BIOTECHNOLOGY COMMITTEE
Spring 2009
Committee Report
PLANS & GOALS
DeAnn F. Smith
Chair Biotechnology
Amy E. Hamilton
Board Liaison
Mercedes K. Meyer
Vice Chair Biotechnology
Tel: 617-832-1264
Dsmith@foleyhoag.com
Tel: 317-276-3169
hamilton_amy_e@lilly.com
Tel: 202-842-8821
Mercedes.Meyer@dbr.com
The Biotechnology Committee strives to be an active resource for biotechnology patent
practitioners. Topics of interest (controversial or otherwise) are covered in various forums such
as the committee’s website and CLE programs at the stated meetings. The committee also serves
as a resource for AIPLA when positions relevant to biotechnology are taken. Recent examples
of such assistance include commenting on the USPTO’s proposed rule changes regarding
Markush claim practice and biological deposits, and assisting in the creation of an AIPLA
position regarding the Becerra bill, which sought to prohibit the patenting of genetic material.
The Biotechnology subcommittee chairs are:
1.
International Issues:
Anne Marie Verschuur (EP) Nauta Dutilh Annemarie.Verschuur@nautadutilh.com
Paul Cole (EP)
Lucas
Paulgcole@yahoo.co.uk
Mark Penner (CA)
Fasken
mpenner@fasken.com
Objective: To report on case law and rule changes that impact biotechnology abroad.
2.
Legislative Issues
Hathaway Russel
Foley Hoag
hrussell@foleyhoag.com
Objective: To keep the membership updated on changes in federal legislation that
impacts biotechnology
3.
USPTO Liaison
John Calve
solo practitioner
jcalve_patents@verizon.net
Objective: To attend and report to our membership on all USPTO Customer Partnership
Meetings held at the USPTO for the Pharmaceutical – Chemical – Biotechnological arts.
4.
Case Law Updates
Tina Katcheves
Saul Ewing
kkatcheves@saul.com
Larissa Piccardo
Baker Botts
Larissa.piccardo@backerbotts.com
Objective: To prepare case law summaries on all relevant case law impacting
biotechnological inventions.
5.
Web Microsite
Ellen Lin
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Kirkland Ellis
elin@kirkland.com
6.
Amicus Committee Liaisons
Amicus Committee Members Warren Woessner
Amy Sun
David Cupar
Maria Patente
FUTURE MEETING IDEAS

Patent Pools in the Pharmaceutical and Biotechnology Industries and Antitrust
Concerns.

Optimizing Patent Term vs. Patent Scope in the US. Considering the certain entry of
follow-on biologicals in the near future, exclusivity strategies for biologicals should
include deliberate consideration of optimizing patent term. Pursuing patent "scope" can
compromise this objective. Among the potential topics are: §154, §156, the interplay of
these two provisions, timing of filing, §112, para. 1, the new appeal rules,
unity/restriction practice, declaration practice, and probably others. If for no other reason
than to correct one big mistake that people make about §156, I think that there would be
value in a session on this topic, some time (Spring Meeting Topic)

Exclusivity Strategies in Light of Follow-On Biologicals. Is the patent strategy
different for data exclusivity periods of 5 years versus 10, 12, or even 14 years? Might
the doctrine of equivalents have renewed pertinence because of the possibility that a
follow-on biological may not necessarily have the same structure as the reference
product? – A pro & con debate.

Bilski's Wake: Patenting Tailored Therapies (hits both diagnostics and treatments).
This could be broadened by including recent biotech industrial applicability, sufficiency,
dose regimen cases from Europe (Lilly can assist in identifying European counsel).
Challenges to drafting and prosecuting in light of recent developments in patentable
subject matter cases (Metabolite, Bilski, Classen, Prometheus).

Erecting and Policing Firewalls when Collaborators Compete. Ethics credits
possible. With companies partnering more than ever, the potential for breach of legal and
equitable obligations has increased. How do you erect a firewall? When should you lay
the foundation for a firewall? How do you decide who can be "above" the firewall? How
do you detect and staunch breaches in the wall? Which people and systems are most
problematic? How do you deal with the potential when negotiating the agreement? What
to do if you believe that your partner is misappropriating your information to assist its
R&D? What kind of information

Conflicts of Interest in Collaborative Arrangements. Could be combined with the
previous topic and perhaps also with anti-trust in a session on Legal Issues in
Collaborative Arrangements.
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
Offensive Use of SPCs in Europe. Get an SPC on your patent that covers another’s
product - and other entity will have to pay me royalties beyond the 20 year term of your
patent. An apparently unintended consequence of SPC law with significant impact on
freedom to operate strategies (Lilly can assist in identifying European counsel).

Tracking Kubin and Its Implications on Patent Prosecution and Litigation for Biotech
Patents.
We are also planning the Spring meeting to be held jointly with the Chemical Committee
and have solicited ideas from James T. Kelley of Eli Lily. Most of the future meeting ideas have
also come from Mr. Kelley.
We welcome everyone’s interest and participation. If you have any questions or
comments regarding the committee, please contact us.
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