IP Counsels FALL CONFERENCE PROGRAM GUIDE. Committee Conference ANNAPOLIS, MD NOVEMBER 13 15, Program Guide sponsored by

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1 IP Counsels Committee Conference 2017 FALL CONFERENCE ANNAPOLIS, MD NOVEMBER 13 15, 2017 PROGRAM GUIDE Program Guide sponsored by

2 Program Agenda PROGRAM AGENDA ANNAPOLIS, MD NOVEMBER 13 15, 2017 All Sessions will be held in Chesapeake Ballroom, 2 nd Floor. MONDAY, NOVEMBER 13, :30 am 4:30 pm REGISTRATION OPEN 12:00 pm 3:15 pm IPCC BUSINESS MEETING & WORKING LUNCHEON *Open to IP Counsels Committee company members only 3:15 pm 3:30 pm REFRESHMENT BREAK 3:30 pm 4:30 pm OPENING SESSION: AVOIDING THE ETHICAL MINEFIELD OF BIOPHARMACEUTICAL PATENT LITIGATION AND PROSECUTION Sponsored by: O Melveny & Meyers LLP This panel will offer an in-depth survey of the awarding of attorney s fees in biopharmaceutical patent litigation cases over the past two years. The panel s discussion will also specifically examine potential adverse evidentiary inferences flowing from litigation misconduct, as well as discuss common ethical violations observed by the United States Patent and Trademark Office. Filko Prugo Registered Patent Attorney, O Melveny & Meyers LLP Lisa Pensabene Head, Life Science Litigation, O Melveny & Meyers LLP Kimberly Weinreich Staff Attorney, Office of Enrollment and Discipline, United States Patent and Trademark Office 4:45 pm 5:15 pm WELCOME REMARKS BY F. SCOTT KIEFF, FORMER COMMISSIONER, UNITED STATES INTERNATIONAL TRADE COMMISSION Sponsored by: European Patent Office Introductory Remarks by: Klaus-Peter Döpfer, PhD Director, European Patent Office WiFi Sponosored by: Womble Bond Dickinson (US) LLP 2 NOVEMBER 13 15, 2017 ANNAPOLIS, MARYLAND

3 5:30 pm 7:30 pm WELCOME RECEPTION Sponosored by: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Fox s Den Annapolis Enjoy cocktails, craft beer, and fall fare in the heart of Historic Annapolis, just a few short blocks from the conference hotel! Our walking group will depart at 5:25 pm from the hotel lobby (approx. 7 minute walk) Program Agenda TUESDAY, NOVEMBER 14, :00 am 9:15 am BREAKFAST & FIRESIDE CHAT WHEN MARKET INCENTIVES JUST AREN T ENOUGH: INCENTIVIZING INVESTMENT IN LOW MARGIN, LOW VOLUME, OR LOW UTILIZATION THERAPEUTIC PRODUCTS Sponsored by: Brinks Gilson & Lione MODERATOR Jennifer Fox Shareholder, Brinks Gilson & Lione SPEAKER: Kevin Outterson Professor of Law, Boston University 9:30 am 10:45 am SESSION 1: IN THE HOT SEAT: UPCOMING CASES IN THE SUPREME COURT AND FEDERAL CIRCUIT Sponsored by: Choate Hall & Stewart LLP This panel will tackle a number of issues from the Supreme Court including expected fallout from patent venue decision TC Heartland v. Kraft, IPR constitutionality, sovereign immunity in IPR s, among others presently under review. Eric Marandett Co-chair, Intellectual Property Litigation Practice Group, Choate Hall & Stewart LLP Nathan Edwards Director, Intellectual Property, Vertex Pharmaceuticals James Harrington Senior Vice President, Chief Intellectual Property Counsel, Shire Pharmaceuticals Charlene Stern Vice President, Legal, Editas Medicine Sophie Wang Attorney, Choate Hall & Stewart LLP BIO.ORG/IPCC #BIOIPCC 3

4 Program Agenda 10:45 am 11:00 am REFRESHMENT BREAK TUESAY, NOVEMBER 14 CONTINUED... 11:00 am 12:15 pm SESSION 2: DOUBLE PATENTING AND DIVISIONAL PRACTICE: HOW DO WORLDWIDE POLICIES IMPACT LIFECYCLE MANAGEMENT STRATEGIES? Sponsored by: Choate Hall & Stewart LLP This panel will review key decisions on double patenting and divisional practice, and furthermore will discuss current US PTO practices, will compare and contrast them with divisional practice in other jurisdictions, and will provide practical recommendations for lifecycle management that can avoid double patenting pitfall risks. MODRATOR: Brenda H. Jarrell Co-chair, Life Sciences Group and the Intellectual Property Group, Choate Hall & Stewart LLP Andy Bentham Partner, Patent Attorney, J A Kemp MJ Edwards Intellectual Property Attorney, Gilead Sciences Jesse Fecker Senior Director, Chief US Patent Counsel, Ferring Pharmaceuticals Kathleen Fonda Senior Legal Advisor, Office of Patent Legal Administration, United States Patent and Trademark Office 12:30 pm 1:45 pm A VIEW FROM THE BENCH KEYNOTE LUNCH FEATURING THE HONORABLE KATHLEEN O MALLEY, UNITED STATES COURT OF APPEALS, FEDERAL CIRCUIT Sponsored by: McNeill Baur PLLC INTRODUCTORY REMARKS Ameila Feulner Baur, PhD Founder and Managing Partner, McNeill Baur PLLC 4 NOVEMBER 13 15, 2017 ANNAPOLIS, MARYLAND

5 2:00 pm 3:15 pm SESSION 3: INHERENT OBVIOUSNESS: HOW IT IS BEING APPLIED AND WHAT IT MEANS FOR YOUR CASES Sponsored by: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP What is inherent obviousness, where did it come from, and how is it being applied? What types of claims may be more susceptible to inherent obviousness challenges? What limits has the Federal Circuit placed on the doctrine? This panel will consider these factors and the implications on cases moving forward. Howard W. Levine Kirsten Braun, PhD Counsel, IP Litigation, AstraZeneca William B. Raich, PhD Christopher Verni Vice President, Chief IP Counsel, Sarepta Therapeutics 3:15 pm 3:30 pm REFRESHMENT BREAK Program Agenda 3:30 pm 4:45 pm SESSION 4: RECENT TRENDS IN POST-GRANT PROCEEDINGS AND THEIR IMPACT ON LIFE SCIENCE PATENTS Sponsored by: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP This panel will address the impact post-grant proceedings have had on life science patents, including recent cases and statistics on institution rates, final written decisions, and types of challenged claims. The panel will also provide perspectives on Oil States, sovereign immunity and IPR proceedings, and in-house counsel s views of the benefits and detriments of post-grant proceedings. Linda A. Wadler Chuck Cappellari Associate VP, Chief IP Counsel, Diagnostics, Hologic Sanya Sukduang Joel West Williams Senior Staff Attorney, Native American Rights Fund BIO.ORG/IPCC #BIOIPCC 5

6 Program Agenda 5:30 pm 8:30 pm ACTIVITY AND DINNER RECEPTION MARYLAND STYLE! Sponosored by: McDonnell Boehnen Hulbert & Berghoff LLP Join us on a brief bus tour of Historic Annapolis en route to the waterside Yellowfin Steak & Fish House for a Maryland-style crab feast! We ll roll out the paper and steam the crabs while our event host teaches us how to pick Maryland Blue Crabs like the pros. Crab picking will be followed by a full Maryland-style buffet (non-seafood options will be available). Buses will depart from the Annapolis Waterfront Hotel at 5:15 pm from the main lobby. WEDNESDAY, NOVEMBER 15, :00 am 9:15 am BREAKFAST 9:30 am 10:45 am SESSION 5: I KNOW KUNG FU : POLICY, STRATEGY AND THE FUTURE OF LIFE SCIENCE PRODUCTS Sponsored by: Fitzpatrick Statutes, court decisions, federal regulations and initiatives all impact how we approach innovation in the life science space and seek protection of that innovation. This panel looks at examples of recent developments, ranging from the impact of regulatory guidances and initiatives to government policy and recent court decisions, on life science intellectual property in the US and beyond. This will include a discussion of issues such as the FDA guidelines on interchangeability for biosimilars, the FDA initiative regarding generic complex products, US governmental approach to international IP protection and the potential impact of certain recent court decisions. Ha Kung Wong Partner, Fitzpatrick Claire M. Vasios, PhD Vice President, Intellectual Property, Alkermes, Inc., Alkermes, Inc. 10:45 am 11:00 am REFRESHMENT BREAK 6 NOVEMBER 13 15, 2017 ANNAPOLIS, MARYLAND

7 WEDNESDAY, NOVEMBER 15, 2017 CONTINUED... 11:00 am 12:15 pm SESSION 6: BIOSIMILARS UPDATE Sponsored by: Fitzpatrick This panel will present an update on biosimilar IPR and litigation statistics along with a discussion of, and industry perspective on, recent biosimilar decisions including the aftermath of the Supreme Court decision in Sandoz v. Amgen, and recent developments in the Amgen v. Hospira litigation, including the award to Amgen of infringement damages for pre-marketing activity. Robert S. Schwartz, PhD Partner, Fitzpatrick Larry Coury, PhD Senior Director, Dispute Resolution, Regeneron Pharmaceuticals Christopher E. Loh Partner, Fitzpatrick ADJOURNMENT Program Agenda BIO.ORG/IPCC #BIOIPCC 7