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Case 1 :04-cv-00171-GIVIS Document 58 Filed 07/06/2005 Page 1 of 3
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Jane 28, 2005
Date of Redacted Version: [July 6, 2005]
VIA HAND DELIVERY
The Honorable Kent A. Jordan {REDACTED VERSION
U.S. District Court for the District of Delaware DOCKET ITEM 53]
844 North King Street
Wilmington, Delaware 19801
Re: Glaxo Group Limited v. Teva Pharmaceuticals USA, Inc. et al.,
Civil Action No. 04-l7l~KAJ
Dear Judge Jordan:
This letter raises discovery issues that were first brought to the Cou.rt’s attention on February 25
and March 3l, 2005. Plaintiff patentee, Glaxo Group Limited (“Glaxo"), is faced with a refusal by
defendant Teva Pharmaceuticals USA, Inc. ("Teva USA") to: (i) admit, without qualification, that its
accused product meets all of the claim limitations in Glaxo’s U.S. Patent No. 5,068,249 (the “‘249
patent,” attached as Exh. 1) except for the disputed "ethanol" limitation in claims 1, 2, 3 and l 1; and (ii)
produce essential discovery that is highly relevant to the issues in this case. Teva’s refusal to abide in
good faith by the Court’s instruction during the February 25, 2005 teleconference (see Exh. 2, Tr. pg. 20
lines 9-24) to provide a written confirmation narrowing the issues for trial is significantly impacting
Glaxo’s ability to develop its patent infringement case within the timeframe set forth in the Court’s
Scheduling Order. Glaxo’s attempts, since September 2004, to obtain basic and fundamentally relevant
discovery on the remaining issues also have been frustrated at every turn by Teva’s lack of cooperation.
1. Defendanfs Refusal to Admit the Non-Ethanol Claim Limitations in the ‘249 Patent
The ‘249 patent is directed to the use of a stabilizing effective amount of ethanol to stabilize
ranitidine, or its physiologically acceptable salts, in an oral aqueous formulation. Glaxo respectfully
refers the Court to the second paragraph of (}laxo’s February 22 letter to the Court for a more complete
explanation ofthe patented technology.
During the parties February 25 teleconference with Your Honor, Teva’s counsel committed to
contirrrr in writing, by supplementing 'l`eva’s response to Glaxo’s lnterrogatory No. 6, Teva’s
admission that its accused product meets all of the ‘249 patent claim limitations with the exception of
the equivalence of Q to the claimed “ethanol" limitation. 'l`eva’s agreement was in
exchange for Glaxo’s agreement to limit infringement discovery to the so-called “ethanol" claim

Case 1:04-cv—00171-Gl\/IS Document 58 Filed 07/06/2005 Page 2 of 3
The Honorable Kent A. Jordan
June 28, 2005
l’age 2
limitation. As the Court noted: "So the only thing in issue, you’re [Teva] going on the record right
now to say the only thing that you are saying is different about the formation of your client’s product is
this one distinction that the plaintiff has drawn between the substitution of ethanol for the-
- is that right?” To which Mr. Schuman responded “Yes, Your Honor.” Transcript at page 20.
Defendant’s Amended Responses to Glaxo’s lnterrogatory Nos. 6 and 7, however, are hedged and
couched in a manner that, in Glaxo’s view, is unsatisfactory. (Teva Responses attached as Exh. 3).
'l“eva’s answers are not what the Court ordered or what Glaxo contemplated based on Teva’s above-
quoted exchange with the Court.
Glaxo then prepared and served Requests for Admission to narrow the issues for discovery and
trial. Glaxo’s requests were met with further hedging in the form of numerous objections and qualified
admissions. (Teva’s Responses attached as Exh. 4). Teva apparently takes the view that since the
Court has not yet construed the language of the ‘249 patent claims, it cannot make unqualified
admissions. Glaxo asks for an Order that Teva either admit, without qualification, Glaxo’s Requests
for Admission Nos. l-3, 6, 11-21 and 24 (that its accused, generic ranitidine oral solution product
meets all of the non—ethanol claim limitations) or produce immediately all discovery directed by Glaxo
to all of the “249 claim limitations.
2. Teva’s Refusal to Produce the Novopharm Formulation Documents
The issue we addressed previously, and revisit now, focuses on Teva’s use of-
as an equivalent for ethanol in its generic ranitidine oral solution formulation. Teva’s subsidiary,
Novopharm Limited (“Novopharm"), actually developed the formulation, but after nine months of
repeated, specific requests for all of the relevant Novopharrn formulation documents, including certain
unproduced portions of Novopharmfs ANDA for ranitidine oral solution, we have been given some,
but not all, of the extent documents.
Teva identified in its Initial Disclosures served on August 12, 2004, and two recent depositions
confirm, that highly relevant Novopharm documents exist regarding l\lovophann’s selection of
—as the equivalent of choice used in the formulation of Teva’s generic ranitidine oral
solution. Glaxo seeks these documents because they are evidence of infringement and evidence ofthe
validity and nonobviousness of the ‘249 patent. Glaxo Wellcome, Inc. v. Plmrmdyne Corp., 32 li.
Supp. 2d 265, 284-87 (D. Md. 1998). The choices made in the formulation and development ofthe
accused product and the alternative pathways tried and abandoned (2. g., unsuccessful efforts to design
around the patented invention) are key indicia of infringement and validity. See id. The formulation
and development work can provide highly relevant evidence of infringement (ag., how and why
—was used as a substitute for ethanol; what effect the amount oi has
on stability; what alternatives were tried; what problems were encountered/overcome) and can be
probative of secondary indicia of non~obviousness (ag., copying, long~t`e1t need, lack of viable
alternatives). See ict
Glaxo has identified the specific documents repeatedly, most recently in two letters dated June
6, 2005, following the depositions of a Teva witness and a Novopharm witness, and a letter dated June

Case 1:04-cv—00171-G|\/IS Document 58 Filed 07/06/2005 Page 3 of 3
The Honorable Kent A. Jordan
June 28, 2005
Page 3
20, 2005. (Letters attached as Exhs. 5, 6, and 7). Teva has not yet responded. Glaxo requests an Order
that Teva produce immediately the documents requested in the letters attached, especially the following
documents: testing and development reports, lab notebooks, experimental data and analyses for batches
3G-043l, 1853-005, l853·015, 1853-017, 3213PD and 399-0l through 399-l0 (formulations utilizing
varying concentrations of- In the alternative, Glaxo requests the Court consider an
appropriate sanction (e.g., entry of a Judgment of patent infringement) under Fed. R. Civ. P. 37(b) and
(c).
3. Reguest for Ruling on Non~·Pagy `Evidenee
Glaxo has notified counsel for Teva that Glaxo intends to admit evidence from the Pharrnadyne
trial at the trial of this case, including the relevant deposition and trial testimony and exhibits of
Pharmadyne formulators Drs. Anita K. Runyan, Prasad Gullapalli and Nitin Patbak. This evidence is
highly relevant to the equivalence of _ and ethanol and the secondary indicia of non-
obviousness supporting the validity of the ‘249 patent. Teva also has made several broad document
requests for the evidence from the trial of the Pharmariyrze matter, and that evidence has been made
available to counsel for Teva. it is Glaxo’s position that these documents are admissible pursuant to
Fed. R. Evi. 804(b)(1), and that the aforementioned personnel are unavailable as that term is detined
hy Fed. R. Evid. 804(a)(5). The litigations against Teva and Pharmadyne involve—and
have defendants with the same interests and motivations. Please see Hill v. Equitable Bari/c National
Assoc., 1l5 F.R.D. 184, 185-86 (D. Dei. 1987) ("The presence of another adversary with the same
motive to cross»examine, coupled with a substantial identity of issues would permit this Court to admit
the deposition from a different action to this action.” citing George Whitten, Jr., Inc. v. State University
Coast. Inc., 359 F. Supp. l037, l039 (D. Mass. l973), a]j"d on other grounds, 493 F.2d I77 (lst Cir.
1974)). Thus, further depositions of Anita Runyan, Prasad Gullapalli, and Nitin Pathak should not be
required as a precondition to the admissibility of the Pharmadyne trial evidence at the trial of this case
against Teva. Glaxo respectfully requests an Order confirming the admissibility of the Pharmadyne
trial evidence without requiring further deposition testimony of the Pharmadyne witnesses.
Respectfully submitted,
/s/' Francis DiGiovanrzi
Francis DiGiovanni
ce: Clerk ofthe Court (by hand)
Josy W. Ingersoll, Esq- (by hand)
Mark D. Schuman, Esq. (via e-mail)
Brian P. Murphy, Esq. (via e—mail)
Enclosures
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