Free Letter - District Court of Delaware - Delaware

Case 1:04-cv-00350-KAJ Document 103 Filed 01/06/2006 Page 1 of 3
RICHARDS, LAYTON Sr FINGER
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January 6, 2006
VIA HAND DELIVERY
& CM/ECF FILING
The l·Ionorable Kent A. Jordan
United States District Court
District of Delaware
844 N. King Street
Wilmington, DE 1980}.
Re: Reliant Pltcwmaceirticals, Inc. v. Abbott Labomtorics, et ai.,
C.A. No. 04-350-KAJ
Dear Judge Jordan:
I write on behalf of Defendant Laboratoires Fournier S.A. ("Fournier") to address Reliant
Pharmaceuticals, Inc.’s letter to the Court of January 5, 2006 (DI. l0.2). A teleconference is
scheduled with Your Honor for January 9, 2006 at 2:30 pan.
In essence, Reliant seeks to review Fournier and Abbotfs documents to determine
whether the documents contain any possible discoverable or relevant information. This is
contrary to the rules of discovery. The information Reliant demands does not bear on the
validity of the patents—in-suit, would not otherwise lead to the discovery of admissible evidence,
is voluminous, constitutes commercially sensitive information, and production at this late date
would impose a significant burden upon Fournier.
Reliant seeks to compel production of Fournier and Abbott’s NDA l9—304 (covering
TriCor® capsules) The request is predicated upon Reliant’s unsubstantiated belief that the
information may possibly bear on validity of the patents. Reliant states that it ‘°believes,
notwithstanding Fournier’s assertion to the contrary} that clinical testing was perforated in the
United States before January l997 and that such testing, if it occurred, "lil·;ely constitutes prior
public use," _S_e_e Reliant’s Letter of January 5, 2006 at 2 (DI. 102),. Not only is Reliant’s
allegation baseless, it is plainly wrongr in fact, Reliant was on notice that its argument was
factually incorrect before Reliant tiled its letter with the Court. §_e,e_ Letter from T. Bicldiam to E.
Huang of January 5, 2006 (attached as Exhibit A).
RLFI-2966566~l

Case 1:04-cv-00350-KAJ Document 103 Filed O1/06/2006 Page 2 of 3
Honorable Kent A. Jordan
January 6, 2006
Page 2
Reliant has acknowledged that clinical testing of Fournier and Abbott’s .200 ing capsules
that are the subject of NDA l9—304 constitutes a potential anticipatory prior public use only if
Fournier provided the capsules to patients in the United States for testing before January l7,
l997, the priority date of the patents-in—suit. Fournier has repeatedly represented to Reliant that
no clinical trials —— or any other use ofthe micronized capsules ·— toolc place within the United
States until after NDA l9—30~’i was approved, ig, ge; February 9, 1998. Accordingly, the entire
factual predicate for Reliant’s insistence on access to the NDA —— that there may have been
clinical testing or any other use in the United States prior to January 1997 -— is incorrect and has
been specifically rebutted by Fournier’s statements to the contrary. Apparently, however, no
level of assurance ·~ including a declaration from Fournier -— short of production of NDA l9—30¤l
will appease Reliant’s demands.
The demand that Fournier produce NDA l9—304 is also unreasonably burdensome. As
Fournier has informed Reliant, the supplement to NDA l9-304 pertaining to Fournier’s
micronized capsule product consists of approximately 80,000 pages of documents. With the
close of fact discovery looming near and given Fournier’s repeated assurances and consistent
position over the past year regarding NDA 19~304, it is unreasonable for Reliant to demand that
Fournier now expend large amounts of resources merely in order to accommodate Reliant’s
fishing expedition.
Furthermore, NDA l9~304 contains highly coniidential and commercially sensitive
information. Reliant’s argument that NDA 19-304 covers a discontinued product and, therefore,
the information contained within is “not highly confidential or valuable” is overly simplistic and
misleading. The NDA contains highly confidential information such as clinical methodologies,
fonnulation processes, product development, and detailed manufacturing specifications that are
extremely valuable and are held in strict confidence by Fournier and the NDA is still maintained
as confidential by the U.S. Food and Drug Administration. In fact, NDA 19804 is valuable
enough that Reliant’s NDA 2l—695 is based upon the safety and efficacy data in NDA i9—304,
demonstrating the commercial value ofthe underlying information.
Moreover, Reliant is a direct competitor of Fournier and Abbott, and the hann that could
result hom even an unintentional disclosure of technical information is substantial. Reliant’s
business partner and manufacturer of its fenoiibrate product, Ethyphann S.A., is a French
company that competes with Fournier in Europe. Reliant’s Initial Disclosures under Rule 26
identify Ethypharm personnel as being individuals with knowledge of the issues in this litigation.
Accordingly, Reliant’s demand renders the threat of disclosure of confidential and commercially
sensitive information to direct competitors real and immediate.
The information contained in NDA l9»304 has no legitimate purpose in this litigation.
Further, the burden of producing the requested discovery at this late date is substantial and
unwarranted. For these reasons, Fournier respectfully respects that the Court deny Reliant’s
motion to compel.
tart-zoscssa-1

Case 1:04-cv-00350-KAJ Document 103 Filed O1/06/2006 Page 3 of 3
Honorable Kent A. Jordan
January 6, 2006
Page 3
We look forward to speaking with Your Honor on Monday aiiernoon.
Respectfully submitted,
Anne Shea Gaza
ASG:csi
Enclosure
cc: Mary B. Graham, Esq.
Philip A. Rovner, Esq.
Eric Huang, Esq.
William F. Cavanaugh, 311, Esq.
Chad J. Peterman, Esq.
Charles D. Ossola, Esq.
Timothy C. Biekliam, Esq.
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