Free Notice to Take Deposition - District Court of Delaware - Delaware

Case 1:04-cv—OO940—JJF Document 49-2 Filed O9/23/2005 Paget of 3
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Definitions
A. The Procter & Gamble Company incorporates by reference herein the definitions
set forth in its First Set of Requests for the Production of Documents and Things.
B. Teva USA. means Teva Pharmaceuticals USA, Inc. and any and all officers,
directors, employees, agents, attorneys, representatives, partners, affiliates and all other persons
or entities acting or purporting to act or that have acted or purported to act on behalf of any of the
foregoing.
C. Teva israel means Teva Pharmaceutical Industries, Ltd. and any and all officers,
directors, employees, agents, attorneys, representatives, partners, affiliates and all other persons
or entities acting or purporting to act or that have acted or purported to act on behalf of any ofthe
foregoing.
Topics of Examination
l. The composition of Teva’s ANDA Risedronate Sodium Tablets.
2. The synthesis of the risedronate sodium used in Teva’s ANDA Risedronate Sodium Tablets
and Related Drugs.
3. The decision by Teva USA. and/or Teva Israel to develop a generic version of Actonel®.
4. Any studies, test, analyses, investigations and/or evaluations done by or on behalf of or
known to Teva USA. and/or Teva Israel concerning the market for risedronate, the needs
met by Actonel®, and the commercial success of Actonel®.
5. The research, design, development and production of Teva’s ANDA Risedronate Sodium
Tablets and Related Drugs, including without limitations any research and development
relating to risedronate, any research and development relating to Actonel®, any research
and development relating to generic versions of Actonel®, any research and development
relating to alternatives to Actonel®, and the amount of money and time invested by Teva
USA. and/or Teva Israel in the research, design, and development of Teva’s ANDA
Risedronate Sodium Tablets.
6. Any studies, test, analyses, investigations and/or evaluations done by or on behalf of or
known to Teva USA. and/or Teva Israel concerning the bioavailability, absorption,
toxicity, or metabolism of risedronate in mammals.
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analyses, studies, information, evaluations, and data contained or referenced in ANDA 77-
132, and/or relied upon by Teva USA. and/or Teva israel in preparing ANDA 77-·l32, the
decision to prepare and tile ANDA 77-i32, and the amount of money and time invested by
Teva USA. and/or Teva Israel in the preparation and filing of ANDA 774.32.
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or plans to obtain should ANDA 77—l32 obtain approval from the U.S. Food and Drug
Administration.
9. Knowledge, notice, and/or consideration by Teva U.S.A. and/or Teva lsrael ofthe ° 122
patent prior to the filing of ANDA 77—l32, including without limitation, the person(s) at
Teva U-S.A. and/or Teva Israel who first learned ofthe ‘l22 patent, the circumstances
through which they tirst learned ofthe ‘l22 patent, and any analysis of the ‘122 patent.
10. Any patent policy in effect at Teva l}.S.A. and/or Teva Israel at any time since entry into
the generic market for risedronate was first contemplated,
11. The factual basis for Teva’s contention that Teva’s ANDA Risedronate Sodium Tablets do
not and will not infringe any claim of the ‘l22 patent either directly or indirectly, or under
the doctrine of equivalents.
12. The factual basis for Teva’s contention that one or more claims ofthe patents»in-suit are
invalid and unenforceable under the patent laws of the United States, 35 U.S.C. §§ 1 et
seq., and more particularly under 35 U.S.C. §§ 102 and 103.
l3. All prior art that Teva contends anticipates any claim of the ‘l22 patent, including without
limitation, the claim(s) of the ‘122 patent allegedly anticipated by each reference, the
element(s) of each such claim allegedly described explicitly in the reference, and the
element(s) of each such claim alleged to be inherent in the reference.
14. All prior art that Teva contends renders the ‘l2?. patent obvious (either alone or in
combination with other prior art), including without limitation, the claim(s) of the ‘122
patent allegedly rendered obvious, every combination of prior art references alleged to
render each such claim obvious, any evidence that allegedly shows a motivation to
combine the prior art references, and the education level and experience that a person of
ordinary skill in the art of the claimed invention allegedly would possess.
15. The factual basis for any contention by Teva that the ‘122 patent is invalid due to a prior
public use or on—sale bar, including without limitation a description of each instance or
event that is alleged to constitute a prior public use or sale in the United States and the
claim(s) of the ‘l22 patent alleged to be invalid as a result.
I6. The factual basis for any contention by Teva that the ‘122 patent is invalid due to a failure
to satisfy the written description, enablement, and/or best inode requirements.
l7. The factual basis for any contention by Teva that the ‘l22 patent is invalid due to
invcntorship.
18. The factual basis for any contention by Teva that the ‘122 patent is invalid due to
indefiniteness.
19. The factual basis for any contention by Teva that the ‘122 patent is unenforceable due to
inequitable conduct, including without limitation, all information alleged to have been
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Case 1:04-cv—OO940—JJF Document 49-2 Filed O9/23/2005 Page 3 of 3
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misrepresented such information, the factual basis for any contention that such infomation
was material, and any evidence that shows or suggests that the alleged misrepresentation or
omission was made with the intent to deceive the i”TO.
20. Any document retention and destruction policy in effect at Teva U.S.A. and/or Teva israel
at any time since entry into the generic market for risedronate was first contemplated.
2]. Efforts made by Teva U.S.A. and/or Teva Israel to collect documents for production to
P&G in response to its Requests for Production of Documents and Things, including what
locations and whose tiles were searched
2.2. Documents and things concerning the foregoing topics.
23. Persons knowledgeable about the foregoing topics.
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