Free Letter - District Court of Delaware - Delaware

Case 1 :04-cv-00350-KAJ Document 102 Filed O1/05/2006 Page 1 of 3
tter
Anderson
Corroon nr
l3i3 North l\·lsukct Sims!
RO Br.} gui . .
~r·~·ei~»ii ai i¤e>—=e=i §‘.§$;‘§.@[.¥§?.:‘£§.?r§'.t.St[...,,t.
**02 98* Gm sez 984-6140 Direct new
\\’\\'\\7.[]l)1ll3I”·llII(iltl`S|1lI.CUI!) Fax
January 5, 2006
VIA ELECTRONIC FILING
The Honorable Kent A. Jordan
United States District Court
J. Caleb Boggs Federal Building
844 N. King Street
Room 6325 — Lockbox 10
Wilmington, DE 19801
Re: Reliant Pharmaceuticals, Inc. v. Abbott Laboratories and
Laboratoires Fournier S.A.. D. Del., C.A. No. 04—350··KAJ
Dear Judge Jordan:
Pursuant to Section 3(e) ofthe November 29, 2004 Scheduling Order (D.l. 36), I write
on behaif of plaintiff and counterclaim defendant Reliant Pharmaceuticals, Inc., (“Reliant") to
seek the Court’s assistance to resolve a discovery dispute with Laboratoires Fournier SA.
("Fournier"), one of the two defendants in the above-referenced matter. Reliant and Fournier
have conferred but have been unable to resolve this dispute. Reliant respectfully requests that
the Court enter an order cornpeiling Fournier to provide the discovery discussed below or set a
briefing schedule to allow the parties to fully brief this issue. A telephone conference to address
these issues has been scheduled for Monday, January 9, 2006, at 2:15 p.m.
Fournier has refused to produce documents and information concerning New Drug
Application ("NDA") 19-304. NDA l9··304 is relevant to invalidity of the claims of the patents-
in·suit. Reliant believes that these documents will demonstrate that Abbott’s TRICOR 200 mg
capsule product is prior art that invalidates the claims of the patents·in-suit.
Abbott, through Orange Book patent listings with the Food & Drug Administration
(“FDA"), has asserted that its second and third generation TRICOR products are covered bythe
patents—in-suit. Those products were approved for marketing by the FDA pursuant to Abbott’s
NDA 2l—203 and NDA 21-656 respectively. Abbott’s first generation TRICOR product was
approved for marketing pursuant to NDA 19-304, originally filed by Fournier and later licensed

Case 1:04-cv-00350-KAJ Document 102 Filed 01/05/2006 Page 2 of 3
The Honorable Kent A. Jordan
January 5, 2006
Page 2
to Abbott. Neither Fournier nor Abbott have listed the patents-in-suit in the Orange Book for
NDA 19~304.
Fournier received approval for NDA 19-304, as originally tiled, in December l993, for a
norumicronized fenotibrate formulation. The originally approved product was never marketed in
the United States. In June 1997, Forunier sought approval, through a supplement to NDA 19·—
304, for a new 200 mg micronized fenotibrate formulation. That new formulation was similar if
not identical to Fournier’s Lipanthyl 200M micronized fenotlbrate capsule product, which was
marketed in Europe at the time. Fournier secured approval ofthe supplement to NDA l9-304 in
February 1998. The product was subsequently licensed to Abbott and marketed as the TRICOR
200 mg micronized fenofibrate capsule product. This product has since been discontinued by
Abbott.
Reliant asserts that the TRICOR 200 mg capsule anticipates many claims ofthe patents-
in··suit because the subject product ofthe supplement to NDA 19-304 is identical to the
Lipanthyl 200M capsule product, which meets every limitation ofthe claims ofthe asserted
patents.
Although Lipanthyl 200M was sold in Europe but apparently not offered for sale under
that name in the United States, Reliant believes, notwithstanding Fournier’s assertion to the
contrary, that, inthe context of preparing its supplement to NDA 19~304, Fournier provided
samples of the 200 mg micronized product to patients in the United States for testing. If these
samples were provided to patients for testing before January 1997, this testing likely constitutes a
prior public use. Based on the timing ofthe filing of the supplement to NDA 19-304 in June
1997, Reliant believes that there is a high likelihood that samples were provided to patients for
use in the United States. Reliant is entitled to investigate this product, the supplement to NDA
19-3 04, and such testing.
Reliant sought documents relating to the now—discontinued TRICOR 200 mg product and
NDA 19-304 in at least Document Request Nos. 12, 13, 16, 20 and 21, served January 7, 2005.
The parties exchanged documents in September 2005. Neither Fournier nor Abbott produced
any part of`NDA 19-304. Reliant also has sought deposition testimony of Fournier regarding
Lipanthyl 200M and NDA 19··304 in Topics 39 and 51-53 ofthe Notice of Deposition of
Fournier, served September 15, 2005. Abbott has represented that it has no information
concerning the supplement to NDA l9—304 because it did not acquire rights in the product until
atter NDA i9-304 was approved. Fournier has stated that it will not produce documents or a
witness concerning the TRICOR 200 mg product or NDA 19-304, arguing that such information
is not relevant to any claim or defense in this action. Such evidence, however, is also likely to
lead to the discovery of admissible evidence and is therefore discoverable here.
Fournier will likely argue that the probative value of the discovery sought should be
weighed against its confidentiality. This discovery, however, relates to a drug that is two
generations removed from the drug that Abbott and Fournier currently market as TRICOR in the

Case 1:04-cv-00350-KAJ Document 102 Filed O1/05/2006 Page 3 of 3
The Honorable Kent A. Jordan
January 5, 2006
Page 3
United States. Abbott stopped marketing it in September 2001, after its NDA 2l~20.3 was
approved. This discovery is not highly confidential or valuable. The confidentiality ofthe
discovery sought will be adequately protected by the Stipulated Protective Order in this case and
should not be cause to preclude discovery.
Given that discovery ends January 27 and that the parties are scheduling depositions in
the month of January, Reliant respectfully asks the Court to compel Fournier to produce the
supplement to NDA 19-304 and documents relating to the testing of the product for the
supplement as soon as possible to enable Reliant to fully prepare its case.
Reliant is prepared to brief this issue fully should the Court deem it necessary.
Respectfully,
TKTQW
Philip A. Rovner
PAR/kgin/Pac/risaaova
cc: Eric Huang (Quinn, Emanuel, Urqubart, Oliver & Hedges LLP)
Leslie M. Hill (Arnold & Porter LLP)
Eugene Gelemter (Patterson, Belknap, Webb & Tyler LLP)
Mary B. Graham (Morris, Nichols, Arsht & Tunnell)
Timothy C. Bickham (Steptoe & Johnson, LLP)
Anne Shea Gaza (Richards Layton & Finger PA)

Case 1:04-cv-00350-KAJ

Document 102

Filed 01/05/2006

Page 1 of 3

Case 1:04-cv-00350-KAJ

Document 102

Filed 01/05/2006

Page 2 of 3

Case 1:04-cv-00350-KAJ

Document 102

Filed 01/05/2006

Page 3 of 3