Robert S. MacWright, J.D., Ph.D., the new head of tech transfer at the Salk Institute, will moderate a panel at the 2011 Annual Meeting of the Association of University Technology Managers (AUTM) on March 1st in Las Vegas. The panel, entitled, “The Ever Changing Kaleidoscope of U.S. Patent Law,” will examine what MacWright terms “a decade of meddling by the legislature and the courts.” The “panel of experts” – that will include, Sandra Kuzmich of Frommer Lawrence, Gonzalo Merino, J.D., Ph.D., of Columbia and me – will review the current state of affairs and “with considerable risk of error, [we] will also make predictions about other changes that may lie ahead.”
Apart from encouraging you to attend this session (Tuesday, D1 on the program), the trend of judicial decisions at all levels to weaken patent protection for pharma/biotech inventions is alarming. The big losses like KSR (which eliminated the rigorous TSM test for obviousness), Merck v. Integra (expanded safe harbor for drug research), Ariad (“Yes, Virginia, Section 112 does contain a written description requirement”), and Myriad (No patent protection for DNA or for diagnostics used in personalized medicine) have tended to overshadow smaller but still significant anti-patent decisions like In re Kubin (Deuel reversed), In re Fisher (ESTs and SNPs lack utility) and In re Alonso (good-bye to the “monoclonal antibody exception”).
The Federal Circuit’s holding in Prometheus v. Mayo was one of the few bright spots (methods of screening for drug efficacy and medical treatment are patentable – yea!) but even this decision may be reviewed by the Supreme Court – again (it granted cert. once). And while it is difficult to see the Supreme Court’s Bilski decision as a good thing, at least an entire category of patentable subject matter was not eliminated. If the “M or T” test had been affirmed, the Federal Circuit would have been required to invalidate most of the Myraid diagnosis claims. Now Judge Rader has to figure out how to support a holding that the Myriad “comparing DNA sequence” claims are less abstract than Bilski’s claims to hedging commodity risk. And he is the judge that the ACLU is trying to recuse as prejudiced in favor of biotech! It’s going to be an interesting year.