IP CounselsCommittee Conference

SPRING CONFERENCENEWPORT BEACH, CA | MARCH 27–29, 2017

Program Guide sponsored by

PROGRAM GUIDE

2017

IP CounselsCommittee Conference

NOVEMBER 13–15, 2017 Annapolis, MD

FALLCONFERENCE

2017 BIO INTELLECTUAL PROPERTY COUNSELS COMMITTEE

2 MARCH 27–29, 2017 • NEWPORT BEACH, CALIFORNIA

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NEWPORT BEACH, CALIFORNIA | MARCH 27–29, 2017All sessions will be in the Grand Ballroom.

MONDAY, MARCH 27, 2017

11:30 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 BREAKSponsored by: Marshall, Gerstein & Borun LLP

3:30 pm – 4:30 pm OPENING SESSION: MAKE AMERICAN INVENTIONS PATENT ELIGIBLE AGAINSponsored 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

TUESDAY, MARCH 28, 2017

8:00 am – 9:15 am BREAKFAST & FIRESIDE CHAT WITH GUEST SPEAKERSponsored by: Seed IP Law Group LLP

Interviewed by: Jeffrey C. Pepe, Ph .D ., Partner, Seed IP Law Group LLP

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.

3BIO IP COUNSELS COMMITTEE CONFERENCE • BIO.ORG/IPCC • #BIOIPCC

PROGRAM

AGENDA

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: Ewa Davison, Ph .D ., Associate, Fenwick & West LLP David Tellekson, Partner, Fenwick & West LLP

10:45 am – 11:00 am REFRESHMENT BREAKSponsored by: Marshall, Gerstein & Borun LLP

11:00 am – 12:15 pm SESSION 2: DANCE LESSONS: AN UPDATE ON U.S. BIOSIMILARS LITIGATION AND OTHER RECENT DEVELOPMENTSSponsored 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

TUESDAY, MARCH 28 continued

4 MARCH 27–29, 2017 • NEWPORT BEACH, CALIFORNIA

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12:30 pm – 1:45 pm LUNCHBuffet 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 LLPSpeakers: 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 REFRESHMENT BREAKSponsored by: Marshall, Gerstein & Borun LLP

3:30 pm – 4:45 pm SESSION 4: HOT TOPICS IN IP LICENSINGSponsored 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 LLPSpeakers: Charlene Stern, Senior Director, IP and Legal Affairs,

Editas Medicine, Inc .

TUESDAY, MARCH 28 continued

5BIO IP COUNSELS COMMITTEE CONFERENCE • BIO.ORG/IPCC • #BIOIPCC

PROGRAM

AGENDA5:30 pm – 8:30 pm ACTIVITY AND DINNER RECEPTION

WEDNESDAY, MARCH 29, 2017

8:00 am – 9:15 am BREAKFAST & FIRESIDE CHAT FAIR WINDS AND FOLLOWING SEAS?: WHAT THE NEW ADMINISTRATION MAY MEAN FOR PATENTSSponsored by: Morrison & Foerster LLP

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 LLPSpeaker: Mark Whitaker, President, AIPLA

9:30 am – 10:45 am SESSION 5: EMERGING TRENDS AND LEGAL DEVELOPMENTS IN POST GRANT PROCEEDINGSSponsored 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 GroupSpeakers: Michael Lisi, Vice President, General Counsel,

Roche Molecular Diagnostics Christopher Noyes, Partner, WilmerHale

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!

6 MARCH 27–29, 2017 • NEWPORT BEACH, CALIFORNIA

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Biotech entrepreneurs need lawyers who

understand not just their business, but their

science. At Fenwick, you’ll be supported by

more than 75 experienced attorneys and

in-house staff with life sciences degrees,

including 20 with Ph.D.s or M.D.s. We have

a deep understanding of how life sciences

companies are formed and financed and how

they can best protect their intellectual property.

See us at our Tuesday morning sessions

Session 2: 11:00 am – 12:15 pm

Dance Lessons: An Update on U.S. Biosimilars Litigation

and Other Recent Developments: This panel will provide an

update on critical aspects of the BPCIA, Hatch-Waxman cases,

and issues relating to biosimilar and generic drugs.

Session 1: 9:30 am – 10:45 pm

Toto, I’ve a feeling we’re not in Texas anymore... This

panel will provide an update on recent and upcoming patent

cases, including a report on the previous day’s TC Heartland

argument before the Supreme Court.

fenwick & west

SILICON VALLEY NEW YORK SAN FRANCISCO SEATTLE SHANGHAI

FENWICK.COM

WEDNESDAY, MARCH 29 continued

10:45 am – 11:00 am REFRESHMENT BREAKSponsored by: Marshall, Gerstein & Borun LLP

11:00 am – 12:15 pm SESSION 6: ETHICAL ISSUES IN THE PHARMACEUTICAL INDUSTRY, INCLUDING IN HATCH-WAXMAN AND BIOSIMILAR LITIGATIONSSponsored 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 FiggSpeakers: Derek Dahlgren, Partner, Rothwell Figg Li Westerland, Bavarian Nordic

Adjournment