The Mayo v. Prometheus event hosted at George Washington School of Law with the Biotechnology Industry Organization created an opportunity for a panel of thought leaders to distill meaning from the case, the impact on personalized medicine, and possible solutions to the Court created problem.*
Is the decision a game-changer?
Judge Paul R. Michel, former Chief Judge of the Court of Appeals for the Federal Circuit handling patent cases, concluded that the Mayo v. Prometheus represents a “shift in attitude between the Supreme Court and Federal Circuit. There’s a certain amount of trust, a certain amount of respect, a certain amount of suspicion that there might be some deeper immersion, deeper familiarity, harder thinking and greater exposure [to patent law] at the Federal Circuit than the Supreme Court itself can offer,” he said. “The game changer I see here is the Supreme Court is effectively saying ‘We’re done with the Federal Circuit.’ They don’t get any credit for greater immersion, greater expertise, harder thinking or anything of the sort.” While many of the panelists disagreed on what exactly the Supreme Court concluded in the Mayo v. Prometheus decision, it was clear that all the panelists shared in the concern expressed by Judge Michel.
Some might think that a 9-0 decision represents a shared consensus of opinion on how to handle the “law of nature” exemption for patents. Not so according to former Solicitor General to the United States, Seth Waxman. Waxman asserted that when this Supreme Court rules unanimously “its language cannot be taken at face value.” This court rarely suggests edits or withholds their votes unless certain language is included. “But in the end, there is no way that all nine justices thought that this opinion has the broad consequences that people are catastrophizing. I do not believe that every single justice on the Supreme Court thought that the entire field of molecular diagnostics, everything in personalized medicine, that’s over. There’s just no way that there was that level of consensus about how the patent laws have to be reasonably read.”
How will Prometheus affect the Myriad case?
The panelists expressed disagreement over how Prometheus would impact Myriad with some asserting a clear difference between the abstract idea claims in Mayo versus the tangible molecules in Myriad. However, Donald Dunner from Finnegan indicated that future litigants are going to take Prometheus to the ultimate extreme until district courts agree and the federal circuits have to disagree and until the Supreme Court disagrees again.
However, all panelists agreed that the Courts and the Department of Justice were unclear on the science. Professor Christopher Holman stated that no rigorous claim construction had occurred in the District Court. As a result, there is as lot of misperception of what exactly the patent covers in the Myriad case. Professor Holman argued that the Court created distinctions between isolated cDNA and gDNA that do not make any scientific sense. Seth Waxman added that the considerable challenge for articulating the science and what the patent covers in the remand of Myriad is to correct the “unfortunate formulation conceived immaculately.”
How will these decisions affect businesses?
Paul Yasger, head of IP for Abbott Laboratories, stated that while the Prometheus decision may be good for litigators and patent office fees, it is not good for business because of the uncertainty it creates. Phil Johnson, Chief Intellectual Property Counsel at Johnson & Johnson, pointed out that “capital is hard to come by these days and people are reluctant.” Johnson and Johnson can invest money in R&D projects involving shampoo instead of biomarker research. He said investors “have other things they can invest in but I don’t think we, and I mean mankind, can afford it.”
Michael Walker, Chief Intellectual Property Counsel at Dupont pointed out that these decisions have an impact beyond personalized medicine. 60% of Dupont’s R&D is in Ag and Food research and industrial biosciences such as biofuels. Mr. Walker concluded that businesses have large settled business expectations in this technology and they look at Prometheus and Myriad and wonder if their technologies are just natural phenomena.
What are the solutions going forward?
Phil Johnson at J&J concluded that making it hard to get patent protection cannot help innovation because who will fund that work. In this day and age, government sources of additional money are unlikely. Chief Judge Michel pointed out that this is exactly the problem when the Court makes assumptions about patents stifling innovation without providing any convincing evidence that it was so. Michel pointed out that the articles cited “don’t prove the point that the Court is assuming. The preemption problem is all hypothesized as far as I can tell.” Finally, Michel concluded it is dangerous to have unelected judges with no expertise in measuring the retarding effects compared to the beneficial effects make these kinds of decisions.
Hal Wagner, partner at Foley & Lardner, argued that in spite of the lack of evidence of the stifling effect of patents on research, the rest of the world allows for an exemption for experimental use. It does not hurt the patent owners and it gets rid of the stifling argument. Dr. Sauer pointed out that Judge Newman, among other Judges on the Federal Circuit has expressed frustration on the lack of cases on this issue as researchers are not being sued and so the court cannot explore the U.S. exemption.
Chief Judge Michel closed the meeting by suggesting that participants focus their energy and attention on the federal circuit panels and district courts dealing with 101 issues over the next 12 months. If at the end of the year it is a terrible mess then go to Congress for a solution.
*Comments by the panelists should not be taken to bind the clients, companies, law firms, or other organizations with which they are affiliated.