Biotech Patent Case Law Updates at the IPCC

Patently BIOtech

By John W. Cox, Counsel at Alston+Bird LLP

The Spring 2012 BIO Intellectual Property Counsels’ Committee (IPCC) Conference, held in Austin, Texas, provided an excellent forum for intellectual property (IP) practitioners in the biotech industry to socialize, network, and participate in panel discussions focusing on the dynamic developments in the patent laws.  The conference began for the general participants over margaritas and Tex-Mex fare, where attendees were already discussing recent Supreme Court and Federal Circuit decisions impacting the industry.  By the final panel on Wednesday morning, the Supreme Court had handed down two more opinions impacting the biotech industry.

Patent practitioners have been monitoring the guidance provided by the Federal Circuit since its creation almost 30 years ago.  The patent laws for biotech inventions have evolved over much the same time period, stemming from Diamond v. Chakrabarty in 1980.  But in the past few years, more cases involving biological arts have not only reached the Federal Circuit but been taken up by the Supreme Court.  Indeed, it appears that the Supreme Court has been more active in the patent field related to the biotech industry since the Fall 2011 BIO IPCC meeting than any similar time period.  Moreover, two new acts of Congress impacting the industry have come into play, namely the America Invents Act and the Biologics Price Competition and Innovation Act.

The first of two panels discussing case law focused on Prometheus and the guidance – or lack thereof – provided therein.  The panel, including Richard P. Bress of Latham & Watkins and Raymond Chen of the U.S. Patent & Trademark Office (PTO), provided insight into the Supreme Court’s opinion, describing the new frontier for biotech IP.

The final panel took up the mantel to update the conference on a wide range of case law that will impact the practice of IP in biotech.  Four of the most talked about cases in patent law happen to impact the biotech industry, and they are either currently active or were recently decided.  Deepro Mukerjee, of Alston & Bird, led a discussion of Novo Nordisk, the case decided by the Supreme Court just the previous day.  Dr. Jitty Malik, also of Alston & Bird, presented the Therasense case, which, until Prometheus, was the main case IP practitioners had been talking about.  Steve Reese, of Olswang in London, provided the European perspective on the standards to obtain or avoid injunctions in patent cases and compared that with the recent Kimberly-Clark decision.  Any one of these cases could have spurred discussion on the Supreme Court’s recent interest in patent cases.  Together, they signal both danger and opportunity to patent practitioners in this industry and have BIO member companies and IP practitioners alike looking to the Supreme Court and Federal Circuit together for guidance.

To close out the conference, Dr. Judy Jarecki-Black of Merial returned us to the Myriad Genetics case, which the Supreme Court vacated and remanded back to the Federal Circuit in view of Prometheus.  Dr. Jarecki-Black raised a myriad of issues associated with the case—from ethical considerations to the scope of patentable subject matter in the biotech industry and what is necessary to save claims directed to genetic diagnostic testing—leading a dynamic discussion to formerly close out the conference.

All of the attendees, panelists included, are now figuring out what to do in view of Prometheus.  The PTO recently provided guidelines to its examiners based on that opinion, though the impact of the 9-0 decision has yet to make itself heard in other cases.  That, however, is not the situation for the industry itself.  BIO member companies are considering how to pursue their research and protect their IP, aware that the Supreme Court has moved the boundaries of the frontier for patentable subject matter in this field.

Despite the clock signaling the end of the Spring 2012 BIO IPCC program, the attendees once again returned to the Prometheus and Myriad Genetics cases.  The venerable Driskill Hotel heard musings about what will happen as Myriad Genetics moves up and down the appellate ladder.  The conference provided a forum at which IP practitioners came together to see old friends and meet new ones, enjoy some Texas hospitality, and get briefed on the hot topics in IP currently impacting the industry.  At its close, instead of scattering to the south Texas winds, we departed with renewed interest in considering, together, what dangers and opportunities this new frontier holds.

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