Legal Series: Bio & Pharma Law in 2012 LIVE Webcast
Constant innovation and development in The Biotech and Pharma industries bring out constant changes in the law. Attorneys must keep up with most substantive legal issues in order to remain a value to their clients.The Knowledge Group is producing a LIVE web cast which will explore the latest and greatest changes and updates in Biotech and Pharma Law. Legal Series: Bio & Pharma Law in 2012 LIVE Webcast is a must attend for: Outside Attorneys, General Counsel, and Risk Officers & Senior Executives at Biotech and Pharma companies.
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.
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
Who Should Attend:
- Biotech/Pharma Attorneys
- IP Attorneys
- General Counsel
- Senior Executives
- Consultants & Clients in the Biotech and Pharmaceutical Industries
José P. Sierra is a Principal in the Boston and Delaware offices of Fish & Richardson. Mr. Sierra works in the firm’s pharmaceutical and medical device industry practices focusing on qui tam/whistleblower litigation, white collar and government investigations, corporate governance and risk management. Follow Mr. Sierra’s PharmaRisc blog where he discusses the legal, compliance and corporate governance risks and issues that pharmaceutical, medical device and biotech companies often face; Pharma Risc can be followed herewww.pharmarisc.com. Mr. Sierra has nine years of legal experience in the pharmaceutical and health care products industry, including expertise in compliance, ethics, internal investigations, and commercial litigation. Mr. Sierra also served for more than 10 years as an Assistant U.S. Attorney in New Jersey, where he investigated and prosecuted violations of federal fraud, racketeering and corruption charges.
José P. Sierra is a Principal in the Boston and Delaware offices of Fish & Richardson. Mr. Sierra works in …
Konstantin Linnik, Ph.D., is an Intellectual Property (IP) lawyer with the Boston law firm Nutter McClennen & Fish LLP. He advises biotech and pharma companies on protection and enforcement of their IP and other IP-related matters. Previously, Dr. Linnik was Senior Corporate Counsel and the lead patent counsel for Pfizer research units located in Cambridge, Massachusetts; Düsseldorf, Germany; and Ottawa, Canada. He is also an adjunct faculty member at Suffolk University Law School where he teaches IP licensing
Konstantin Linnik, Ph.D., is an Intellectual Property (IP) lawyer with the Boston law firm Nutter McClennen & Fish LLP. He …
Print and review course materials
Method of Presentation:
NY Category of CLE Credit:
Unlock All The Knowledge and Credit You Need
Leading Provider of Online Continuing Education
It's As Easy as 1, 2, 3
Get Your 1-Year All Access Pass For Only $199
About Fish & Richardson P.C.
Fish & Richardson is a global law firm providing strategic counseling and litigation services to innovative clients who seek to protect and maximize the value of their intellectual property (IP). With more than 375 attorneys and technology specialists practicing IP strategy and counseling, IP litigation, and business litigation, Fish is known for its superior technical expertise. Fish has been named top patent litigation firm in the country for eight straight years, a premier IP firm for America’s biggest companies, and an elite top tier law practice. For more information, visitwww.fr.com or follow @fishrichardson on Twitter.
About Nutter McClennen & Fish LLP
Nutter McClennen & Fish serves as counsel to leading pharmaceutical, medical device and biotechnology companies in a range of legal areas including intellectual property, corporate finance and transactions, litigation, employment and real estate. The firm also works with emerging companies in these industries to help them realize value from innovation, supporting them with strategic legal advice and counsel in corporate, IP and other areas critical to start-up and acceleration. To learn more about Nutter, visit www.nutter.com.