Posts Tagged ‘Mayo v Prometheus’

Genetic Technologies v. LabCorp. – Mayo Redux.

Tuesday, September 16th, 2014

It was Mayo redux with a vengeance in the September 23, 2014 decision in Genetic Technologies Ltd. v. Laboratory Corp. of Amer. Holdings et al., Civil Action No. 12-1736-LPS-CJB (D. Del. 2014).  Magistrate Judge Burke released an opinion invalidating claim 1 of Genetic Technologies U.S. Patent No. 7,615,342 as claiming non-patentable subject matter under s. 101 that could have been stenciled from the PTO s.101 Guidelines. Claim 1 was directed to a method to predict potential sprinting, strength or power performance in a human. The claim had an “analyzing step” to look for variations in the ACTN3 gene of the human, a “detecting step” to determine the presence of two 577R alleles at a loci of the ACTN3 protein and (c) a “predicting step” positively associating two copies of the allele with the performance elements.

Citing Mayo v. Prometheus and PerkinElmer v. Intema copiously, the correlation between the alleles and athletic performance was held to be a natural law and the analyzing and detecting steps were the “employment of … routine conventional process[es]” that were not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. The “predicting step” was dismissed as “’no more than an instruction [to] apply the [natural] law.’ Prometheus, 132 S Ct at 1297.”

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Nautilus v. Biosig – Solving Insoluble Ambiguity?

Monday, June 2nd, 2014

Today the Supreme Court unanimously rejected the Fed. Cir.’s standard for resolving challenges to validity under s.112 para.2, based on whether or not a claim was “amenable to construction” and not “insolubly ambiguous”. Noting that Nautilus had urged that a patent is invalid when the level of ambiguity is such that “readers could reasonably interpret the claim’s scope differently” and that Biosig and the Solictor had argued s.112(2) is met when the patent provides “only” reasonable notice of the scope of the claimed invention, the Court attempted to reach a middle ground:

“Cognizant of the competing concerns, we read s. 112, para. 2 to require that a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty…[citing]” Markman, 517 U.S., at 389 (claim construction calls for ‘the necessarily sophistication analysis of the whole document,’ and may turn on evaluations of expert testimony.”

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PERSONALIZED MEDICINE TAKES OFF WHILE DIAGNOSTIC ASSAYS ARE GROUNDED

Tuesday, September 25th, 2012

A front-page article yesterday in the New York Times and other major newspapers reminded me that drug development and methods of medical treatment will be driven by the genomics of increasingly sub-divided patient populations. As reported by GenomeWeb, summarizing an article in Nature (Sept. 23, 2012), “members of the Cancer Genome Atlas presented a multifaceted genetic analysis of breast cancer, characterizing four main subtypes of the disease and uncovering shared molecular features between one of these subtypes and tumors from another part of the body.”

I won’t try to go into detail about their findings, but they were able to connect one particularly nasty form of “triple negative” breast cancer to ovarian cancer. Ironically, post-Myriad, “triple negative” basal-like breast cancer and ovarian cancers shared mutations and other alterations in genes such as BRCA1/2. This suggests that drugs like the platins that are useful to treat ovarian cancer, but are not generally used for breast cancer, might be efficacious to treat this new “subclass” of tumor.

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Mayo v. Prometheus – A European View

Thursday, March 29th, 2012

A Guest Post from Paul Cole, European Patent Attorney, Lucas & Co; Professor of IP law, Bournemouth University.

Is a claim to an assay patent-eligible when all its features are known save for how it should be interpreted? The interpretation is clinically significant because it allows a family of drugs to be administered safely even though a minority of patients are at risk of significant and in some instances fatal side-effects. Before the invention knowledge was available to enable the practical steps in the assay to be carried out and measurements had been made but their clinical interpretation was not understood.

A European answer is to be found partly in the “any hardware” approach first set out in T 931/95 PBS PARTNERSHIP/Controlling pension benefits system and approved by the Enlarged Appeal Board in in G 3/08 PRESIDENT’S REFERENCE. It was pointed out that a computer-readable data storage medium had the technical effects of being computer-readable and of being capable of storing data and is patent-eligible under EPC arts 52(2) and (3). On that basis it could not become ineligible merely because it was storing computer program X, any more than a cup which was a technical article could become ineligible merely because it was decorated with picture X. There was no case-law to support the view that a claim to “a computer-readable storage medium with program X written on it” should lose its technical character merely because it was too generic or functionally defined.

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