By Donald Zuhn --
Reflecting upon the events of the past twelve months, Patent Docs presents its fifth annual list of top biotech/pharma patent stories. For 2011, we identified a dozen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. On Monday, we counted down stories #12 to #10, and yesterday, we covered stories #9 to #7. Today, we present stories #6 to #4. As with our other lists (2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.
6. Supreme Court Hears Prometheus & Federal Circuit Decides Classen
Last month, the U.S. Supreme Court heard oral argument in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which involves the patent-eligibility of claims directed to methods for determining whether an effective amount of a drug is being administered to a patient. A decision in Prometheus should come some two years after the Court issued its opinion on the patent-eligibility of (business) method claims in Bilski v. Kappos. Shortly after handing down its decision in Bilski in 2010, the Court granted certiorari, vacated the Federal Circuit opinion, and remanded both Prometheus and Classen Immunotherapies, Inc. v. Biogen IDEC. The Federal Circuit decided Prometheus on remand in December 2010, and last June, the Court again granted certiorari. The Federal Circuit revisited Classen in August, finding that the claims of one patent in suit were not patent-eligible under § 101, and that the claims of two other patents were patent-eligible, because the latter recite methods that include "the physical step of immunization on [a] determined schedule" and thus are "directed to a specific, tangible application."
For information regarding this and other related topics, please see:
• "Mayo Collaborative Services v. Prometheus Laboratories at the Supreme Court: Oral Argument Tomorrow," December 6, 2011
• "Deciphering the Patent-Eligibility Message in Prometheus, Myriad and Classen," September 20, 2011
• "Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011) -- Additional Views from Chief Judge Rader," September 8, 2011
• "Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011) -- Judge Moore's Dissent," September 6, 2011
• "Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)," August 31, 2011
• "Another Academic with Solutions to Problems that Don't Exist," January 31, 2011
5. Supreme Court Interest in Patent Law on the Rise
In little more than a week last spring, the Supreme Court was in the unusual position of issuing opinions on three separate patent cases. On May 31, the Court in Global-Tech Appliances, Inc. v. SEB S.A. affirmed a Federal Circuit decision upholding a jury verdict that defendants were liable for inducing infringement, finding that willful blindness requires not only the existence of a known risk but a high probability of that risk that is appreciated by the defendant, coupled with active efforts by the defendant to avoid knowing that the induced activities are infringing. On June 6, in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., the Court rejected the idea that employment is enough, absent an agreement, to vest ownership of a patented invention. Finally, on June 9, the Court in Microsoft Corp. v. i4i Limited Partnership held that 35 U.S.C. § 282 requires an invalidity defense to be proved by clear and convincing evidence. With the Prometheus decision on tap, and AMP v. USPTO possibly coming before the Court, 2012 will bring even more Supreme Court decisions on important patent law issues.
For information regarding this and other related topics, please see:
• "Microsoft Corp. v. i4i Limited Partnership (2011)," June 9, 2011
• "Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (2011)," June 6, 2011
• "Global-Tech Appliances, Inc. v. SEB S.A. (2011)," May 31, 2011
4. Embryonic Stem Cell Patenting Suffers Setback in Europe
In a blow to human embryonic stem cell (hESC) research in Europe, the European Court of Justice (ECJ) determined in October that hESCs are not patent-eligible subject matter. The decision evoked Europe's "moral" position against biotech patenting some 30 years ago, which allowed the rest of the world (and predominantly the U.S.) to develop an entirely new industry with little European competition. With regard to the stem cell decision, the question remains whether the ruling will foster or hinder innovation, and it will take perhaps a generation to understand the full extent of the ban. While not related to the ECJ decision, California-based stem cell pioneer Geron Corporation announced in November that it was discontinuing further development of its human embryonic stem cell (hESC) programs and would be seeking partners for each of the programs, with the company focusing on its oncology programs instead.
For information regarding this and other related topics, please see:
• "Geron Discontinues hESC Programs," November 16, 2011
• "Comparative Study on Patenting of Human Embryonic Stem Cells," November 16, 2011
• "Let the Experiment Begin: Impact of ECJ Stem Cell Ruling on Synthetic Blood Development," November 15, 2011
• "No More Patents for Cells Derived from Human Embryos in EU," October 18, 2011
• "European Court of Justice Renders Stem Cell Decision," October 18, 2011
• "GOP Candidates Unified in Opposition to Embryonic Stem Cell Research," August 16, 2011
• "European Court of Justice Considers Embryonic Stem Cell Ban," May 11, 2011
• "The Hinxton Group Foresees Stem Cell Issues and Proposes Solutions," April 4, 2011
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