Legal Series: Bio & Pharma Law in 2012 LIVE Webcast

SEGMENT 1:
José P. Sierra, Principal, 
Fish & Richardson P.C.

• Government enforcement against pharmaceutical/life science companies in the area of the False Claims Act, 31 U.S.C. Sections 3729 et. al., particularly in the areas of off-label marketing and kickback violations.
• The Constitutional challenges to the FDA’s off-label marketing rules, focusing particularly on U.S. v. Caronia and Par Pharmaceutical, Inc. v. U.S. et al.
• The problem with Government enforcement against corporate individuals, focusing particularly on the “Park Doctrine” and the Government setbacks in U.S. v. Lauren Stevens and U.S. v. Stryker Biotech, et al.

SEGMENT 2:
Konstantin M. Linnik, Ph.D., Partner, 
Nutter McClennen & Fish LLP 
On March 20, 2012, the United States Supreme Court ruled in Mayo Collaborative Services v. Prometheus Laboratories. The decision is expected to have long-term ramifications in the pharmaceutical and biotechnology industries, particularly, for the bourgeoning fields of diagnostics (Dx) and personalized medicines (PM). The Court unanimously held that Prometheus’s claims involving the correlation between blood levels and optimal dosages were unpatentable as a “law of nature.”

Shortly following that decision, the Court has granted the petition for writ of certiorari in the “gene patenting” case, Association for Molecular Pathology v. Myriad, vacating and remanding the case back to the Federal Circuit for re-consideration in light of Mayo. The webinar will cover:

• The facts of the Mayo and Myriad cases and the Court’s rationale in Mayo
• How broad is the reach of this decision and what it means for holders of intellectual property on Dx and PM
• How the Federal Circuit is expected to rule in Mayo and Myriad
• Review of typical questionable patent claims and analysis of issues
• New claiming strategies
• Remediation strategies for IP holders
• Assessment of Freedom-To-Operate positions in light of the decisions