On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. In the words of Myriad “[t]his appeal … presents this Court with one of the most basic issues under patent law: should Myriad be able to enforce its patents to enjoy its remaining exclusivity or does section 101 of the Patent Act effectively say that Myriad can patent almost nothing related to its ground-breaking discovery?” Myriad Opening Brief (“Opening”) at page 4. In addition to responding to Myriad’s query regarding its patent estate, the Federal Circuit’s review has the potential to provide much needed clarity for diagnostic innovators and patent holders, as well as the U.S. Patent and Trademark Office, regarding the scope and reach of the U.S. Supreme Court’s recent patent-eligibility decisions.

Ambry Genetics and BRCA1/2 Testing

On the same day the Supreme Court issued (Assn. for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2120 (2013)) (“AMP”), Ambry Genetics Corp. (“Ambry”) announced that it would begin offering its own BRCA test at a price undercutting the price of Myriad’s test. Soon thereafter, Myriad sued Ambry in the U.S. District Court for the District of Utah alleging infringement of select claims from several of Myriad’s U.S. patents covering pairs of synthetic DNA strands or “primer pairs” and methods for analyzing BRCA1 and BRCA2 sequences. More specifically, Myriad’s asserted claims relate to pairs of single stranded DNA primers for use in the polymerase chain reaction (PCR). Other asserted claims cover methods for screening germline mutations in the BRCA1 gene.

Myriad also moved for a preliminary injunction, arguing that the sale of Ambry’s test caused Myriad irreparable harm. Ambry opposed the motion, alleging that the claims were invalid under 35 U.S.C. §§ 101, 102, 103 and 112. The district court denied Myriad’s motion for preliminary injunction, finding that damages would be adequate to compensate the company for its harm should it subsequently prevail. The district court also found that Ambry had raised a substantial question that the asserted claims were invalid under 35 U.S.C. § 101 (patent-eligibility) because the method claims, as a group, were similar in form to the abstract method claims invalidated in AMP.

Myriad’s Appeal

Myriad appealed, noting the district court improperly extended the reach of Mayo and AMP: “While the Supreme Court may have ruled that the isolated BRCA genes themselves were not patentable, it declined to go any further, and stated that Myriad could lawfully claim applications of that gene, including for example, BRCA cDNAs. It is thus manifestly not the case – as the district court found – that Myriad’s methods of diagnosis employing BRCA-related probes and primers are “conventional” or unlawfully preempt use of the gene, and it is manifestly not the case that pairs of short, single-stranded BRCA-related DNA primers created in the lab to initiate the polymerase chain reaction (“PCR”) in order to replicate portions of the BRCA genes are unpatentable “products of nature” under the Supreme Court’s precedent.” Opening at pages 4-5.

Myriad further argues that the Supreme Court’s 2013 AMP decision does not preclude the patenting of applications of that knowledge – applications of the knowledge of the BRCA gene sequences. Opening at pages 5-6.  Myriad alleges that the district court erred in its analysis of the method claims, in particular its application of the 2012 U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) (Mayo) decision. As summarized by Myriad, the district court’s application of the “Mayo” test for whether a claim is patent-eligible is: “‘whether the Method Claims as issue set forth an ‘inventive step’ aside from the patent ineligible subject matter, and beyond ‘well-understood, routine, conventional activity previously engaged in’ by those in the field; and 2) whether allowing the Method Claims risks preempting the use of a natural law, natural phenomenon, or abstract idea.” Opening at pages 21-22 (internal citations omitted).

Myriad further argues that the district court also erred in failing to review and analyze the claims as a whole in that the court improperly split the claims into pieces, ignored the BRCA gene sequence elements in the claims, and then found that the remaining claim elements were no more than conventional activities that were well-understood and uniformly employed by those working in the field. Myriad asserts that when the claims are viewed as a whole, they are patentable applications of its discovery of the BRAC sequences.

With respect to the primer pairs, Myriad alleges that the district court erred in finding them to be ineligible products of nature because they are designed and made by scientists in a laboratory and have a utility distinct from isolated DNA fragments.

The ACLU’s Brief in Support of Ambry

The American Civil Liberties Union (ACLU), the Association for Molecular Pathology, the Breast Cancer Action, the Public Patent Foundation, and AARP, (collectively “ACLU”), as Amici Curie, filed a brief in support of Appellee Ambry Genetics.

The Method Claims

Interestingly but not surprisingly, the ACLU suggests a different test for the analysis of Myriad’s method claims. The ACLU asserts that to apply Mayo, the court should determine whether the claimed method “is based on an inventive concept, and whether the patent ties up the use of underlying natural phenomena.” ACLU Brief at page 6. Under this test the ACLU argues, Myriad’s method claims do not satisfy 35 U.S.C. § 101 because the claims are only directed at whether a patient has a BRCA1 mutation, which is a law of nature. In the ACLU’s view, the additional methods steps in the claims are simply routine, preparatory steps that were not invented by Myriad. In addition, Myriad’s patented technology is alleged to disproportionately tie up the use of the underlying natural laws.

The Primer Claims

The primer claims also are alleged to lack patent-eligibility. The ACLU asserts that the primers sequences are the same as naturally-occurring sequences of the BRCA1 gene and they do not have markedly different characteristics from naturally-occurring DNA. The primers are noted to hybridize to complementary segments of DNA, and based on this inherent natural function, are therefore argued to be analogous to the strains of bacteria in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).

Patents and the First Amendment

The ACLU also argues that the patents raise constitutional problems by monopolizing areas of knowledge and inquiry and claiming thought, and thereby interfering with scientific inquiry. Myriad’s patent claims, in the ACLU’s opinion, give Myriad control over an entire body of knowledge that violates the Constitution.

The parties’ briefs are attached. Myriad Opening Brief; Ambry Response BriefMyriad Reply Brief; ACLU Amicus Brief