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IP Alert: Federal Circuit Adds to the Myriad of Section 101 Decisions

December 18, 2014

Yesterday, in In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation, the Court of Appeals for the Federal Circuit held certain claims of two patents owned by Myriad Genetics, Inc., to be invalid for claiming unpatentable subject matter. This is the latest appellate decision to have addressed patents owned by Myriad; see these earlier alerts reporting others:
IP Alert: U.S. Supreme Court Issues Decision in AMP v. Myriad 
IP Alert: Federal Circuit Releases Highly Anticipated Decision in AMP v. Myriad 
IP Alert: Supreme Court Vacates and Remands Myriad Gene Patent Case  

The presence of an altered BRCA1 gene is correlated in some cases to increase cancer risk. Myriad Genetics owns a number of patents relating to medical testing for altered BRCA1 genes and has filed a number of lawsuits to enforce these patents. In the present case, Myriad sued Ambry Genetics Corporation to enjoin alleged infringement of claims in three patents. Two of the patents specified “DNA primers” useful in the BRCA1 analysis, and the third patent claimed a method for screening for an altered BRCA1 gene. 

The court held that all of the claims were invalid under 35 U.S.C. 101 for claiming unpatentable subject matter. Considering first the DNA primer claims, the court took the following claim as representative:

A pair of single-stranded DNA primers for determination of a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction, the sequence of said primers being derived from human chromosome 17q, wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.

Following the U.S. Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, the Federal Circuit determined that these DNA primer claims were unpatentable. The court reasoned that the DNA primers “necessarily contain the identical sequence of the BRCA sequence directly opposite to the [DNA] strand to which they are designed to bind,” and that the claimed primers were “structurally identical to the ends of DNA strands found in nature.” The court rejected a number of Myriad’s arguments to the contrary.

Turning to the asserted method claims, the phrasing of these claims was complex, but in essence each of these claims specified screening for an alteration of the BRCA1 gene by comparing certain sequences of the gene with “wild-type” BRCA1 sequences. The claim specified that the comparisons should be accomplished using standard comparison techniques. 

The court held that these claims were invalid as well. Following the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (discussed in an earlier alert here) the Federal Circuit determined that these claims were effectively drawn to a law of nature. Specifically, the court determined that claims recited “patent-ineligible elements,” namely, an abstract mental process of comparing and analyzing two gene sequences. The remaining claim elements specified the way in which the gene sequence was to be compared. The court reasoned that “[n]othing is added by identifying the techniques to be used in making the comparison because those comparison techniques were the well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences.”  

In reaching its opinion, the court expressed concern that the method claims were sufficiently broad as to preempt a large swath of research. Myriad attempted to analogize these claims to a different claim of one of the patents that an earlier panel of the court had suggested was patent- eligible. The court rejected this analogy, pointing out that the earlier-discussed claim had specified certain “expressly identified” gene alterations, namely, any of the 10 predisposing mutations of the BRCA1 sequence discovered by the patentee. In contrast, the claims at issue in this case were found to be “significantly broader and more abstract, as they claim all comparisons between the patient’s BRCA genes and the wild-type BRCA genes.” 

This latest Myriad decision gives further insight into the Federal Circuit’s section 101 reasoning, particularly in biotechnology cases. For more information, please contact Allen E. Hoover, the author of this alert.


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