SAN DIEGO—The Biotechnology Industry Organization (BIO) held its 2014 International Convention during the last week of June in San Diego and, as in prior years, it was stimulating, challenging and exhausting. With thousands of exhibitors and tens of dozens of Session Tracks and Specialty Forums, it was impossible to attend each event, meet each exhibitor or absorb the deluge of information presented. (Fortunately, BIO provides recorded content for much of the convention that can be obtained from their website at www.bio.org).
With regard to intellectual property, the overriding question was the scope of subject matter eligibility, particularly with respect to natural products, in view of the Supreme Court’s Myriad and Mayo decisions and the guidelines of the U.S. Patent and Trademark Office (PTO) for implementing these decisions, promulgated in March. Thus, the convention featured talks by the acting deputy director, Michelle Lee, as well as from the authors of the guidelines from the office’s legal department, Drew Hirshfeld and June Cohan. There were also panel discussions, such as “Patent Eligibility from the Trenches: Practical Implications of the Supreme Court’s Prometheus and Myriad Decisions,” featuring former Deputy Director Terry Stanek Rea and a press conference from BNA on a white paper reporting the results of a survey of how the office is applying the patent eligibility guidelines.
While the acting deputy director’s talk was short on substance, Hirshfeld and Cohan were more informative. It is clear from their presentations that they have been taken aback somewhat by the furious objections to the guidance and that they appreciate that there are instances where the guidance overstepped the Supreme Court’s instructions or came to an ill-thought out result. (A striking example of the latter is the portion of the guidance holding gunpowder to be patent-ineligible, as a mere mixture of sulfur, charcoal and saltpeter consists of all naturally occurring substances.) It is also clear that the office believes that on balance the guidance accurately interprets the Supreme Court’s opinions, but particularly for combination inventions the office appears ready to concede that functional differences (in gunpowder, the capacity to explode) can render a combination patent eligible even though the individual components are not. Cohan set forth a hypothetical claim list regarding an isolated antibiotic and coyote antibodies thereto and discussed with the audience the relative patent eligibility of these claims (which are posted on the PTO’s website at www.uspto.gov).
Former PTO Solicitor Nancy Linck commented to the PTO officials as follows:
“As former solicitor and one of the first officers of the PTO to pull together guidelines, I would like to suggest a different approach, and it’s one we took. What you’re dealing right with now is a very negative Supreme Court, and they’re knocking down patents right and left. We were dealing with Supreme Court cases that went back to the antitrust era, cases like Parker v. Flook and Gottschalk. The approach we took was to push back wherever we could. So when I hear you ask questions, ‘Is this enough?’ to lend patentability to the invention, if you have to ask that question, you’ve read the cases, the answer should be ‘Yes.’ If there is any question in your mind you should grant the patent, because that is the only way we are going to get back on track. If you buy into what the Supreme Court is doing, hook, line and sinker, you are really going to damage the biotech industry.”
Not surprising, Linck got a round of applause at the end of her remarks.
Rea’s panel consisted of not only Rea but also in-house counsel for Ariosa Diagnostics (the declaratory judgment plaintiff in a suit before the Federal Circuit that takes the position that the combination of the Myriad and Mayo decisions renders genetic diagnostic testing claims patent ineligible). Not surprisingly, Ariosa argued that the PTO and the courts should read these cases as broadly disqualifying patents on natural products and methods relating to them; in their view, even claims to recombinant vectors comprising a naturally occurring DNA should be patent ineligible because genetic engineering methods are “routine and conventional.” Rea cautioned restraint by the office, and asked the audience to advise our clients to encourage them to pursue claims outside the scope of the guidelines to help the office “get it right.” She also mentioned that the deadline for written comments was extended by the office until July 31, 2014 and said “[each] and every person in [the audience] has a moral duty” to provide comments on the guidelines to help the office “get it right.”
The BNA press conference discussed the results of their white paper entitled “Stopped at the Threshold: The Practical Implications of the Supreme Court’s Mayo and Myriad Decisions on Biotechnology Patent Practices” (an executive summary of this report can be found at www.bna.com/BIO_2014_PR). Key findings of the report include:
- Rejections under the Mayo decision were based on finding a correlation between a biological molecule and a health or disease condition
- PTO suggestions for claim amendments to salvage such claims themselves raised validity and enforcement issues
- Rejections under the Myriad decision were based on structural identity between a molecule as it occurs in nature and as isolated; isolation is no longer sufficient
- Patent-eligible claims must distinctly distinguish what is claimed from the naturally occurring substance
The overwhelming impression remaining from the BIO Conference is that biotechnology inventions are embattled and at risk, from all branches of government, and that the public is thus endangered by a lack of investment in biotechnology inventions that can no longer be protected by patents.
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.
(Opinions of the columnist do not necessarily reflect those of the publishers, editors or staff of DDNews.)