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“There is still significant protection for many inventions in the life sciences. We just have to face the law as it is. – Dr Douglas Bucklin
From left to right: John White, Rachel Elsby, Douglas Buckner, Kae Gruner
On the last day of IPWatchdog LIVE last week, a panel titled “Jurassic Patents: Genetic Engineering and the Future of Life Science Innovation,†moderated by the CEO of the PCT Learning Center and founding partner of Berenato & White, John White, discussed the challenges of patenting discoveries in the life sciences in light of recent legal developments. The panel included trial attorney and partner at Akin Gump, Dr. Rachel Elsby, patent attorney and shareholder of Volpe Koenig, Dr. Douglas Bucklin, and McGuire Woods food and drug attorney and counsel, Kae Gruner.
Current status of Articles 101 and 112
Dr. Elsby began by discussing the state of the patent law currently in dispute, turning to 35 USC §101 and §112. Section 101 provides 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 enabling provision, lists the requirements for a patent specification, which must contain a written description sufficient to permit another person skilled in the art to make or use the invention. Noting the recent Myriad and Mayo Decisions of the past decade, Dr. Elsby explained that the rate of defendants using Section 101 as a defense against counterfeiting has skyrocketed. That said, however, section 101 is not the biggest issue for litigators – section 112 is. While Section 101 challenges are manageable for patent litigators, Section 112 challenges are not that easy because, according to Dr. Elsby, it is much more difficult to sufficiently validate claims. In other words, it’s hard to show a reviewer early on that a life science product will work the way you say it is, while research is still ongoing. In addition, the courts do not appreciate the intricacies of the claimed technologies and the accompanying claims drafting issues, thus providing an opportunity for infringers to successfully challenge Section 112 patents for lack of clearance.
Dr Bucklin joined the discussion, noting that, for patent attorneys, “it sounds bleak; misfortune and darkness. He agreed that in the drafting, clauses 101 and 112 are both a huge problem. For clarity, he said, the USPTO provides examples of properly drafted Section 101 claims. However, these examples are inconsistent. Thus, the only way forward is to take the invention and map it to the closest example possible for this invention, even if there are inconsistencies between the examples. He also noted that the rubric used by reviewers to assess claims has changed from a two-step process to a five or six-step process with multiple sub-questions, which hinders predictability in pursuing claims. “A thorough understanding of how examiners use this algorithm in the case is the prosecutor’s starting point,†he said.
A high level of specificity is required
Regarding section 112, Dr Bucklin explained that when advising clients, he makes it clear that a high level of specificity is paramount. Due to the rapid evolution of life science technologies, rapid filing of applications is necessary. However, inventors may not yet have examples to prove that the invention does what the claims say it does. It is not enough to say, for example, that the invention is an antibody that binds to something, said Dr Bucklin. He must be able to explain the sequence to the examiner. He further explained the treatment claims:
In a treatment request, you must activate it by indicating both the treatment dose and its mode of action. . . So how do you show the reviewer that it works like you said? If you don’t have it, you’ll have an activation battle.
Shorten the path to activation
In order to counter this, patent applications in the life sciences can now easily exceed a hundred pages, as inventors try to cover all possible scenarios of activation.
White intervened briefly to agree and share his admiration for life science patent practitioners: “It’s the practice of affidavits, 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 deposit. You just have to roll with what you have. When everything is dissected in 15 years in a district court at some point, you should have guessed. “
However, there may still be a reduction in the length of claims, said Dr Elsby, who noted the recent Amgen case, in which the court rejected a written description of more than 100 pages as not actually meeting the clearance requirement:
[The court essentially said] Of course you gave us a roadmap [to enable the invention], but someone who comes after you has to do as much work as you do. . . so you did not shorten the path. The solution may be to shorten the path to get there.
Bringing up his own idea on how to shorten the path to activation, Dr Bucklin proposed, “I would ask the inventor, did you make the antigen just a little different?” Maybe the to treat making the antibody is what’s special about what you did. However, he recommended that life science practitioners continue to write specifications to include all embodiments.
FDA exclusivity considerations
On the regulatory side of things, Gruner expressed how critical it is for the pharmaceutical customer to understand how valuable FDA exclusivity can be as an alternative form of protection, as opposed to patents. Exclusivity is a period of time during which a brand-name drug enjoys market protection against generic competitors, by delaying generic FDA approvals until that period of exclusivity has expired. Exclusivity is an important consideration, Gruner said, because it can last for years, just like patent protection. This is especially true of biologics, which have a potential exclusivity period of up to 12 years and experience patent difficulties due to stability issues and development challenges. Agreeing with this sentiment, Dr Elsby added, “Regulatory exclusivity is better protection for biologics than patents.
Offering their final advice to the audience, the panel suggested the following:
There are tough questions in the law for pharmaceuticals, but there is still a lot of innovation, we will move forward and these things will be protected. – Dr Rachel Elsby
Keep writing your nominations like all of these bad things haven’t happened, but add embodiments of how you might approach it in the future … write your set of demands for where you want go. . . There is still significant protection for many inventions in the field of life sciences. We just have to deal with the law as it is. – Dr Douglas Bucklin
Understanding your customers’ business strategy is essential in determining what type of protection to look for. Make sure that whatever role you play in the overall patent strategy, different stakeholders are on the same page and make sure you understand their business purpose. There is value to diversify [protections] . . . make sure your strategy is consistent and [aligns with] overview, to protect this product throughout its service life. – Kae Gruner
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