PROGRAM GUIDE IP Counsels. Committee Conference. Program Guide sponsored by SPRING CONFERENCE

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1 PROGRAM GUIDE IP Counsels Committee Conference 2017 SPRING CONFERENCE NEWPORT BEACH, CA MARCH 27 29, 2017 Program Guide sponsored by

2 FALL 2017 BIO INTELLECTUAL PROPERTY CONFERENCE COUNSELS COMMITTEE IP Counsels Committee Conference NOVEMBER 13 15, 2017 Annapolis, MD

3 NEWPORT BEACH, CALIFORNIA MARCH 27 29, 2017 All sessions will be in the Grand Ballroom. MONDAY, MARCH 27, :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 3:30 pm 4:30 pm OPENING SESSION: MAKE AMERICAN INVENTIONS PATENT ELIGIBLE AGAIN Sponsored by: McDonnell Boehnen Hulbert & Berghoff LLP This panel will discuss proposed amendments to 35 U.S.C. 101 and the likelihood of obtaining a legislative fix to the subject matter eligibility problem, the differential impact of the Alice/Mayo analytic framework on U.S. applications and foreign counterpart applications, and how the framework brings U.S. law into conflict with express provisions of the TRIPS Agreement. Moderator: Donald Zuhn, Partner, McDonnell Boehnen Hulbert & Berghoff LLP Speakers: David Boundy, Partner, Cambridge Technology Law LLC Paul Cole, Partner, Lucas & Co. Kevin E. Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff LLP Robert Sachs, Partner, Fenwick & West 5:30 pm 7:30 pm WELCOME RECEPTION Join us for cocktails, hors d oeuvres, and a west coast sunset over the pier at 21 Oceanfront Restaurant. Buses will depart from the Balboa Bay at 5:15 pm. One return trip will be available post-event, departing the restaurant at approximately 7:35 pm. TUESDAY, MARCH 28, :00 am 9:15 am BREAKFAST & FIRESIDE CHAT WITH GUEST SPEAKER Sponsored by: Seed IP Law Group LLP Interviewed by: J effrey C. Pepe, Ph.D., Partner, Seed IP Law Group LLP 2 MARCH 27 29, 2017 NEWPORT BEACH, CALIFORNIA

4 9:30 am 10:45 am SESSION 1: TOTO, I VE A FEELING WE RE NOT IN TEXAS ANYMORE... Sponsored by: Fenwick & West LLP This panel will provide an update on recent and upcoming patent cases, including TC Heartland v. Kraft Foods (venue), Bristol-Myers Squibb Co. v. Superior Court of California (personal jurisdiction), Life Technologies v. Promega (overseas patent infringement), and Impression Products v. Lexmark International (patent exhaustion). Special emphasis will be given to developments in forum selection. Recent decisions from the Federal Circuit (Acorda, certiorari denied) and the Supreme Court of California (Bristol-Myers Squibb, certiorari granted) have interpreted personal jurisdiction broadly as to life sciences companies, rendering critical the U.S. Supreme Court s approach to venue in TC Heartland. The panel will explore how filing patterns may change assuming reversal of the Federal Circuit s expansive approach to venue, and report on the previous day s TC Heartland argument before the Supreme Court. Speakers: TUESDAY, MARCH 28 continued Ewa Davison, Ph.D., Associate, Fenwick & West LLP David Tellekson, Partner, Fenwick & West LLP 10:45 am 11:00 am 11:00 am 12:15 pm SESSION 2: DANCE LESSONS: AN UPDATE ON U.S. BIOSIMILARS LITIGATION AND OTHER RECENT DEVELOPMENTS Sponsored by: Fenwick & West LLP This panel will provide an update on U.S. biosimilars litigation and other recent developments, including: the Supreme Court s anticipated decision in Amgen v. Sandoz, which will address whether the patent dance provisions of the Biologics Price Competition and Innovation Act (BPCIA) are mandatory, or just optional, as the Federal Circuit found; how litigation stays pending Inter Partes Review impact the 30-month regulatory stays in Hatch-Waxman litigation; whether Judge Sleet s opinion in Bayer Pharma AG v. Watson Labs., Inc. will revive efforts by branded drug manufacturers to argue that evidence of copying is relevant to secondary considerations of non-obviousness; the boundaries of the Paragraph IV certification requirement in the context of a Section 505(b)(2) NDA Application, including what reference listed drug should be used; and recent FDA Guidance regarding biosimilars. Speakers: Virginia DeMarchi, Partner, Litigation Group, Fenwick & West LLP Melanie Mayer, Ph.D., Partner, Litigation Group, Fenwick & West LLP BIO IP COUNSELS COMMITTEE CONFERENCE BIO.ORG/IPCC #BIOIPCC 3

5 TUESDAY, MARCH 28 continued 12:30 pm 1:45 pm LUNCH Buffet lunch will be served outside in the Coconut Grove (immediately outside the Grand Ballroom foyer), weather permitting. 2:00 pm 3:15 pm SESSION 3: WHAT S MINE, WHAT S YOURS, AND WHAT S OURS? AVOIDING TRAPS FOR THE UNWARY IN COLLABORATIONS Sponsored by: Foley Hoag LLP This panel will provide examples of real-world trade secret, contract, and misappropriation disputes (reported and unreported) to identify risks and share practical advice about how to avoid them. We will offer suggestions on how to anticipate problems by drafting clear provisions about ownership and use of inventions, trade secrets, and know-how, as well as patient databases and biological samples obtained during the course of collaboration, including rights to improvements and grantbacks. We will discuss how to educate scientists and manage information, including through secure firewalls, to ensure that your proprietary information is protected and your independent projects are not inadvertently contaminated with the other side s proprietary information. Moderator: Barbara Fiacco, Partner, Foley Hoag LLP Speakers: David Pauling, Associate General Counsel and Senior IP Counsel, Sutro Biopharma, Inc. Robin Walker, Research & Business Development Counsel, Biogen 3:15 pm 3:30 pm 3:30 pm 4:45 pm SESSION 4: HOT TOPICS IN IP LICENSING Sponsored by: Foley Hoag LLP With the growth of partnering and collaborations in research and clinical development, the opportunities and pitfalls arising from IP licensing have taken on new importance. This panel will discuss selected issues in IP licensing, including application of the Brulotte rule after Kimble v. Marvel Entertainment; alternative structuring of royalties and payments not tied to licensee sales; special challenges associated with governmental entity licensors arising from federal and state FOIA statutes; and traps for the unwary patent prosecutor resulting from licensing arrangements that may trigger on-sale bar or public use challenges. Moderator: Don Ware, Partner, Foley Hoag LLP Speakers: Charlene Stern, Senior Director, IP and Legal Affairs, Editas Medicine, Inc. 4 MARCH 27 29, 2017 NEWPORT BEACH, CALIFORNIA

6 ACTIVITY AND DINNER RECEPTION Dinner sponsored by: Fitzpatrick, Cella, Harper & Scinto Enjoy southern California Hawaiian style! Come enjoy some casual lawn games and beers followed by a luau dinner on the Balboa Bay Resort s outdoor lawn and private beach. The Members Lawn is accessible through the hotel main lobby, to the rear of the porte cochere. Casual attire and light layers recommended for beachfront relaxation! WEDNESDAY, MARCH 29, :00 am 9:15 am BREAKFAST & FIRESIDE CHAT FAIR WINDS AND FOLLOWING SEAS?: WHAT THE NEW ADMINISTRATION MAY MEAN FOR PATENTS Sponsored by: Morrison & Foerster LLP 5:30 pm 8:30 pm An engaging fireside chat with Mark Whitaker, President of AIPLA, exploring the patent policy initiatives on which the Trump administration and Congress are likely to focus and their potential impact on biopharma, potential IP leadership in the Trump administration, and how the administration s trade initiatives could impact IP protections at home and abroad. Moderator: David Manspeizer, Partner, Morrison & Foerster LLP Speaker: Mark Whitaker, President, AIPLA 9:30 am 10:45 am SESSION 5: EMERGING TRENDS AND LEGAL DEVELOPMENTS IN POST GRANT PROCEEDINGS Sponsored by: WilmerHale This panel will focus on emerging trends and recent legal developments in Post Grant Proceedings impacting PTAB practice for life sciences and biotechnology companies. The panel will analyze recent legal developments arising from practice at the PTAB, including standing to appeal, motions to amend, joinder practice, and the scope of the AIA estoppel provisions. The panel will also discuss recent data on IPR proceedings, including institution rates and the types of patents challenged. Moderator: Lisa Pirozzolo, Partner and Co-Chair, IP Litigation Practice Group Speakers: Michael Lisi, Vice President, General Counsel, Roche Molecular Diagnostics Christopher Noyes, Partner, WilmerHale BIO IP COUNSELS COMMITTEE CONFERENCE BIO.ORG/IPCC #BIOIPCC 5

7 WEDNESDAY, MARCH 29 continued 10:45 am 11:00 am 11:00 am 12:15 pm SESSION 6: ETHICAL ISSUES IN THE PHARMACEUTICAL INDUSTRY, INCLUDING IN HATCH-WAXMAN AND BIOSIMILAR LITIGATIONS Sponsored by: Rothwell Figg What to avoid and how to avoid it: Foreign Corrupt Practices Act issues; privacy; data breaches; use of private investigators/cybersleuthing of competitors and their KOLs; off-label use promotion; clinical trial reporting; and the duty of disclosure. This panel will discuss real-world ethical issues parties face in the pharmaceutical industry, with an emphasis on how those issues affect Hatch-Waxman and Biosimilar litigation. This includes the anti-bribery provisions under the Foreign Corrupt Practices Act (including such issues as hiring the children of government officials), and those applicable to foreign firms and persons; privacy laws and data breaches; the use of private investigators and cybersleuthing (including the use of social media) of competitors and their key opinion leaders; off-label promotion; stricter clinical trial data reporting requirements; and patent applicants duty of disclosure to the Patent Office. The panel will also discuss best practices for avoiding the many pitfalls facing companies in this industry. Moderator: Steven Lieberman, Partner, Rothwell Figg Speakers: Derek Dahlgren, Partner, Rothwell Figg Li Westerland, Bavarian Nordic Adjournment 6 MARCH 27 29, 2017 NEWPORT BEACH, CALIFORNIA