As University of Missouri law professor Dennis Crouch reports on Patently-O, the Supreme Court has agreed to revisit Mayo Collaborative Services v. Prometheus Laboratories, Inc. and hear Mayo’s petition on the patentable subject matter eligibility of medical diagnostic methods. (See related eNews post here.) The issue raised on appeal is “whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve ‘transformations’ of body chemistry.”
The claims asserted by Prometheus are directed toward a method of “optimizing therapeutic efficacy” by first administering an active drug (6-thioguanine) to a subject and then using the subject’s metabolite blood-level to adjust future doses of the drug. Thus, Crouch explains, most of the claims are centered around three ordered steps of:
- administering the drug to the subject;
- determining the amount of drug in the subject’s blood; and
- recalibrating the drug dosage based on Step Two.
The district court found the claims invalid as lacking patentable subject matter. On appeal, the federal circuit reversed, holding that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.” That decision was based on the court’s machine-or-transformation test that was subsequently de-emphasized by the Supreme Court in Bilski v. Kappos (2010). In the wake of its Bilski decision, the Supreme Court vacated the federal circuit’s Prometheus decision and remanded for a new opinion. On remand, the federal circuit again affirmed that the Prometheus claims are eligible for patent protection.
“This will be an exciting (and tense) time for diagnostic companies after the Supreme Court, without explanation, declined to issue an opinion in Laboratory Corporation of America v. Metabolife Laboratories because the appeal was ‘improvidently granted,’” patent attorney Stephen Albainy-Jenei of Frost Brown Todd observes on Patent Baristas. “Several medical associations have argued that patents on such diagnostic methods could impede the practice of medicine and raise the costs of medical treatment. If that were the standard, all medical patents would be unpatentable.”
Sources: Patently-O and Patent Baristas
Posted June 22nd, 2011 under Tech Transfer
|
|
|
|
Write a comment