Posts Tagged ‘Mayo v Prometheus’

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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Happy Birthday To Me – Patents4Life is Three!

Tuesday, March 20th, 2012

Three years ago, when I started this Blog (or is it “Blawg”?), the hot topics were In re Kubin and the summary affirmance of Classen by the Fed. Cir. Today, along with the looming AIA regulations, Mayo v. Prometheus and Caraco are awaiting decision by the Supreme Court, and St-Gobain Ceramics v. Siemens and  AMP v. Myriad are awaiting decisions on their petitions for cert. The old Chinese curse, “May you live in interesting times!” is “new again”, even if “The Art of War” is not on the Times  bestseller list (but “American Sniper” is).

Well, the IP world around us has been nothing if not interesting. It is foolish to try to predict what will hold our (and the courts’ ) interest over the next year, much less three years. However, a trend that is easy to spot is the interest exhibited by the current Supreme Court in IP cases. When I did my list of the top ten IP stories of 2011, six of them involved the Supreme Court.

Another one is the rise of IP and bioethics issues related to “personal genomics”, “genome-scale testing” or “companion diagnostics” (however you wish to term it). Today, the journal, Narrative Inquiry in Bioethics announced that it will publish an issue devoted to personal stories from individuals who have received results from genome-scale testing – such as from a SNP profile (bet you haven’t heard that term in a while). On the flight home from AUTM, I read a story about one such individual in the LA Times – a professor who had his entire genome sequenced and posted it so that any group could venture a diagnosis or other observation. One group spotted a marker for type II diabetes, which the prof obligingly developed after recovering from a viral infection.

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