[author: Kwame Mensah]

A free-flowing panel discussing the potential impact of Mayo Collaborative Services v. Prometheus Laboratories, Inc. on the future of personalized medicine and diagnostic method patents in the United States, and the possible slippery slope that could be encountered if its holding is stretched to the claims in the Myriad case as well as other composition of matter claims, kicked off the IP-related breakout sessions of BIO 2012.  Sitting on the panel were Annabelle Bennett, a judge sitting on the Federal Court of Australia; Hans Sauer, Associate General Counsel for BIO; and Thomas Triolo, Senior Counsel Merck & Co., Inc.  The session was moderated by Jennifer Gordon, a partner at Baker Botts L.L.P.  The panel was highly attended, but somewhat surprisingly, most of the attendees were non-attorneys.  In view of this, Mr. Triolo summarized the claims at issue Prometheus, as well as its holding.  Dr. Sauer then summarized the history of the claimed diagnostic method leading up to the filing of the lawsuit.  This led to a discussion of what is viewed by most patent practitioners as a major faux pas by the Supreme Court; that is bringing novelty analysis into a determination of patentable subject-matter.

Ms. Bennett went on to thoroughly opine on what she felt the impact of this type of analysis might have on an attorney as well as on judges.  In her view, the patentable subject-matter test should be seen as a threshold test, with novelty and obviousness analyzed after this test is completed, not simultaneously with the test.  She stated that the Supreme Court has seemingly created a new test where novelty is not only analyzed before section 101 analysis, it factors into the determination.  She believes that this could create a situation that makes claim drafting and patent prosecution difficult because "the test has been muddled."  Mr. Triolo noted that the Court stated that one should "take a peek" at novelty and obviousness during the analysis.  Hence, the Court has provided no real guidance for prosecutors to surmise what types of claims will pass muster under section 101.  As for its effect on judges, Ms. Bennett believes that it will be difficult for them to apply the holding to other cases in the future.  For example, was the Court limiting its holding to the facts of Prometheus?  Or should its holding be applied broadly, e.g., to biological composition of matter claims?  She warned that if this is the situation, it would put the U.S. "in a very different place from the rest of the world."

Ms. Gordon then moved the discussion toward how the USPTO is dealing with Prometheus.  The only guidance that the Office has provided so far is that a claim must encompass significantly more than a natural law (see "USPTO Issues Preliminary Guidance on Mayo v. Prometheus").  The Office makes no mention however, regarding a novelty component in the analysis.  Dr. Sauer commented that the Office is struggling with how to handle currently pending cases in view of the number of cases that have been and are being remanded in view of Prometheus.  He stated later in the session that the prevailing feeling at the Office is one of disappointment in the holding.  He pointed out that the Office has not signed any of the briefs being currently submitted for the Myriad case and is not happy with the Department of Justice's stance on the case.  In a sense, the Office believes that the DOJ's contentions are making it difficult to examine and grant patents.  Regarding ideas for how prosecutors should draft claims going forward, Ms. Gordon stated that it may be necessary to add more specific methodology (which could be interpreted as meaning more "active" steps) to claims to get around the "framework" developed by the Court in Prometheus.

The discussion then moved to whether the holding in Prometheus will be applicable to the re-hearing of the Myriad case.  Mr. Triolo stated that it was hard for him to find the relevance of the holding to composition claims.  He did however follow up by saying that one could argue that, e.g., an isolated DNA molecule is a product of a natural product, but that was not necessarily an argument he agreed with.  Dr. Sauer stated that it was his belief that the claims at issue in the Myriad case should be reviewed under Chakrabarty because its law is still good law and is controlling for compositions of matter or articles of manufacture.  He does not believe that Prometheus is applicable to compositions of matter.  He hastened to read too much into the GVR of the Myriad case by analogizing it to the time when Chakrabarty was decided; at that time Flook, which encompassed an abstract idea, was good law.  The Court did not use Flook in its analysis in Chakrabarty.

The upcoming months and years will determine the future of personalized medicine in the U.S.  There are several pending cases that will play roles in this determination.  Ms. Gordon opened up the panel by stating that the claims that will be at issue going forward (claims that focus on the importance of biomarkers) highlight the tension between personalized medicine and affordable health care.  In one sense, this debate is viewed in the public as "patent vs. patient."  However, even in view of this somewhat negative perception, many in the patent community believe that patent practitioners should continue to try to get patents for these very important personalized medicine-related inventions.  Patent Docs will continue to bring you updates from BIO 2012 throughout this week.  And if you are at BIO, stop by and see the Docs at booth 1335.