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Legal Series: Bio & Pharma Law in 2012
   LIVE Webcast  


Event Details:                                                                                                                                                          

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.

Course Level: Intermediate
Prerequisite: None
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Group, LLC
Recommended CLE/CPE Hours: 1.75 - 2.0
Advance Preparation: Print and review course materials
Course Code: 124248
Recording Fee: $299 (Please click here for details)


Featured Speakers for Legal Series: Bio & Pharma Law in 2012 LIVE Webcast :

Agenda  (click here to view more)
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

Fish & Richardson P.C.
José P. Sierra
speaker bio »»

Nutter McClennen & Fish LLP
Konstantin M. Linnik, Ph.D.
speaker bio »»

Who Should Attend?

- Biotech/Pharma Attorneys
- IP Attorneys
- General Counsel
- Senior Executives
- Consultants & Clients in the Biotech and Pharmaceutical Industries

Why Attend?

This is a must attend event for anyone interested in understanding the significant changes in pharmaceutical and biotech law.

- Detailed guidance given by the most qualified key leaders & experts
- Hear directly from key regulators & thought leaders
- Interact directly with panel during Q&A

Register now! Get the chance to ask, learn and interact with the speakers and fellow practitioners, live. Advanced registration is recommended as space is limited. Please click the registration button below to enroll in this course today.

Registration Information:                                                                                                                                    

Please note, the event date is firm although it may be subject to change. Please click here for details.
The Knowledge Group, LLC is producing this event for information purposes only. We do not intend to provide or offer business advice. The contents of this event are based upon the opinions of our speakers. The Knowledge Congress does not warrant their accuracy and completeness. The statements made by them are based on their independent opinions and does not necessarily reflect that of The Knowledge Congress' views. In no event shall The Knowledge Congress be liable to any person or business entity for any special, direct, indirect, punitive, incidental or consequential damages as a result of any information gathered from this webcast.





Legal Series: Bio & Pharma Law in 2012
LIVE Webcast

Event Sponsors / Speaker Firms:

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, visit or follow @fishrichardson on Twitter.

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


The Knowledge Group, LLC is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN, 37219-2417. Website:


We are an approved multi-event sponsor in the state of California. Our provider ID is: 14451. In Texas, Illinois, and Virginia, we submit programs for individual approval in advance. In all other states, once attendance is verified, participants are emailed an official certificate of attendance which they submit to their respective State Bar Associations. Our programs are created with continuing education in mind and are therefore designed to meet the requirements of all State Bar Associations. If you have any questions, please email our CLE coordinator at:

Attention New York Attorneys:

This program is approved for CLE credit under New York’s Approved Jurisdiction policy. The Knowledge Group, LLC is an approved sponsor in the state of California, a New York Approved Jurisdiction. This program fulfills the non-traditional format requirement of exceeding 60 minutes in length. Please note only experienced attorneys (more than 2 years) are eligible to receive CLE credit via non-traditional format learning platforms. The Knowledge Group will verify attendance during the webcast via secret words (3 per credit hour) and by auditing attendees log in and log out records. All verification instructions will be provided during the webcast. Once attendance verification requirements have been completed, the attendee will be issued a certificate of attendance be The Knowledge Group for the course with the recommended number of credit hours. The Certificate of Attendance is normally sent via email in 24 hours or less.

To Claim Your CLE Credits:

The attorney should simply include credits earned via Knowledge Group webcasts when computing the total number of CLE credits completed, and keep the Knowledge Group Certificate of Attendance for a period of at least four (4) years in case of audit. An attorney may count towards her/his New York CLE requirement credit earned through the Approved Jurisdiction policy without notifying the CLE Board.

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Enrolled Agents Sponsor ID Number: 7602U

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