And Myriad Genetics, Inc. v. Ambry Genetics Corp. (In re Brca1-And Brca2-Based Hereditary Cancer Test Patent Litig. Univ. of Utah Research Found.), 2014-1361

• Decision Date: 17 December 2014
• Docket Number: 2014-1366,2014-1361
• Parties: IN RE BRCA1-AND BRCA2-BASED HEREDITARY CANCER TEST PATENT LITIGATION UNIVERSITY OF UTAH RESEARCH FOUNDATION, THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, HSC RESEARCH AND DEVELOPMENT LIMITED PARTNERSHIP, ENDORECHERCHE, INC., AND MYRIAD GENETICS, INC., Plaintiffs-Appellants, v. AMBRY GENETICS CORPORATION, Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

IN RE BRCA1-AND BRCA2-BASED HEREDITARY CANCER TEST PATENT LITIGATION

UNIVERSITY OF UTAH RESEARCH FOUNDATION, THE TRUSTEES
OF THE UNIVERSITY OF PENNSYLVANIA, HSC RESEARCH AND
DEVELOPMENT LIMITED PARTNERSHIP, ENDORECHERCHE, INC.,
AND MYRIAD GENETICS, INC., Plaintiffs-Appellants,
v.
AMBRY GENETICS CORPORATION, Defendant-Appellee.

2014-1361
2014-1366

United States Court of Appeals for the Federal Circuit

December 17, 2014

Appeals from the United States District Court for the District of Utah in Nos. 2:13-cv-00640-RJS and 2:14-md-02510-RJS, Judge Robert J. Shelby.

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JONATHAN E. SINGER, Fish & Richardson P.C., of Minneapolis, Minnesota, argued for plaintiffs-appellants. With him on the brief were DEANNA J. REICHEL; and GEOFF D. BIEGLER, of San Diego, California. Of counsel on the brief were DAVID G. MANGUM, MICHAEL R. MCCARTHY, KRISTINE E. JOHNSON, and C. KEVIN SPEIRS, Parsons Behle & Latimer, of Salt Lake City, Utah.

WILLIAM G. GAEDE, McDermott Will & Emery LLP, of Menlo Park, California, argued for defendant-appellee. With him on the brief were ERIC W. HAGEN and JAMES W. HILL; M. MILLER BAKER and DANIEL K. GREENE, of Washington, DC, and JOHN C. LOW, of Houston, Texas.

SANDRA S. PARK, American Civil Liberties Union Foundation of New York, New York for amici curiae. With her on the brief was LENORA M. LAPIDUS. Of counsel on the brief was BARBARA JONES, AARP Foundation Litigation of Pasadena, California.

Before PROST, Chief Judge, CLEVENGER and DYK, Circuit Judges.

DYK, Circuit Judge.

Plaintiffs are the University of Utah Research Foundation, The Trustees of the University of Pennsylvania, HSC Research and Development Limited Partnership, Endorecherche, Inc., and Myriad Genetics, Inc. (collectively "Myriad"). Myriad owns U.S. Patent No. 5,753,441 ("the '441 patent"), U.S. Patent No. 5,747,282 ("the '282 patent"), and U.S. Patent No. 5,837,492 ("the '492 patent"), which cover compositions of matter and methods relating to the BRCA1 and BRCA2 genes. Defendant is Ambry Genetics Corporation ("Ambry"), a company that

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sells medical kits designed to test for the presence of gene mutations linked to breast and ovarian cancer.

Myriad sought to, inter alia, enjoin alleged infringement of six claims of three patents: claims 7 and 8 of the '441 patent, claims 16 and 17 of the '282 patent, and claims 29 and 30 of the '492 patent. Myriad appeals from a decision of the District Court for the District of Utah denying Myriad's motion for preliminary injunction. Because we hold that these claims are directed to ineligible subject matter under 35 U.S.C. § 101, we affirm and remand.

BACKGROUND

The Supreme Court has addressed some of the patents at issue here in its June 13, 2013, opinion in Association for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013) ("Myriad"), as has our court in Association for Molecular Pathology v. United States Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011), vacated, 132 S. Ct. 1794 (2012), and Association for Molecular Pathology v. Myriad, 689 F.3d 1303 (Fed. Cir. 2012), aff'd in part, rev'd in part, 133 S. Ct. 2107 (2013). This case involves claims of those patents not previously considered by the Supreme Court or by this court. A brief summary of the relevant factual background follows.

In the 1990s, Myriad and its partners discovered the precise locations and sequences of the BRCA1 and BRCA2 genes, mutations of which are linked to hereditary breast and ovarian cancers. By discovering the particular locations and sequences of the genes, Myriad was able to determine the typical sequences of the genes most often found in humans (i.e., the "wild-type" sequence for each), as well as mutations, which depart from the two wild-type sequences. Some mutations are harmless, but other mutations are correlated with an increased likelihood of

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developing particular cancers. By testing for the presence of these mutations, doctors can determine whether the patient is particularly prone to developing breast or ovarian cancer. Myriad's efforts to commercialize its discovery through the sale of medical test kits have been successful; to date, Myriad has earned roughly $2 billion in revenue from the sale of the tests.

The Supreme Court, in its Myriad decision, held that claims of the '282 patent directed to isolated DNA were drawn to patent-ineligible subject matter because the isolated DNA strands, which are naturally occurring and separated from the rest of the human genome, were natural phenomena. See Myriad, 133 S. Ct. at 2117-19. Thereafter, generic competitors, including Ambry, entered the market for medical kits designed to test for susceptibility to particular kinds of cancer.

On July 9, 2013, Myriad sued Ambry in the United States District Court for the District of Utah and, on that same day, requested a preliminary injunction. Myriad's amended complaint alleges infringement of sixty-six claims across fifteen different patents. The preliminary injunction motion asserted, inter alia, the six claims listed above.¹

On March 10, 2014, the district court denied Myriad's motion for preliminary injunction. In a detailed, 106-page opinion, the court found that Myriad was unlikely to

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succeed on the merits because the claims were likely drawn to ineligible subject matter, although it found that Myriad would likely suffer irreparable harm from the denial of the injunction and the public interest was in equipoise. The court found that the balance of hardships slightly favored Ambry.

The four composition of matter claims now on appeal are directed to primers, which are "short, synthetic, single-stranded DNA molecule[s] that bind[] specifically to . . . intended target nucleotide sequence[s]." J.A. 13. The court held these were likely patent ineligible because they claim so-called products of nature—that is, they claim the same nucleotide sequence as naturally occurring DNA.

The two method claims now on appeal involve comparisons between the wild-type BRCA sequences with the patient's BRCA sequences. The court reasoned that these method claims were likely ineligible because "the only 'inventive concepts' in the[] [m]ethod [c]laims are the patent ineligible naturally occurring BRCA1 and BRCA2 sequences themselves." J.A. 93. As found by the district court, "the other steps set forth in the method claims are conventional activities that were well-understood and uniformly employed by those working with DNA at the time Myriad applied for its patents . . . ." J.A. 94.

We have jurisdiction pursuant to 28 U.S.C. §§ 1292 and 1295. We review the district court's denial of a motion for preliminary injunction for abuse of discretion, but we review legal issues relating to that denial de novo. Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1375 (Fed. Cir. 2009); Globetrotter Software, Inc. v. Elan Computer Grp., Inc., 236 F.3d 1363, 1367 (Fed. Cir. 2001). The ultimate question of patent eligibility under

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§ 101 is an issue of law, reviewed de novo. Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1333 (Fed. Cir. 2012).

DISCUSSION I

We consider separately the asserted composition of matter claims and the asserted method claims. We address first the composition of matter claims (the "primer" claims). Claim 16 of the '282 patent is representative. It is directed to:

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.

'282 patent col. 155 ll. 23-29. Claim 17 of the '282 patent and claims 29 and 30 of the '492 patent are similar to claim 16 of the '282 patent.

Our analysis of the primer claims under § 101 is guided by the Supreme Court's Myriad decision. In its 2013 Myriad decision, the Supreme Court reviewed claims 1, 2, 5, 6, and 7 of the '282 patent, claim 1 of U.S. Patent No. 5,693,473, and claims 1, 6, and 7 of the '492 patent. Myriad, 133 S. Ct. at 2113 n.2. Six of the nine claims covered isolated DNA molecules, which are DNA strands that have been separated from the rest of the human genome. The remaining claims, claims 2 and 7 of the '282 patent and claim 7 of the '492 patent, covered isolated cDNA molecules, which are synthetically created DNA molecules consisting only of exons—DNA nucleotides that

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code for amino acids. Myriad, 133 S. Ct. at 2111; Myriad, 689 F.3d at 1329 n.12.

The Court held ineligible the isolated DNA claims, explaining: "Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them." Myriad, 133 S. Ct. at 2116. Rather, "Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA[ genes]." Id. Even if Myriad made a "[g]roundbreaking, innovative, or even brilliant discovery," id. at 2117, that is not enough. With respect to the isolated DNA, "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention." Id. The Court held that "[g]enes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material." Id. at 2120.

The cDNA claims, however, were held to be patent eligible under § 101. cDNA is an exon-only sequence, with no introns, that does not occur in nature, "except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA." Id. at 2119. To the extent that the exon-only sequence does not exist in nature, the lab technician "unquestionably creates something new when cDNA is made." Id.

The primers before us are not distinguishable from the isolated DNA found patent-ineligible in Myriad and are...