Myriad Gene Patent Litigation

On May 12, 2009, a group of plaintiffs led by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit against Myriad Genetics, the U.S. Patent and Trademark Office (USPTO) and other defendants. The lawsuit – Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. – alleges that patents on two human genes associated with breast and ovarian cancer (BRCA1 and BRCA2) are invalid and unconstitutional. This page aggregates all of the Genomics Law Report’s coverage of the Myriad litigation, as well as coverage of other relevant legal and policy developments pertaining to the issue of gene patents.

Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision

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:


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Filed under Biobanking, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Industry News, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

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.


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Patenting and Personal Genomics: 23andMe Receives its First Patent, and Plenty of Questions

Earlier this week 23andMe, the Silicon Valley-based personal genomics company, was awarded its first patent: US Patent Number 8,187,811, entitled “Polymorphisms associated with Parkinson’s disease”.

23andMe co-founder Anne Wojcicki announced the issuance of the patent via a post on the company’s blog late Monday evening, attempting to strike a tenuous balance between her company’s oft-championed philosophical devotion to providing individuals with “unfettered access to their genomes” and its desire to commercialize the genomic information so many of those very same individuals have shared, free of charge, with 23andMe. With its new patent, 23andMe also injected itself into the middle of what Wojcicki herself described as the “hot debate” surrounding the patentability of “inventions related to genetics.” Wojcicki’s announcement appeared to catch more than a few of the company’s customers by surprise, sparking concern about the company’s intentions on 23andMe’s blog, Twitter and elsewhere, along with rapid and pointed commentaries from Stuart Hogarth and Madeleine Ball, among others.

Of the various questions asked of and about 23andMe and its new patent, these may be the three most common: Where did this patent come from, and why didn’t I hear about it before? What does 23andMe’s patent cover? How is 23andMe going to use its patent? Let’s take each question in turn.


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Filed under Biobanking, Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomics & Society, Industry News, Informed Consent, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP

Myriad Finally Reaches the Supreme Court (But Only For a Moment)

Yesterday, the Supreme Court (as we predicted last week that it might) GVR’d the certiorari petitions (pdf) of both parties in the Myriad Genetics case.

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.


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

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.


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Filed under General Interest, Genetic Testing/Screening, Genomics & Medicine, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Pending Litigation

Classen: Has the Federal Circuit Lost Interest in Patentable Subject Matter?

Allison Williams Dobson is an attorney, scientist and lecturer in the Norfolk, Virginia area and is a regular GLR contributor.

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.”


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ACLU and Myriad Both Seek Further Federal Circuit Review

As we suspected they might, the plaintiffs in Association for Molecular Pathology v. Myriad Genetics have filed a petition (pdf) seeking a rehearing of the recent federal Circuit decision. More surprisingly, Myriad has also, though its petition (pdf) is very narrowly focused.

The Plaintiffs’ Petition. Two things are interesting about the plaintiffs’ petition from a procedural standpoint. First, the ACLU lawyers requested rehearing by the three-judge panel that decided the case earlier this summer, not en banc rehearing by all members of the court. (But a majority of the judges of the full court could still decide to rehear the case en banc; they could do so if they found that the case “involves a question of exceptional importance.”) Second, the plaintiffs have asked for rehearing on only two of the issues they lost: that isolated genes are proper subject matter for product patents, and that only one of the named plaintiffs—Dr. Harry Ostrer, formerly of NYU—has standing to bring the case. The plaintiffs did not challenge that portion of the panel’s decision that upheld—unanimously—Myriad’s patents on a method of screening potential cancer therapeutics.


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Pigs Return to Earth: Federal Circuit Reinstates Most—But Not All—of Myriad’s Patents

The Federal Circuit’s long-awaited decision (pdf) in Association for Molecular Pathology v. USPTO (the Myriad gene patent litigation) was issued this past Friday.  As we were writing, with the economy having slowed to a barely perceptible crawl and a government default looming more likely by the hour, there were plenty of reasons to believe that the sky was falling.  But the Myriad decision was not, and is not, one of them.

For the most part, the Federal Circuit’s 2-1 decision returned the law to the state it was in before District Judge Sweet’s opinion turned things upside-down last March.  Although full of interesting rhetoric, the court’s three lengthy opinions (a total of 105 pages) are less remarkable for what they decide than for what they invite higher authorities—the Supreme Court and the Congress—to decide down the road.

First, the scorecard.  The court’s judgment—that is, the holding, or outcome—was joined by Judges Lourie and Moore.  A third member of the panel, Judge Bryson, dissented in part, meaning that he joined only a portion of the judgment (more on that below) and disagreed with another part.


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Prometheus Returns to the Supreme Court, Medical Method Patent Speculation Intensifies

While everyone has been busy speculating about whether the Supreme Court will ultimately take the Myriad case, the justices (at least four of them—see below) sprung a surprise this week by deciding to review the Federal Circuit’s decision in another biomedical patent case, Prometheus v. Mayo.

The patents at issue in Prometheus involve a method of administering a drug (specifically thiopurine drugs used to treat gastrointestinal and other autoimmune diseases), measuring the drug’s level in a patient’s body, and then adjusting the dosage of the drug. The Supreme Court will hear the case this fall and should (see below) issue a ruling by next summer, thus drawing to a close a legal journey that began more than three years ago in a California district court.


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Filed under Genetic Testing/Screening, Genomic Policymaking, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Update: Proposed Second Opinion Safe Harbor for Genetic Diagnostic Testing Withdrawn

We reported yesterday on a proposed Patent Act amendment that, if successful, would create a safe harbor for second opinion genetic diagnostic testing. While conceptually simple, the proposed amendment would have left genetic testing developers and providers, patent holders and courts with considerable uncertainty about the safe harbor’s appropriate interpretation and application.

Initially offered by Representative Debbie Wasserman Schultz (D-FL) in April, the amendment surfaced again this past week in the Manager’s Amendment to H.R. 1249 (pdf), the House’s attempt at patent reform legislation.

As news of the proposed amendment spread, it generated a flurry of activity on Capitol Hill. The American Civil Liberties Union (ACLU), the group largely responsible for coordinating the plaintiffs in the Myriad gene patent litigation, spearheaded the charge. An ACLU-led coalition wrote in opposition to the proposed amendment (pdf), arguing that the proposed second opinion safe harbor “would fail to block all patent holder objections to [second opinion] testing, fails to address the many other limitations on scientific research arising out of the issuance of [gene patents], and risks allowing gene patent holders to argue that Congress implicitly endorses the validity of such patents.” The group was joined in its efforts by the American Medical Association, the Association for Molecular Pathology (the first named plaintiff in Myriad) and others, who collectively lobbied Rep. Wasserman Schultz and her colleagues to avoid creating “unintended harms to patients, medical professionals and genetic researchers.”


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Regulation