Univ. of Utah Research Found. v. Ambry Genetics Corp. (In re Brca1 & Brca2-Based Hereditary Cancer Test Patent Litig.)

• Decision Date: 10 March 2014
• Docket Number: MDL Case No. 2:14–MD–2510.,Case No. 2:13–CV–00640–RJS.
• Court: U.S. District Court — District of Utah
• Parties: In re BRCA1– and BRCA2–BASED HEREDITARY CANCER TEST PATENT LITIGATION. This Document Relates to: University of Utah Research Foundation, et al., Plaintiffs, v. Ambry Genetics Corporation, Defendant.

3 F.Supp.3d 1213

In re BRCA1– and BRCA2–BASED HEREDITARY CANCER TEST PATENT LITIGATION.This Document Relates to:University of Utah Research Foundation, et al., Plaintiffs,

v.Ambry Genetics Corporation, Defendant.

MDL Case No. 2:14–MD–2510.

Case No. 2:13–CV–00640–RJS.

United States District Court,

D. Utah,

Central Division.

Signed March 10, 2014.

David G. Mangum, C. Kevin Speirs, Kristine E. Johnson, Michael R. McCarthy, Parsons Behle & Latimer, Matthew S. Gordon, Benjamin G. Jackson, Myriad Genetics Inc., Salt Lake City, UT, Elizabeth M. Flanagan, Fish & Richardson PC, Wilmington, DE, Geoff D. Biegler, Fish & Richardson, San Diego, CA, Jonathan E. Singer, Fish & Richardson PC, Minneapolis, MN, for Plaintiffs.

Daniel Greene, William G. Gaede, III, McDermott Will & Emery LLP, Menlo Park, CA, Edgar R. Cataxinos, H. Dickson Burton, Joseph A. Walkowski, Traskbritt PC, Salt Lake City, UT, Eric W. Hagen, Vanessa Lefort, McDermott Will & Emery, Los Angeles, CA, John C. Low, McDermott Will & Emery LLP, Houston, TX, for Defendant.

MEMORANDUM DECISION AND ORDER DENYING PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION

ROBERT J. SHELBY, District Judge.

On June 13, 2013, the Supreme Court issued a unanimous decision holding that “genes and the information they encode are not patent eligible simply because they have been isolated from the surrounding genetic material.” Association for Molecular Pathology v. Myriad Genetics, Inc. (AMP), –––U.S. ––––, 133 S.Ct. 2107, 2120, 186 L.Ed.2d 124 (2013). This case arises in the aftermath of that decision.

Plaintiff Myriad Genetics, Inc. (Myriad) is recognized as the winner in the “race” to locate and sequence the BRCA1 and BRCA2 genes.¹ Myriad invested millions of dollars, including money obtained via public grants, in an effort to locate and sequence those genes in the early–to–mid–1 990s. Once it did, Myriad sought and obtained related patents, some of which will begin to expire in August 2014. Myriad also developed and commercialized tests to screen people for the presence of harmful variations in these genes. Myriad launched its flagship ‘BRACAnalysis' test in 1996 and debuted its ‘myRisk’ test in 2013. Ford Decl. at ¶¶ 1–3, 8 (Dkt. 6).² Between 1997 and 2013, Myriad's revenue from its BRACAnalysis test steadily increased, and now totals more than $2 billion. Kearl Decl. at 6 (Dkt. 107). Myriad earned that revenue by carefully guarding its patent rights and preventing others from providing screening tests for the BRCA1 and BRCA2 genes. From the mid–1990s, until the Supreme Court's AMP decision, Myriad was the lone provider of full-sequence BRCA1 and BRCA2 tests in the United States. Ford Decl. at ¶ 8.

Within days of the Supreme Court's AMP decision, Defendant Ambry Genetics Corporation (Defendant) announced plans to sell tests less expensive than Myriad's to screen BRCA1 and BRCA2 genes. Since then, other companies have followed suit—publicly offering such tests or announcing plans to do so. ³

Soon after Defendant announced it would begin to offer BRCA1 and BRCA2 testing, Plaintiffs filed this action, complaining that Defendant's genetic testing infringes several of Plaintiffs' patents.⁴Plaintiffs now move the court for a preliminary injunction enjoining Defendant's sales or offers to sell “genetic tests including a BRCA1 or BRCA2 panel” pending trial on the merits.⁵ Plaintiffs' Motion focuses on ten claims in the patents-in-suit: 1) four claims to pairs of synthetic DNA strands, called “primers”; and 2) six methods claims for analyzing BRCA1 and BRCA2 sequences. Plaintiffs argue these claims remain patent eligible after the AMP litigation, and that Defendant's testing infringes the patents containing these claims. Plaintiffs contend an injunction is necessary to prevent irreparable harm to their pricing structure, share of the BRCA1 and BRCA2 testing market, corporate reputation, and other exclusive benefits they might enjoy during the remainder of their patents' terms.

Defendant opposes Plaintiffs' Motion, arguing that Plaintiffs cannot show that they are likely to succeed on the merits of their infringement claims because Defendant has raised a “substantial question” concerning the subject matter eligibility of Myriad's BRCA1 and BRCA2–related patents, particularly in light of the recent AMP litigation. Defendant further contends there are substantial questions concerning whether: 1) its testing infringes Plaintiffs' patent claims; 2) the patents at issue are invalid because the inventions they claim were anticipated and obvious; and 3) the patents are invalid due to indefiniteness or lack of written description. Defendant also argues that Plaintiffs will suffer no immediate, irreparable harm to their pricing, market share, or reputation. Finally, Defendant asserts that its business will be devastated and the public interest harmed if an injunction issues because the public would lose access to less expensive, more complete, and more innovative cancer testing.

On September 11 and 12, and October 7, 2013, the court received testimony and argument on Plaintiffs' Motion. Additionally, the parties have submitted numerous declarations from experts. Having carefully considered the relevant authorities, briefing from the parties and amici, oral argument, testimony, and the evidence, the court concludes Plaintiffs are not entitled to a preliminary injunction. The court finds that although Plaintiffs have shown they are likely to be irreparably harmed if an injunction does not issue, Defendant has raised substantial questions concerning whether any of the patent claims at issue in Plaintiffs' Motion are directed toward patent eligible subject matter under 35 U.S.C. § 101. In light of Defendant's showing, Plaintiffs are unable to establish that they are likely to succeed on the merits of their claims. Neither have Plaintiffs established that the equitable factors support issuance of the requested injunction. Having failed to satisfy their burden, Plaintiffs' Motion for Preliminary Injunction must be denied.

I. FACTUAL BACKGROUNDA. The Parties

1. Plaintiffs

Myriad is a Delaware molecular diagnostic corporation with its principal office in Salt Lake City, Utah. The University of Utah is a Utah nonprofit educational and research institution in Salt Lake City. The University of Pennsylvania is a Pennsylvania nonprofit educational and research institution in Philadelphia. The Hospital for Sick Children is a pediatric health care and research facility located in Toronto, Ontario. Endorecherche is a Canadian medical research corporation in Ste–Foy, Quebec. Myriad owns the following patents-in-suit: the '155, '400, '379, '721, '497, '510, '258, ' 237, '776, and '571 Patents. See supra note 4 (listing complete numbers for patents-in-suit). Myriad is the exclusive licensee of the '999, '282, '441, ' 492, and '857 Patents. The University of Utah is the owner or co-owner of three patents at issue in this case, the '999, '282, and '441 Patents. The University of Utah, University of Pennsylvania, the Hospital for Sick Children, and Endorecherche are the co-owners of the '857 and '492 Patents. The University of Utah Research Foundation, also a Plaintiff, has received from Myriad over $40 million in royalties under some of the patents at issue in this case over the past two decades. Pershing Decl. at ¶ 4 (Dkt. 112).

2. Defendant

Defendant is a clinical diagnostic and genomic services company in Aliso Viejo, California. In the hours after the Supreme Court issued its AMP decision, Defendant announced that it would begin offering a number of its own tests that include BRCA1 and BRCA2 screening. Defendant now offers a menu of at least six tests that include screening for BRCA1 and BRCA2: a combined BRCA1/BRCA2 test, BRCA Plus, BreastNext, PancNext, Ova Next, and CancerNext. Chao Decl. at ¶ 16, Exhs. B–G (Dkt. 56). Defendant's BRCA1/BRCA2 test is available for $2,200—substantially less than the price for comparable testing offered by Myriad. Id.

3. Amici

The court permitted the filing of a joint Amicus Curiae brief in support of Defendant's Opposition to Plaintiffs' Motion for Preliminary Injunction. (Dkt. 79.) Amici are the American Civil Liberties Union (ACLU) and ACLU of Utah Foundation, Inc. (ACLU Utah), Public Patent Foundation (PUBPAT), Association for Molecular Pathology (AMP), Breast Cancer Action (BCAction), and the AARP. The ACLU and PUBPAT represented the individual and organizational plaintiffs in the AMP litigation, including two of the amici here, AMP and BCAction. AARP also filed amicus briefs in the AMP litigation.

The ACLU describes itself as a “nationwide, nonprofit, nonpartisan organization with over 500,000 members” with the stated goal of protecting rights protected under the Constitution. Id. at 4. ACLU Utah is a regional affiliate of the ACLU. Id. PUBPAT is a not-for-profit legal services organization affiliated with the Benjamin N. Cardozo School of Law and is concerned with patent policy issues. Id. at 4–5. AMP is “an international not-for-profit professional association representing over 2,000 physicians, doctoral scientists and medical technologists who perform laboratory testing based on knowledge derived from molecular biology, genetics and genomics.” Id. at 5. AMP claims an interest in this matter because, in its view, the issues in this case will impact “the provision of and innovation in genetic testing.” Id. BCAction is “a national, grassroots advocacy and education organization” working to end breast cancer. It holds itself out as “the watchdog of the breast cancer movement.” Id. AARP is a “nonpartisan, nonprofit organization with a membership dedicated to addressing the needs and interests of people age fifty and older,” seeking to “enhance the quality of life for all by promoting independence, dignity, and purpose.” Id. at 6. AARP's mission is focused, in part, on healthcare-related issues. Id.B. Background on Genetics

Plaintiffs and Defendant generally do...