Archive for July, 2011

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.”


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.


District Court Dismisses Stem Cell Ban Suit

Thursday, July 28th, 2011

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.

Inequitable Conduct in Canada – Disarming the “Atomic Bomb”

Monday, July 25th, 2011

This is a guest post from Brian W. Gray of Norton Rose.

This week a significant decision for patent owners was released from our Canadian Federal Court of Appeal. A copy of the case is found at the end of this post. The case highlights some interesting contrasts with U.S. law.

Perhaps the most significant is the fact that the court made clear that a general duty of good faith is not part of Canadian patent law. The court noted the U.S. problems with the doctrine of inequitable conduct at paragraph 128 mentioning the “ever expanding doctrine of inequitable conduct.” At paragraph 150, the court took note of the recent CAFC decision in Therasense and that court’s description of inequitable conduct as the “atomic bomb” of patent law.

The court made the point that the requirement to respond in good faith to a requisition (examiner’s report) in section 73 (1) (a) of the Canadian Patent Act was not for the courts to decide (paragraph 150) and that the section 73 duty could not be used to invalidate an issued patent. There is another provision in our statute (section 53) that does apply to issued patents but it only relates to untrue material allegations in the petition or to omissions or additions in the specification if willfully made for the purpose of misleading.

The court also made some interesting observations about anticipation in the context of a disclosure and prior sale of a device for testing, deciding the disclosure was subject to confidentiality based on practice in the industry and that the prior sale did not make the invention “available to the public.” This of course contrasts with the U.S. “on sale” bar and also shows that in many situations the Canadian standard of “available to the public” will produce a different result with respect to novelty than the U.S. public use and on sale standard,

The case also illustrates the rather relaxed standard of the Canadian courts concerning misnomer of inventors, where in many cases, particularly where the issue of inventorship does not affect ownership, our courts have found such errors not to be “material.” See paragraphs 114 and 129.


therasense 2