Wegner Paper Probes Myriad Decisions Flaws

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. Wegner’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

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , , , , | Leave a comment

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

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.”

Continue reading

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , , , , , , | 2 Comments

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

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.

10-1406

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , , , , , , | Leave a comment

District Court Dismisses Stem Cell Ban Suit

On July 27, in Sherley v. Sibelius, Judge Royce Lamberth reversed himself, and dismissed the 2010 lawsuit that initially led to a freeze on Government funding for human embryonic stem cell research, conducted under the terms of the 2009 NIH Guidelines. His decision tracks the reasoning of  an April 29th decision by the Court of Appeals that lifted the injunction that he had imposed on the implementation of the Guidelines (See, my post of May 2, 2011: “Appeals Court Overturns Stem Cell Ban”).  The Guidelines had been formulated to implement President Obama’s executive order 13505 that, in turn, lifted Bush’s 2001 Executive Order banning such funding.

The Court of Appeals had found that the preliminary injunction was improperly granted and the Guidelines were not in conflict with the 1996 Dickey-Wicker Act, banning funding for certain research involving human embryos. The plaintiffs’ counsel, Steven H Aden of the Alliance Defense Fund, a pro-life “legal alliance of Christian attorneys”,  was quoted by the WSJ as considered their options for appeal, and called embryonic stem cell research “illegal and unethical” in a story on the ADF website.

Posted in Stem Cells/Cloning | Tagged , , , , , | Leave a comment