2009.Spring.Committee.Report.A.doc

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HOU02:1173156.1

BIOTECHNOLOGY COMMITTEE

Spring 2009
Bulletin
Report

On Thursday May 14, 2009, a
the chemical and biotechnology committees
held a joint meeting
.
The first half of the meeting was directed to discussions of reconstructing
prior art examples and
the use of such information in litigation. Scientist Dr. Leonard J. Chyall of Aptuit Consulting
spoke about using a scientific expert to reproduce examples and testify in patent litigation.
Following Dr. Chyall’s presentation, ther
e was a pointed talk about strategies surrounding the
use of a scientific expert and related issues that can arise during litigation.

The second

half
focused on patent term adjustment (“PTA”), patent term extensions (“PTE”),
termin
al disclaimers and how best to avoid delay in the U.S. and foreign patent offices

in order
to maximize patent life term
.
James J. Kelley
.
Assistant General Patent Counsel
of
Eli Lilly
&
Co. moderated and
spoke to the importance
of patent term. He began by identifying the
motivation for the session in both concerns over the pursuit of patent scope at the risk of lost
patent term and due diligence observations. He specifically discussed how PTE is applied in
light of PTA, and the

limits on the amount of patent term to be restored for drug products and
total period of Effective Patent Term (“EPT”)

and how relevant the timing of these terms are
with respect to clinical testing
. He spoke to attorney influence over the
effective pate
nt term
(
EPT
)
, highlighting the fact that the attorney has the most influence over the time it takes to issue
the patent and some influence over the time between the start of patent term and the start of
testing phase.
Jim
provided the results of a
survey of 48 human drugs that qualified for PTE
since 1996 and the average times for various milestones including: (1) patent issuance; (2) the
amount of time from the beginning of the patent term until IND effective date (“delay”); (3) time
from IND effec
tive date to NDA completion (“testing” period); (4) time form the NDA
acceptance until NDA approval (“review” period); and (5) EPT, each for both biologics and
small molecules.
Jim
also provided the group with a mathematical model illustrating PTE
c
onsidering the variables of the length of review, prosecution, delay and
clinical
testing. To
conclude,
Jim
compared and summarized the effects of PTE and PTA on drug products.

Jim’s

presentation

as well of those of the other speakers in the second

half of the meeting are
available
at:
http://www.aipla.org/MSTemplate.cfm?Section=Spring_20091&Site=Biotechnology&Template
=/ContentManagement/ContentDisplay.cfm&ContentID=21332
.

Jeffrey
P.
Kushan of Sidley Austin
(Washington, DC)

int
roduced the basis for accumulating
PTA credit under 35 U.S.C. Section 154 and discussed how one can lose accumulated PTA
credit. Jeff also highlighted the ongoing dispute over the PTO’s interpretation of the overlap
between prosecution delay PTA and the 3
-
year PTA. Jeff provided illusory examples of the
overlap issue, and took several questions from the group. He warned that supplemental
submissions such as
a
supplemental IDS or any paper that does not fall within an exemption will
be charged as delay af
ter a first response by the applicant
. Jeff further discussed certain safe
harbors and cautioned that PTO inaction can be held against applicant
even
if the applicant
makes a written status inquiry after a response is
filed. Finally, Jeff recommended to preserve
your rights under
Wyeth v. Doll

and request reconsideration (petition) of the PTA within 2
months of issue date of the patent.

HOU02:1173156.1

Vicki

G.
Norton
, Ph.D.

of Duane Morris
(
San Diego
, CA)

discu
ssed

the “patent squeeze” of
recent decisions under Sections 102, 103 and 112. She specifically addressed recent decisions:
In re Gleave

and
In re Chuang

where bispecific antisense oligodeoxynucleotides and isolated
polypeptides
respectively
were held not

patentable under Section 102 based on prior art
disclosures.
Vicki
also discussed
In re Kubin
,

where an isolated nucleic acid molecule was held
not patentable under Section 103. She
aslo addressed the written description issues rais
ed in

Ariad v. Eli Lilly

where a method for reducing NF
-
kB activity
was found unpatentable,
and
ICU
Medical v. Alaris
,

where claims to needleless connector valves were found to lack a written
description.

Pam
ela D.

Politis
, Ph.D.

of Endo Pharmaceuticals
addressed

the strategies that maximum patent
term and the balancing act one must do between aggressively protecting claim scope against the
onslaught of considerations over patent term, and patent term adjustments and extensions. She
provided a
n

ins
tructive timeline related to pharmaceutical patent protections and highlighted the
priorities in procuring protections for innovative pharmaceuticals. She recommended that less
may mean more in filing the initial patent application covering a small molecu
le platform.