Posts Tagged ‘ACLU’

« Older Entries

AMP Petitions for Cert. and A Look Back

Friday, December 16th, 2011

The Association for Molecular Pathology (AMP) has petitioned the Supreme Court to review the Fed. Cir.’s opinion of July 29th, that isolated BRCA DNA sequences are patentable subject matter. Its brief (a copy available at the end of this post) contains little that is new in the way of argumentation, and relies heavily on the “rule” it found in Chakrabarty that a composition of matter must possess markedly new characteristics upon isolation, as compared to its naturally-occurring state, in order to be patent eligible.

But as the year closes, let’s take a minute to mourn what was lost in July. As I noted in my July 31st post on the decision, “The one hundred plus pages of opinion spent only about five pages on the ‘diagnostic’ method claims….Judge Lourie took care to distinguish the transformative elements of the claims at issue in the Prometheus decision from the minimalist Myriad method claims.” In fact, Judge Lourie found that the method claims which only involve “comparing” and “analyzing” DNA sequences fail the M&T test and are no more than abstract ideas. However, in re-reading the opinion, I was surprised to note that at least one “diagnostic method” claim was also found patent-ineligible. Claim 2 of the ‘857 patent reads:

(more…)

Tags: , , , , , , , , , , , , , , , , ,
Posted in Patentable Subject Matter | Comments Off

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.”

(more…)

Tags: , , , , , , , , , , , , , ,
Posted in Patentable Subject Matter | 1 Comment »

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.

Tags: , , , , , , , , , , , , , , , ,
Posted in Patentable Subject Matter | Comments Off

ACLU Files Its Brief in Myriad – Argues DNA Is A Blueprint Without a Name

Friday, January 28th, 2011

On November 30, 2010, the ACLU filed its brief at the Federal Circuit in AMP et al. v. USPTO and Myriad Genetics, Inc. et al. If you have been reading my posts on this suit, you are by now probably tired of reading the same positions repeated over and over by various brief writers and commentators. (My most recent post was on Myriad’s brief, filed October 22d.) There have been more than ten amicus briefs filed for both sides. The Myriad supporters argue that cases like “the adrenaline decision,” Bergy and Chakrabarty indicate that man-made compositions should be broadly patentable, including ones isolated and purified from natural sources that are structurally and functionally distinct from the “native” forms. The ACLU and its supporters cite Funk Bros., American Fruit Growers and the odd 1931 In re Marden CCPA decisions as support that this view would permit patents on gold nuggets panned from a stream or a fallen leaf (see pages 14 and 46 of the ACLU brief for a re-run of this argument) and that DNA is likewise unchanged by isolation from the genome.

However, it is interesting to see how far the ACLU will reach to support its nearly metaphysical argument that DNA is pure information. At pages 42-43, it ratchets up its arguments to the point of scientific absurdity:

“The [Myriad] claims acknowledge that, unlike other chemicals, DNA stores specific information – as dictated by the order of nucleotides – that serves as the blueprint for all of the proteins, cells, and organs that make up the human body. While chemical molecules like water can be described as H2O, HOH, or OH2 because they consist of any two hydrogen atoms and an oxygen atom, DNA is not described according to the sugars and phosphates of its backbone, but by its nucleotide sequence. Because this blueprint is the defining characteristic of DNA and remains the same before and after isolation, isolated DNA has neither a distinctive name, character, and use from naturally-occurring DNA nor markedly different characteristics.”

(more…)

Tags: , , , , , , , , , , , , , ,
Posted in Patentable Subject Matter | Comments Off

« Older Entries