In a decision issued March 10, 2014, Judge Shelby of the U.S. District Court for the District of Utah denied Myriad’s motion for a preliminary injunction against Ambry Genetics Corp. While Ambry had challenged the validity of the Myriad BRCA claims on several grounds, the district court ruled on the most interesting one–patent eligibility. In particular, the court found that Ambry had “raised a substantial question” whether Myriad’s Primer Claims and Method Claims are directed to “patent [in]eligible products of nature and abstract ideas.” If Myriad does not appeal this decision, it is likely to lose not only its infringement suit against Ambry, but also its pending suits against other accused infringers.

The Myriad Claims at Issue

The court divided the Myriad BRCA claims at issue into the Primer Claims and the Method Claims.

The Primer Claims included claims 16 and 17 of U.S. Patent No. 5,747,282 and claims 29 and 30 of U.S. Patent No. 5,837,492. Claims 16 and 17 of the ’282 patent are representative.

16. A pair of single-stranded DNA primers for determination of a nuycleotide [sic] sequence of a BRCA1 gene by a polymerase chin [sic] reaction, the sequence of said primers being derived from human chromosomne sic] 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.

17. The pair of primers of claim 16 wherin [sic] said BRCA1 gene has the nucleotide sequence set forth in SEQ ID NO:1.

It is important to recognize that the recited primers have nucleotide sequences that correspond to fragments of the naturally occurring BRCA1 and BRCA2 sequences.

The Method Claims included claims 7 and 8 of U.S.Patent No. 5,753,441, claim 4 of U.S. Patent No. 6,033,857, claim 5 of U.S. Patent No. 6,951,721, and claims 2 and 4 of U.S. Patent No. 5,654,155. Claim 4 of the ’857 patent is representative:

4. The method of claim 2 wherein the detection in the alteration in the germline sequence is determined by an assay selected from the group consisting of (a) observing shifts in electrophoretic mobility of single-stranded DNA on non-denaturing polyacrylamide gels, (b) hybridizing a BRCA2 gene probe to genomic DNA isolated from said tissue sample, (c) hybridizing an allele-specific probe to genomic DNA of the tissue sample, (d) amplifying all or part of the BRCA2 gene from said tissue sample to produce an amplified sequence and sequencing the amplified sequence, (e) amplifying all or part of the BRCA2 gene from said tissue sample using primers for a specific BRCA2 mutant allele, (f) molecularly cloning all or part of the BRCA2 gene from said tissue sample to produce a cloned sequence and sequencing the cloned sequence, (g) identifying a mismatch between (1) a BRCA2 gene or a BRCA2 mRNA isolated from said tissue sample, and (2) a nucleic acid probe complementary to the human wild-type BRCA2 gene sequence, when molecules (1) and (2) are hybridized to each other to form a duplex, (h) amplification of BRCA2 gene sequences in said tissue sample and hybridization of the amplified sequences to nucleic acid probes which comprise wild-type BRCA2 gene sequences, (i) amplification of BRCA2 gene sequences in said tissue sample and hybridization of the amplified sequences to nucleic acid probes which comprise mutant BRCA2 gene sequences, (j) screening for a deletion mutation in said tissue sample, (k) screening for a point mutation in said tissue sample, (l) screening for an insertion mutation in said tissue sample, (m) in situ hybridization of the BRCA2 gene of said tissue sample with nucleic acid probes which comprise the BRCA2 gene.

The Preliminary Injunction Inquiry

In order to be granted a preliminary injunction, the party seeking the injunction must be able to satisfy the following four factors, with the first two being critical:

1. it has a likelihood of success on the merits
2. it is at risk of irreparable harm in the absence of the preliminary injunction
3. the balance of hardships tips in its favor
4. an injunction is in the public interest

Judge Shelby found that Myriad had shown that it was likely to suffer irreparable harm without an injunction, but had not shown a likelihood of success on the merits in view of Ambry’s patent eligibility challenges. Judge Shelby also found that the balance of hardships tipped in Ambry’s favor (because it would lose its business), and that there were “compelling public interest arguments advanced by both sides,” such that the public interest factor did not weigh in favor of granting or denying an injunction.

The Myriad Primer Claims

The district court found two reasons to doubt the patent eligibility of the Primer Claims.

First, applying the Supreme Court decision in Myriad, Judge Shelby concluded:

[T]his court interprets AMP to stand for the proposition that even synthetic, non-cDNA, isolated DNA is patent ineligible where it reflects the same nucleotide sequence as the genomic DNA.

In so doing, the court rejected Myriad’s arguments that synthetically made DNA is patent eligible subject matter.

Second, conducting a more independent analysis based on Myriad, Funk Brothers and Chakrabarty, Judge Shelby found that Ambry had raised a substantial question because the primers were “not ‘markedly different’ from naturally occurring DNA.” In this section of the analysis, the court found that Myriad’s arguments regarding the recitation of pairs of primers were unavailing in view of Funk Brothers, and determined that the usefulness of the primers in PCR does not support patent eligibility because PCR merely exploits natural hybridization properties.

The Myriad Method Claims

As summarized in the district court decision, Myriad’s primary argument in support of the patent eligibility of the Method Claims was that they “employ specific laboratory testing processes that apply Myriad’s discovery of the BRCA1 and BRCA2 genes to develop physical steps that were not well-understood, routine, or conventional at the time the patents were filed.” The court analyzed the claims in view of the Supreme Court decision in Prometheus, which it read as requiring it to consider two points:

1. whether the Method Claims at 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.

The court’s determinations were not favorable to Myraid on either point.

With regard to the first point, the court found:

[T]he only “inventive concepts” in their Method Claims are the patent ineligible naturally occurring BRCA1 and BRCA2 sequences themselves. The claims contain no otherwise new process for designing or using probes, primers, or arrays beyond the use of BRCA1 or BRCA2 sequences in those processes.

With regard to the second point, the court found:

[I]f allowed, Plaintiffs’ Method Claims would essentially foreclose the most widely used means to study and test for BRCA1 and BRCA2 genes.

The court also found “striking” similarities between the Myriad Method Claims and the claims at issue in Ariosa Diagnostics, Inc. v. Sequenom, Inc., where the U.S. District Court for the Northern District of California found that Sequenom’s claims to methods of diagnosing fetal conditions by detecting cell-free fetal DNA in maternal plasma were not patent eligible. (This PatentDocs article by Kevin Noonan has a good summary of the Sequenom case and Sequenom’s arguments in its pending appeal to the Federal Circuit.)

Thus, the court determined that Ambry had “raised a substantial question concerning the Method Claims’ subject matter eligibility.”

Based on the foregoing, the court concluded that Myriad had not established a likelihood of success on the merits, and so was “not entitled to a preliminary injunction at this time.”

Is This the End for the Myriad BRCA Claims?

Although the decision here is not a final decision on the merits of the patent eligibility issue, it is difficult to imagine Judge Shelby reaching a different conclusion after further proceedings, unless the Federal Circuit issues more guidance in the meantime (as it may do in Sequenom.) Thus, it is likely that Myriad will appeal this decision, unless it is able to reach settlement agreements with Ambry and the defendants in its other pending patent infringement suits. Although Myriad recently settled with Gene By Gene, this decision likely will undermine Myriad’s ability to negotiate favorable terms with the remaining defendants.