The Supreme Court today granted a writ of certiorari (meaning they agreed to hear the appeal) in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., et al., the famous case centered on patents covering two human genes: BRCA1 and BRCA2.
Of note is that the Court limited its grant of the appeal to the first of the three questions posed by the petitioners/plaintiffs: “Are human genes patentable?”
Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.”
The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:
Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the Final Myriad Decision Might Not Matter for Personalized Medicine)
The latest chapter in the Myriad gene patent litigation was written yesterday, with the Federal Circuit issuing its much anticipated opinion (pdf) after rehearing the case following the Supreme Court’s unanimous decision earlier this year in Prometheus v. Mayo.
Or perhaps we should say that the latest chapter was “rewritten” as, in a move that surprised approximately nobody, and as we predicted earlier this spring, the Federal Circuit reached precisely the same result in its opinion today as it did last July when it issued its first substantive ruling in the Myriad litigation. Below, we examine how the Federal Circuit applied Mayo to Myriad, what the next step in the Myriad litigation is likely to be (spoiler alert: it’s another appeal) and why we think the final opinion in this case, whenever it arrives and whatever it says, might not matter all that much.
Applying Mayo to Myriad. As mentioned, the only major change since the last time the Federal Circuit ruled in Myriad, and the reason for the re-hearing, was the Supreme Court’s decision earlier this spring in Mayo.
However, Mayo was about method patents and the boundary between a patent-eligible method and a law of nature. It was not about product patents or the product of nature doctrine. Since the Federal Circuit had already invalidated all but one of Myriad’s method patents even before the Supreme Court tightened the criteria for method patents in Mayo, it was hard to see much of substance changing the second time around.
Big news, right? Not really.
What this means is that the Court Granted cert in Myriad, but for the limited purpose of Vacating the Federal Circuit’s July 2011 decision and Remanding the case to that court for reconsideration in light of the Supreme Court’s decision last week in Prometheus.
Prometheus Patents Struck Down, 9-0: Mayo Collaborative Services v. Prometheus Laboratories, Inc. Analysis
In a strong rebuke to the Federal Circuit, a unanimous U.S. Supreme Court held (pdf), on March 20, 2012, that Prometheus Laboratories’ claims to methods of administering drugs to treat gastrointestinal autoimmune diseases do not meet the patentable subject matter standard of section 101 of the Patent Act. The representative claim quoted by the Court recites, “A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder” comprising two steps: (a) administering one of a class of drugs (thiopurines) and (b) determining the level of a specified metabolite, “wherein” a level below a given threshold “indicates a need to increase the amount of said drug subsequently administered” [to improve efficacy], and a level above the threshold “indicates a need to decrease the amount of said drug subsequently administered” [to avoid toxicity].
History of the Case. Mayo originally bought and used Prometheus test kits that employed the patented method, but it then decided to sell and market its own test, which was similar, but not identical. Prometheus sued for patent infringement. The district court found that Mayo’s test would infringe the Prometheus patents, but it then held the patents invalid as essentially claiming unpatentable laws of nature–in this case, the relationship between the levels of the specified metabolite and the efficacy or toxicity of the relevant drugs.
The America Invents Act (pdf) (AIA), which was signed into law by President Obama on Friday, September 16, 2011, represents the first major legislative adjustment to the U.S. patent system in decades (see previous coverage). Many changes are included in the 37 sections of this bill, and they will not all take effect at the same time. The most controversial details, found primarily in § 3 of the AIA, continue to be analyzed and debated extensively elsewhere, but there are several elements that may be of particular interest to GLR readers.
First-to-file (§ 3): The most significant change is from a “first-to-invent” system to a “first-to-file” system. Until now, it has been possible for
inventor A to challenge the application of inventor B, who filed an earlier application for the same invention, based on evidence that inventor A had actually invented first.
But First: The Federal Circuit Has Denied the Plaintiff’s Motion for Rehearing in Myriad: This week, the Federal Circuit issued a one-word order—“Denied”—turning down both parties’ requests for rehearing by the three-judge panel that decided that case originally. The parties now have 90 days to file a certiorari petition asking for Supreme Court review.
This news is not surprising considering the Federal Circuit’s most recent treatment of patent-eligible subject matter under § 101 of the Patent Act. On August 31, 2011, another 2-1 divided panel issued its opinion (three very strong opinions, really) in Classen Immunotherapies, Inc. v Biogen Idec (pdf).
The majority finds that two of the three method patents in dispute claim subject matter that is patent-eligible under § 101. However, the court also emphasizes repeatedly that the two patents “may not” meet the other requirements for patentability imposed by §§ 102 (novelty), 103 (nonobviousness), and/or 112 (adequate written description). The thrust of the majority’s message is becoming a familiar mantra–the statutory role of § 101 is to act as a “coarse eligibility filter”–a gateway to the real tests–and not the “final arbiter of patentability.”
Yesterday brought the long-anticipated oral argument in the Myriad gene patent litigation. After much speculation, the final panel consisted of Judges Lourie, Bryson and Moore. Following the Myriad argument, Judge Lourie was replaced on the panel for the remainder of the day’s cases by Judge O’Malley, lending support to speculation that Judge O’Malley recused herself from the Myriad argument because her lawyer-spouse filed an amicus brief in the case.
What We Learned from the Myriad Oral Argument. For all of the attention focused on the Myriad oral argument, most spectators have only one very practical question: did Monday’s argument provided any meaningful clues with respect to how the Federal Circuit might rule on appeal of the lower court’s startling ruling?
In a word: no. In a few more: we learned nothing from the Myriad argument that leaves us better able to predict how the Federal Circuit will rule in this case.
On Monday at 10 a.m., the lawyers for both sides will argue the Myriad case (Association for Molecular Pathology v. USPTO) before a three-judge panel of the United States Court of Appeals for the Federal Circuit in Washington. Here are a few things about oral argument in general, and this case in particular, that interested observers may want to keep in mind.
Who’s on the Panel? Federal cases on appeal are almost always heard initially by a panel of three randomly selected judges. (In rare cases all the judges of a circuit will rehear the case together, or en banc—no way to predict if that will eventually happen here.) The Federal Circuit will announce the panel for this case on Monday morning on its website. As of now, all we know is that Myriad—and only Myriad—will be heard by “Panel B+.” The + means that the makeup of that panel will be different from that of Panel B, which will hear the three other cases also scheduled for this 10 a.m. session (a panel customarily hears four arguments in a session). The + designation sometimes means that one member of the regular panel (here, B) has recused (disqualified) him or herself from the case because of some conflict, necessitating a replacement.
Robert Cook-Deegan contributed to this commentary. Dr. Cook-Deegan is Director of the Center for Genome Ethics, Law & Policy at Duke University Institute for Genome Sciences and Policy’s and is currently on leave at the Fondation Brocher in Hermance, Switzerland.
The past few months have brought a number of significant research and commercial developments in the BRCA diagnostic testing market, particularly in Europe. These developments have been met by enigmatic comments from the management of Myriad Genetics, the sole provider of commercial BRCA diagnostic testing in the United States and a defendant in ongoing and closely-scrutinized gene patent litigation. What can these recent developments tell us about Myriad’s future plans in both Europe and the U.S.?
The Next Generation of BRCA Testing. Myriad’s current BRCA diagnostic test, BRACAnalysis (pdf), uses a combination of two traditional technologies—Sanger sequencing and PCR—to identify mutations associated with a significant risk of breast cancer and/or ovarian cancer in the BRCA1 and BRAC2 genes. Although Myriad has dabbled with next-generation sequencing technologies, Myriad has yet to announce any concrete plans to apply any of the increasingly numerous and powerful next-generation sequencing technologies to its BRACAnalysis testing.
Others, however, are moving rapidly in exactly this direction.