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Prometheus, Myriad, and the future of personalized medicine.

In June of 2010, the Supreme Court decided Bilski, and in a 71 page opinion possibly changed the landscape with respect to patentable subject matter under 35 USC §101.  The biotechnology sector has anxiously waited to see how the Federal Circuit would apply the Bilski decision to methods of medical treatments, diagnostic methods cases, and biological molecules themselves.

The Federal Circuit may have provided a glimpse into the future with its decision last month in Prometheus v. Mayo, the closely watched diagnostic method case.  In an opinion authored by Judge Lourie, the Court delivered a seemingly simple message: it is business as usual for method of treatment claims.

Promethus is the sole and exclusive licensee of two patents claiming generally a method for optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder.  The method comprises the steps of “administering” a drug and “determining” a drug metabolite level, as well as a step wherein the level of metabolite determined “indicates a need” to change the amount of drug administered.  In March of 2008, the district court granted Mayo’s motion for summary judgment of invalidity under §101.  Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 04-CV-1200, 2008 WL 878910 (S.D. Cal. Mar. 28, 2008).  The court reasoned that the “’administering’ and ‘determining’ steps are merely necessary data-gathering steps for any use of the correlations [between the amount of drug administered and the level of metabolite following administration]” and that “as construed, the final step – the ‘warning’ step (i.e. the ‘wherein’ clause) – is only a mental step.” Further, the district court concluded that the “wherein” steps were natural phenomena and that the claims wholly preempted the use of the natural phenomena.

On appeal, the Court of Appeals of the Federal Circuit (CAFC) reversed the district court’s decision and upheld the asserted claim’s validity under the (at the time) definitive Bilski “machine-or-transformation” test.  In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) and Prometheus Laboratories, Inc. v Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009).  The CAFC reasoned that both the “administering” and “determining” steps were transformative under the second prong of the test: patent eligible if it “transforms a particular article into a different state or thing.”  Id. (quoting Bilski, 545 F.3d at 954).  Mayo timely filed its petition with the Supreme Court for a writ of certiorari.

The day after Bilski was decided, the Supreme Court granted certiorari in Prometheus and immediately vacated the CAFC’s decision and remanded the case for reconsideration in light of Bilski.   The question loomed large as to just how much there was for the CAFC to reconsider.  The answer appears to be “not much.”

Recall that the Supreme Court in its decision in Bilski provided little more than a punt back to the lower courts with respect to determining patent eligible subject matter.  Rather than providing clarity of the scope of §101 and the three acknowledged exceptions of laws of nature, physical phenomena and abstract ideas, the Court provided that the “machine-or-transformation” test is a “useful and important tool” yet is not deemed to be the exclusive test for patent eligible subject matter under 35 USC §101.  Unfortunately or not, the Court failed to provide any additional “useful or important” tools for the lower courts to utilize when determining patent eligible subject matter under §101.

The CAFC, relying heavily on its prior reasoning, reconsidered Prometheus and in essence stated that the Supreme Court did not disavow the “machine-or-transformation” test, and applied the test as a “useful tool” and again found for Prometheus.

So what does this mean for the future of method of treatment claims and more importantly diagnostic methods and the personalized medicine approaches that rely on them?  That remains to be seen but here are some things to watch for:

  • It is likely that Mayo will petition the Supreme Court for certiorari again but whether or not the Court will grant it is anybody’s guess.  It is not clear from the Bilski decision whether or not the Supreme Court believes it is responsible for providing additional guidance on patent eligible subject matter.
  • The CAFC has yet to issue an opinion in the Classen v. Biogen IDEC case.  Briefly, the claims at issue in Classen involve a method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group relative to a control group of mammals.  The method comprises the steps of immunizing mammals in the treatment group with one or more doses of one or more immunogens according to the immunization schedule, and comparing the incidence, prevalence, frequency or severity of the chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.  The CAFC originally affirmed the district court’s decision that Classen’s claims were not patent eligible under the “machine or transformation” test.  However, should the CAFC on remand from the Supreme Court apply the same reasoning as it has in Prometheus regarding the transformative effect of “administering” a drug, it seems that the Court has the opportunity to change its mind in Classen and find that “immunizing” with one or more immunogens is equally as transformative as “administering” a drug.
  • Perhaps one of the most interesting cases to be decided by the Federal Circuit this year is Myriad.  Myriad’s claims at issue are generally of two types: composition claims drawn to isolated DNA sequences and process or method claims of detecting alterations in a human subject’s BRCA1 gene sequence.  As the issues pertain to 35 USC §101, Judge Sweet of the Southern District of New York found that the composition claims were not patent eligible because the claimed isolated DNA is not markedly different from native DNA as it exists in nature.  Further, the Court found that the method claims were not patent eligible for failing to meet the “machine or transformation” test.  Although the district court considered Myriad’s arguments that the method claims necessitate the transformative step of extracting and analyzing the DNA sequences of human subjects to perform the methods, Judge Sweet was not persuaded.  Resolution of the composition of matter claims will likely rely heavily on claim construction.  However, it will be interesting to see whether or not the CAFC will rely again on the “machine or transformation” test as the “useful tool” for determining if Myriad’s method claims comprise patent eligible subject matter.

The Prometheus decision suggests that the CAFC is not willing to categorically exclude certain subject matter as unpatentable under §101.  Rather, the emerging theme from the CAFC appears to be that §101 is intended to be construed relatively broadly and is not to be used as a substitute for challenging the novelty, non-obviousness, and written description and enablement requirements of §102, §103, and §112, respectively.

At the heart of personalized medicine lies the diagnostic tests that reveal genetic markers associated with particular disease states and patient responsiveness to certain therapies.   Advancements in this field of medicine rely heavily on the investment of research and development dollars into both basic research to identify the appropriate genetic markers and development of an FDA-approved clinical test to determine the presence, absence, or correlative level of the appropriate genetic markers.  The incentive to invest in these advancements must come from somewhere.  The question remains whether the Supreme Court, Congress, or the biotechnology industry itself will decide just where that incentive will come from.