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Case 1 :04-cv-00171-GIVIS Document 69 Filed 09/28/2005 Page 1 of 4
``` CONNOLLY BOVE LODGE 8: HUTZ LLP
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September 21, 2005
VIA HAND DELIVERY
The Honorable Kent A. Jordan
U.S. District Court for the District of Delaware
844 North King Street
Wilmington, Delaware 19801
Re: STATUS REPORT
Glaxo Group Limited v. Teva Pharmaceuticals USA, fac. et al.,
Civii Action No. 0-4-1 71-KAl
Dear Sndge Jordan:
We represent Plaintiff patentee, Gtaxo Group Limited ("Glaxo"), and write to inform Your Honor of
the present status of this patent infringement litigation in anticipation of the October 7, 2005 telephone
status conference. This is an action for patent infringement under the Hatch—Waxrnan Act where
piaintiff Glaxo accuses defendants’ generic ranitidine hydrochloride oral syrup product of infringing the
ciaims of Glaxo’s U.S. Patent No. 5,068,249 (“‘the °249 patent").
1. Tevzfs Document Production Faiiurc
a. Documents Re uested
Defendants have made little progress in pursuing document discovery requests by Glaxo since our June
30th discovery teleconference, and Giaxo stili has not received the documents from defendant Teva
Pharmacetnicals USA, Inc. and its Israel parent Teva Pharmaceutical Industries Limited ("Teva") that
we have been trying to obtain for the past twelve months. Teva still has not produced the documents
that Teva agreed should be produced, (see Transcript ("Tr.") at pp. 9-I1 (Exit. A)) and that we believe
were required to `ee produced, pursuant to the 1 une 30, 2005 teleconference, particularly:
(i) the testing and development reports and laboratory notebooks relating to the
formulation of ranitidine hydrociiioride oral syrup (both
fonnolations);

Case 1:04-cv—00171-Gl\/IS Document 69 Filed 09/28/2005 Page 2 of 4
The Honorable Kent A. Jordan
September 21, 2005
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(ii) experimental stability data and analyses for ranitidine oral syrup batches 3G-0431,
1353-005, l853~015, 1853—0l’7, 32l3PD and 399-01 through 399—l0 (formulations
utilizing varying concentrations cli;
(iii) the tiles and documents of Subrata l\/Iaaumder, the chief formulator of Teva’s
ranitidine oral syrup product; and
(iv) the preforrnulation information package for ranitidine oral syrup.
This information is relevant to— ranitidine stabilizing properties — the only claim
limitation disputed by Teva on the question of Teva’s infringement ofthe ‘249 patent claims, as was
stipulated by Teva’s counsel during the June 30, 2005 teleconference. (Exh. A at p. 5:3-25). Glaxo
repeatedly has identified these specific documents, and others, most recently in letters dated September
i3 and lil, 2005, in two letters dated June 6, 2005, following the depositions ofa Teva witness and a
Novopharm witness, in a letter dated Qlune 20, 2005, and in our June 28, 2005 letter to the Court, which
was the subject of our June 30tli teleconference. (Letters attached as Exhs. B, C, D, E, F and G). There
is no excuse for Teva’s failure to produce clearly relevant documents identified in the attached letters,
which Teva agrees are relevant and should be produced! (Exh. A at pp. 9:23-l l :21). At this late
juncture ofthe case, after repeated, specific requests by Glaxo spanning twelve months, Teva has failed
to act in good faith and has not produced any additional documents since our June 30th conference:
“Tl~lE COURT: .... ltlhis is a dispute about whether good faith efforts have and are
continuing to take place to obtain concededly relevant documents, and you folks need to
get on the same page and talk to each other about how to make that happen. And I
expectjust exactly that, discussion and good faith efforts to make stuffhappen."
(Exh. A at p. ll: 13-E9). lt has not happened, despite Glaxo’s urgent, repeated requests for Teva to
produce the documents at issue.
b. Teva’s Pharmascience Excuse
During our June 30th teleconference with the Court, we were advised by 'l`eva’s counsel for the first
Qnme that requested documents were allegedly no longer in ’l`eva’s possession, but rather were in
possession ofa third~pany Canadian company. (Exh. A, at pp. l0:2l—l1:7). Since June 30th, Glaxo
has been urgently attempting to obtain documents from Pharrnascience, a Canadian corporation that we
were told had acquired a production facility where Teva’s accused ranitidine hydrochloride oral syrup
formulations were developed, tested, and produced. After informal requests made by Glaxo to
Pharmascience were rebuffed, Glaxo obtained a Letter of Request from Your Honor on August 2, 2005
asking the Canadian court to compel Pharmascience to produce the documents. Pharmascience,
however, has refused to produce the documents and has filed a motion to quash the subpoena that was
issued by the Canadian court pursuant to Your 1-1onor’s Letter of Request. Pharmascience has also
indicated that they will invoke the Canadian Business Concerns Records Act, R.S.Q.c.D.-12, to
completely block the production of any documents to Glaxo and the examination of any witness.

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The Honorable Kent A. Jordan
Scpiembcr 21, 2005
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Glax0’s 0121)/ caption now would be $0 challenge ihc ccnstétuticnaiiiy ofthe Act, a process ihat could
take wel} 0vcr a 0116: year. Phzu·mascicnc©’s position was reaffirmed at a hcasing that was ccnducicé by
the Canadian Court cm Friday, September 16, 2005.
Glaxo has also mqucstcd that Teva (or its corporate affiiiatvz, Ncvopharm) seek return 01`what are in
essence Teva (Novcpharm) documents from Pharmascécnccg Teva has saié it is "chccking" but has not
produced any documents or further correspondence to Phammscicncc-: making such TEQUBSIS. Glaxo
sacks these documents because they arc potential evidence of infringement and 0f ihc validity and
ncncbvéousncss ofthe T249 patcm. Glaxo Wellcome, Inc. v. Pharmadyne Corp., 32 F. Supp. 2d 265,
284-87 (D. Md. 1998). The choices made in {hc formulation and development ofthe accused product
and the alternative pathways triad and abandoned (eg., unsuccessful efforts tc design around the
patented invention) are key indicia of énfingcmcm and validity. Id. Teva is hiding behind
Pharmascicncc’s Canadian domicile t0 avoid its discovery obligations.
c. Tcva’s Failure t0 Ugdatc Its ANDA Stabiiitv Data
We: aiso have been requesting, without success, ihat Teva, as is its cbligaticn to supplement discovery
responses, update its production of ongoing stability testing and data for its ANDA batch cframizidinc
mai syrup. The FDA requires thai al} applicants, including Teva, perform both accelerated and r00m—
temperature stability studies OH thc product for which the applicant seeks approval. Stability
measurements arc taken periodically (ag., cvezy three months for mom temperature stability studies)
and the updated testing and data is provided 10 FDA. Teva must have this information, but has so far
. Updated discovery of Tcva’s ongoing stability testing data for its ANDA
product is, therefore, important for evaluation in connection with the submission of a Ruiz: 26(a) expert
report.
2. Dcgositions
Glam has taken iwo depositions, one 0fa Ncvcphamn witness and one 0f El Teva witness, both related
$0 the limited documents related to the formulation work. Numerous discovery requests from both 0f
these depositions remain unanswered. (See Exh. H). Duc 20 the incomplete document production by
Teva, inriuéing twelve months of unfulfilled promises 0f producing the requested documentation, we
have refrained from taking additional depositions 0f Teva. Because: {be November 2, 2005 deadline
for submitting initial expert reports pursuant t0 Rule 26(a) is fast approaching, Glaxo has noticed
additional depositions cffour Teva witnesses as wcii as {wc 30(b)(6) depositions in October, although
Teva has not yet confirmed the deposition dates requested except {oy S. Mznzumdcr on October E4. if
any additional documents are produced after the depositions, these depositions wiii have $0 be
continued and taken 21 second time at Tcvzfs expense.
3. Proposed Scheduling Modification
The parties arejcnimly proposing aa $11011 extension ofthc dates for submitting initial and rebuttal expert
reports (t0 December 19, 2005 and January E6, 2006) and {0; concluding al} disccvcxg/(Fcbma1‘y 13,

Case 1:04-cv—00171-Gl\/IS Document 69 Filed 09/28/2005 Page 4 of 4
The Honorable Kent A. Jordan
September 21, 2005
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2006), a copy ofthe signed stipulation is attached. (See Exh. I). Because ofthe limited time remaining,
we are fearful that Teva has effectively sahotaged the discovery schedule and that meeting even this
modified discovery schedule is contingent upon receiving the requested and admittedly relevant
documents immediately, but we have no confidence that Teva will make it happen:
THE COLRT: . . . Mr. Murphy. . . is there anything else we need to address while
we’re all on the line together?
MR. MURPHY: No, Judge. Only to note that vve’re running short on time to resolve
these issues. And so we will try. We would ask for cooperation to do this as quickly as
possible so we don’t run into the discovery cutoff date.
THE COURT: Fm sure you are going to get it; right, Mr. Schuman?
MR. SCHUMAN: Yes. We’re motivated to move fast, Your Honor.
Far from moving fast, Teva has done little or nothing at all to assist Glaxo in obtaining the requested
documents. We request that the Court order the extended dates jointly proposed bythe parties subject
to Gtaxo reserving its right to request a further extension to obtain the requested documents. ln the
alternative, Glaxo renews its request that the Court consider an appropriate sanction (e. g., entry of a
iudgrnent ofpatent infringement) under Fed. R. Civ. P. 3'?(b) and (c) against Teva.
4. The Pharmadvne Discovery
Glaxo has received the objections of Teva with respect to the designated deposition and trial testimony
ofthird-party witnesses who formulated Phannadyne’s infringing ranitidine oral solution using
Anita K. Runyan, Prasad Gullapalti and Nitin Pathak, who testified to the
stabilizing effect of—on ranitidine in an oral syrup formulation. We are reviewing
these objections and intend to take whatever action is necessary to ensure the admissibility ofthis
evidence against Teva.
Respectfully submitted, _
tfYQ_irL(‘A`§ E")
Francis DiGiovanni
cc: Clerk ofthe Court (by hand)
losy W. Ingersoll, Esq. (by hand)
ivlark D. Schuman, Esq. (via Federal Express)
Brian P. Murphy, Esq. (via Federal Express)
4lS256_l

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