Myriad’s Continuing Patent Debate

20 October 2014 Personalized Medicine Bulletin Blog

On October 6, 2014, the U.S. Court of Appeals for the Federal Circuit entertained oral argument in the interlocutory appeal of the district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. If you missed oral argument, the parties’ Supplemental Briefs filed in late September set forth some of the key points raised during oral argument. My prior post of September 29, 2014 summarizes the status of the dispute and the parties’ positions on patent-eligibility.

Myriad and Alice

 

Myriad focused its Supplemental Brief on the application of the U.S. Supreme Court’s most recent patent-eligibility opinion, Alice Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014) (“Alice”),arguing that application of Alice confirms the patent-eligibility of Myriad’s contested claims. According to Myriad, Alice’s two-part test asks (1) is the claim directed to one of the three categories of unpatentable subject matter, and if the answer to the first question is yes, then (2) do the claim elements both individually and as a whole recite “enough” to transform the unpatentable subject matter into a patent-eligible application? Myriad Supplemental Brief at page 1.

In applying Alice, Myriad notes that the district court failed to apply the test to the claims as a whole. Indeed, Alice explicitly “reiterates the importance of looking at the claims as whole and expressly confirms the rule in Diehr [Diamond v. Diehr, 450 U.S. 175 (1981)].” Myriad’s Supplemental Brief at page 7. Rather, the district court separated anything related to the BRCA genes from the claims and then found the remaining claim elements routine and conventional in the abstract.

The Primer Claims

Myriad first asserts that the claims directed to primer pairs are not directed to a “product of nature” because the pair is structurally and functionally different than a single fragment of DNA, that was found to fail Section 101 in the Supreme Court’s Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (“AMP”). Myriad argues that the coordinated pair is not found in nature (even in un-isolated form) and that the primers work together to prime a PCR reaction – a reaction that does not occur in the human body.

The Method Claims

Myriad’s claims to detecting BRCA1/2 mutations are noted to rely on specific techniques for the mutation detection and therefore yield valuable diagnostic information to the benefit of patients. In applying the Alice two part test, Myriad argues that that steps of the method claims, when considered together, effect an improvement in a technical field – by using Myriad’s probes and primers that Myriad invented. As such and in particular claims 7 and 8, are applications of Myriad’s knowledge of the BRCA sequences.

Ambry and Alice

 

The Primer Claims

In contrast, Ambry argues that the primer claims are patent-ineligible because, in addition to reciting patent-ineligible products of nature, the claims fail under Alice because they are a generic component (i.e., natural BRCA sequence) used to amplify a person’s gene sequence to access the sequence information for the patent-ineligible sequence comparison.

The Method Claims

Ambry’s argues that under Alice, the combination of unpatentable subject matter and a generic physical application is no more patent eligible than a claim reciting only the unpatentable subject matter.” Ambry Supplemental Brief at page 3. As applied to Myriad’s method claims, they argue, the additional steps are merely conventional and generic – e.g., generic steps of, hybridization, amplifying, and sequencing. Ambry also counters Myriad’s arguments that their claims are the application of knowledge discovered from the sequencing the BRCA genes and notes that Alice (and other precedents) precludes such distinction between the knowledge itself and its application. Therefore, Ambry argues that the human action of sequencing, hybridizing or amplifying BRCA DNA does not make the patent ineligible subject matter, patent eligible.

A Single Test?

 

As this case illustrates, the Federal Circuit has the challenge of developing a workable test to determine patent-eligibility, without regard to the exclusionary category of the claim. It is difficult to apply precedent developed to address an “abstract idea” (Alice) to claimed methods (laws of nature) or claimed products (products of nature). The question is then, whether one test is appropriate to determine patent-eligibility without regard to the particular technology. Perhaps, that is the first issue the Federal Circuit will address for the parties to this dispute and for the benefit of clearer guidance for the public.

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