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Posts Tagged ‘ metabolite laboratories ’

Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Prometheus Decision*

Posted: Wednesday, Mar 21, 2012 @ 2:20 pm | Written by Eric Guttag | 34 comments
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Posted in: Biotechnology, Eric Guttag, Guest Contributors, IP News, IPWatchdog.com Articles, Medical Devices & Methods, Patentability, Patents, US Supreme Court

Justice Breyer delivered the opinion of a unanimous Court.

Well, Justice Breyer, the writer of the dissenting opinion in Laboratory Corp. v. Metabolite Laboratories, Inc., finally got his wish.  Writing the opinion for a unanimous Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Breyer ruled that a claimed drug dosage calibration method based on previously unknown “precise correlations between metabolite levels [of administered thiopurine drugs] and likely harm or ineffectiveness” was patent-ineligible under 35 U.S.C. § 101 because it “adds nothing to the laws of nature that is not already present when the steps [of the claimed method] are considered separately.”  While I’m not surprised that Breyer ruled the claimed method patent-ineligible, his reasoning in Mayo Collaborative Services is, in my view, often nonsensical, and is fraught with unfortunate statements that could potentially eviscerate the patent-eligibility of drug testing methods (as well as related medical diagnostic methods) generally under 35 U.S.C. § 101.

Briefly, the claimed method in Mayo Collaborative Services determined (calibrated) the proper dosage of thiopurine drugs to treat both gastrointestinal and non-gastrointestinal autoimmune diseases.  What the claimed method sought to do was optimize therapeutic efficacy while minimizing toxic side effects.  The claimed method had essentially only two steps:  (1) administering a thiopurine drug to a patient; and (2) determining the level of metabolites of the drug in the patient after administration.  The claimed method also concluded with some “wherein clauses” that, if certain drug metabolites were below a certain level, that would indicate a need to increase the amount of the drug administered.  Conversely, if those drug metabolites were above a certain level, that would indicate a need to decrease the amount of the drug administered.  See CAFC: Method for Calibrating Drug Dosage Is Transformative.



5th Anniversary: Supreme Lab Corp. Non-Decision Revisited

Posted: Tuesday, Jun 21, 2011 @ 12:50 pm | Written by Gene Quinn | 5 comments
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Posted in: Gene Quinn, IP News, IPWatchdog.com Articles, Patentability, Patents, US Supreme Court

Justice Stephen Breyer wanted to decide the case, thankfully enough others didn't.

Court Watchers know that there are approximately 8,000 peti­tions filed with the Supreme Court each year and an additional 1,200 applications of various kinds are filed per year that can be acted upon by a single Justice.  There is simply not enough time to consider each case where Supreme Court review is sought, so the Court has historically been very selective in choosing cases, normally only issuing full opinions in roughly 85 cases each year. Notwithstanding, this Supreme Court has shown great interest in patent matters, particularly questions of fundamental importance such as what is patent eligible subject matter (See Bilski v. Kappos and Mayo v. Prometheus), what is considered obvious (See KSR v. Teleflex) and the appropriate level for the presumption of validity of an issued patent (See Microsoft v. i4i).  The Roberts Court is no doubt placing its stamp on patent law, and it does not appear as if that will cease any time soon.

Notwithstanding, tomorrow is an anniversary of a peculiar Supreme Court event.  Five years ago the United States Supreme Court decided not to issue a ruling in the case of Laboratory Corporation of America v. Metabolite Laboratories. This may not seem like an appropriate event to revisit, or even a noteworthy decision at all, but the issue in the case — what is patent eligible subject matter — has continued to be a question of great concern to the courts, including the Supreme Court.  Indeed, with the Supreme Court recently granting cert. in Mayo v. Prometheus, it seems that it is only a matter of time before the issues in Lab Corp. make their way to a decision on the merits by the Supreme Court.



Bilski Tea Leaves: Remembering the Lab Corp. Non-decision

Posted: Monday, Jan 18, 2010 @ 11:59 pm | Written by Gene Quinn | 8 comments
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Posted in: Bilski, Biotechnology, Gene Quinn, IP News, IPWatchdog.com Articles, Patents, US Supreme Court

It has been just over two months since the Supreme Court heard oral arguments in Bilski v. Kappos, and we likely have at least several more months to wait for a ruling. Notwithstanding, pundits and commentators are certainly trying to figure out what the Supreme Court will do, engaging in thought exercises and gazing into crystal balls. The crystal ball of preference is history, tied together with a healthy bit of speculation based on how similar cases and issues were previously addressed by the Court. No single case could be more telling with respect to how the Supreme Court may rule than a case in which they did not rule — Laboratory Corporation of America v. Metabolite Laboratories. In this case the United States Supreme Court decided not to issue a ruling, which may not seem noteworthy at first glance. After all, approximately 8,000 petitions are filed with the Supreme Court each year, and an additional 1,200 applications of various kinds are filed per year that can be acted upon by a single Justice. There is simply not enough time to consider each case where Supreme Court review is sought, so the Court has historically been very selective in choosing cases, normally only issuing full opinions in roughly 80 to 100 cases each year. But, as is frequently the situation with the Supreme Court, there is more than meets they eye with respect to Lab Corp.