2011Fall Biotech Committee Report to Board

AIPLA Committee Report

DATE: October 11, 2011 MEETING: 2011 Annual

COMMITTEE NAME: Biotechnology

COMMITTEE LEADERSHIP:  Out-going Chair: Karen Canady (canady & lortz LLP, Los Angeles)  In-coming Chair: Jim Kelley (Eli Lilly and Company, Indianapolis)  In-coming Vice Chair: Carol Nielsen (Nielsen IP Law LLC, Houston)

SUBCOMMITTEES:

Subcommittees Focused on Member Services

 Program Development: Lynn Tyler (Barnes & Thornburgh LLP, Indianapolis)  Biotech Buzz: Dan Lev (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, D.C.)  Case Law Updates: Melanie Szweras (Bereskin & Parr LLP, Toronto)  USPTO Relations: Suzannah Sundby (Smith, Gambrell & Russell, LLP, Washington, D.C.)  Web Microsite: Tim Meigs (Becton Dickinson)  Membership Communications: Tina Katcheves (Lonza, Walkersville MD)

Subcommittee Focused on Global Outreach

 International Issues: Annemarie Verschuur (Nauta Dutilh, Netherlands)

Subcommittee Focused on Advocacy

 Global Advocacy: New subcommittee in October 2011; leadership being sought

Subcommittee Focused on Public Education

 Biotech Patent Education: New subcommittee in October 2011; Karen Canady (canady & lortz LLP, Los Angeles) will lead this new subcommittee. DISCUSS THE OVERALL MISSION OF THE COMMITTEE AS IT RELATES TO AIPLA’s VISION, MISSION, and VALUES:

To realize the promise of Biotechnology in health, energy, environment, and food requires a reliable, global IP system that rewards innovation without inhibiting it and protects investments in new products and new jobs. Biotechnology IP practitioners and companies, however, face very significant challenges in helping the world realize this promise. The overall mission of the Biotechnology Committee is to serve as resource, educator, and advocate for its members, AIPLA, government institutions, and people everywhere so that the promise of Biotechnology may be more fully realized globally.

The Committee has traditionally focused most of its energies on serving our members, fostering their professional and leadership development, helping nurture and mentor them as they advance within our profession, keeping them informed in an ever-evolving legal environment, and enriching the diversity of the profession in which we practice, while responding to their personal and professional needs. The Committee maintains this focus, while adding others.

The Committee is increasing its efforts to serve public policy leaders, whose mission is to develop, implement and maintain our intellectual property system, assisting them with objective and unbiased analysis, and helping establish and maintain fair and effective global laws and policies that stimulate and reward innovation and creative works in keeping with the public interest. A newly- formulated Advocacy subcommittee will identify opportunities for assisting legislative, judicial, and administrative bodies globally with respect to Biotechnology IP.

The Committee is also increasing its efforts to serve the public, providing education as to the daily value and benefits of a strong intellectual property system that fosters incentives for creativity & innovation, while balancing the public’s interest in healthy competition, reasonable costs and basic fairness. A new subcommittee, the Biotech Patent Education subcommittee, will work with AIPLA and members to improve public understanding of and support for appropriate IP protection for Biotechnology innovation and development. This new subcommittee will be led by Karen Canady, our out-going Chair.

DISCUSS THE COMMITTEE’S ACTIVITIES RELATED TO ADVOCACY, PLEASE ALSO INCLUDE COOPERATION WITH OTHER COMMITTEES TO SUPPORT THESE ACTIVITIES, if any:

Our former “Legislative Issues” subcommittee has been renamed the “Global Advocacy” subcommittee, with a new, more expansive objective statement. The subcommittee will expand from merely monitoring legislative developments, mainly in the United States, to monitoring and reporting legislative, judicial, and administrative developments in the United States, Canada, Europe, the Far East, Australia, and Latin America that relate to IP protection for biotechnology. The subcommittee will coordinate this global “watch” with our International Issues subcommittee. When issues are identified, the subcommittee will work with committee leadership, our Amicus liaison, the Amicus Committee, Board liaison, and/or AIPLA leadership and staff to formulate timely, objective, unbiased analysis and to develop policy positions that AIPLA should espouse. We will cooperate and coordinate with IP Practice in Europe, IP Practice in Japan, IP Practice in Latin America, and IP Practice in the Far East, and Special Committee on IP Practice in China and with staff and Board members responsible for achieving AIPLA’s strategic advocacy goals.

DISCUSS THE COMMITTEES ACTIVITIES RELATED TO PUBLIC EDUCATION, PLEASE ALSO INCLUDE COOPERATION WITH OTHER COMMITTEES TO SUPPORT THESE ACTIVITIES, if any:

The Committee has created a Biotech Patent Education subcommittee under the leadership of Karen Canady, immediate past chair of the Committee. The subcommittee will begin to help committee members and AIPLA find ways to teach those outside the IP world about the value that patents (and IP generally) play in protecting biotech and medical innovation and providing incentives for the development of new products and services. This is crucial not only because of the role that IP will play in improving the economy, but also because of the central role that patents will continue to play in the development of biological and diagnostic products. The subcommittee hopes to play a role particularly with respect to the emotional issue of gene patenting.

To respond to membership input and to contribute toward achieving AIPLA’s strategic goals, the Committee will give preference in program development to Public Education at the Mid-Winter Institute meeting and to Global Outreach at the spring meeting, unless an emergent issue or coordination with AIPLA’s Professional Program committee warrants otherwise.

The Biotech Patent Education subcommittee will coordinate its efforts with those of AIPLA’s Public Education committee and with AIPLA staff and Board members who are responsible for achieving AIPLA’s Public Education strategic goals.

DISCUSS THE COMMITTEES ACTIVITIES RELATED TO MEMBER SERVICE, PLEASE ALSO INCLUDE COOPERATION WITH OTHER COMMITTEES TO SUPPORT THESE ACTIVITIES, if any:

The bulk of the Committee’s activities will continue to relate to providing member services via six subcommittees:

Program Development – developing and executing committee meeting programs and at least four webinars annually; coordination with the Professional Programs committee is essential.

Biotech Buzz – producing the committee’s monthly electronic newsletter to members

Case Law Updates – producing monthly reviews of US judicial and administrative decisions affecting Biotechnology, and increasingly including reviews of cases from around the world

USPTO Relations – attending and providing materials and a report from quarterly Biotechnology/Chemistry Partnership meetings with USPTO personnel; materials and reports are made available at the Committee’s web microsite.

Web Microsite – designing, uploading, maintaining, and archiving announcements, presentations, reports, case law updates, webinar recordings, etc. for future use by members Membership Communications – surveying members annually and as needed throughout the year when member input is desired

DISCUSS THE COMMITTEES ACTIVITIES RELATED TO GLOBAL OUTREACH, PLEASE ALSO INCLUDE COOPERATION WITH OTHER COMMITTEES TO SUPPORT THESE ACTIVITIES, if any:

The committee is enhancing its International Issues subcommittee. The objectives of the subcommittee are to report on cases, legislation, and rule changes that impact biotechnology outside the United States and to monitor and advise membership regarding differences in patentability and enforcement of biotechnological subject matter in various countries. The subcommittee reports developments that may lead to AIPLA submitting comments or other involvement. The focus has historically been on Europe and Canada. We are expanding our focus to include Australia, Asian countries, especially Japan, India, Korea and China, Latin American countries, especially Mexico and Brazil, and emerging economies as they become more relevant to biotech practitioners and companies. We would like to see liaisons between this subcommittee and other practice committees to facilitate these efforts, and we encourage volunteers to continue to build our international biotech wiki database of information on protecting biotechnology in various countries.

To respond to membership input and to contribute toward achieving AIPLA’s strategic goals, the Committee will give preference in program development to Public Education at the Mid-Winter Institute meeting and to Global Outreach at the spring meeting, unless an emergent issue or coordination with AIPLA’s Professional Program committee warrants otherwise.

The International Issues subcommittee will coordinate its efforts with those of various internationally-focused AIPLA committees and with AIPLA staff and Board members who are responsible for achieving AIPLA’s Global Outreach strategic goals.