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Association for Molecular Pathology v. Myriad Genetics, No. 11-725, (formerly Association for Molecular Pathology v. U.S. Patent and Trademark Office) is a lawsuit challenging the legality of gene patents in the United States, specifically challenging patents over breast cancer genes BRCA1/2 held by Myriad Genetics and the University of Utah. The ACLU and Public Patent Foundation represent the plaintiffs, and Jones Day represents Myriad. The case was heard in the Southern District of New York.

The declaratory judgment suit was originally filed against the Myriad, the Trustees of the University of Utah, and the U.S. Patent and Trademark Office (PTO), but the PTO was severed from the case by the district court.

On March 29, 2010, Judge Robert W. Sweet issued a 156-page decision, which declared the patents invalid. Newsweek declared it a "surprise ruling." Sweet's decision stated: "DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C. §101." The decision also found that comparisons of DNA sequences involved in these patents are abstract mental processes, therefore also unpatentable. The decision was appealed.

About 2000 human genes have been patented in the United States before this ruling.

Myriad appealed, challenging the court's jurisdiction and its decision. Myriad argued that it had not accused the plaintiffs of infringement, so they lacked standing to file a declaratory judgment suit. Myriad also raised two arguments in favor of patent eligibility. Briefing for the appeal to the Court of Appeals for the Federal Circuit (CAFC) was completed as of February 2011. Oral arguments before the CAFC took place on April 4, 2011.

Myriad, the defendant-appellant, was supported by at least 15 amicus (friend of the court) briefs. The plaintiff-appellees' position received support from 12 amicus briefs, including a joint brief on behalf of the American Medical Association, the American Society of Human Genetics, the American College of Obstetricians and Gynecologists, the American College of Embryology, and the Medical Society of the State of New York.

On October 29, 2010, the Department of Justice provided a surprising and unsolicited brief that supports the appellees in part and appeared to contradict the PTO's own position. The DOJ brief suggests that claims covering isolated naturally-occurring human genetic sequences are not properly patentable.

On July 29, 2011 the Federal Circuit overturned the District court in part, and upheld the decision in part. The Federal Circuit overturned the District Court's finding that the claims covering isolated gene sequences are invalid and also overturned the invalidity of some of the diagnostic claims; the Federal Circuit upheld the finding that the claims for the diagnostic methods that only compare or analyze sequences - that have no transformative step - are invalid.

On October 12, 2011 the ACLU and the Public Patent Foundation said they intended to petition the Supreme Court of the United States (SCOTUS) to overturn the decision. On December 7, 2011, the ACLU filed a petition for a writ of certiorari to SCOTUS. On March 26, 2012, the SCOTUS decided: "The petition for a writ of certiorari is granted. The judgment is vacated, and the case is remanded to the United States Court of Appeals for the Federal Circuit for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc." SCOTUS decided on March 20, 2012 in Mayo Collaborative Services v. Prometheus Laboratories, Inc. that certain kinds of diagnostic claims were not patentable, and in making this ruling, SCOTUS threw away the original Appeals ruling ("vacated") it and ordered the Appeals court to hear the case afresh, this time with the Prometheus case in mind.

On August 16, 2012, the Federal Circuit issued a decision that was nearly identical to its original decision. The Federal Circuit again reversed the district court’s decision on isolated DNA molecules; the Federal Circuit found that such molecules are patent-eligible under § 101 because they are nonnaturally occurring compositions of matter. It also reversed the district court’s decision concerning assays to find drugs to treat cancer; the Federal Circuit again found that these assays are patentable. And again - now reinforced by the Prometheus decision, the Federal Circuit affirmed the lower court’s decision, that method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible. Such claims were held to include no transformative steps and therefore cover only patent-ineligible abstract, mental steps.

Myriad Genetics' president, Peter Meldrum, released a statement that they were "Very pleased with the favourable decision the court rendered today which again confirmed that isolated DNA is patentable." The ACLU announced that it was evaluating whether to file another Supreme Court appeal. Intellectual property experts interviewed by the American Journal of Medical Genetics prognosticated that another Supreme Court case was likely even before the August 16 CAFC decision "because Prometheus doesn’t answer all the questions in Myriad".

References

1. Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 09-cv-4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010).
2. Begley, Sharon (March 29, 2010). "In Surprise Ruling, Court Declares Two Gene Patents Invalid". The Daily Beast. Retrieved 2012-06-28.
3. Hamblett, Mark (March 30, 2010). "Genes Linked to Breast, Ovarian Cancers Are Ruled Unpatentable". New York Law Journal. Retrieved 2012-06-28.
4. ^ Shipman, Joan (March 30, 2010). "BRCA1/2 patents ruled invalid in PUBPAT/ACLU lawsuit". S U P R A S P I N A T U S. Retrieved 2012-06-28.
5. "ACLU Challenges Patents On Breast Cancer Genes: BRCA". American Civil Liberties Union. June 26, 2012. Retrieved 2012-06-28.
6. Dennis Crouch (Apr. 4, 2011). "Federal Circuit Hears Myriad Gene Patent Case". PatentlyO.com. {{cite news}}: Check date values in: |date= (help)
7. Amicus Briefs in AMP v. USPTO: AARP, Patent Docs, Jan. 28, 2011.
8. Association for Molecular Pathology v. U.S. Patent and Trademark Office, Fed. Cir., No. 2010-1406 (appellee brief filed Nov. 30, 2010).
9. Andrew Pollack (Nov. 1, 2010). "Gene Patent Ruling Raises Questions for Industry". New York Times. {{cite news}}: Check date values in: |date= (help); Italic or bold markup not allowed in: |publisher= (help)
10. Heidi Ledford (Nov. 2, 2010). "US government wants limits on gene patents". Nature News. {{cite news}}: Check date values in: |date= (help); Italic or bold markup not allowed in: |publisher= (help)
11. http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf
12. Pollack, Andrew (July 29, 2011). "Gene Patent in Cancer Test Upheld by Appeals Panel". The New York Times.
13. "Federal Circuit: Isolated Human DNA Molecules are Patentable". Patently-O. July 29, 2011. Retrieved 2012-06-28.
14. Harvey, Tom (October 12, 2011). "Utah firm's gene patent case could go to Supreme Court". The Salt Lake Tribune. Retrieved 2012-06-28.
15. "Paper Chase: ACLU asks Supreme Court to rule on gene patent case". JURIST. December 8, 2011. Retrieved 2012-06-28.
16. "Federal Circuit Decision of August 16, 2012" (PDF). Federal Circuit. August 16, 2012. Retrieved 2012-08-16.
17. Patnetly-O on Myriad Fed Circuit Decision
18. http://www.bbc.co.uk/news/health-19294050
19. Utah’s Myriad wins another round in gene-patent case. By Tom Harvey, The Salt Lake Tribune, Aug 16 2012
20. http://onlinelibrary.wiley.com/doi/10.1002/ajmg.a.35522/pdf

External links

• Patenting Human Genes and Genetic Tests: Recent Developments. National Advisory Council on Human Genome Research. May 17, 2010. Powerpoint presentation.
• District court decision (mirror) Opinion, United States District Court, Southern District Of New York, Association For Molecular Pathology, et al., plaintiffs, vs. United States Patent and Trademark Office, et al., defendants (09 Civ. 4515)
• Myriad Gene Patent Litigation in Genomics Law Report. Newsletter published by law firm of Robinson Bradshaw & Hinson.
• Patently-O blog explaining Federal Circuit's August 16, 2012 decision. by Dennis Crouch, Associate Professor at University of Missouri School of Law
• Myriad wins gene patent ruling from US appeals court, Reuters, 16 Aug 2012

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