer could be any one of laundry

18:46.782 --> 18:50.802
list. The second polymer could be any one of laundry lists. In Europe

18:50.866 --> 18:53.702
allows you to choose one from one list,

18:53.836 --> 18:57.286
but not choose two from separate lists. So you

18:57.308 --> 19:01.190
would have to have a section that said the first polymer is

19:01.260 --> 19:05.354
this. And then the second polymer could be chosen from this list.

19:05.472 --> 19:09.066
Or the first polymer is this. And the second polymer could be chosen from

19:09.088 --> 19:12.406
this list. They don't like, I'm sure there's

19:12.438 --> 19:17.294
some statutes somewhere in their coding, but you

19:17.332 --> 19:20.842
can't choose multiple species from multiple lists. You're only allowed

19:20.906 --> 19:24.030
one laundry list from a species selection.

19:25.090 --> 19:28.546
So where this client ran a foul of it

19:28.568 --> 19:31.954
is that their technology had developed substantially over

19:31.992 --> 19:35.506
time from that really early filing. And so while they had coverage for

19:35.528 --> 19:39.720
it, it was coverage in the laundry list. Whereas the true technology

19:40.330 --> 19:43.558
laid in other polymers that

19:43.564 --> 19:46.886
they hadn't really fully reduced to practice yet because at the time they thought that

19:46.988 --> 19:50.570
these two polymers were the thing. But then their technology evolved where

19:50.640 --> 19:53.654
one polymer was the same, but the other one had changed.

19:53.782 --> 19:57.306
And unfortunately, the way it was all crafted at

19:57.328 --> 20:00.986
that early date, you kind of had to select from two

20:01.008 --> 20:04.286
different lifts to make it work. And they

20:04.308 --> 20:05.280
didn't like that,

20:09.810 --> 20:13.522
let me say. Do you think that part of the problem

20:13.576 --> 20:16.994
there was filing too early or

20:17.032 --> 20:20.686
was it life? I wasn't part of that original

20:20.798 --> 20:23.986
decision. I mean, I think at the time it does work. Like what they were

20:24.008 --> 20:27.426
doing did work. I think they might have moved away from it

20:27.528 --> 20:31.558
for more flexibility and I think maybe cheaper manufacturing of

20:31.564 --> 20:35.138
their product. I think so. It's hard to say because I wasn't

20:35.154 --> 20:37.880
there at the ground floor of kind of what they had at that time.

20:38.330 --> 20:41.240
It was fully enabled, I think, though, and stuff like that at that time.

20:42.090 --> 20:45.498
I don't know. It's hard to say though, like should they have waited a

20:45.504 --> 20:48.906
little bit or something and maybe captured other embodiments or

20:48.928 --> 20:52.534
fully reduced them to practice? And this relates

20:52.582 --> 20:55.502
a little bit to the Amgen case we're going to talk about today, right?

20:55.556 --> 20:59.118
Yes, exactly. Long lists. And do

20:59.124 --> 21:03.360
you even have protection for such long lists if you don't have data

21:03.970 --> 21:08.160
on all of those combinations? Interesting questions,

21:08.950 --> 21:11.460
which I don't know if we'll answer today, but we can try.

21:12.630 --> 21:15.794
The only thing I came across, I've always historically kind of had

21:15.832 --> 21:19.362
the view that you can't slow prosecution. Like you can expedite prosecution,

21:19.426 --> 21:23.446
but you can't slow it down. But it came across this and

21:23.468 --> 21:27.942
it looks like there is a way to suspend activity

21:28.006 --> 21:31.434
on your case. And actually, I think intel is one of the biggest users of

21:31.472 --> 21:34.842
this, but you can actually ask for

21:34.896 --> 21:36.540
suspension for cause,

21:37.950 --> 21:41.258
obviously cost the petition fee. You can't have

21:41.264 --> 21:44.506
an outstanding action item or you can do some kind of limited suspension

21:44.538 --> 21:48.350
of action after an rc. A cpa isn't as common anymore.

21:48.850 --> 21:52.394
And then for a processing fee, that's only a three month delay.

21:52.522 --> 21:55.920
And then you can defer examination not exceeding three years.

21:57.990 --> 22:01.742
I think that deferral of examination is three years from the earliest

22:01.806 --> 22:05.074
priority date. Okay, good to know. And that

22:05.112 --> 22:08.626
cost like three years on every continuation. You know what

22:08.648 --> 22:11.720
I mean? It's it's it's very limited. Yeah.

22:12.570 --> 22:16.054
And the cause can catch you up. I mean, it has to be definitely for

22:16.092 --> 22:18.680
cause. And the reasonings are pretty clear.

22:19.850 --> 22:23.766
If you all have seen this before, what are the causes that I'd

22:23.798 --> 22:26.490
have to look it up? I don't remember, but I remember them being kind of

22:26.560 --> 22:30.818
strange, stipulations. These are codified

22:31.014 --> 22:34.510
causes. There could be business

22:34.580 --> 22:36.000
causes, too. Right.

22:37.810 --> 22:41.120
I seem to recall something about cost,

22:42.790 --> 22:45.906
as in something is happening with the business and

22:45.928 --> 22:49.506
there's a reasonable cause to delay. And it was

22:49.608 --> 22:53.090
fee related and not because you couldn't

22:54.150 --> 22:58.278
pay the fee or pay the council to do it, but because

22:58.444 --> 23:02.150
something else was going on in your business. But I don't remember exactly.

23:02.220 --> 23:05.190
I'd have to look it up. Yeah. Interesting.

23:05.340 --> 23:09.166
Okay. And then obviously, the office can suspend

23:09.218 --> 23:12.438
activity on cases for various reasons. I think we've

23:12.454 --> 23:16.026
seen a lot about the hyatt cases where his patents have been

23:16.048 --> 23:19.610
pending for a long time with the suspended activities.

23:20.430 --> 23:23.754
Anyway, so interesting piece of tidbit.

23:23.802 --> 23:25.680
So you can slow it down.

23:27.090 --> 23:30.266
All right. So getting into the meat of today, says, Dave,

23:30.298 --> 23:34.314
as you already alluded to kind of talking about section

23:34.362 --> 23:38.922
112, particularly written description enablement

23:38.986 --> 23:41.518
and not really best mode, but best mode is in the same paragraph. So it's

23:41.534 --> 23:45.342
kind of in there, but just kind of give everybody a reminder of

23:45.416 --> 23:48.854
what the statute actually says. It says,

23:48.892 --> 23:52.534
the specification shall contain a written description of

23:52.572 --> 23:55.782
the invention and of the manner and process of making

23:55.836 --> 23:59.350
and using it in such full, clear, concise and exact terms

23:59.420 --> 24:03.274
as to enable any person skilled in the art. To which it pertains or

24:03.312 --> 24:07.066
with which it is most nearly connected to, to make and use the

24:07.088 --> 24:10.406
same, and shall set forth the best mode contemplated by the inventor

24:10.438 --> 24:13.722
or joint inventor of carrying out the invention. So I've highlighted

24:13.786 --> 24:17.920
obviously the written description, the kind of qualifying statement there is

24:18.850 --> 24:23.662
manner in process of making and using it enablement clear

24:23.716 --> 24:27.298
and concise terms to enable person to make and use the same and

24:27.304 --> 24:28.770
then like it's the best mode.

24:30.310 --> 24:33.666
Honestly, the conclusion that I come to and you'll kind of see

24:33.688 --> 24:37.206
and be interesting, the dialogue here. I have some questions at the end to kind

24:37.228 --> 24:40.646
of spur some thoughts and deeper thinking on it,

24:40.668 --> 24:44.438
but I almost feel like and there's some great

24:44.524 --> 24:47.846
quotes from former Chief Justice raider in

24:47.868 --> 24:51.066
a dissenting opinion on, I think, a 2010 case about this,

24:51.088 --> 24:54.426
too, which I fully agree with, that maybe enablement and

24:54.448 --> 24:58.170
written description really shouldn't be separate. Can they really be separated?

24:59.550 --> 25:03.006
I think some of the reason why it stated the way

25:03.028 --> 25:06.106
it is, I think the original intent was that written description,

25:06.138 --> 25:09.178
you prove possession of the invention,

25:09.354 --> 25:12.718
whereas enablement is more to teach somebody a

25:12.724 --> 25:15.706
skill in the art, how to make and use the invention, kind of help promote

25:15.738 --> 25:19.058
the progress of the useful arts. And then best mood, right? You can't keep the

25:19.064 --> 25:22.962
best mood for yourself. But I feel like

25:23.096 --> 25:26.014
I know there's a lot of like, if you look online, there's tons of analogies

25:26.062 --> 25:29.974
around how you could in theory prove possession but not

25:30.092 --> 25:33.158
teach someone how to make and use it. But I don't really think you can.

25:33.324 --> 25:37.174
But anyways, we'll go through the court case in detail. I have a

25:37.212 --> 25:40.890
few things I pulled for the district court part

25:40.960 --> 25:44.746
as well. But again, really curious about you all's dialogue about it

25:44.768 --> 25:48.918
too. So the overview I start with in Ray wands,

25:49.014 --> 25:52.490
partly just because this is kind of where some of this all began.

25:53.070 --> 25:56.358
This is where the wands factors come from. And interestingly,

25:56.454 --> 25:59.818
wands was an antibody case. And interestingly,

25:59.914 --> 26:02.800
30 plus years later, we're back at an antibody case,

26:03.170 --> 26:06.500
still talking about enablement and can't seem to figure it out.

26:07.190 --> 26:10.946
We also talk about the written description test. There's two tests that can be used

26:10.968 --> 26:14.766
to identify whether a written description meets

26:14.798 --> 26:19.570
the criteria of the written description. And then we'll talk about Amgen versus Sanofi

26:20.070 --> 26:24.134
and talk about some background of pcst nine and the ldl R

26:24.172 --> 26:27.094
receptor and the antibodies that they were developing at that time. And then again,

26:27.132 --> 26:30.666
questions for discussion, that these are things that kept me going through my

26:30.688 --> 26:34.650
head when I was working through this. But again, curious what everybody thinks.

26:36.110 --> 26:39.786
So, in Ray wands, the whole purpose of the wands patents were to create an

26:39.808 --> 26:43.306
immunoassay to detect hepatitis B surface antigen.

26:43.418 --> 26:47.086
So obviously, hepatitis B, bad deal would

26:47.108 --> 26:50.510
be great if you could detect it in amino acids. The interesting

26:50.580 --> 26:54.254
thing is that they were using they were trying to get igm antibodies

26:54.302 --> 26:58.382
instead of the typical igg antibodies, which are used for immunoassays.

26:58.526 --> 27:01.806
So as a quick primer on antibody basics

27:01.838 --> 27:04.900
for anybody who doesn't know antibodies thank you.

27:06.630 --> 27:09.918
They're quite little miracles, I hearkens.

27:09.934 --> 27:13.814
Back to my love of immunology. There are five different

27:13.852 --> 27:17.754
kinds of antibodies or classes of antibodies. And you can see that

27:17.792 --> 27:21.782
this bottom piece is the FC region. It's relatively static.

27:21.846 --> 27:26.102
And then these are the variable regions which are the things that bind antigens

27:26.246 --> 27:28.300
epitopes in the body.

27:29.870 --> 27:33.726
So igg is probably the one we think the most of. This is the

27:33.748 --> 27:37.038
antibody that crosses the placenta because it's small.

27:37.204 --> 27:40.410
This is the antibody that's really the workhorse

27:40.490 --> 27:44.718
of the adaptive immune response. So when your immune

27:44.734 --> 27:48.754
response is in full gear and you're trying to

27:48.792 --> 27:52.302
kill cells that are infected with a virus.

27:52.446 --> 27:56.206
A lot of the idg is the workhorse of this existence

27:56.238 --> 27:57.940
serum in monomeric form.

28:00.150 --> 28:03.014
So that's like the main one I think most people think of. But there's also

28:03.052 --> 28:06.322
igm, which is a pretty powerful antibody, too. It's the earliest antibody

28:06.386 --> 28:09.898
that's created it's, usually in pentameric form. So five of them are kind of

28:09.904 --> 28:13.338
together. And that's why Ostein doesn't traverse the

28:13.344 --> 28:17.798
placenta because it's freaking huge. But it's

28:17.814 --> 28:21.466
also involved in activation of the complement pathway. So that

28:21.488 --> 28:25.006
means that, like, a garbage collector of the immune system can come and bind the

28:25.028 --> 28:29.162
FC region of igm and then kind of engulf

28:29.226 --> 28:32.990
whatever is attached to it. So it's really great for

28:33.060 --> 28:36.882
kind of killing things that need to be killed once that antibody binds to it.

28:37.016 --> 28:40.930
Not to say that igg can do it, but igm is a good fixer.

28:41.750 --> 28:45.166
iga is your mucosal

28:45.198 --> 28:49.434
surface antibody. It's secreted a lot in your mucosal surface,

28:49.502 --> 28:53.266
is a great frontline defense that your epithelial cells to attack viruses

28:53.298 --> 28:56.706
and bacteria. It's a good neutralizing

28:56.738 --> 29:00.758
antibody. igd, it's never been known

29:00.774 --> 29:04.380
what it does in all the years. We still don't really know what it does.

29:04.830 --> 29:07.690
It's expressed on immature B cells.

29:08.190 --> 29:11.658
What it does. It's probably needed. I'm actually curious now if somebody ever did

29:11.664 --> 29:15.118
a knockout mouse of igd and what happened, but anyways, we don't really know

29:15.124 --> 29:18.734
what igd does. It just kind of hangs out there. And then ig is

29:18.772 --> 29:22.646
your histamine allergic

29:22.698 --> 29:26.770
reaction antibody. So that's involved with cells,

29:28.390 --> 29:31.966
with activating cells of the more allergic reaction.

29:31.998 --> 29:35.554
So eosinophils neutrophils. But for discussion

29:35.602 --> 29:39.334
today, we're most curious about igm in

29:39.372 --> 29:43.110
Ray, wands and then igg for Amgen B sanofi.

29:44.090 --> 29:46.550
They may have questions about antibodies.

29:49.290 --> 29:52.758
It's kind of something that jumped out at me about the Amgen.

29:52.854 --> 29:56.470
One of the Amgen claims is they talk about these antibodies and these epitopes.

29:56.550 --> 30:00.414
And then one of the dependent claims is wherein the epitop is

30:00.452 --> 30:04.586
a functional epitope, which in patent

30:04.618 --> 30:08.686
terms, that really jumped out at me. Like, functional is like a big

30:08.788 --> 30:12.474
keyword, obviously. Right. But is that a standard

30:12.612 --> 30:16.098
bio term that someone would know?

30:16.184 --> 30:20.222
Like, oh, this epitope is non functional and this epitope is functional?

30:20.286 --> 30:23.810
Or is that like a standard biological term

30:24.470 --> 30:27.606
or not? The way I would interpret that is

30:27.628 --> 30:30.914
that so epitopes are the things that antibodies recognize.

30:31.042 --> 30:34.886
And honestly, I don't think we know enough about antibodies and

30:34.908 --> 30:38.506
the cells that produce antibodies to make an

30:38.528 --> 30:41.978
educated guess about what thing they're going to bind on what, you know, like,

30:42.144 --> 30:45.930
that's why I mean, that's why vaccines are hard to make,

30:46.000 --> 30:49.786
right? That's why it's hard to you'll see from all the

30:49.808 --> 30:53.226
research that Amgen and Ray and wand did, it's really

30:53.248 --> 30:56.974
hard to make to get an antibody, to find an antibody that is

30:57.012 --> 31:00.730
specific for a thing. So when they say a functional epitope,

31:00.890 --> 31:03.998
what it says to. Me is that I'm sure there's tons of

31:04.004 --> 31:07.538
things that antibodies buying that are not functional, but it's a way to

31:07.704 --> 31:11.026
take something and then engulf it, neutralize it,

31:11.208 --> 31:14.834
change it, whatever. But that just

31:14.872 --> 31:17.380
because the antibody binds, like, over here,

31:18.550 --> 31:22.214
doesn't mean it's going necessarily to block a receptor from binding. But maybe because

31:22.252 --> 31:25.826
the antibody bind over here, it's going to cause some other pathway

31:25.858 --> 31:29.426
to kick off over here. But it didn't bind a functional epitop of the protein.

31:29.538 --> 31:33.014
So that's how, for the pcsk Nine protein,

31:33.062 --> 31:36.262
clearly, it has ligand binding activity.

31:36.326 --> 31:39.626
Right. It binds the ldl receptor and causes it

31:39.648 --> 31:41.690
to be internalized and degraded.

31:42.510 --> 31:46.074
But in theory, other antibodies could exist that bind psk

31:46.122 --> 31:50.174
Nine and other areas that may be block binding to hdl or

31:50.212 --> 31:53.666
actually ldl proper and not the receptor, which I have a diagram of that,

31:53.688 --> 31:58.206
too. So that's what I would say from a functional

31:58.238 --> 32:01.970
epitope versus, you know, other epitope.

32:03.830 --> 32:07.138
I think a lot of parts of proteins have a function.

32:07.224 --> 32:10.278
We just don't know what they are and how to tease that out, because I

32:10.284 --> 32:14.262
think there's a lot of compensatory things, and then proteins change

32:14.316 --> 32:17.330
shape when you start messing with their amino acid residues,

32:17.490 --> 32:20.714
but maybe they're still kind of functional for some things we

32:20.752 --> 32:24.106
just don't understand. That's. Part of my beef, I think,

32:24.128 --> 32:27.994
a little bit with the court's handling of amgen is

32:28.032 --> 32:31.318
that I think a lot of, like, the so called unpredictability

32:31.414 --> 32:35.406
is just inherent in physiology. It's not I

32:35.428 --> 32:39.146
think they did a good job, probably, of guiding somebody about how antibody

32:39.178 --> 32:41.630
science has been around for decades.

32:42.290 --> 32:46.254
So I think that's well vetted out. I think it's more the fact that physiology

32:46.302 --> 32:49.586
is hard and physiology is unpredictable. But I

32:49.608 --> 32:53.730
don't think we should be preventing companies from creating therapeutics

32:54.070 --> 32:57.510
just because physiology is hard and we don't fully understand everything.

32:57.660 --> 33:00.520
Even in a very non nascent field,

33:01.450 --> 33:07.474
when you say functional, maybe ready

33:07.532 --> 33:11.014
to do the function that you're talking about in the claim.

33:11.142 --> 33:15.718
So primed or set up or I'm

33:15.734 --> 33:19.690
still kind of struggling with just the concept, but yes,

33:19.840 --> 33:22.762
in the psk Nine claims,

33:22.826 --> 33:26.766
they were very particularly, I think, interested in I think I

33:26.788 --> 33:28.240
have the claim somewhere here.

33:29.890 --> 33:33.390
Yeah. Sorry to jump ahead. No, it's okay. Yeah, they're interested

33:33.460 --> 33:37.402
in the areas that they were interested in blocking

33:37.466 --> 33:40.734
psk Nine blinding to the ldl receptor.

33:40.862 --> 33:44.882
So it's going to be any functional epitope that

33:44.936 --> 33:49.266
would otherwise promote pcsk Nine binding to ldlr.

33:49.378 --> 33:53.174
So it's going to be a pocket in psk Nine that

33:53.212 --> 33:56.694
binds to ldlr, and they basically want to create something that prevents that from

33:56.732 --> 33:58.760
happening. Okay.

33:59.710 --> 34:02.620
Yeah. That is interesting language, though, David. I agree.

34:04.190 --> 34:07.850
That would send me for the hills. Don't say that in a claim.

34:08.190 --> 34:11.686
Right, okay. And then antibody

34:11.718 --> 34:15.614
design, because there's a lot of talk about antibody design again,

34:15.652 --> 34:19.614
antibody design has been around since, like, the 1970s,

34:19.652 --> 34:23.006
and probably actually it was well known in the 1970s. So it's

34:23.028 --> 34:26.862
actually, I think, been around probably for better part of a century,

34:26.926 --> 34:30.302
honestly. But typically what happens is you immunize an animal,

34:30.366 --> 34:33.726
typically a rabbit, with your protein

34:33.758 --> 34:36.622
of interest or an epitope of it, and lots of adjuvant.

34:36.766 --> 34:40.466
It's usually some kind of bacterial products that ramp

34:40.498 --> 34:43.506
up the immune system, because immune system isn't going to react to just a random

34:43.538 --> 34:46.726
protein fragment. It needs something to ramp it

34:46.748 --> 34:51.042
up. So sometimes it's like a lipopolysaccharide

34:51.106 --> 34:54.534
piece from a bacteria or all sorts of weird things

34:54.572 --> 34:57.420
and adjuvant. So the idea is just to ramp up the immune system.

34:57.870 --> 35:01.882
Of course, your immune system gets ramped up. The B cells start

35:01.936 --> 35:05.226
secreting antibodies. And of course it's like lots of antibodies,

35:05.258 --> 35:08.954
right? Because it's not only antibodies to your protein or different parts of your protein,

35:09.002 --> 35:11.790
different epitopes, but it's also to the stuff in the adjuvant,

35:13.410 --> 35:17.058
a whole bunch. It's a mixed bag of things. And then you

35:17.144 --> 35:20.290
eventually isolate those lymphocytes. If you put lymphocytes

35:21.110 --> 35:24.526
basically white cells out of blood. If you put them into a tissue culture dish,

35:24.558 --> 35:27.906
they're going to die. They're not immortal. So what

35:27.928 --> 35:31.126
you do is you fuse them with tumor cells, usually some

35:31.148 --> 35:34.498
kind of myeloma cells. You put them into specific media where it kills

35:34.514 --> 35:38.242
anything that hasn't fused. So you get these fused hybridomas,

35:38.306 --> 35:41.526
as they're called, and then you usually do some kind of screening

35:41.558 --> 35:45.066
mechanism to try to find the ones of interest. And so you

35:45.088 --> 35:48.300
basically do a limiting dilution assay to get one cell

35:48.670 --> 35:52.138
per well. And then you do some kind of binding assay to

35:52.144 --> 35:55.722
see if it is binding to the thing of interest. And then you would expand

35:55.786 --> 35:59.358
the selected clones and probably do more testing right, to see

35:59.444 --> 36:03.454
in this case how much it bound to your particular

36:03.572 --> 36:07.106
high affinity antibody, low affinity antibody, is it what kind of

36:07.128 --> 36:10.318
binding affinity does it have? Whatever, maybe what epitopes

36:10.334 --> 36:13.634
does it bind to? What's it actually binding to? That's kind of the general

36:13.672 --> 36:17.298
process. But again, this was well known. It was

36:17.464 --> 36:20.646
stated in Ray wands that this was well known at the time of

36:20.668 --> 36:24.086
filing nra wands, and that was in the late 1970s,

36:24.108 --> 36:27.302
I think. So now we're 30 plus 30

36:27.356 --> 36:31.122
years after nra wands. So now antibiotchlogy is like really

36:31.196 --> 36:34.842
well known, right? Because you have 30 plus years plus all the years

36:34.896 --> 36:38.426
pre nra wands. So I think we can say that

36:38.448 --> 36:41.290
antibody design and screening is quite well known.

36:41.790 --> 36:45.386
So in general, nra wands, and for those who didn't know what enray meant,

36:45.418 --> 36:48.960
it just means in the matter of so in this case,

36:50.770 --> 36:54.446
there's no defendant because it's just an appeal from the at

36:54.468 --> 36:57.742
that time, the Board of Patent Appeals and interferences,

36:57.886 --> 37:00.578
which is now the ptab, in a slightly different form.

37:00.744 --> 37:04.338
But it was just his appeal from that decision. So there was no

37:04.424 --> 37:08.278
defendant, there was no infringing party or anything like that. They just didn't like what

37:08.444 --> 37:11.766
the bpai had said. So the

37:11.788 --> 37:15.314
suit was brought by two of the three inventors, jack wans

37:15.362 --> 37:19.230
and Vincent Zorovsky, and the base of their patent was upheld.

37:19.330 --> 37:22.586
So what the Federal Circuit had said

37:22.608 --> 37:26.058
at that time was that they had provided sufficient experimental support

37:26.144 --> 37:30.006
for the breadth of the requested claims in the context that experiments

37:30.038 --> 37:34.038
in genetic engineering produced, at best, unpredictable results.

37:34.054 --> 37:37.486
And I love that quote because that encapsulates my frame of mind a little bit

37:37.508 --> 37:40.666
with all of this. Is that your genetic engineering,

37:40.698 --> 37:43.040
you're trying to get B cells to produce something,

37:43.490 --> 37:47.002
and at best you're going to get unpredictable results because of just the nature

37:47.066 --> 37:50.686
of how it like I said, you're injecting something into an animal that's

37:50.718 --> 37:54.126
just not your protein. It's a whole bunch of other junk to rev

37:54.158 --> 37:57.198
up the immune system. So trying to find the needle in the haystack, that's what's

37:57.214 --> 38:00.886
always going to be. Just one other stat about this. I looked

38:00.908 --> 38:05.010
this up, so I remember it being a crazy frequency. So in a limiting dilution

38:05.090 --> 38:08.438
assay. So the frequency of a B cell that

38:08.444 --> 38:12.086
is specific for your epitope of interest, so like your protein fragment

38:12.118 --> 38:15.462
that you put in the injection here, the average

38:15.526 --> 38:19.866
frequency is 0.5% to 5% in

38:19.888 --> 38:23.978
the normal B cell repertoire. So when the B cell spits out all these antibodies,

38:24.074 --> 38:27.578
your antibody of interest, it's going to be a mixed

38:27.594 --> 38:31.806
bag, right? Probably is 0.5% to 5% in

38:31.828 --> 38:35.770
a normal repertoire. So to put that into perspective, it's not a

38:35.780 --> 38:39.154
lot that you're looking for. And then the other part that was

38:39.192 --> 38:43.022
interesting, that the court had said regarding the Wands patent, it provided considerable

38:43.086 --> 38:45.606
guidance, high level of skill in the art,

38:45.708 --> 38:49.414
methods needed were well known. And so again,

38:49.452 --> 38:53.398
kind of encapsulates that kind of the pieces were there and

38:53.484 --> 38:57.480
it was upheld. So the Wands factors came from this.

38:57.850 --> 39:00.822
This is our test for enablement quantity of experimentation,

39:00.886 --> 39:04.326
necessary amount of direction or guidance, presence or absence

39:04.358 --> 39:07.466
of working examples, nature of the invention, state of the art,

39:07.648 --> 39:10.938
relative skill of those in the art, predictability or unpredictability of

39:10.944 --> 39:14.686
the art, breadth of the claims. But there's also a separate test

39:14.708 --> 39:18.366
for written description. And this kind of dates back to this.

39:18.548 --> 39:22.106
regents of University of California versus lilian Co. And I couldn't

39:22.138 --> 39:25.406
even in this case find the explicit stating of these two tests.

39:25.438 --> 39:29.166
But it kind of picks up in later court

39:29.198 --> 39:32.786
cases that these are like two tests that are used and you actually see

39:32.808 --> 39:36.786
it in amgen's case as well, but they have

39:36.808 --> 39:40.854
a representative species test. So do you have a

39:40.892 --> 39:44.002
representative number of species that fall within the genus

39:44.066 --> 39:47.574
which we've kind of heard this and been talking about this. And then are there

39:47.612 --> 39:51.070
structural features common to the members of the genus so that one of the skill

39:51.090 --> 39:54.778
in the art could visualize and recognize the members? So I

39:54.784 --> 39:58.374
think, again, that's things we've been talking about right. Is there some common feature

39:58.422 --> 40:01.566
amongst all of these? And then do you show a

40:01.588 --> 40:05.066
representative number of species that are captured by the genus?

40:05.258 --> 40:08.746
So, again, fast forward 30 plus years still in antibodies,

40:08.858 --> 40:12.170
but this time it's amgen versus Sanofi,

40:12.250 --> 40:15.454
federal Circuit 2020. And I'll give some background around the balancing

40:15.502 --> 40:19.346
around with the court, but the purpose of the amgen patents were to

40:19.368 --> 40:23.006
produce an antibody to bind pcsk Nine to prevent it from binding

40:23.038 --> 40:26.622
to ldlr, to reduce ldl cholesterol

40:26.686 --> 40:30.086
levels. So, remember, ldl is the bad cholesterol, hdl is the good

40:30.108 --> 40:34.274
cholesterol. And so when you have pcsk

40:34.322 --> 40:37.842
Nine, it basically binds

40:37.906 --> 40:41.706
the ldl receptor and I think basically

40:41.808 --> 40:45.606
promotes more ldl receptor

40:45.638 --> 40:49.206
from materializing. But there's also been studies that show that psk

40:49.238 --> 40:52.826
Nine can also bind ldl and can also bind hdl.

40:52.858 --> 40:56.254
And the purpose of that is a little bit less well understood, but the whole

40:56.292 --> 40:59.614
goal was to have actually, sorry.

40:59.652 --> 41:03.246
When Pspcsk Nine binds the

41:03.268 --> 41:07.170
ldl receptor, it prevents it from being able to bind ldl,

41:07.830 --> 41:11.218
whereas if you can block psk Nine, then you can get it

41:11.224 --> 41:15.086
to bind ldl, and so you can kind of get rid of ldl

41:15.118 --> 41:18.546
in the system. So with monoclonal antibodies, the whole

41:18.568 --> 41:22.530
goal of their Ripatha antibody, which was the subject of their patent,

41:22.610 --> 41:25.846
was the idea to create antibodies to bind psk Nine, to prevent it

41:25.868 --> 41:29.158
from binding to the ldl to the ldl receptor.

41:29.334 --> 41:33.046
But again, it might have other effects, other binding

41:33.078 --> 41:37.020
domains for other things like hdl and ldl. Yeah, let me just

41:38.270 --> 41:42.154
it's more than just the purpose of binding

41:42.202 --> 41:45.498
is to internalize it. So ultimately the goal

41:45.514 --> 41:48.590
is to prevent the internalization of ldl.

41:49.570 --> 41:53.742
Right. So it can actually bind with prevent internalization

41:53.806 --> 41:57.006
of ldlr receptor or the ldl receptor.

41:57.198 --> 42:00.546
Right, right. The receptor and the ldl, I think,

42:00.568 --> 42:02.260
are internalized together.

42:03.990 --> 42:08.194
Yes, when they bind together. But when Pspcsk Nine binds,

42:08.242 --> 42:11.826
it's also internalized, but then it's degraded into the lysosome.

42:12.018 --> 42:15.320
I see. Okay. Destroyed. I see. Right.

42:16.010 --> 42:18.934
That was kind of the hope. And they developed a whole product line around it.

42:18.972 --> 42:22.490
rapata. So this is kind of the bouncing around that happened.

42:22.560 --> 42:26.154
They went to the district court at the first pass.

42:26.352 --> 42:29.898
The patents were found to be not invalid for lack of

42:29.904 --> 42:33.420
written description and enablement. The patents were found to be not

42:33.890 --> 42:37.374
found to be non obvious. Not obvious. And there was found to be no

42:37.412 --> 42:40.922
willful infringement. But apparently amgen had woken

42:40.986 --> 42:44.046
a sleeping giant in sanafi because that should have been enough. Right.

42:44.068 --> 42:47.602
Sanofi is off the hook. They didn't infringe, but Sanofi said,

42:47.656 --> 42:50.834
well, you woke us now.

42:50.952 --> 42:54.990
So Sanofi appealed to the Federal Circuit and basically

42:55.080 --> 42:59.202
said, especially on the written description and enablement

42:59.266 --> 43:02.706
pieces. And Federal Circuit basically told the district court

43:02.738 --> 43:06.840
that they had given the jury improper instructions in

43:07.290 --> 43:11.446
telling the jury how to decide written description and enablement. So they remanded

43:11.478 --> 43:14.940
it back to the district court. The jury said again

43:15.310 --> 43:19.270
that it was valid for written description enablement.

43:19.430 --> 43:23.662
The judge used kind of like a lesser known tool to

43:23.716 --> 43:27.694
kind of go over the jury's head and said no,

43:27.732 --> 43:32.142
no, I disagree with you jury. You've said this twice now that

43:32.276 --> 43:36.066
I disagree that it's not enabled, but there is written description support.

43:36.248 --> 43:39.886
So then amgen appealed to the Federal circuit, which is what we're discussing

43:39.918 --> 43:43.940
today. And then of course, as we know or see

43:44.550 --> 43:48.178
it stands. That final decision from the district court stands. And so the amgen

43:48.194 --> 43:50.280
appeals to the Supreme Court, which is yet to come.

43:53.610 --> 43:56.818
This is an older quote from an older

43:56.834 --> 44:00.386
case, but it says, to prove that a claim is invalid for lack of enablement,

44:00.418 --> 44:03.606
a challenger must show by clear and convincing evidence that a person of ordinary

44:03.638 --> 44:07.242
skill in the art would not be able to practice the claimed invention without

44:07.296 --> 44:11.278
undue experimentation. This undue experimentation tends to be read

44:11.444 --> 44:15.230
back into the statute, but it does not exist in the statute.

44:16.370 --> 44:20.462
We tend to say it is. So here

44:20.516 --> 44:24.302
amgen's claims for two of their patents, the same written description.

44:24.446 --> 44:28.482
So claim one is a monoclonal antibody that

44:28.536 --> 44:31.954
when bound to pcsk Nine binds at least to one

44:31.992 --> 44:36.254
of the following residues of pcsk Nine. So there's, I think, 15 residues

44:36.302 --> 44:39.806
there and where in the monoclonal antibody blocks binding

44:39.838 --> 44:43.606
a pcsk Nine to the ldl receptor, claim 29.

44:43.628 --> 44:47.346
This is just a representative, I don't think I grabbed them all. But claim

44:47.378 --> 44:51.126
29 was a pharmaceutical composition having the same characteristics

44:51.158 --> 44:54.426
of claim one. But it blocks the binding of pcsk Nine to

44:54.448 --> 44:58.838
ldlr by at least 80%. So kind of a binding functional requirement.

44:59.014 --> 45:02.890
And then claim one of the seven four one patent was

45:03.040 --> 45:06.778
again an isolated monocle antibody that binds pcsk Nine

45:06.944 --> 45:10.574
where the monoclonal antibody binds an epitope on pcsk Nine

45:10.612 --> 45:13.966
comprising at least one of those two residues and where

45:13.988 --> 45:17.490
in the monocle antibody it blocks binding pcsk Nine to ldlr.

45:17.910 --> 45:22.180
So they did have testimony that,

45:22.870 --> 45:26.546
for example, there's two experts that testified seemingly there was a Doctor reese, and he

45:26.568 --> 45:30.226
testified that I don't believe based on good protein structural principle,

45:30.258 --> 45:33.798
an antibody could bridge across without interacting with

45:33.884 --> 45:37.318
those amino acids in between. So that this was in response to them asking

45:37.404 --> 45:41.306
him if just one amino acid was enough or if

45:41.328 --> 45:45.126
like two were enough on disparate sides of the binding pocket.

45:45.238 --> 45:48.646
And he basically said that I don't think an antibody

45:48.678 --> 45:52.320
could bind just one and not hit other ones in between,

45:53.090 --> 45:56.906
but also that if it were only binding

45:56.938 --> 46:00.426
one in a structural limitation, it wouldn't

46:00.458 --> 46:04.554
suffice the functional limitation which is blocking binding a pcsk

46:04.602 --> 46:08.338
Nine. So their claim has these two facets of it, right, the structural piece and

46:08.344 --> 46:11.634
a functional piece that for

46:11.832 --> 46:15.410
yes, their structural piece is such that it says at least one of.

46:15.560 --> 46:19.378
But then their functional piece brings in this added complexity that has to block

46:19.554 --> 46:23.830
pcsk Nine binding to the receptor. And so arguably

46:24.970 --> 46:29.666
just one amino acid binding just one amino acid wouldn't fulfill

46:29.698 --> 46:32.746
the functional feature of the claim. So, I mean,

46:32.848 --> 46:35.578
right. There might be a problem a little bit. Right. Then why not claim at

46:35.584 --> 46:39.450
least two or three amino acids? But that's another discussion point.

46:39.600 --> 46:42.814
Actually have a question about that. Okay. Claim one

46:42.852 --> 46:46.602
in 165. Well, both of them are claiming an antibody,

46:46.746 --> 46:50.400
isolated monoclonal antibody. Then they say

46:51.250 --> 46:53.830
when bound to pce canine,

46:54.010 --> 46:57.186
the monoclonal antibody binds to at least one

46:57.208 --> 47:00.466
of those residues. But that's already kind

47:00.488 --> 47:04.580
of like claiming a thing by its function.

47:06.790 --> 47:09.734
Am I getting that's already functional language in the first half?

47:09.772 --> 47:13.734
Right. Yeah. There's no explicit step there, and there maybe should

47:13.772 --> 47:17.670
be, but there's no structure. There's no structure of the antibodies.

47:18.090 --> 47:21.910
Yeah, I mean, they do maybe this is a

47:21.980 --> 47:25.626
112 F means plus function discussion, but they

47:25.648 --> 47:29.626
do, I think, have 26 sequence listings for

47:29.648 --> 47:33.790
antibodies in their spec and a few three dimensional

47:34.130 --> 47:37.662
images of the antibody. It does make you wonder

47:37.716 --> 47:40.830
if to some degree, should they or claims be limited to that,

47:40.980 --> 47:44.366
then that's what I think, because this

47:44.388 --> 47:48.898
is preposterously broad to me field.

47:49.064 --> 47:52.334
But to just say an isolated monoclonal antibody

47:52.462 --> 47:56.406
and not explicitly say which antibodies, what their

47:56.428 --> 47:59.494
layout is, how they look, and they do have some

47:59.532 --> 48:03.640
examples of those, but if you transfer this to any other field,

48:04.490 --> 48:09.238
you can get what you disclose and their equivalents.

48:09.414 --> 48:13.226
And I'm not sure we know what the equivalent would be to this

48:13.248 --> 48:16.826
isolated monoclonal antibody just from

48:16.848 --> 48:18.460
their spec. Yeah.

48:21.890 --> 48:25.214
So it's hard to define where proteins bind to each other.

48:25.332 --> 48:28.714
Right. That's a really hard science. And then to boot,

48:28.762 --> 48:32.174
to find, to make an antibody that very

48:32.212 --> 48:35.374
specifically targets that same pocket, I think is really hard.

48:35.412 --> 48:37.666
But if you were to this is where I like, have a little bit of

48:37.688 --> 48:41.326
like because if you were to really strictly claim

48:41.358 --> 48:45.300
an antibody, structurally, your body is going to make

48:46.070 --> 48:49.710
20 of them different next time you immunize.

48:49.870 --> 48:53.480
Right. So it'd be really easy to design around because

48:55.050 --> 48:58.146
the antibody could bind any subset

48:58.178 --> 49:01.478
of these epitopes and still exhibit the same function. So that's where I

49:01.484 --> 49:04.780
mean, I agree. And I don't know how you would do it, right?

49:05.630 --> 49:09.366
Because even if you said I guess you could say it's an igg antibody,

49:09.478 --> 49:12.770
right. Because at least you're kind of but there's tons

49:12.790 --> 49:15.950
of subtypes of igg, so is that enough?

49:16.100 --> 49:19.742
But then there's I don't know. This is why I have a hard time because

49:19.796 --> 49:23.986
to really claim it takes so long to develop an antibody and

49:24.008 --> 49:27.358
then to be able to easily design around by just immunizing another animal and finding

49:27.374 --> 49:31.678
a different one, it would be a maximum

49:31.774 --> 49:34.930
year exercise. And I think

49:35.000 --> 49:38.678
the purpose of some of this analysis and case law is

49:38.764 --> 49:42.086
and the reason they're kind of pointing back

49:42.108 --> 49:45.800
at amgen and saying, we don't like this. It's too broad. It's to that

49:46.330 --> 49:49.750
is they don't want to stifle future innovation by giving

49:49.820 --> 49:53.842
this sort of monopolized product that

49:53.996 --> 49:58.102
ends up in a product to one player.

49:58.246 --> 50:01.550
Right? And I'm not sure that this claim does that,

50:01.620 --> 50:05.054
but I think that's the bigger concern. So then

50:05.092 --> 50:08.442
to get around that kind of concern in other fields,

50:08.586 --> 50:12.030
you end up describing more explicitly

50:12.870 --> 50:16.530
examples that could be used and more explicitly

50:16.870 --> 50:20.114
exactly the how of what you're doing.

50:20.312 --> 50:23.666
So the reason they brought in macro into this,

50:23.688 --> 50:27.606
which is a software case, is because they are making a

50:27.628 --> 50:31.142
parallel to blackbox software that

50:31.196 --> 50:35.366
says maybe I have a machine learning something that

50:35.388 --> 50:38.690
does these five things. But I never say in my specification

50:38.770 --> 50:42.522
what these five things are. And I also never say like in detail

50:42.656 --> 50:46.698
and I also never say what that machine learning system looks like. And when

50:46.704 --> 50:50.362
you begin to put that together, you have written description problems

50:50.416 --> 50:54.094
but you also have enablement problems later. Right? Because you don't have

50:54.132 --> 50:57.520
enough of the actual guts of what's going on.

50:57.890 --> 51:01.498
Right, this is more complex than that. So it's

51:01.514 --> 51:04.674
kind of peculiar to me that they dragged that in, but I can understand the

51:04.712 --> 51:08.034
sentiment. Yeah, I agree with

51:08.232 --> 51:13.090
as I was reading this case, I had the same thoughts kristen, you did coming

51:13.160 --> 51:16.658
from other technology areas because this also isn't my

51:16.744 --> 51:20.326
background. But then Ashley, you just said something that is kind

51:20.348 --> 51:25.494
of like the other side of that coin, which is that these

51:25.532 --> 51:29.718
biotech companies put tons of resources into developing these

51:29.884 --> 51:33.279
very useful drugs or antigens or

51:33.779 --> 51:37.610
whatever and how do they protect them in a way that

51:37.680 --> 51:41.680
doesn't let their competitor just super easily design around it?

51:42.290 --> 51:45.866
It is an interesting question, but I totally

51:45.898 --> 51:49.982
agree with kristen's analysis. From the patent law

51:50.116 --> 51:51.230
perspective,

51:53.970 --> 51:57.358
they're not teaching someone how to make and use exactly

51:57.444 --> 52:01.106
what they've said in the claim. So it does seem to be an

52:01.128 --> 52:04.226
issue. Well, I would argue that they don't in the claim, but I think

52:04.248 --> 52:05.460
they do in the spec.

52:08.550 --> 52:12.006
Yeah, some exactly. So like there's a few I think one of

52:12.028 --> 52:15.286
the again, this is not my field, so actually if

52:15.308 --> 52:18.882
I'm wrong but I know one of the experts

52:18.946 --> 52:22.374
said you can't even reliably take a protein

52:22.422 --> 52:25.978
sequence and know how it will fold from first. No, it's true,

52:26.064 --> 52:29.578
but again, I think that's a physiology problem.

52:29.664 --> 52:32.190
You know what I mean? It's like this science,

52:34.210 --> 52:37.866
the basis of these cases is antibody science

52:37.978 --> 52:40.986
and that has been around for better part of a century.

52:41.098 --> 52:44.574
So that's how they predictable. But yes, protein chemistry and

52:44.612 --> 52:48.638
protein binding and protein three dimensional proteins change shape

52:48.654 --> 52:51.858
too when they bind each other, right? There's these you know, it was always a

52:51.864 --> 52:55.698
joke in grad school. It was like oh, it underwent a conformational change when

52:55.704 --> 52:59.026
you couldn't explain something because you know, proteins change when they

52:59.048 --> 53:03.154
bind to each other and when they bind to receptors receptors internalize

53:03.202 --> 53:07.080
or they change shape, all sorts of weird things happen that we don't understand.

53:08.090 --> 53:11.338
I definitely see it's a tricky problem. This particular

53:11.424 --> 53:15.242
case to me seems like a land grab, though. It seems

53:15.296 --> 53:19.274
like they found a few things that worked and now they're trying to grab the

53:19.312 --> 53:23.390
entire country. But maybe

53:23.540 --> 53:27.440
again, it's not my field. But if they had

53:27.890 --> 53:31.742
identified a protein structure of

53:31.796 --> 53:35.860
the antibody that bound to these particular

53:37.190 --> 53:40.818
residues of the pcsk nine and

53:40.824 --> 53:44.580
then they said, okay, the antibody has to have this

53:45.530 --> 53:49.234
whatever DNA sequence, this protein, this amino acid

53:49.282 --> 53:53.158
sequence, that to me would be a little bit different. Because now

53:53.324 --> 53:56.134
you're saying we found a thing.

53:56.332 --> 53:59.462
Sure, you can change a whole bunch of other stuff, but this is the key

53:59.516 --> 54:03.114
nugget that binds to these key residues and that's what we

54:03.152 --> 54:06.938
found. And then sure, anybody who just adds some junk on

54:06.944 --> 54:10.726
the end can't just copy that and design around it, but that's not what they're

54:10.758 --> 54:14.206
saying, right? They're saying like, we found a few things that work and

54:14.228 --> 54:17.840
now we're going to block anyone from finding anything else that works.

54:18.210 --> 54:21.390
Well, maybe they did this in their examples in the spec

54:21.460 --> 54:25.422
and so maybe we have a handful of examples that do exactly what david's requesting

54:25.566 --> 54:29.134
and so then the claim would necessarily

54:29.182 --> 54:32.434
be limited to those pieces and their

54:32.472 --> 54:36.274
equivalents. But how big is the and their equivalence,

54:36.322 --> 54:40.360
right? And how much is the undue experimentation in this field?

54:40.810 --> 54:44.914
That's another thing. I think this needs a redefinition

54:45.042 --> 54:48.714
of undue experimentation because of the complexity of this

54:48.752 --> 54:52.058
field. Right? But I don't know how you do that in a

54:52.064 --> 54:56.086
court. From a blocking

54:56.118 --> 54:59.334
perspective. I think the interesting thing is that sanofi

54:59.382 --> 55:02.542
did create an antibody that performed a function that was different

55:02.596 --> 55:05.914
and didn't infringe. You know what I mean? So from a blocking

55:05.962 --> 55:10.202
perspective, it's not as broad as it appears because sanofi

55:10.346 --> 55:14.066
created an antibody that got around this that was

55:14.088 --> 55:17.966
the first district court where they didn't infringe,

55:18.158 --> 55:21.730
right? And so I definitely see the point.

55:21.800 --> 55:25.906
But also I wonder how blocking it truly is because sanofi was able

55:25.928 --> 55:29.250
to do it with reasonable time frame.

55:29.670 --> 55:33.186
But all fair points. This is where I'm kind of bipolar

55:33.218 --> 55:36.262
on this topic because in one sense I'm like, gosh, the amount of

55:36.316 --> 55:39.514
time and money that they poured into this to get it, and then to do

55:39.552 --> 55:42.922
point mutations of every of those 15

55:42.976 --> 55:46.410
amino acids on ldlr to figure out

55:46.480 --> 55:49.766
which one is the important amino acid. That would take freaking

55:49.798 --> 55:54.410
forever to do point mutations. And what, the protein doesn't

55:54.930 --> 55:58.366
fold well then is ambient not binding because it

55:58.388 --> 56:01.754
didn't fold appropriately? Or is it not binding because it's really not the right epitope?

56:01.802 --> 56:04.942
You know what I mean? It's a kind of a pandora's box. So I also

56:04.996 --> 56:08.240
get not doing all those point mutations to figure it out.

56:09.190 --> 56:12.526
So some of the things that the federal circuit did say was that the binding

56:12.558 --> 56:16.226
limitation is itself enough here to require undue experimentation. So the

56:16.248 --> 56:20.962
whole idea that screening these things for a binding limitation

56:21.026 --> 56:23.378
would be a lot of work. Right. So even if you found a whole bunch

56:23.394 --> 56:26.370
of antibodies, that you'd have to figure out their binding feature.

56:26.450 --> 56:29.894
Right. And then the Federal Circuit also said,

56:29.932 --> 56:33.386
we also agree with the district court that this invention is in an

56:33.408 --> 56:36.758
unpredictable field of science with respect to satisfying the full scope of the functional

56:36.774 --> 56:39.734
limitations, which I would disagree a little bit. Because if we go back to nra

56:39.782 --> 56:43.200
Wands, they said that this was like a highly predictable field.

56:44.210 --> 56:47.658
Same field 30 plus years later, and now they're saying it's

56:47.674 --> 56:51.114
unpredictable. But yet anti science is highly predictable.

56:51.162 --> 56:52.830
At least it wasn't in Ray Juan.

56:56.470 --> 56:59.854
But how big does this have to be before it becomes unpredictable

56:59.902 --> 57:03.266
again? Right? You're saying that the experimentation that would

57:03.288 --> 57:06.614
have to be done to just identify what was going on in

57:06.652 --> 57:10.214
the amgen claim basically is

57:10.332 --> 57:14.118
really involved in extremely lengthy of time. So does that become

57:14.284 --> 57:17.954
more unpredictable, as larger as that gets larger?

57:18.082 --> 57:21.466
I don't know. Does complexity and length of

57:21.488 --> 57:25.098
time mean unpredictable or does it just mean having patience in

57:25.104 --> 57:28.554
the process? Right. And that's why I wonder what this case too,

57:28.592 --> 57:32.170
a little bit, is that, yes, it's like a long process

57:32.240 --> 57:35.834
and yes, you get a lot of hits, but there is well known screening methods,

57:35.962 --> 57:39.486
well known creation methods, well known. So is

57:39.508 --> 57:43.186
it just that people don't want to go through this lengthy couple

57:43.208 --> 57:47.074
of year process to design around and build upon, or is it really

57:47.112 --> 57:50.260
undue experimentation? I think there's like

57:50.710 --> 57:54.242
a patience versus unpredictability true,

57:54.296 --> 57:56.600
unpredictability question. Okay.

57:57.530 --> 58:01.266
And that maybe wouldn't be undue experimentation because that's just what's

58:01.298 --> 58:04.582
required to find out this information. Right.

58:04.636 --> 58:07.960
And actually, there's an interesting to have some quote later.

58:09.690 --> 58:13.466
Yeah, this is the interesting part from one of their

58:13.648 --> 58:17.974
experts. They had another expert, Dr. Jackson. So in the amigen

58:18.022 --> 58:21.914
patent, they disclosed a roadmap for how to make

58:22.032 --> 58:25.854
these antibodies. And their Dr. Jackson expert said

58:25.892 --> 58:29.838
the significant similarity between the research plan

58:30.004 --> 58:33.438
used by Dr. Jackson and the roadmap disclosed in

58:33.444 --> 58:36.926
the patent demonstrates that a person of ordinary skill in the art attempting to obtain

58:36.958 --> 58:40.546
a claimed antibody that is not disclosed or is a

58:40.568 --> 58:44.130
variant of a disclosed antibody would have to do essentially the same amount

58:44.200 --> 58:47.922
of work as the inventors of the patent ensued. And I think that's okay

58:48.056 --> 58:50.246
if you have to do the same amount of work. That's the whole point of

58:50.268 --> 58:53.382
the patent system. You're not given something for free. You got to do the same

58:53.436 --> 58:57.142
work, but you're guided. And so they

58:57.196 --> 59:00.806
use that to say that it creates undue experimentation. And I

59:00.828 --> 59:04.378
would actually argue that it's the opposite, that just because you have to do

59:04.384 --> 59:07.546
the same thing doesn't mean undue experimentation actually means that you did a really good

59:07.568 --> 59:10.700
job of describing it. And it's just a crappy long process.

59:11.230 --> 59:13.820
So I found that really interesting,

59:16.130 --> 59:19.806
disagree with their conclusion there. But I think it sounds

59:19.828 --> 59:23.086
like they gave a really good roadmap and actually the roadmap that

59:23.108 --> 59:26.834
their expert put together versus the roadmap and the patent were super similar.

59:27.032 --> 59:30.654
And so I don't think that's unconventional or undo experimentation.

59:30.702 --> 59:34.338
I think that it's just a long, arduous process. And if you want to

59:34.344 --> 59:38.226
compete in the space, you're going to have to go through the process when

59:38.248 --> 59:41.954
you said something, their physiology is unpredictable. But the prior slide,

59:42.082 --> 59:45.586
you're looking at the antibody technology being unpredictable,

59:45.698 --> 59:48.140
which I don't think it is.

59:49.150 --> 59:52.986
I would argue that it's not. I wonder and

59:53.088 --> 59:56.586
this is all kind of coming together, right? Actually, what you

59:56.608 --> 59:59.942
were saying, I think, was that and kristen,

1:00:00.006 --> 1:00:03.358
you were saying let's just assume for a

1:00:03.364 --> 1:00:07.562
moment that the specification, because there's tons of sequences in there, the specification

1:00:07.626 --> 1:00:11.518
does provide a bunch of different antigen sequences that

1:00:11.604 --> 1:00:16.114
are starting points. I guess maybe if

1:00:16.152 --> 1:00:19.714
the claim was interpreted with the 112

1:00:19.752 --> 1:00:24.190
F type with means plus function type considerations

1:00:24.350 --> 1:00:27.654
now, you wouldn't say this is any antigen that

1:00:27.692 --> 1:00:31.762
binds to this residues. These are the antigens

1:00:31.826 --> 1:00:35.478
that we have disclosed because it's means plus function.

1:00:35.644 --> 1:00:40.694
So I wonder if really if

1:00:40.732 --> 1:00:44.454
you have this good starting point and good is all relative,

1:00:44.502 --> 1:00:47.980
right? But let's say you have a good enough starting point that you know what

1:00:48.830 --> 1:00:52.254
antigens you're trying to test, then you make those

1:00:52.292 --> 1:00:56.314
antigens. And now I think actually you're saying going through the screening

1:00:56.362 --> 1:00:59.646
process is routine. Right. But I think

1:00:59.668 --> 1:01:03.546
an issue comes in when you don't even know what antigen

1:01:03.578 --> 1:01:07.570
you're starting with. If you just have no idea what

1:01:07.640 --> 1:01:10.786
protein sequence you're starting with at all. And you just need to make that up

1:01:10.808 --> 1:01:14.834
from scratch, make every possible protein sequence in the world

1:01:14.952 --> 1:01:17.358
and then test them against these residues.

1:01:17.534 --> 1:01:21.014
Clearly undo experimentation. There's no way no one would know

1:01:21.052 --> 1:01:24.102
how to do that. But it comes back to the spec.

1:01:24.236 --> 1:01:27.206
And I think actually what you brought up is a really good point. If this

1:01:27.228 --> 1:01:30.742
is 112 F, it means plus function

1:01:30.796 --> 1:01:34.390
type language. Now, now you're, you do have a good starting point, which totally,

1:01:34.470 --> 1:01:38.326
I think, changes the calculation about how much experimentation

1:01:38.358 --> 1:01:42.554
is needed. And actually, I think you bring up a good point, too, just from

1:01:42.592 --> 1:01:45.734
a nomenclature perspective, you know, you were using that.

1:01:45.792 --> 1:01:49.530
So antigens are kind of what are used to inject

1:01:49.610 --> 1:01:53.418
the rabbit and then antibiotics are what are created in response to those antigens.

1:01:53.514 --> 1:01:56.786
I wonder if that's another way, because I think they disclosed a whole bunch of

1:01:56.808 --> 1:01:59.810
antibody sequences, I think, but maybe antibody, sorry,

1:01:59.880 --> 1:02:03.586
antibody. No, it's okay. So they did a whole bunch of antibody sequences. But I

1:02:03.608 --> 1:02:07.586
wonder if another way too would be to provide the antigen

1:02:07.618 --> 1:02:10.680
sequences, right? What are the chunks of pcsk? Nine.

1:02:11.450 --> 1:02:14.774
Maybe they do. I don't know. That's what confused me,

1:02:14.812 --> 1:02:18.514
because some of their protein sequences are antigen

1:02:18.562 --> 1:02:21.946
binding proteins. So I interpreted that because I'm not an

1:02:21.968 --> 1:02:26.010
expert, I interpreted that as part of the sequence of the antibiotics.

1:02:27.470 --> 1:02:31.210
Antigen binding. Say it again. Antigen binding antigen

1:02:31.290 --> 1:02:34.686
binding proteins. Light chains and

1:02:34.708 --> 1:02:37.630
heavy chains of antigen binding proteins.

1:02:39.410 --> 1:02:43.698
The light and heavy chains. So that's these

1:02:43.864 --> 1:02:47.186
okay, so those are antibodies, but those

1:02:47.208 --> 1:02:49.250
are sequences of parts of the antibodies.

1:02:51.110 --> 1:02:54.882
Like I said, this is a fixed region based on the class

1:02:54.936 --> 1:02:58.194
and subclass of the antibody. So, like, igg one has around.

1:02:58.232 --> 1:03:02.514
ig two. So anyways, I kind of went through this and did my own factor

1:03:02.562 --> 1:03:06.166
analysis. Open for discussion. So quantity of

1:03:06.188 --> 1:03:10.658
experimentation necessary. Again, I think antibiot generation is well known.

1:03:10.834 --> 1:03:14.214
It's been around for a better part of a century. But physiology is unpredictable,

1:03:14.262 --> 1:03:17.366
right? If you inject the same thing into a rabbit that they injected,

1:03:17.398 --> 1:03:20.602
are you going to get the same thing? No, because is it at the same

1:03:20.656 --> 1:03:23.934
strain of mouse or is the same strain of rabbit? Has that

1:03:23.972 --> 1:03:27.680
rabbit seen other things that your rabbit hasn't seen?

1:03:28.690 --> 1:03:32.366
There's even vendor differences, right? We even saw when

1:03:32.388 --> 1:03:36.430
we did research that C 57 black mice

1:03:36.510 --> 1:03:40.658
from one vendor had different

1:03:40.744 --> 1:03:44.642
things behaved in our experiments differently than C 57

1:03:44.696 --> 1:03:48.410
black from another. They overall behaved

1:03:48.430 --> 1:03:51.318
the same. But there were some nuanced differences where you're like,

1:03:51.484 --> 1:03:54.738
these mice are not they're supposed to be genetically identical, but they're

1:03:54.754 --> 1:03:58.626
not. I think that just physiology is unpredictable,

1:03:58.658 --> 1:04:02.440
and I don't think we should punish companies for physiology being hard.

1:04:03.930 --> 1:04:06.726
Amount of direction and guidance. I think they did give a lot of guidance.

1:04:06.758 --> 1:04:09.018
I think that's even admitted to that, they gave a lot of guidance. They had

1:04:09.024 --> 1:04:12.326
a roadmap for creating these. They had working examples.

1:04:12.358 --> 1:04:16.490
Was it enough? Did it show enough species,

1:04:16.570 --> 1:04:20.186
enough representative species? I don't know. The nature

1:04:20.218 --> 1:04:23.614
of the invention, state of the Art, I think it

1:04:23.652 --> 1:04:26.480
kind of follows with the other ones. I didn't go too deeper into those.

1:04:27.010 --> 1:04:30.430
The relative skill in the Art, I think they even admitted in Ray wands

1:04:30.510 --> 1:04:33.074
again, 30 plus years ago, that the skill in the Art was high at that

1:04:33.112 --> 1:04:36.334
time. So I would argue that skill in the Art is still high for antibody

1:04:36.382 --> 1:04:40.046
science. And then again, physiology is unpredictable.

1:04:40.078 --> 1:04:43.158
But I would say that antibody science is, I mean, for what it is and

1:04:43.164 --> 1:04:47.206
for how long it's been around, it's not that unpredictable. You inject a

1:04:47.228 --> 1:04:50.726
rabbit or a mouse or whatever, an animal with something, you're going

1:04:50.748 --> 1:04:54.058
to get, b cells are going to react to that. You're going to be

1:04:54.064 --> 1:04:57.562
able to get them out. Now, is it going to be the exact

1:04:57.616 --> 1:05:01.258
same thing that amgen created? No, but again, that's the physiology,

1:05:01.274 --> 1:05:03.630
the unpredictability part of physiology.

1:05:06.370 --> 1:05:10.478
Just a quick comment on that. It's possible that

1:05:10.564 --> 1:05:14.270
when wands was putting this predictability

1:05:14.350 --> 1:05:18.414
or unpredictability of the Art up, they meant literally defined

1:05:18.462 --> 1:05:21.550
predictable arts and literally defined unpredictable arts.

1:05:21.630 --> 1:05:25.406
And so typically, this kind of science falls into unpredictable

1:05:25.438 --> 1:05:29.014
art. So maybe it wasn't explicit about what

1:05:29.052 --> 1:05:32.646
they were doing, but that it was categorized in this unpredictability field.

1:05:32.828 --> 1:05:36.598
Yeah, maybe a little bit, at least would weigh into the

1:05:36.604 --> 1:05:39.994
analysis. Yeah. Similar kind of question is actually

1:05:40.032 --> 1:05:43.334
when you say physiology, are you including

1:05:43.382 --> 1:05:47.340
both parts of the claim? Are you including that first part of the claim where

1:05:48.110 --> 1:05:51.514
antibody binding to a residue, is that part of physiology

1:05:51.562 --> 1:05:53.550
or is that not part of physiology?

1:05:57.090 --> 1:06:01.310
I don't think that's unpredictable because pcsk Nine

1:06:01.380 --> 1:06:05.106
does bind to ldlr and it's in that pocket. So if

1:06:05.128 --> 1:06:08.546
you can find something that prevents that binding, it's going to be in

1:06:08.568 --> 1:06:12.850
that pocket. Right. If you were shown

1:06:13.350 --> 1:06:17.362
3d structure, let's even say, of an antibody, would you know whether

1:06:17.416 --> 1:06:20.200
it was going to bind to one of those things? No.

1:06:21.130 --> 1:06:24.754
That's why I think it's unpredictable. Like you might be able to make an antibody,

1:06:24.802 --> 1:06:28.342
but making an antibody that does what you want it to do is unpredictable.

1:06:28.406 --> 1:06:32.140
You have to do it by experimentation. Right, right.

1:06:33.630 --> 1:06:36.410
But that's the whole, like they're teaching with the guidance. Right,

1:06:36.480 --> 1:06:39.926
right. It's still unpredictable, even though they've brought

1:06:39.958 --> 1:06:43.114
some things about it. It's a hard one,

1:06:43.152 --> 1:06:46.166
for sure. kristen had to hop off.

1:06:46.208 --> 1:06:49.646
She's an examiner call, and we'll try to wrap up here a little bit,

1:06:49.668 --> 1:06:53.498
too. So both of the cranes, again, they were reasonably broad.

1:06:53.674 --> 1:06:58.606
They did identify specific amino acids, but there probably could have been some gut

1:06:58.638 --> 1:07:02.386
check and saying kind of like what their experts said, you probably can't find an

1:07:02.408 --> 1:07:05.954
antibody that's only going to bind one amino acid and inhibit function. You probably do

1:07:05.992 --> 1:07:09.098
need two plus three plus amino acids.

1:07:09.134 --> 1:07:12.966
They probably should have been more realistic in that at minimum, in that

1:07:12.988 --> 1:07:16.466
sense, that an antibody binding just one amino

1:07:16.498 --> 1:07:20.726
acid. I don't know if that's really a thing for

1:07:20.748 --> 1:07:24.006
the rent description part of this. Obviously the Supreme Court is taking up the enablement

1:07:24.038 --> 1:07:27.706
piece, not written description, but in reviewing the district court what they

1:07:27.728 --> 1:07:31.578
had said. So there's the representative species test, and they looked at amino

1:07:31.594 --> 1:07:34.350
acid sequence similarity, 3d structure,

1:07:34.850 --> 1:07:38.474
and all kind of found that Amgens and the compare antibodies

1:07:38.522 --> 1:07:42.560
were structurally similar. So interestingly, even though sanofi did not

1:07:42.870 --> 1:07:46.866
infringe AMGEN's claim, their antibodies were structurally similar when

1:07:46.888 --> 1:07:50.066
they looked at them, and there was 80% similarity in

1:07:50.088 --> 1:07:53.490
amino acid sequences between amgens and competitor antibodies.

1:07:54.470 --> 1:07:57.998
But interestingly, AMGEN's disclosed antibodies covered more classes

1:07:58.014 --> 1:08:01.362
of antibodies. So I think that weighs in favor of the whole representative species,

1:08:01.426 --> 1:08:04.374
because it wasn't just I think it was probably still all,

1:08:04.412 --> 1:08:07.846
igg would be my guess, but maybe not. Maybe there are some other ones in

1:08:07.868 --> 1:08:11.626
there, but it covered a good swath of classes, which I think goes towards that

1:08:11.648 --> 1:08:15.398
representative species. They say just a molecule antibody, but they showed support for lots

1:08:15.414 --> 1:08:18.746
of different classes. And then they had

1:08:18.768 --> 1:08:22.446
substantial evidence showing that while binding to different residues across the

1:08:22.468 --> 1:08:25.738
sweet spot, that they blocked pcs canine binding

1:08:25.754 --> 1:08:29.630
to the ldl receptor through a variety of binding interactions.

1:08:30.930 --> 1:08:34.386
So I think it's interesting too, sounds like at least based on

1:08:34.408 --> 1:08:38.846
this, that they had some data to suggest that their different antibodies

1:08:38.878 --> 1:08:42.178
that they had created did bind in that sweet spot in a

1:08:42.184 --> 1:08:45.602
few different ways. So maybe that

1:08:45.656 --> 1:08:49.320
lends itself more to a broader claim, to the fact that they were able to

1:08:50.170 --> 1:08:52.774
all bind in that sweet spot, but bind in kind of a little bit different

1:08:52.812 --> 1:08:56.200
ways. But just in general,

1:08:56.650 --> 1:08:59.894
thinking about this, this was a quote back

1:08:59.932 --> 1:09:03.318
from ariad versus lily in 2010 the Federal Circuit

1:09:03.334 --> 1:09:06.582
basically said there was little difference between describing an invention and enabling

1:09:06.646 --> 1:09:10.362
one to make and use it. And that rich description enablement often rise and fall

1:09:10.416 --> 1:09:14.186
together. So I'm kind of surprised that the Federal Circuit has reviewed

1:09:14.218 --> 1:09:17.226
these things in isolation and that the Supreme Court

1:09:17.258 --> 1:09:20.814
is taking these things up in isolation. Because honestly, the more I dig into

1:09:20.852 --> 1:09:24.430
this world, the more I don't think they should be separate,

1:09:25.910 --> 1:09:30.114
especially when both parts of the statute say the

1:09:30.152 --> 1:09:33.630
written description should allow somebody to make and use it and enablement

1:09:33.710 --> 1:09:36.020
should allow somebody to make and use it.

1:09:38.230 --> 1:09:41.446
I don't know. I would love I don't think that

1:09:41.468 --> 1:09:45.142
this is a good example of a case where it does one or the other.

1:09:45.276 --> 1:09:49.282
I don't know if they can be separated, but that's my personal

1:09:49.356 --> 1:09:52.938
opinion. I'm going to read this just because it

1:09:52.944 --> 1:09:57.018
was if you have a chance and you're curious, if you go back to

1:09:57.104 --> 1:10:01.002
the area pharmaceuticals versus eli lilly 2010

1:10:01.056 --> 1:10:04.998
Federal Circuit decision. Former Chief Judge raider

1:10:05.174 --> 1:10:08.602
gives an amazing dissent opinion which encapsulates

1:10:08.666 --> 1:10:11.214
like, I wish I would have read this several days before instead of just like

1:10:11.252 --> 1:10:15.006
this morning, because I'm like, oh, this is like my feeling on it.

1:10:15.188 --> 1:10:19.266
But this is what he says. So the language that the majority uses to explain

1:10:19.368 --> 1:10:22.734
possession, as shown in the disclosure, not only fails to justify

1:10:22.782 --> 1:10:25.842
a separate test, it also fails to distinguish the test

1:10:25.896 --> 1:10:29.254
for written description from the requirements for enablement. The level

1:10:29.292 --> 1:10:32.594
of detail required to satisfy the written description requirement,

1:10:32.722 --> 1:10:35.878
according to the majority, varies depending on the nature and scope of the

1:10:35.884 --> 1:10:39.400
claims and on the complexity and predictability of the relevant technology.

1:10:39.850 --> 1:10:42.986
These considerations, however, mirror the wan's factors for

1:10:43.008 --> 1:10:46.166
enablement, which include as the things we've

1:10:46.198 --> 1:10:49.466
all seen. The Court attempts to distinguish enablement by observing that

1:10:49.488 --> 1:10:52.458
although written description enablement often rise and fall together,

1:10:52.624 --> 1:10:56.426
requiring a written description of the invention plays a vital role in curtailing claims

1:10:56.458 --> 1:11:00.666
that did not require undue experimentation to make and use and thus satisfy enablement,

1:11:00.778 --> 1:11:04.714
but that have not been invented and thus cannot be described.

1:11:04.842 --> 1:11:08.546
Yet if a person of ordinary skill is enabled to make and

1:11:08.568 --> 1:11:12.418
use a novel and nonobvious invention clearly recited in

1:11:12.424 --> 1:11:15.714
the claims. I fail to see how that invention can be said to have not

1:11:15.752 --> 1:11:19.286
been invented or be in some need of some undefined level of

1:11:19.308 --> 1:11:22.886
additional description. It is inconsistent to say

1:11:22.908 --> 1:11:26.434
that on its filing date, the patent does not show that the inventor possessed

1:11:26.482 --> 1:11:30.342
subject matter that the claims actually encompass and the specification

1:11:30.406 --> 1:11:33.754
fully enables. And the other interesting piece

1:11:33.792 --> 1:11:37.194
of history, they learned that prior to 1836,

1:11:37.392 --> 1:11:41.226
your whole invention was just described in a written description. There was no claims.

1:11:41.338 --> 1:11:44.798
So the written description was the claims and

1:11:44.804 --> 1:11:48.718
then it was only after with the 1836 Patent Act

1:11:48.884 --> 1:11:52.494
that claims started being a part of how

1:11:52.532 --> 1:11:56.018
we draft patent applications. And so those claims served the

1:11:56.024 --> 1:11:59.218
purpose of distinguishing the invention while the

1:11:59.224 --> 1:12:02.338
specification as a whole must enable. So that was kind

1:12:02.344 --> 1:12:06.360
of the thought process around, I think, written description enablement is that

1:12:06.970 --> 1:12:10.854
before everything was in that written description, but now they kind of pulled it out

1:12:10.892 --> 1:12:14.370
to distinguish the invention versus enabling,

1:12:14.530 --> 1:12:18.018
what the claim said. But maybe I think those lines

1:12:18.034 --> 1:12:20.442
have blurred a lot. anyways, I don't know if we have time for these.

1:12:20.496 --> 1:12:24.214
I mean, we've kind of talked about these. Can we separate

1:12:24.262 --> 1:12:26.330
enablement from writ description?

1:12:30.110 --> 1:12:33.406
I don't think you can, but there's a lot of blogs out there that think

1:12:33.428 --> 1:12:36.766
you can and some judges clearly think you can. Chief Judge raja doesn't think

1:12:36.788 --> 1:12:40.414
you can. But I don't know, I think we all

1:12:40.452 --> 1:12:41.840
agree with you, actually.

1:12:43.330 --> 1:12:47.506
I don't know. So the more I read it, I get the intent of

1:12:47.528 --> 1:12:51.330
it. The whole possession versus making and using it.

1:12:51.480 --> 1:12:55.438
I mean, that's what examiners say too, right? Like if you have some weird

1:12:55.454 --> 1:12:59.266
things in your claims, they say they invent your possesses and

1:12:59.288 --> 1:13:03.270
stuff. I just don't know if you can really separate them.

1:13:03.340 --> 1:13:06.454
And that's actually what concerns me about the Supreme Court taking it up because

1:13:06.492 --> 1:13:09.978
they worry that they're just going to muddle it more than they're going

1:13:09.984 --> 1:13:13.526
to clarify because they are only looking at enablement and they're not looking at written

1:13:13.558 --> 1:13:14.410
description.

1:13:18.030 --> 1:13:21.726
Good question. They seem really similar. I mean, are there some

1:13:21.908 --> 1:13:25.454
subtle? Is it a genus species thing? I'm not

1:13:25.492 --> 1:13:29.386
sure. Yeah, right. Just sort of as a summary comment

1:13:29.418 --> 1:13:33.410
while you're looking for that, this amgen patent has a ton

1:13:33.480 --> 1:13:36.894
of examples in it. When you start looking into all the sequence

1:13:36.942 --> 1:13:41.154
ids, there's a ton of examples and they even line up

1:13:41.272 --> 1:13:44.906
various protein sequences to show similarities

1:13:45.038 --> 1:13:48.178
and there is a lot of guidance,

1:13:48.274 --> 1:13:53.014
right? So with

1:13:53.052 --> 1:13:56.630
the means plus function claim interpretation,

1:13:57.390 --> 1:14:05.558
including as we were talking about what's

1:14:05.574 --> 1:14:08.906
the word? Like it's equivalent. So you've given

1:14:08.928 --> 1:14:11.740
you a ton of examples, you've given some roadmap, now you get everything.

1:14:12.590 --> 1:14:16.058
Let's say it's a means plus function claim, you're only entitled to what you've

1:14:16.074 --> 1:14:19.514
described and the equivalence. Right? So if they've

1:14:19.562 --> 1:14:25.010
described it well and described some of these common

1:14:25.080 --> 1:14:28.900
features between their different examples, you would imagine that any

1:14:29.670 --> 1:14:33.902
other antibody that has those common features would be equivalent

1:14:34.046 --> 1:14:37.682
in some definition of it. So it gets really complicated

1:14:37.746 --> 1:14:42.658
and I think actually I totally see your perspective as what's

1:14:42.674 --> 1:14:46.150
the role of the patent system? We need to allow

1:14:46.220 --> 1:14:49.494
company, we need to foster innovation and

1:14:49.612 --> 1:14:52.826
allow companies to leverage their work and prevent other people from

1:14:52.848 --> 1:14:55.514
just copying them. And then, as kristin brought up,

1:14:55.712 --> 1:14:59.034
you can't have land grabs either because that

1:14:59.072 --> 1:15:02.846
doesn't foster innovation. No either. So it is a

1:15:02.868 --> 1:15:06.046
tough question that comes down to the specific facts of the case.

1:15:06.148 --> 1:15:11.086
Right. And hopefully the Supreme Court will

1:15:11.108 --> 1:15:14.590
drill into those facts and do the right analysis.

1:15:15.090 --> 1:15:17.920
Yeah, 100%.

1:15:19.910 --> 1:15:23.506
I think to Christmas point too, that it's probably going to be highly dependent on

1:15:23.528 --> 1:15:26.886
each art. But I

1:15:26.908 --> 1:15:30.434
think what does have to remembered by the courts and inventors alike

1:15:30.482 --> 1:15:33.874
is that the patent system isn't meant to make innovation

1:15:34.002 --> 1:15:37.590
and designing around easy, it's meant to

1:15:37.660 --> 1:15:40.922
provide you a path to do it right. And so

1:15:40.976 --> 1:15:44.506
some sciences just take a long time to do, even if

1:15:44.528 --> 1:15:48.566
you have a perfect roadmap and perfect protocols,

1:15:48.678 --> 1:15:51.600
some of it just takes a really long time to do,

1:15:52.370 --> 1:15:55.438
especially in the pharmaceutical antibody, whatever world.

1:15:55.604 --> 1:15:58.634
It's a long horizon no matter how much you're taught.

1:15:58.682 --> 1:16:02.746
Right, but that doesn't mean that it's undue experimentation

1:16:02.858 --> 1:16:05.578
and it'll be interesting to see if they take that up in the Supreme Court

1:16:05.594 --> 1:16:09.986
too, or whether Congress is at some point because that's not in

1:16:10.008 --> 1:16:12.626
the statute. Again, that's one of those things that have kind of been read into

1:16:12.648 --> 1:16:16.146
the statute that doesn't actually exist in the

1:16:16.168 --> 1:16:18.360
statute. It's kind of precedent. Right.

1:16:18.970 --> 1:16:22.326
So what's the role of that and how codified is

1:16:22.348 --> 1:16:25.926
that going to be? I was curious, and I

1:16:25.948 --> 1:16:29.638
don't really know the difference in mechanics as far as levels

1:16:29.654 --> 1:16:33.078
of courts, but who composes the jury?

1:16:33.174 --> 1:16:36.780
So is that people with ordinary skill in the art?

1:16:43.410 --> 1:16:47.534
I've seen a glimpse of it as it all went over my head, but if

1:16:47.572 --> 1:16:50.926
I was on that jury, I would have a pretty hard time.

1:16:51.108 --> 1:16:54.238
Right? You mean just not in a

1:16:54.244 --> 1:16:57.806
normal district court case? Who composes who's in the jury?

1:16:57.838 --> 1:17:01.934
Yeah, just like any average citizens.

1:17:01.982 --> 1:17:03.540
Right, normal people.

1:17:06.870 --> 1:17:10.566
Actually, I think the court system fails. The patent system is

1:17:10.588 --> 1:17:13.890
that even with the Supreme Court, I don't think it's any secret

1:17:13.970 --> 1:17:17.362
that a lot of the people who are in the different

1:17:17.436 --> 1:17:20.540
courts and even like this of the juries and stuff like that,

1:17:22.110 --> 1:17:25.562
they are not read into the level of detail

1:17:25.616 --> 1:17:29.020
they need to be, to one, understand the technology

1:17:29.890 --> 1:17:33.262
necessarily and then make decisions around

1:17:33.316 --> 1:17:37.166
that technology. Because I think a lot of judges in

1:17:37.188 --> 1:17:41.146
courts show their lack

1:17:41.178 --> 1:17:44.722
of understanding sometimes when you hear them, when they write

1:17:44.776 --> 1:17:49.266
these opinions and stuff like that. So does

1:17:49.288 --> 1:17:53.250
beg the question should the jury selection process be different for patent cases?

1:17:54.790 --> 1:17:58.310
Do you have some people that it's like normal late public. But then you do

1:17:58.380 --> 1:18:01.814
have a special bank of people that you

1:18:01.852 --> 1:18:04.978
pull from that somehow. It's a mixed

1:18:04.994 --> 1:18:08.534
bag. I don't know. Yeah, I agree. You mean actually, it does

1:18:08.572 --> 1:18:13.254
seem like a lack of technical understanding can lead to some poor

1:18:13.382 --> 1:18:16.650
decisions at some of these levels in some of these cases.

1:18:17.390 --> 1:18:21.130
I think what one would say would be that's the role of the experts

1:18:22.350 --> 1:18:26.702
to bring it down, but they're expert forward and their

1:18:26.756 --> 1:18:29.994
questions are asked of them and the jury

1:18:30.042 --> 1:18:33.838
and judges are interpreting what these experts said.

1:18:33.924 --> 1:18:34.880
But yeah,

1:18:37.250 --> 1:18:41.410
I'll just say I agree with actually that the lack of technical understanding

1:18:41.750 --> 1:18:46.706
of other parties involved does lead to some weird

1:18:46.818 --> 1:18:50.514
results sometimes. And you've been a part of some expert testimony

1:18:50.562 --> 1:18:54.454
kind of stuff, dave too, haven't you? Right. Have you been part

1:18:54.572 --> 1:18:58.534
of an actual is there an education

1:18:58.652 --> 1:19:01.570
piece for the jury? Does somebody sit up there and say,

1:19:01.660 --> 1:19:05.418
kind of like what I did here, but like, here's, here's antibodies, here's what

1:19:05.424 --> 1:19:09.050
they look like, here's what they do, here's what they mean to kind of bring

1:19:09.120 --> 1:19:13.370
people along? Or is it kind of like, here's the deep end, here's our expert?

1:19:14.590 --> 1:19:18.286
Right. I believe it's a little bit

1:19:18.388 --> 1:19:22.254
up to, I think, the prosecution and the defense for what

1:19:22.292 --> 1:19:25.918
they present. I think the instructions given to them. So I've

1:19:25.934 --> 1:19:29.922
been involved in arbitration cases, not nothing

1:19:29.976 --> 1:19:34.498
that ever went before a jury and a judge, so I

1:19:34.504 --> 1:19:38.694
don't have a direct experience with that. But I

1:19:38.732 --> 1:19:43.606
think that it's up to the

1:19:43.628 --> 1:19:47.574
prosecution of the defense and what they present, the evidence that they can be

1:19:47.692 --> 1:19:51.066
overall general education about how anybody's work. That could be

1:19:51.088 --> 1:19:54.474
something that they could present. I think you brought up that the

1:19:54.512 --> 1:19:58.010
instructions to the jury weren't quite right. I think what

1:19:58.080 --> 1:20:01.614
the jury does get instructions on from the

1:20:01.652 --> 1:20:03.760
court itself is the law.

1:20:05.090 --> 1:20:08.222
They're explained what the laws are,

1:20:08.276 --> 1:20:12.494
but they're not explained about the technology. I believe, outside of

1:20:12.532 --> 1:20:16.066
whatever the two sides choose to

1:20:16.088 --> 1:20:19.506
present. Interesting. I feel like there should be like you're selected for

1:20:19.528 --> 1:20:22.980
this jury. Now you're going to spend a few hours

1:20:23.670 --> 1:20:27.106
listening to some expert, just some random person you're right.

1:20:27.128 --> 1:20:30.754
That's not in bed with anybody or

1:20:30.792 --> 1:20:34.386
whatever, and you can have legal

1:20:34.418 --> 1:20:37.666
counsel in that room to make sure nothing is said that would sway

1:20:37.698 --> 1:20:41.046
anybody, but just give us a one to four hour

1:20:41.148 --> 1:20:44.018
deluge on this technology. Right.

1:20:44.124 --> 1:20:47.958
I feel like there could be benefit maybe from that. Now some litigators

1:20:47.974 --> 1:20:51.102
are going to comment on this podcast saying that we all don't know

1:20:51.156 --> 1:20:54.560
anything about litigation, we have no idea what we're talking about.

1:20:55.010 --> 1:20:58.160
Probably listen to these chumps over there.

1:21:02.850 --> 1:21:07.374
I was in a jury trial Friday, and I mean, it was extremely

1:21:07.422 --> 1:21:11.214
cut and dry, some of the most simple instructions that you could imagine,

1:21:11.262 --> 1:21:14.354
and it was a pretty hard time interpreting that.

1:21:14.392 --> 1:21:18.318
And so I'm thinking of this and I'm like, I just don't know how

1:21:18.344 --> 1:21:21.474
you get there. You need to read that district court, the district court

1:21:21.522 --> 1:21:23.030
case for this tie,

1:21:25.370 --> 1:21:29.014
I think you'd have to read it 16 times to get the full lay

1:21:29.052 --> 1:21:32.346
of it. The other quick

1:21:32.368 --> 1:21:36.154
thought I had. Again, nothing too crazy. But it's just would have been

1:21:36.192 --> 1:21:39.546
better to not include functional requirements, because it seems like a lot of

1:21:39.568 --> 1:21:42.054
the recent enablement issues identix, wyeth,

1:21:42.102 --> 1:21:46.094
enzo all fell because they had these functional requirements that

1:21:46.132 --> 1:21:49.610
seemed to create uncertainty, at least in the eyes of the court,

1:21:49.770 --> 1:21:53.310
for screening compounds that were covered by the claim. So I do wonder

1:21:53.380 --> 1:21:57.126
if I don't know how you would otherwise claim

1:21:57.178 --> 1:22:00.754
it, right? Because without it's even broader, but I don't know, it seems

1:22:00.792 --> 1:22:03.394
to be a red flag a little bit when you start putting that functional stuff

1:22:03.432 --> 1:22:07.298
in there. There's a quote in this case while functional

1:22:07.314 --> 1:22:10.678
claim limitations are not necessarily precluded in claims that

1:22:10.684 --> 1:22:14.630
meet the enablement requirement, such limitations pose high hurdles,

1:22:14.970 --> 1:22:18.774
filling the enablement requirement for claims with broad functional

1:22:18.822 --> 1:22:21.420
language. Right? Yeah,

1:22:22.750 --> 1:22:24.860
exactly. The judges agree.

1:22:27.390 --> 1:22:29.660
anyways, that was kind of it.

1:22:30.910 --> 1:22:34.698
Yes, this is from the Mpepi. This part was an unfinished

1:22:34.714 --> 1:22:38.638
part, but enablement serves the dual function of ensuring adequate disclosure of

1:22:38.644 --> 1:22:42.202
the claimed invention and that preventing claims broader

1:22:42.266 --> 1:22:45.614
than the disclosed invention. Broad claim language is

1:22:45.652 --> 1:22:49.154
used at the peril of losing any claim that cannot be enabled across

1:22:49.192 --> 1:22:51.890
its full scope. But again, that's the mpep.

1:22:52.790 --> 1:22:55.302
This could be a whole other thing we're not going to go into today.

1:22:55.356 --> 1:22:59.926
But the other part that's been bugging me lately about patent law is that

1:23:00.108 --> 1:23:03.622
there is court precedent that is binding based

1:23:03.676 --> 1:23:07.286
on laws and then there's the mpep. And some

1:23:07.468 --> 1:23:10.558
of the mpep is based on court

1:23:10.594 --> 1:23:13.786
precedent, but some of it is the world that

1:23:13.808 --> 1:23:17.242
the USPTO wants it to be and not as it is or how

1:23:17.296 --> 1:23:21.006
USPTO perceives it to be and not as it is. So if

1:23:21.028 --> 1:23:23.790
you strictly follow all the things of the mpep,

1:23:25.010 --> 1:23:29.690
your patent practice isn't going to be great because the mpp tries

1:23:29.770 --> 1:23:33.306
to mirror court precedent, but it still is an administrative

1:23:33.338 --> 1:23:37.154
body's interpretation of court precedent and a group of people that no court has

1:23:37.192 --> 1:23:40.946
signed off on. Right? And so there

1:23:40.968 --> 1:23:44.434
is good tidbits in the mpep that are directly tied to case law.

1:23:44.552 --> 1:23:47.774
There's other things that are said like this, which I don't know if this ties

1:23:47.822 --> 1:23:50.786
back to any court case or any precedent,

1:23:50.818 --> 1:23:54.246
you know what I mean? I don't know. anyways, that's my beef. There's like a

1:23:54.268 --> 1:23:58.118
paper that just came out by out member who but I want

1:23:58.124 --> 1:24:02.074
to read now. It's about that whole thing of like some stuff is

1:24:02.112 --> 1:24:05.674
actually based on precedent in the mpp. Some is just the

1:24:05.712 --> 1:24:09.242
uspto's interpretation or how they want the world to be,

1:24:09.376 --> 1:24:12.618
but not as it is. And if you follow that strictly, you're probably going

1:24:12.624 --> 1:24:16.686
to be in trouble. Anyway, I'll get my

1:24:16.708 --> 1:24:20.286
soapbox for today, but thanks for

1:24:20.308 --> 1:24:23.282
the good dialogue, everybody, and some really great points.

1:24:23.336 --> 1:24:27.730
I don't know if we solved the problem, but we definitely provided a good quagmire.

1:24:29.830 --> 1:24:31.700
Yeah. Thanks, Ashley. That was great.

1:24:33.990 --> 1:24:37.918
Thanks for participating and we'll

1:24:37.934 --> 1:24:41.458
see you next month. All right, that's all for today, folks. Thanks for listening,

1:24:41.474 --> 1:24:45.234
and remember to check us out@aurorapatants.com for more great podcasts,

1:24:45.282 --> 1:24:49.014
blogs and videos covering all things patent strategy. And if you're an agent

1:24:49.052 --> 1:24:51.878
or attorney and would like to be part of the discussion or an inventor with

1:24:51.884 --> 1:24:56.582
a topic you'd like to hear discussed, email us at podcast@aurorapatants.com.

1:24:56.716 --> 1:25:00.062
Do remember that this podcast does not constitute legal advice, and until

1:25:00.156 --> 1:25:01.740
time keep calm and patent on.