Posts Tagged ‘Myriad’

Top 2011 IP Stories on Patents4Life

Saturday, December 31st, 2011

I spent a day or two looking back over the breaking IP news that resulted in posts on Patents4Life. I wrote most of them, but want to take a pause to thank regular contributors Paul Cole, Ron Schutz and Stefan Danner for their help. Patents4Life was originally intended to be a “blawg” focused on IP developments affecting the Life Sciences and, as 2011 comes to a close, I have put together a “top ten” list of stories to which attention had to be paid – by all of us in most cases – litigators, prosecutors and tech transfer professionals in the U.S. and abroad. The single most-apparent trend in IP last year was the increasing globalization of IP law – consider inter-office work-sharing and the prosecution highway. But I don’t want this column to go on into 2012, so here, in reverse order, are the “legal events” that dominated the netwaves in 2011. (I apologize for what I hope will be minor errors of fact and spelling – I am writing this from notes I made while back-tracking through the year.)

10. The Stem Cell Suits. In Sherley v. Sebelius, the district court finally dismissed the suit which had resulted in a ban on Federal funding for stem cell research, after the Court of appeals reversed its initial decision. (See Post, July 28th). However, in October, the Court of Justice of the EU ruled that claims to embryonic stem cells or even to cells that could become sources for embryonic stem cells were not patentable. (See post, Oct. 18th). Some types of gene therapy were indicated to be allowable. The future of embryonic stem cells is cloudy with a chance of further retreats like Geron’s.

9. On October 18th, Saint-Gobain petitioned for cert., urging the Supreme Court to answer a burden of proof question that comes down to: “Does holding a patent on an improvement on a patented invention that does not literally infringe insulate the accused infringer from infringement under the doctrine of equivalents?” This question has been simmering under the surface of infringement law for decades, the Fed. Cir. is clearly divided and the Supreme Court might bite. See Post of March 8, 2011 as well as October 14th post.

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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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