Posts Tagged ‘Myriad lawsuit’

AMC v. Myriad – “Laws of Nature” Exception Does Not Include Isolated DNA

Sunday, July 31st, 2011

As noted in my last “flash” post, a divided three-judge Fed. Cir. panel (Judges Lourie, Bryson and Moore) issued an opinion holding that the isolated DNA sequences and the drug-screening method claimed by Myriad are patentable subject matter, not natural phenomena, while affirming that the diagnostic method claims which only involve “comparing” or “analyzing” DNA sequences fail the M&T test and are no more than abstract ideas. The one hundred-plus pages of opinion spent only about five pages on the “diagnostic” method claims. Since I previously commented on their vulnerability following both Bilski and the proposed PTO Guidelines, I will not offer much analysis here, except to note that Judge Lourie took care to distinguish the transformative elements of the claims at issue in the Prometheus decision from the minimalist Myriad method claims. See slip op. at 52-53. See, e.g. my post of Oct. 29, 2010 on the Myriad method claims.

My summary of the panel’s holding above reflects the opinions authored by Lourie and Moore, who agreed on all of these points. Judge Bryson agreed on the cDNA claims and the method claims, but would have found the claims to isolated naturally occurring “genes” and gene fragments patent-ineligible. Essentially, he bought the Government’s “magic microscope’ argument that if you can “see” the sequence in the chromosome (or otherwise in its natural setting), isolation of the sequence does not afford anything “materially different from the native genes. In this respect, the genes are analogous to the ‘new mineral discovered in the earth,’ or the ‘new plant found in the wild’ that the [S. Ct.] referred to in Chakrabarty. It may be very difficult to extract [them]. But that does not make them the products of invention.”

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Divided Panel Finds DNA Molecules Patentable – Cancer Screening Claims Too Abstract

Friday, July 29th, 2011

Today a divided Fed. Cir. panel of Judges Lourie, Moore and Bryson – Lourie writing for the “majority” – reversed the district court judge, in AMP v. Myriad, holding that isolated DNA sequences are patent-eligible subject matter and not natural products. While the majority found that the drug candidate screening claims were not patent-ineligible as natural phenomena and also reversed the district court on this point, the panel found that the diagnostic claims that just recited comparing or analyzing the difference between the sequence of a patient’s BRCA gene(s) and a reference “normal” gene sequence were patent-ineligible as overly “abstract,” e.g., as abstract ideas, and so affirmed the decision below.

Another interesting wrinkle is that the panel decided the merits before they were aware that the only plaintiff who they had ruled had standing, Dr. Harry Ostrer, had left his position and joined Albert Einstein, an august institution, but one that does not offer clinical lab screening assays. More later, after I read past the first 10 pages of this 106 page decision.

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Federal Court Hears Myriad Gene Case This Morning

Tuesday, April 5th, 2011

The following is a guest post from Professor Ann McCrackin

I attended oral arguments at the CAFC on Monday for Association for Molecular Pathology v. Myriad Genetics, Inc.   The three-judge panel included Judge Bryson, Judge Lourie and Judge Moore.  Most of the questions came from Judges Bryson and Moore.  The arguments were directed to three issues:  jurisdiction, patent eligibility of the composition-of-matter claims, and patent eligibility of the method claims.

Myriad’s attorney, Gregory Castanias, argued that there was no case or controversy for declaratory judgment jurisdiction.  Judge Moore seemed troubled that the District Court’s standing criteria would allow consumers to challenge patents just because they desired a cheaper product.  On the merits, Castanias argued that  isolated DNA is structurally distinct from naturally occurring DNA and therefore does not exist in nature.  Judge Bryson asked whether Myriad’s claims would cover the entire human genome.  Judge Moore noted that the claims do not cover the entire chromosome, but wanted to know how isolated DNA is different from a mineral which is extracted from a rock.   Judge Lourie noted that a gene is structurally different when it is isolated, but a mineral is not structurally different when it is removed from the rock.  Castanias also argued that the method claims are patent-eligible, but was questioned by Judge Lourie regarding whether the steps of “comparing” in the claims were just a thought process.  Castanias also mentioned the Federal Circuit’s post-Bilski decision in RCT v. Microsoft.

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AUTM Panel To Address A “Myriad” Of Challenges

Thursday, February 24th, 2011

Robert S. MacWright, J.D., Ph.D., the new head of tech transfer at the Salk Institute, will moderate a panel at the 2011 Annual Meeting of the Association of University Technology Managers (AUTM) on March 1st in Las Vegas.  The panel, entitled, “The Ever Changing Kaleidoscope of U.S. Patent Law,” will examine what MacWright terms “a decade of meddling by the legislature and the courts.” The “panel of experts” – that will include, Sandra Kuzmich of Frommer Lawrence, Gonzalo Merino, J.D., Ph.D., of Columbia and me – will review the current state of affairs and “with considerable risk of error, [we] will also make predictions about other changes that may lie ahead.”

Apart from encouraging you to attend this session (Tuesday, D1 on the program), the trend of judicial decisions at all levels to weaken patent protection for pharma/biotech inventions is alarming. The big losses like KSR (which eliminated the rigorous TSM test for obviousness), Merck v. Integra (expanded safe harbor for drug research), Ariad (“Yes, Virginia, Section 112 does contain a written description requirement”), and Myriad (No patent protection for DNA or for diagnostics used in personalized medicine) have tended to overshadow smaller but still significant anti-patent decisions like In re Kubin (Deuel reversed), In re Fisher (ESTs and SNPs lack utility) and In re Alonso (good-bye to the “monoclonal antibody exception”).

The Federal Circuit’s holding in Prometheus v. Mayo was one of the few bright spots (methods of screening for drug efficacy and medical treatment are patentable – yea!) but even this decision may be reviewed by the  Supreme Court – again (it granted cert. once). And while it is difficult to see the Supreme Court’s Bilski decision as a good thing, at least an entire category of patentable subject matter was not eliminated. If the “M or T” test had been affirmed, the Federal Circuit would have been required to invalidate most of the Myraid diagnosis claims. Now Judge Rader has to figure out how to support a holding that the Myriad “comparing DNA sequence” claims are less abstract than Bilski’s claims to hedging commodity risk. And he is the judge that the ACLU is trying to recuse as prejudiced in favor of biotech! It’s going to be an interesting year.