IPWatchdog LIVE ‘Jurassic Patents’ Panel Explores Patenting Challenges for Life Sciences Innovation

By Nancy Braman
September 21, 2021

“There is still meaningful protection for many inventions in the life sciences area. We just have to deal with the law as it is.” – Dr. Douglas Bucklin

From left: John White, Rachel Elsby, Douglas Buckner, Kae Gruner

On the final day of IPWatchdog LIVE last week, a panel titled “Jurassic Patents: Genetic Engineering and the Future of Life Science Innovation,” moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, examined the challenges of patenting discoveries in the life sciences in light of recent legal developments. The panel included patent litigator and partner at Akin Gump, Dr. Rachel Elsby, patent prosecutor and shareholder with Volpe Koenig, Dr. Douglas Bucklin, and food and drug lawyer and counsel at McGuire Woods, Kae Gruner.

Current State of Sections 101 and 112

Dr. Elsby began by discussing the state of patent law currently in litigation, by turning to 35 U.S.C. §101 and §112. Section 101 states that anyone who invents or discovers a new and useful process, machine, manufacture, or composition of matter or a new and useful improvement thereof is entitled to a patent. Section 112, the enablement provision, lists requirements for a patent’s specification, which must contain a written description sufficient to enable another person of skill in the art to make or use the invention. Noting the recent Myriad and Mayo decisions of the last decade, Dr. Elsby explained that the rate of defendants using Section 101 as a defense to infringement has skyrocketed. That said, however, Section 101 is not the biggest problem for litigators – Section 112 is. Whereas Section 101 challenges are manageable for patent litigators, Section 112 challenges are not so easy because, according to Dr. Elsby, it is much more difficult to sufficiently enable the claims. In other words, it’s difficult to show an examiner early on that a product in the life sciences will work the way you say it works, when research is still ongoing. Furthermore, the courts do not appreciate the intricacies of the technologies being claimed and the claim drafting issues that come with them, thus presenting an opportunity for infringers to successfully challenge the patents under Section 112 for lack of enablement.

Dr. Bucklin joined the discussion, noting that, for patent prosecutors, “it looks bleak; doom and gloom.” He agreed that in drafting, Sections 101 and 112 are both a huge problem. In order to provide clarity, he said, the USPTO provides examples of properly drafted claims under Section 101. However, these examples are inconsistent. So, the only path forward is to take the invention and map it to the closest example possible for that invention, even though there are inconsistencies between examples. He also noted that the rubric used by examiners in assessing claims has grown from a two-step process to a five or six step process with multiple sub-questions, hampering predictability in the prosecution of claims. “A thorough understanding of how the examiners use that algorithm in the case is the place the prosecutor has to start,” he said.

A High Level of Specificity is Necessary

Regarding Section 112, Dr. Bucklin explained that when counseling clients he makes it clear that a high level of specificity is paramount. Because of the rapid developments in life science technology, quick filing of applications is necessary. However, the inventors may not yet have examples to prove that the invention does what the claims say it does. It isn’t good enough to say, for instance, that the invention is an antibody that binds to something, said Dr. Bucklin. He has to be able to lay out the sequence of it to the examiner. He further expounded on treatment claims:

In a treatment claim, you have to enable it by showing both the treatment dose and how it works . . . so how do you show the examiner it works the way you said it works? If you don’t have that, you’ll have an enablement battle.

Shortening the Path to Enablement

In order to counteract this, patent applications in the life sciences can now easily be upwards of a daunting 100+ pages in length, as inventors try to cover every possible scenario for enablement.

White jumped in briefly to agree and impart his admiration for life science patent practitioners: “This is the affidavit practice, they don’t just have to say it, they have to prove it . . . You do what you can with what you have, to be the first to file. You guys just have to roll with what you’ve got. When it’s all dissected in 15 years in front of a district court sometime, you’ll have to have guessed right.”

There may yet be some scaling back in the length of applications though, said Dr. Elsby, who noted the recent Amgen case, in which the court rejected a 100+ page written description as not actually satisfying the enablement requirement:

[The court essentially said] sure you gave us a roadmap [to enable the invention], but someone coming after you has to do just as much work as you did . . . so you didn’t shorten the path. The solution may be to shorten the path to get there.

Contributing his own idea on how to shorten the path to enablement, Dr. Bucklin offered: “I’d ask the inventor, have you made the antigen just a little bit different? Perhaps the process to make the antibody is what’s special about what you’ve done.” However, he did recommend that life science practitioners keep writing specifications to include all embodiments.

FDA Exclusivity Considerations

As far as the regulatory side of things, Gruner expressed how vital it is that the pharmaceutical client understands just how valuable FDA exclusivity can be as an alternate form of protection, as opposed to patents. Exclusivity is a period of time when a brand-name drug is given market protection against generic competitors, through delayal of FDA generic approvals until that exclusivity time period has lapsed. Exclusivity is an important consideration, said Gruner, because it can last years, just like patent protection. This is especially true regarding biologics, which have a potential exclusivity period of up to 12 years and face difficulty in the patenting realm due to stability issues and development challenges. Agreeing with this sentiment, Dr. Elsby chimed in: “Regulatory exclusivity is better protection for biologics than patents.”

Offering their final words of advice to the audience, the panel suggested the following:

There are difficult issues in the law for pharmaceuticals but there’s still a lot of innovation happening, we will move forward and these things will be protected. – Dr. Rachel Elsby

Continue to write your applications as if all this bad stuff didn’t happen, but add embodiments for how you could approach it in the future…draft your claim set for where you want to go . . . There is still meaningful protection for many inventions in the life science area. We just have to deal with the law as it is. – Dr. Douglas Bucklin

Understanding the business strategy of your clients is crucial in determining what type of protections to seek. Make sure that no matter what part you play in the big picture of patent strategy, that the various stakeholders are on the same page, and make sure you understand their business purpose. There’s value to diversifying [protections] . . . make sure that your strategy is consistent and [aligns with] the bigger picture, to protect that product over its lifetime. – Kae Gruner

 

The Author

Nancy Braman

Nancy Braman is a registered U.S. patent attorney. She has been contributing to IPWatchdog since 2019.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 11 Comments comments. Join the discussion.

  1. Greg DeLassus September 21, 2021 3:53 pm

    The problem—in a first to file world—is that it takes time and money to run the studies necessary to generate the data that prove enablement. If you start the studies, and someone else beats you to the filing window with a prophetic application, it can turn out that you spent all that money proving that the other folks’ application is enabled, but you get nothing because their application anticipates yours.

    I would like to propose a change to §112. In any application where the disclosed utility relates to a medical technology, an application without animal data in the application text is per se not enabled. That is to say, the prophetic application: (1) cannot mature into a patent because it fails §112(a); and (2) cannot anticipate a later-filed application with animal data because the prophetic is not “enabling” prior art. This would: (1) incentivize companies to do animal studies validating the technology before filing; and (2) relieve the anxiety that motivates companies to race to file before the trials are done.

  2. Pro Say September 21, 2021 7:38 pm

    Sensible solution Greg.

    Only fly in the ointment could be how “relates” (to a) “medical technology” would be treated / interpreted by the PTO and the courts.

    Think “directed to” in the 101 analysis.

  3. Greg DeLassus September 21, 2021 9:43 pm

    Only fly in the ointment could be how “relates” (to a) “medical technology” would be treated / interpreted by the PTO and the courts.

    Agreed. There would be boundary-drawing issues. I do not want to create a rule, however, that requires actual reduction to practice for all applications, so I propose to create a rule specific to medical technology. The boundary-drawing problem should not be too difficult here.

  4. Anon September 22, 2021 10:40 am

    There is an existing ‘rule’ – you have to actually have possession AT THE TIME OF FILING.

    Elsewise, all you have is a research plan, and everyone (especially the medical folks like Greg) know that such are NOT what the patent system is for.

  5. Xtian September 27, 2021 1:29 pm

    Other issue – FDA requires public disclosure of the clinical trial before the first patient is dosed! I have had examiners use this in obvious rejections. I don’t have possession until the trial is complete, but I just told the world what I am doing. What’s the fix on that?

  6. Greg DeLassus September 27, 2021 3:50 pm

    I think that animal trial data —not human data—should be required for §112(a) compliance. The FDA does not require disclosure of rat studies ex ante.

    If human data were required in the patent, drug R&D would drop to nothing. No company is going to pull the trigger on funds for human studies before a patent is granted. That is just too much money to be throwing around before you know your position vis-à-vis market exclusivity.

  7. Anon September 28, 2021 9:58 am

    GDL,

    If your claimed invention only covers animal use, then you may have a point about the proper legal support.

    Otherwise, you want something special that no other area of innovation obtains through patent law.

    Xtian,

    What about the experimental use exception and the (far more honest) notion of ‘not ready for patenting?’

  8. xtian September 28, 2021 11:14 am

    @anon – the not ready for patenting doesn’t work to overcome a 103 from an examiner.

    related to “you want something special that no other area of innovation obtains through patent law.” I want something special that no other area of innovations obtain through patent law – get rid of Hatch-Waxman. What other area of technology is your competitor exempted from infringement while getting ready to commercialize their product?

  9. Greg DeLassus September 28, 2021 2:00 pm

    [G]et rid of Hatch-Waxman. What other area of technology is your competitor exempted from infringement while getting ready to commercialize their product?

    Terrible idea. I agree that the Hatch-Waxman research exception makes pharma unlike any other industry where infringement is concerned. So what? With the market exclusion that comes from FDA regulation, pharma is different, so it is only fair and sensible that the law should take that difference into account.

    To say that generic companies cannot even begin assembling the data for their applications until the relevant patents have all expired would serve only to exacerbate any already serious problem of prescription drug costs in the U.S. That would be terrible public policy, quite regardless of whether it makes infringement law a tiny bit more theoretically tidy. Title 35 exists for the benefit of the public, not the patent bar.

  10. Anon September 28, 2021 7:40 pm

    xtian,

    Can you explicate your comments a bit (I have a feeling that you have something substantive here, and my apologies for not ‘getting’ it).

  11. xtian September 29, 2021 11:51 am

    I suggest this provocative action – abolish H-W, to point out that the pharma industry has been designated by Congress as requiring unique IP rules because of the public policies that are implicated by the very nature of the inventions in the pharmaceutical industry. (I actually agree with Greg.)

    You advocate with your comment #7 that the law should be applied equally, agnostic to the type of invention patented. Although a noble principle, this cannot occur because of the public policies that are intertwined into the patent law as it pertains to pharmaceutical inventions. So my provocative suggestion was merely meant to point out that pharma is already deemed unique, and that it should be viewed with a different lens when talking about things like §112(a) compliance compared to other technological arts.

Post a Comment

Respectfully add to the discussion.

Name *
Email *
Website