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Register for the 2015 BIO IP & Diagnostics Symposium!

August 18, 2015
The Third Annual BIO IP & Diagnostics Symposium takes place on September 18, 2015 in Alexandria, Virginia! Have you reserved your seat at the Symposium yet? Space is limited. Register today.

The symposium will bring together representatives of academia, government and industry to review the current patent law landscape and evaluate the impact on both the genetic diagnostics and biopharmaceutical sectors. The program will review IP issues for both diagnostics generally and companion diagnostics. It will also explore new collaborations and regulatory developments. BIO aims to inform industry and government alike on how to move the science forward in the current climate.

2015 BIO IP & Diagnostics Symposium

2015 BIO IP & Diagnostics Symposium Agenda


(subject to change)

8:00 a.m. – 2:30 p.m.
Hilton Old Town Alexandria Hotel - Salon AB, Lobby Level
1767 King Street, Alexandria, VA 22314


Please pick up your conference badge and materials in the Salon AB Foyer on the lobby level. Please note, pre-registration is strongly encouraged, as some registration categories may close prior to the event.

Session 1: Strategies for Prevailing on Subject Matter Eligibility Before the PTO and in Litigation

8:15 a.m. – 9:30 a.m.
Hilton Old Town Alexandria Hotel - Salon AB, Lobby Level
Sponsored by: McDonnell Boehnen Hulbert & Berghoff LLP

The panel will discuss the state of law and the current patent environment. Panelists will discuss overcoming challeneges and strategies to work within the framework provided by the PTO and set by the courts.

Moderator: Don Zuhn, Partner, McDonnell Boehnen Hulbert & Berghoff LLP

Panelists:

  • Kevin Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff LLP

  • Gloria Fuentes, Legal Director, Patents, Merck

  • Eric Citron, Partner, Goldstein & Russell, P.C.


Session 2: The Next Phase - How USPTO and PTAB are Identifying Patent Eligible Subject Matter

9:30 a.m. – 10:45 a.m.
Hilton Old Town Alexandria Hotel - Salon AB, Lobby Level
Sponsored by: Brinks Gilson & Lione

This panel will provide an overview of how Examiners and the PTAB are identifying patent eligible subject matter in the fields of diagnostics and diagnostic methods. The panel will also discuss decisions by and cases currently pending at the PTAB and claims recently allowed by Examiners.

Moderator: Jennifer Fox, Counsel, Brinks Gilson & Lione

Panelists:


  • Hon. Michael P. Tierney, Lead Administrative Patent Judge, Trial Section, U.S. Patent  & Trademark Office, Patent Trial & Appeal Board


Networking Break

10:45 a.m. – 11:00 a.m.
Hilton Old Town Alexandria Hotel - Salon AB, Lobby Level

Session 3: Diagnostic Tests-What’s Left to Patent?

11:00 a.m. – 12:15 p.m.
Hilton Old Town Alexandria Hotel - Salon AB, Lobby Level
Sponsored by: Schwegman, Lundberg & Woessner, P.A.

Panelists will briefly discuss the legal history and the role of the “diagnostic conclusion” as a claim element. They will discuss the cumulative impact of recent case law on diagnostic claims reciting natural phenomenon, and Section 101 prosecution strategies to obtain diagnostic method claims in view of the case law and the PTO Guidance.

Moderator: Warren Woessner, Attorney & Founding Shareholder, Schwegman, Lundberg & Woessner, P.A.

Panelists:

  • Benjamin Jackson, Vice President Legal Affairs, Myriad Genetics

  • Leslie Fischer, PhD, Senior Patent Attorney, Novartis Pharmaceuticals Corporation


Working Luncheon & Session 4: Potential Impacts of Regulatory Changes

12:15 p.m. – 2:00 p.m.
Hilton Old Town Alexandria Hotel - Salon AB, Lobby Level
Sponsored by: Covington & Burling LLP

Panelists will focus on the regulatory environment for diagnostic tests. The panel will discuss FDA’s role in regulating LDTs, companion and complementary diagnostic tests, and their regulatory approach to NGS tests.

Moderator: Krista Carver, Partner, Covington & Burling LLP

Panelists:

  • Ellen Flannery, Partner, Covington & Burling LLP

  • E. David Litwack, PhD, Policy Advisor, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health

  • Allen Nunnally, Associate General Counsel, IP & Corporate, Foundation Medicine, Inc.


Closing Remarks

2:00 p.m. – 2:30 p.m.
Hilton Old Town Alexandria Hotel - Salon AB, Lobby Level

Registration

This is the third year BIO is hosting this event and the first year we plan to charge for registration to attend the event. Space is limited and you must reserve your seat. To promote a diverse audience, BIO asks that each company/organization register no more than two (2) people. Exceptions will be made for government attendees. To register, please visit our registration page or contact Caroline Arrington (Carrington@bio.org) at (202) 962-9228.