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

Analyzing The America Invents Act

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.

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Filed under General Interest, Genetic Testing/Screening, Industry News, Legal & Regulatory, Patents & IP, Pending Regulation

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

More News on DNA in Forensics

We recently noted that DNA profiling has greater public approval in the UK than in America. The UK presently operates the largest DNA database in the world with over 5 million profiles. Nevertheless, that country has just taken a giant step in the opposite direction. New civil liberties legislation, dubbed “the freedom bill,” will require authorities to remove hundreds of thousands of unconvicted people from the database, following a ruling from the European Court of Human Rights that “the blanket retention of DNA from people arrested but never convicted of any offence [i]s unlawful.” There are 1.1 million people without convictions presently profiled in the database; however, some of these profiles will not be removed as a result of an exception for “unconvicted terror suspects who have been released.”

Here in the U.S., the Supreme Court will consider the post-conviction DNA testing landscape in the Texas case of Henry Skinner. Thousands of convicts are requesting new DNA testing in light of the increasing number of exonerations based on DNA evidence. Skinner was convicted 15 years ago of murdering his girlfriend and her two developmentally disabled adult sons. At the recommendation of his attorneys, he declined DNA testing for his trial. Texas courts said he doesn’t currently qualify under a state law that grants DNA testing to some convicts, and federal courts refused to overrule Texas. The last time the Supreme Court considered this issue, in 2009, a divided court decided to let Congress and the state legislatures make the rules. Therefore, rules vary from jurisdiction to jurisdiction as to how requests for post-conviction DNA testing are handled. Perhaps this time the Supreme Court will decide to lay down some firmer ground rules.

Filed under Biobanking, Bioinformatics/IT, General Interest, Genomics & Society, Industry News, International Developments, International News, Legal & Regulatory, Pending Litigation, Pending Regulation

Recent Developments in Forensic DNA

The use of DNA in forensics continues to expand. Last year, James Cass reviewed the current system of forensic DNA profiling in the U.S., including CODIS (the Combined DNA Index System, the FBI’s integrated DNA profiling program), the controversial practice of partial/familial searching, and calls from President Obama and others to collect DNA profiles for all Americans in a national database. He posted follow-up pieces focused on advance DNA collection under Katie’s Law, the growing backlog of DNA samples, and familial DNA database searching, which gained support after it facilitated the arrest of the elusive serial killer in California known as the Grim Sleeper.

A number of newer developments have caught our attention.

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Filed under Biobanking, Bioinformatics/IT, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, International News, Legal & Regulatory, Pending Regulation, Privacy

Swine Still Soaring: Federal Circuit Judge Expresses Sympathy for Myriad Analysis

Back in March, we headlined our discussion of the district court judgment in the Myriad case “Pigs Fly.” Guess what?—they’re still aloft. On August 4, in a highly technical patent case that, appropriately enough, involved “porcine virus DNA,” one Federal Circuit judge—dissenting Judge Timothy B. Dyk—suggested that he might agree with the basic principle of the Myriad holding: that isolated DNA sequences are not necessarily patentable.

Judge Dyk’s comments were a bolt out of the blue, as he raised an issue that had not been addressed by the parties or the lower court. Because he is a member of the court that will decide Myriad in the next year or so, Judge Dyk’s comments might be more significant than the district court opinion itself. (The case is Intervet Inc. v. Merial Ltd., Fed. Cir. 8/4/2010.)

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

WARF Reexamination Takes Another Bite Out of Biotech Patents

Two months ago, the Myriad gene patent litigation generated a slew of national and international coverage. We said, “Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims.”  “Is the DNA patent dead?” asked CNN. Wired (apparently answering CNN) declared the “End of Gene Patents Will Help Patients, Force Companies to Change.” Everyone, it seemed, either had an opinion on what the Myriad decision meant for the future of biotechnology or was looking for somebody who did.

It’s not surprising that the Myriad litigation has dominated the headlines. The ACLU’s challenge to Myriad Genetics was a first-of-its-kind frontal attack on gene patents. But with Myriad now on appeal to the Federal Circuit, and a final resolution to that particular piece of litigation likely several years away, a variety of other legal developments are slowly but surely reshaping the biotechnology patent landscape. In the next few years, while frontal attacks such as Myriad are likely to occupy the press and policymakers, those interested in forecasting the future of biotechnology patents will be paying equally close attention to the various collateral attacks on gene, protein, association, diagnostic, and other biotechnology patents and claims.

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Filed under Genomics & Society, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

The Texas Newborn Blood Spot Saga Continues

Contributed by Allison Williams Dobson of the Center for Genomics and Society at the University of North Carolina at Chapel Hill.

The Texas Department of State Health Services (DSHS) could soon face a new federal lawsuit in light of the discovery that it sent 800 anonymous newborn blood samples to a U.S. military DNA lab in 2003 and 2007. As discussed in a post by Adam Doerr on February 2, Texas Civil Rights Project lawyer Jim Harrington successfully negotiated a settlement in 2009 to have DSHS destroy 5.3 million newborn blood samples because it did not obtain informed consent from parents to use the samples for research. Now DSHS has come under criticism over samples it had already released for approved research.

The Texas Tribune reported last Monday under the headline “DNA Deception” that its review of nine years’ worth of e-mails and internal documents, obtained under state sunshine laws,1 revealed a DSHS agreement to help the military build a national mitochondrial DNA (mtDNA) database. The Armed Forces DNA Identification Laboratory claims a legitimate research purpose for the newborn DNA samples—to improve the identification of missing person remains through analyses of highly stable mtDNA.2 Because mtDNA generally lasts longer in a wider variety of tissues than nuclear DNA, it is also more likely to be recovered from particularly old or decayed remains.

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Filed under Biobanking, General Interest, Genomic Policymaking, Informed Consent, Legal & Regulatory, Pending Litigation, Pending Regulation, Privacy

NCI’s New BRCA1 Test: Broader Utility and Another Challenge to Traditional Genetic Tests

switchContributed by Allison Williams Dobson of the Center for Genomics and Society at the University of North Carolina at Chapel Hill.

As reported last week by GenomeWeb, on September 21, 2009, a team led by Shyam Sharan from the National Cancer Institute (NCI) published the development of a new BRCA1 test based on mouse embryonic stem cells. Potentially, the test could prove useful for a much broader range of patients than the controversial Myriad Genetics BRCA1 tests.

The NCI approach focuses more on protein production than DNA analysis. The BRCA1 gene serves as the blueprint for an important tumor suppressor protein. If BRCA1 protein is not produced in sufficient quality and/or quantity, a propensity to develop cancer in the breast tissue often results. The traditional genetic testing approach asks whether a subject carries any of the BRCA1 gene variants that have been associated with increased risk for breast cancer in studies of afflicted families. NCI’s approach asks a significantly different question—rather than focusing on an identified set of “bad” gene variants, NCI asks whether a subject carries BRCA1 variants that serve as adequate blueprints for a functional protein, whether those variants have been previously identified or not. It does this by testing the protein product of the gene.

Until now, women with a family history of breast cancer have been most likely to seek a BRCA genetic test and represent the principal source of BRCA genetic data. Thus Myriad’s patented tests are based on a set of culprit BRCA gene variants found by studying primarily families with a strong propensity toward breast cancer, despite the fact that only 5-7 % of breast cancers are familial. As a result, the Myriad tests only offer useful information about a subset of BRCA1 variants. But many people (both with and without family history) carry other BRCA1 variants of unknown significance (VUS). There just are not enough empirical data yet to support conclusions about the risk associated with VUS.

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Filed under Bioinformatics/IT, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation