Free Redacted Document - District Court of Delaware - Delaware

I Case 1 :O4—cv—OO171-Gl\/IS Document 69-5 Filed O9/28/2005 Page 1 of 2
Morgan. Lewis & Bockius ur '
I is Pam venue Morgan Lewts
!~i¤wY¤rk,t¤Y10t1s—0060 COUNHLGU H. H,
'Fei: 212.30%.6000
I Fax: 212.369.6GOl
WWW.mDfQ&hiEWES.{Dm
Thomas J. Purapa
212-309-2118
I [email protected]¤m
I June 6, 2005
VIA FACSIMILE
E John M. Berns, Esq.
Merchant 8: Gould
I 3200 IDS Center
SD South Eighth Street
Minneapolis, MN 55402
I Re; Glaxo Group Limited v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical
Industries Limited, Civil Action No. 04- I 71 ·KAJ
I Dear John:
I am writing following our telephone conversation on Friday June 3, 2005. Teva has still not
I produced several highly relevant categories of documents regarding the development ofthe
generic formulation. Discovery in this case is being hampered by such non-production and these
documents should be produced immediately.
Particularly important are documents relating to the development lots identified in the lab
notebook for Project P-399, Bates Nos. T77l4—7’742. There are invariably testing reports,
analyses, lab notebooks, studies, stability tests, and other records relating to each of these
i development lots. No such documents have been produced except for development lot 399-10.
These documents should be produced immediately.
I In addition, the "development report" for Novopha1m’s work has still not been produced. This
document was referred to as late as September 2004 and clearly exists in Novopha1·m’s tiles, if
not 'E`eva’s. See, e.g., e·mai1 from Susan Lahtinen to Dereth Li, dated 09/O9/04, at Bates No.
I T7268. At a minimum these two individuals should be contacted for a copy ofthis document.
Likewise, this, or a similar document is also identified at Bates No. T662445632. Also, if there
are reports for each formulation they should all be produced.

l Case 1 :O4—cv—OO171-GI\/IS Document 69-5 Filed O9/28/2005 Page 2 of 2
Morgn Lewis
I It/[3_}"kD,SQhum&¤,E$q, couzuntoas at can
June 6, 2005
H Page 2
Another document that needs to be produced is the "Prefonnulation Infomation Package"
I identified at Bates No. T2596. There are over 20 people identified on that e-mail as having
received a copy of that document. Each of there should be contacted, not only for that document,
but also for any tiles relating to this litigation. If needed, the electronic records at Teva should
n also he searched. lf this is the same document found at Bates No. T1993-2001 please notify us.
Furthermore, the index or table of contents pages for each lab notebook related to ’l`eva’s or
I Novopharm’s ranitidine hydrochloride oral solution formulation should be produced. This
would include lab notebooks from Teva, Novopharm, and any vendors that were used on the
_ project, such as PPD Development.
Finally, there remain outstanding items from our letter to Judge Jordan dated February 22, 2005.
These items include laboratory notebooks 1780, 1928, and 2033, batch records, stability data and
experimental data for the ANDA batch and batches BG-043}, 1853-005, 1853-015, ISS3-017,
i and 3213PD. We are also still awaiting full production ofTeva’s and Novopharnfs marketing
and sales materials.
l We have been asking for these documents for months and would like to receive them U
immediately. l look forward to your prompt response.
I Very truly yours,
I Thomas J. Ptippg

Case 1:04-cv-00171-GMS

Document 69-5

Filed 09/28/2005

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Case 1:04-cv-00171-GMS

Document 69-5

Filed 09/28/2005

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