Posts Tagged ‘Myriad’

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:

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Myriad Petition For Rehearing Denied

Wednesday, September 14th, 2011

On September 13, 2011, the Fed. Cir. panel in AMP v. Myriad denied AMP’s (read ACLU’s) petition for rehearing by the panel. (A copy of the petition can be found at the end of this post.) In challenging the holding that the  claimed isolated DNA molecules are not products of nature, AMP argued that “the language of the patents defines the function, not the structure of the patented genes and gene fragments…the composition claims in the patents are not defined by chemical structure. They are defined by function.” The success of this argument would require the panel to read the term, “[a]n isolated DNA” out of claim 1 of the ‘282 patent:

  1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

Clearly, that was not going to happen, although it appears to be an attempt to riff on dissenter Bryson’s conclusion: “What is claimed in the BRCA genes is the genetic coding material, and that material is the same, structurally and functionally, in both the native gene and the isolated form of the gene.” Slip op. at 13.  However, even “markedly different”  Judge Moore, who presented the best “chemical” analysis of the claims, had no reason to change her views.

AMP’s second argument was hard to follow, but seemed to be based on its opinion that the claimed BRCA1 and 2 gene fragments are inherently present in the body  e.g., in the blood of cancer patients, and so are patent-ineligible natural products. This may be an attempt to reopen the purification vs. isolation argument that held appeal for some of the panel, but arguing that the claimed fragments must arise in vivo “at least some of the time” is not going to carry the day as an inherent anticipation argument, much less as a product of nature argument.

The panel left pending Myriad’s petition for rehearing that challenges AMP et al.’s standing to bring suit, although AMP argued that the American College of Medical Genetics has organizational standing and an additional plaintiff, Ellen Matloff, had conversations about possible infringement with Myriad. AMP may not be in the bottom of the 9th inning yet, but they are in the bottom of the 8th. The panel did such a thorough analysis of the issues that I just don’t see a petition for rehearing en banc getting on base.

 Myriad Petition for Panel Rehearing

Cybersource Corp. v. Retail Decisions, Inc.

Friday, August 19th, 2011

In recent posts, I have worried, then warned, the Fed. Cir. holding that the Myriad “analyzing” or “comparing” diagnostic claims were invalid as abstract ideas, would cloud the IP future of “modern” claims to personalized medicine (see posts of July 29 and 31, 2011 and Oct. 29, 2010). To refresh our collective memories, here is a shortened version of one of the Myriad method claims:

1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises comparing a first sequence…[of] a BRCA1 gene from said tumor sample…with a second sequence …[of] a BRCA1 gene from a nontumor sample of said subject, wherein a difference in the sequence of the BRCA1 gene…indicates a somatic alteration in the BRCA1 gene in said tumor sample.

[US Pat. No. 5,710,001].

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Wegner Paper Probes Myriad Decisions Flaws

Tuesday, August 2nd, 2011

Prof. Hal Wegner goes for the jugular with his analysis of some of the flaws in the legal reasoning behind the holding in the recent AMC v. Myriad decision. [See my post of July 31st 2011 on the decision]. (Prof. Hegner’s paper is attached at the end of this post.) To summarize, he faults the panel for pointedly not grounding their decision that isolated DNA is patent-eligible subject matter on In re Bergy, 596 F.2d 952 (CCPA 1979). In fact, Judge Lourie went out of his way to explicitly write that Bergy was not binding law. However, Wegner notes that Bergy and Chakrabarty were decided as companion cases by the CCPA and consolidated for appeal to the Supreme Court. The Court granted cert. as to both  Bergy  and Chakrabarty, but in its opinion simply noted that Bergy had been dismissed as moot, after the Court had granted cert. Contrary to Judge Lourie’s statement in fn. 7 in Myriad, the second Bergy decision was not vacated by the Supreme Court. The Court only had Chakrabarty to decide,  but it in no way disparaged the CCPA’s earlier decision in Bergy. Bergy was only cited in a footnote in the district court’s opinion, but was heavily relied upon in Myriad’s brief to the Fed. Cir. What’s up with that?

As extensively noted in my post “A Myriad of Questions to Resolve,” May 18, 2010, In re Bergy is arguably the most relevant precedent to the Myriad dispute, since it clearly states that the isolated microorganisms of Bergy are no less patent-eligible than any other chemical compounds, including “countless pharmaceuticals.” Such compounds can be isolated, purified, assembled from simpler “synthons” or prepared by subdividing more complex molecules (my gloss). The distinction that the Myriad panel tries to draw between “isolated” and “purified” –“[DNA] has not been purified by being isolated” – is artificial, not even factual and not relevant to patent-eligibility under s. 101

Prof. Wegner also takes the Myriad panel to task for misusing or at least, for overusing Funk Brothers, to require some sort of novel utility (the dreaded “marked change”) before a composition of matter can be considered for patentability. The Supreme Court did not impose such a test for all future subject matter – the requirement is for the subject matter to be “new and useful.” The comment that the bacterium has “markedly different characteristics from any found in nature” is dictum with respect to the requirements of s. 101. Funk Brothers is a pre-1952 decision that was distinguished in Chakrabarty. It was not decided on the basis of section 101 patent-eligibility. Today, the claims would be patent-eligible under s. 101, and might well pass muster under ss.  102 and 103.

Finally, Prof. Wegner notes – as do I – that the discussion of the patentability of elements like lithium is confusing at best. Judge Lourie attempted to answer Judge Bryon’s comments about the isolation (?) of ionically bonded lithium (e.g. LiCl) by suggesting that the precursor elemental lithium would be unpatentable as not novel. However, Prof. Wegner notes that patents have been granted on elements. Claim 1 at issue In re Seaborg, 328 F.2d 996 (CCPA 1964) was simply to “Element 95.” (Stability was the issue, not patentable subject matter.) It is worth noting that the CCPA has never held, or even stated in dicta, that a newly discovered element would not be patentable.

In my earlier posts, I opined that Myriad could not lose on the DNA claims, and I turned out to be correct (barely). But a double-jointed rattlesnake – to borrow a Disney image – could not follow the lines of reasoning it took to reach that conclusion.

Wegner Paper