Friday, August 17, 2012

Association for Molecular Pathology v. US PTO Decided on Remand

As reported in previous posts, on petition for certiorari the Supreme Court vacated the Federal Circuit's 2011 decision in Association for Molecular Pathology v. US PTO and remanded the case for further consideration in light of its decision in Mayo v. Prometheus. Yesterday, the Federal Circuit issued its decision on remand. Of course, this might not be the end of the story, since the plaintiffs will presumably petition for rehearing by the en banc Federal Circuit and/or certiorari by the Supreme Court. Some believe that the Supreme Court is likely to grant certiorari, based on the diverging opinions of the three Federal Circuit judges, and the arguably short shrift given by the majority to the relevance of Mayo to the Myriad claims.
Not surprisingly, the Mayo decision and the parties' subsequent re-briefing and re-arguing of the case did not alter the views of any of the three Federal Circuit judges deciding the case. As was the case in the first decision, the judges all agreed that the claims directed towards methods of testing for genetic variations in the BRCA genes are patent ineligible.  The majority (Judges Lourie and Moore) held the claims to isolated DNA molecules and the claim reciting a method for using a cell-based assay to screen for potential cancer drugs (claim 20) to be patent eligible. Judge Bryson, in dissent, agreed that claim 20 is patent eligible, but maintained his earlier position that the isolated DNA claims are patent ineligible, based largely on perceived policy concerns.

Writing for the majority, Judge Lourie noted that the only issue to be considered on remand was the applicability of the Supreme Court’s Mayo holding to the patent eligibility of the claims at issue.  He emphasized that the court was not addressing the overall patentability of the claims, only the eligibility of the claimed subject matter for patent protection, nor was the court addressing the policy concerns that had been raised with respect to "gene patents" and Myriads patent enforcement and licensing practices.
With respect to the isolated DNA claims, Judge Lourie found that Mayo "does not control," because the claims are directed towards compositions of matter, not methods. Recall that all of the claims at issue in Mayo were directed towards processes, not compositions of matter, and many  (including myself) have arguedthat Mayo is not applicable to composition of matter claims.

Judge Lourie appears to have adopted this position, explaining that “while Mayo and earlier decisions concerning method claim patentability provide valuable insights and illuminate broad, foundational principles, the "the Supreme Court’s decisions in Chakrabarty and Funk Brothers set out the primary framework for deciding the patent eligibility of compositions of matter, including isolated DNA molecules.” Based on this premise, he ruled that “the issue of patent-eligibility [with respect to composition of matter claims] remains, as it was on the first appeal to this court, whether they claim patent ineligible products of nature.” In the view of the majority, the claimed isolated DNA molecules are not found in nature, and hence are not products of nature, but rather patent eligible compositions of matter.

The majority also held that Mayo did not alter the outcome with respect to the method claims. The patent ineligibility of the method of diagnostic claims was a foregone conclusion  - as interpreted by the Federal Circuit, they could be infringed by merely comparing DNA sequence information, and hence lie much further down the spectrum of patent ineligibility than the claims at issue in Mayo, which at least involved a physical step of analyzing a blood sample taken from a patient.

The patent eligibility of claim 20 was more in doubt. Conceivably, the claim could have been found patent ineligible under a broad reading of Mayo. In fact, Eli Lilly submitted an amicus brief arguing that claim 20 was patent ineligible because it involved a step that could be performed in the mind. If the court had adopted Lilly’s radical theory of patent eligibility, it could have drastically constricted the range of patent eligible methods (and in doing so substantially eased the freedom to operate concerns of research pharmaceutical companies such as Eli Lilly). However, the court declined to go down this route, and did not even mention Lilly’s proposal.
Judge Lourie essentially held claim 20 to be patent eligible because the claimed method is based on a man-made, non-naturally occurring (and hence patent eligible) material, i.e., a cell transformed with a BRCA gene.  This is an interesting interpreation of Mayo. Recall that the method claims found to be patent ineligible in Mayo all center around the analysis of man-made, non-naturally occurring (and hence presumably patent eligible) drugs and drug breakdown products.  Judge Lourie chose not explain the distinction between claim 20 and the method claims at issue in Mayo.

Questions Remaining

The decision leaves unanswered a number of questions. For example, the majority's decision with respect to the isolated DNA claims seems to depend upon the chemical structural differences between the claimed isolated DNA and DNA that occurs naturally. In particular, Judge Lourie emphasized that the isolation of DNA molecules inherently involves the breaking of covalent bonds, and hence the isolated DNA molecule is chemically distinct from its natural counterpart. Where does that leave isolated natural products that are not chemically distinct from their natural counterpart, i.e., what if the isolation of a natural product does not inherently involve breaking covalent bonds?

Judge Lourie makes much of a perceived distinction between "isolation" and "purification" of DNA molecules, and seems to suggest that the mere purification of a natural product might not be sufficient for patent eligibility. This is concerning, because isolated natural products have long been considered patent eligible.  The amicus brief submitted by the Biotechnology Industry Organization provides numerous examples of non-DNA isolated natural products that have been patented, and that have proven highly beneficial to society.

There is also the important question of to what extent methods of diagnostic testing, and personalized medicine, or eligible for patent protection in view of Mayo.  The Myriad method of diagnostic claims held to be patent ineligible in this case were interpreted by the court to cover the mere mental comparison of genetic sequence information, and clearly such claims are patent ineligible. But the vast majority of diagnostic claims involve physical steps such as obtaining physical samples from patients, performing clinical tests on the sample, and/or using the information generated in the treatment of a patient. It is not clear at this point how these claims would fare under a Mayo analysis, but Judge Lourie's opinion with respect to claim 20 suggests he would interpret Mayo in a manner that would maintain patent eligibility of at least some diagnostic/personalized medicine claims, if drafted more narrowly than Myriad’s claims.