2009.Spring.Committee.Report

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B3600929.1

BIOTECHNOLOGY COMMITTEE

Spring

200
9


Committee Report

PLANS & GOALS



DeAnn F. Smith

Chair Biotechnology


Amy
E.

Hamilton

Board Lia
i
son

Mercedes K. Meyer

Vice Chair Biotechnology

Tel: 617
-
832
-
1264

Dsmith@foleyhoag.com

Tel:
317
-
27
6
-
3169

hamilton_amy_e@lilly.com

Tel: 202
-
842
-
8821

Mercedes.Meyer@dbr.com



The Biotechnology C
ommittee 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:

Ann
e

Marie Verschuur (EP)

N
auta Dutilh

Annemarie
.Verschuur@nautadutilh.com


Paul Cole (EP)


Lucas



Paul
gcole@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



Kirkland Ellis


elin@kirkland.com

B3600929.1

-

2

-


6.

Amicus Committee Liaisons


Amicus Commi
ttee Members

Warren Woessner




Amy Sun





David Cupar


Maria Patente


FUTURE MEETING IDEAS




Patent Pools in the Pharmaceutical and Biotechnology Industries and Antitru
st
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. Pursuin
g 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 s
ession on this topic, some time

(
Spring Meeting Topic
)



Exclusivity Strategies in Light of Follow
-
On Biologicals.

Is the patent s
trategy
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
c
an 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.

B3600929.1

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3

-



Offen
sive
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
freedo
m 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.