Just fifteen months after the Supreme Court issued its landmark decision in Association for Molecular Pathology v. Myriad Genetics, Inc. 133 S.Ct. 2107 (2013)(AMP), holding that a naturally-occurring DNA segment is not patent-eligible merely because it has been isolated, Myriad was back at the Federal Circuit on Monday in another battle over the boundaries of patent eligibility for biotech products.

I. Background

On the same day that the Supreme Court decided AMP, Ambry Genetics Corp. announced that it would begin marketing its own BRCA test at a significantly lower cost than Myriad's tests. Myriad sued Ambry in the U.S. District Court for the District of Utah, alleging infringement of several of the remaining claims in its BRCA patent portfolio. The remaining claims included those directed to primer pairs used in PCR and methods for screening germline mutations in the BRCA1 gene. Myriad concurrently filed a Motion for Preliminary Injunction, alleging that it would suffer irreparable harm if Ambry were permitted to launch its product.

The District Court denied the injunction motion, finding that Ambry had raised a substantial question as to the validity of the claims under 35 U.S.C. § 101, since the claims were similar to those rejected in the Supreme Court's Mayo v. Prometheusdecision and the Federal Circuit’s method claims rulings in AMP, which were not reviewed by the Supreme Court. Specifically, the judge held that "[a]side from the patent ineligible, naturally occurring nucleotide sequence of the BRCA1 and BRCA2 genes, the other steps set forth in the Method Claims are conventional activities that were well-understood and uniformly accepted by those working with DNA." While the District Court found that Myriad had shown a likelihood of irreparable harm in the form of price erosion, the court held that the overall balance of hardships favored denying the motion.

II. Federal Circuit Briefing

Myriad appealed, arguing that the Supreme Court decision in AMP should not be applied further than its narrow ruling that the isolated BRCA genes themselves are not patent eligible, and that the Supreme Court had further stated that Myriad could lawfully claim applications of that gene, including cDNAs.

With regard to the primer claims, Myriad argued that "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 Brief at 4-5).

With regard to the method claims, Myriad argued first that the methods are applications of the discovery of the BRCA gene sequences, which the Supreme Court has held are patent-eligible, not the gene sequences themselves. Further, Myriad argued that the District Court erred in splitting the method claim into pieces for analysis rather than analyzing the claim as a whole. Myriad argued that the District Court improperly removed the gene sequence from the claim and then found that the remaining claim elements were no more than conventional activities that were well-understood and uniformly employed by those of skill in the art. Rather, Myriad argued, the process of using these primers was new, and had never been used before.

III. Oral Argument

On Monday, October 6, Chief Judge Prost and Judges Dyk and Clevenger heard oral argument from Myriad and Ambry. Two main issues dominated the argument: the correct implementation of the Mayo test for patent eligibility, and the classification of probes and primers. The impact on the biotechnology industry was also discussed.

a. Correct Test for Patent Eligibility

There has been ongoing speculation as to how the Federal Circuit will interpret the Mayo test for patent eligibility. Chief Judge Prost gave an indication of her view when she immediately stated that she was confused by Myriad's reading of the Mayo test to require a consideration of the claim as a whole. She asked whether the Mayo test did not indicate that the law of nature should be removed from the claim, and the additional steps should be examined to see if they add anything new or non-conventional.

Myriad responded that such a reading of the Mayo test would render method claims that had expressly been found patent eligible by the Federal Circuit to be invalid. In AMP, the Federal Circuit held claims directed to a sequence used in an in vitro assay to be patent eligible. Myriad argued that inserting an isolated gene sequence into a cell with a plasmid, the method upheld as patent eligible in AMP, is as "conventional" to a scientist as using a primer for PCR.

b. Probes and Primers—More Akin to cDNA or Isolated Genomic DNA?

According to Myriad, the primers are essentially the same as cDNA, which the Supreme Court explicitly found to be patent-eligible. Ambry argued, however, that a primer essentially is just isolated DNA, which the Supreme Court held to be unpatentable. When Judge Clevenger asked Ambry about whether a primer may be considered to be like cDNA, Ambry cited Justice Thomas' proviso from AMP that when cDNA is indistinguishable from a portion of genomic DNA, the cDNA is not patent eligible.

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The panel addressed two other issues that could influence the decision, other than the issue of subject matter eligibility. First, though contested both by Myriad and Ambry, Judges Dyk and Clevenger seemed to consider claim 21 of the patent — a dependent screening claim that specified a particular mutation for screening — to be inherently more patent eligible than a broad screening claim that claimed a screen for all mutations. Second, all three judges referenced the standard for preliminary injunctions, indicating that Myriad was arguing the appeal as though the claims had been found invalid, when the standard for preliminary injunction is much lower, requiring only a "substantial question" of invalidity.

The panel inquired about the effect on the biotechnology industry of a holding that primers and screening methods are not patent eligible subject matter. The panel at one point asked Ambry what use Myriad might make of its discovery if it were not permitted to obtain any type of patent protection. Though the panel certainly left room to decide this case on grounds other than the patent eligibility of screening claims and primers, Myriad called for a decision on the merits since it viewed the biotechnology industry as "at sea" as long as this issue remains unresolved.