BIOTECH BUZZ
August, 2012
Annual Meeting Programs, Marriott Wardman Park, Washington, DC ........................................... 2
Thursday, October 25: IP Issues in Novel Venture Financing of Biopharmaceutical Development
(2 HOURS of CLE).......................................................................................................................... 2
Overview of novel venture structures and financing arrangements ....................................... 2
Venture Capital company approaches to investing in clinical development and generation of
IP .............................................................................................................................................. 2
Big pharma partnerships with small biotech/pharma ............................................................. 2
Partnerships with government to commercialize new technologies ...................................... 2
Friday, October 26: Antibody Patents and Patenting Antibodies – US and EP (2 HOURS of CLE).
..................................................................................................................................................... 2
Patenting Antibodies in Europe ............................................................................................... 2
Antibody Patents in the US – Written Description .................................................................. 3
Mid-Winter Institute, Tampa, FL, January 30 - February 2, 2013..................................................... 3
Volunteer Table Moderators Needed for Biotech/Pharma/Chem Lunch on January 31 ............ 3
Webinars .......................................................................................................................................... 3
Latest Biosimilar Developments, September 25, 2012, 12:30 pm EDT........................................ 3
Reprise of Annual Meeting Presentations, TBD ........................................................................... 3
Case Law Reports ............................................................................................................................. 4
In re Walter Beineke, reported by Cathy A. Kodroff, Howson & Howson, Fort Washington, PA. 4
Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., reported by Michael
Stramiello and Nicholas Landau, Ph.D., Bradley Arant Boult Cummings LLP, Birmingham, AL. .. 4
Diagnostics and Gene Patenting SC .................................................................................................. 4
White Paper on IP Issues Relating to Personalized Medicine – Volunteers Needed! .................. 4
Member Announcement .................................................................................................................. 4
Educating Congress, Industry Groups, and the Public on the Consequences of Mayo v.
Prometheus .................................................................................................................................. 4
15 August 2012
1
AIPLA Biotechnology Committee
Annual Meeting Programs, Marriott Wardman Park, Washington, DC
Thursday, October 25: IP Issues in Novel Venture Financing of Biopharmaceutical
Development (2 HOURS of CLE)
Funding for developing new drugs is tight and risk is high. Creative financing and partnering
structures are allowing companies to access funding to run clinical trials and generate new IP.
The objective of the session is to describe the novel arrangements and IP issues that patent
attorneys need to know. Please join us for a COMMITTEE EDUCATIONAL SESSION for 2 HOURS of
CLE, jointly sponsored by the Biotechnology Committee and the Chemical Practice Committee.
3:30-3:40
Committee business
3:40 – 4:00
Overview of novel venture structures and financing arrangements.
Joel Nied, Partner, LeClairRyan
4:00-4:30
Venture Capital company approaches to investing in clinical development and
generation of IP.
Gregory J. Sieczkiewicz, Vice President, Intellectual Property, Flagship Ventures
4:30-5:00
Big pharma partnerships with small biotech/pharma.
Mike Warner, Pfizer, Assistant General Counsel
5:00-5:30
Partnerships with government to commercialize new technologies.
Cindy Fuchs, Technology Development Coordinator and Patent Attorney for the National
Institute of Diabetes and Digestive and Kidney Diseases.
Mr. Neid’s presentation includes ~15 minute presentation and up to ~5 minutes of Q&A. The
other topics include ~20 minute presentations and up to ~10 minutes of Q&A.
Friday, October 26: Antibody Patents and Patenting Antibodies – US and EP (2 HOURS
of CLE).
Please join us for a COMMITTEE EDUCATIONAL SESSION for 2 HOURS of CLE, jointly sponsored by
the Biotechnology Committee and the IP Practice in Europe Committee.
Patenting Antibodies in Europe
The EP panel will explain and critique the EPO’s approach to inventive step and claim scope for
antibodies.
Antibodies and the EPO
Stephen H. Ingham
Ass’t General Patent Counsel
Eli Lilly and Company Limited
Erl Wood Manor
Windlesham, Surrey UK
15 August 2012
International Antibody
Patenting Strategy
Dr. Andreas Huebel
Michalski • Hüttermann &
Partner
Neuer Zollhof 2
D-40221 Düsseldorf
Germany
2
Patenting Antibodies in
Europe
Louise Holliday
D Young & Co LLP
Briton House, Briton Street
Southampton, SO14 3EB
UK
AIPLA Biotechnology Committee
Antibody Patents in the US – Written Description
The US panel will focus on compliance with 35 U.S.C. § 112(a) (written description). A
representative of the USPTO is being requested to explain its “antibody exception” to written
description. Confirmed panelists are Amy Hamilton of Eli Lilly and Company, Professor Chris
Holman of the University of Missouri – Kansas City School of Law, and Hans Sauer of BIO.
Explaining the PTO’s “Antibody
Exception”
Kristi Swart (invited)
Solicitor’s Office
or
George Elliott (backup)
Director 1640, 1650, Tech Support
A Corporate View
Amy E. Hamilton (confirmed)
Deputy General Patent Counsel
Eli Lilly and Company
An Academic View
Chris Holman (confirmed)
Associate Professor of Law
University of Missouri – Kansas City School
of Law
An Industry View
Hans Sauer (confirmed)
Deputy General Counsel for IP
Biotechnology Industry
Organization (BIO)
Mid-Winter Institute, Tampa, FL, January 30 - February 2, 2013
Volunteer Table Moderators Needed for Biotech/Pharma/Chem Lunch on January 31
We are looking for moderators to help lead/guide table discussion on topics related to Track C
(Biotech/Pharma/Chem) on Thursday, January 31, 2013 at the AIPLA Mid-Winter Institute (MWI)
in Tampa, Florida. Each table will have its own moderator. We will have more information on
the specific topics as the date approaches. This would be a wonderful opportunity to participate
in the MWI activities and to help make the MWI a success. If you will be attending the MidWinter Institute and if you would be interested in being a moderator for the lunch tables
assigned to discussion regarding Track C—Biotech/Pharmacy/Chemical during the Thursday
lunch, please contact Debora Plehn-Dujowich.
Webinars
Latest Biosimilar Developments, September 25, 2012, 12:30 pm EDT
The Committee will present a webinar on the latest developments with respect to biosimilars on
September 25, 2012, at 12:30 pm Eastern time. The speakers will include Noel Courage of
Bereskin Parr's Toronto office on Canada and the EU, John Engel of Engel & Novitt on the FDA
guidance documents and other developments, and Denise Kettelberger of Faegre Baker Daniels'
Minneapolis office on litigation-related topics. Please watch your in-box in mid-September for
your invitation and instructions on how to register and participate in the webinar.
The Committee expresses its sincere appreciation to our sponsors, Bereskin Parr, Engel & Novitt,
and Faegre Baker Daniels!!
Reprise of Annual Meeting Presentations, TBD
The speakers at our Annual Meeting, discussed above, may reprise their presentations in
webinars on dates yet to be determined.
15 August 2012
3
AIPLA Biotechnology Committee
Case Law Reports
Case Law Report Link
In re Walter Beineke, reported by Cathy A. Kodroff, Howson & Howson, Fort
Washington, PA.
Case Nos. 2011-1459, 1460 (Fed. Cir., Aug. 6, 2012) (affirming PTO’s rejection of two plant
variety patent applications because the subject organisms were not “newly found seedlings”).
Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., reported by
Michael Stramiello and Nicholas Landau, Ph.D., Bradley Arant Boult Cummings LLP,
Birmingham, AL.
Case Nos. 2012–1062, 1104 (Fed. Cir. Aug. 3, 2012) (holding that the safe harbor provided by
35 U.S.C. § 271(e)(1) precludes a finding of infringement of manufacturing process patents
when the infringing activity generated data that the defendant would likely submit to the FDA).
Diagnostics and Gene Patenting SC
White Paper on IP Issues Relating to Personalized Medicine – Volunteers Needed!
The Diagnostics and Gene Patenting Subcommittee is preparing a white paper titled IP Issues
Relating to Personalized Medicine. The paper is divided into three sections, and the leaders of
this effort are seeking volunteers to assist with the drafting of each section. If you are interested
in assisting with one or more of the sections, please contact one of the following Section Leaders:
Section I: Discussion on Prometheus v. Mayo Decision, including USPTO guidelines and a focus
on how the holding may impact bioinfomatics IP; Section Leader: Ling Zhong, Ph.D., Esq.
RatnerPrestia
Section II: Discussion on Myriad decision; Section Leader: Karen Canady, Ph.D., Esq.
canady+lortz LLP
Section III: Discussion on Confirmatory Genetic Testing, including aspects of regulatory and
legislative activity in diagnostics that may impact IP for genetic testing used in personalized
medicine; Section Leader: Judy Roesler, Esq. Roesler Law Offices, PLLC
Member Announcement
Educating Congress, Industry Groups, and the Public on the Consequences of Mayo v.
Prometheus
A working group of practitioners concerned about adverse effects of the Supreme Court’s Mayo
v. Prometheus decision on isolated DNA patents and other biotechnology inventions is forming.
The purpose of the working group is to educate Congress, the IP community, and the public to
galvanize support for legislative action in advance of the Court’s reconsideration of the Myriad
case. Please contact Suzannah Sundby of Smith, Gambrell & Russell LLP, if you are interested in
participating in this working group.
Chair’s note: The working group that Suzannah Sundby is forming is not an AIPLA-sponsored
group, but its activities may be of interest to some members of AIPLA’s Biotechnology
committee. The Biotechnology committee’s work on these issues is carried out primarily by our
Diagnostics and Gene Patenting subcommittee, which is co-chaired by Judy Roesler and Ling
Zhong, and by our Biotech Patent Education subcommittee, chaired by Karen Canady. Please
contact them if you would like to work on these issues within the context of AIPLA.
15 August 2012
4
AIPLA Biotechnology Committee