Plaintiff's Document Requests

AuthorKenneth L. Dorsney
Pages747-751
Plaintiffs Document Requests
IN THE UNITED STATES DISTRICT COURT
[Name of District]
[DISTRICT COURT CAPTION]
PLAINTIFF’S FIRST SET OF RULE 34 DOCUMENT REQUESTS TO
DEFENDANTS
Pursuant to Rule 34 of the Federal Rules of Civil Procedure, and the applicable
Local Rules of the United States District Court [Name of District], Plaintiff [Name of
Plaintiff] (“Plaintiff”) hereby request that Defendant [Name of Defendant] produce and
permit Plaintiff to inspect and copy each of the documents and things requested below, in
accordance with those rules and the following Definitions and Instructions.
Unless otherwise agreed, production is to be made on or within thirty (30) days at the
offices of [Name of Counsel for Defendant, Address of Counsel for Defendant].
DEFINITIONS
1. The term “’001 patent” means Plaintiff’s United States Patent No. 1.
2. “Applications underlying the ’001 patent” means U.S. Patent Application
Serial No. 1 and U.S. Provisional Application Serial No. 2.
3. “GenX” means [active ingredient] in any form, including without
limitation any salt thereof, or any preparation, formulation, pharmaceutical, or product
comprised of or containing [active ingredient].
4. “Document” means each and every writing, whether an original, a draft, or
a copy, however produced or reproduced, and each and every thing from which
information can be processed or transcribed, and includes, without limitation, all things
meeting the definitions of “writings” and “recordings” as set forth in Fed. R. Evid. 1001.
Any document without any marks such as initials, comments, or notations of any kind is
not deemed to be identical to one without such marks and is to be produced and identified
as a separate document. The term “document” is coextensive in scope with Rule 34 of
the Federal Rules of Civil Procedure.
5. “Thing” means any physical specimen or other tangible item other than a
document.
6. “Concerning” means in any way, directly or indirectly, regarding,
considering, constituting, covering, defining, describing, involving, underlying,
modifying, amending, confirming, mentioning, endorsing, recording, evidencing,
pertaining to, referring to, reflecting, relating to, representing, supporting, qualifying,
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terminating, revoking, canceling, negating or having any connection with the matter
discussed.
7. “Communication” refers to all conversations, agreements, inquiries or
replies, whether in person, by telephone, in writing, or by means of electronic transmittal
devices, and includes, but is not limited to, all correspondence, transmittal slips,
memoranda or notes.
8. “FDA” means the United States Food and Drug Administration, including
without limitation, its employees, scientists, technicians, agents, examiners and
laboratories.
9. “ANDA” means Abbreviated New Drug Application as used in 21 U.S.C.
§ 355(j) and regulations issued by the FDA pursuant thereto.
10. “Foreign counterpart to the ’001 patent” means all non-U.S. patents and/or
patent applications which claim priority or descent, in whole or in part, from any of the
“applications underlying the ’001 patent.”
11. “Defendant” means collectively, jointly, and severally Defendant, and
each of their officers, directors, representatives, employees, agents, partners, corporate
parents, subsidiaries, affiliates, predecessors and successors, including any entities or
persons acting on behalf of Defendant.
12. “Manufacture” means make, whether experimentally or commercially.
13. “Defendant’s ANDA” means ANDA No. 00-001, as referenced in the
Notice Letters.
14. “Defendant’s ANDA Products” means the extended release GenX tablets
which are the subject of Defendant’s ANDA.
15. “Prior Art” encompasses by way of example and without limitation the
subject matter described in each and every subdivision of 35 U.S.C. § 102 and 35 U.S.C.
§ 103.
16. When referring to documents, “to identify” means to provide, to the extent
known: the type of document; general subject matter; date of the document; author(s);
addressee(s); and recipient(s).
17. When referring to a person, “to identify” means to provide, to the extent
known, the person’s full name, present or last known address, and when referring to a
natural person, additionally, the present or last known place of employment. Once a
person has been identified in accordance with this paragraph, only the name of that
person need be listed in response to any subsequent discovery request seeking such
identification.
18. The term “person” means any natural person or business, legal or
governmental entity or association.
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19. Any reference to a corporation or business entity includes all entities and
persons acting on the entity’s behalf as well as all affiliates, divisions, parents,
subsidiaries, predecessors and successors thereof.
20. The terms “and” and “or” shall be interpreted liberally as conjunctive,
disjunctive, or both so that the fullest disclosure of information is achieved.
21. The term “all” means all and each and the term “each” means each and all
so that the fullest disclosure of information is achieved.
22. The singular includes the plural and the plural includes the singular so that
the fullest disclosure of information is achieved.
INSTRUCTIONS
1. All documents and things responsive to these Requests that come into the
possession, custody, or control of Defendant after it has made its first response to these
Requests shall be produced to Plaintiff in accordance with Defendant’s obligation to
supplement responses under Federal Rule of Civil Procedure 26(e). Such documents and
things shall be produced as soon as is reasonably possible after they are located or
obtained.
2. If Defendant has any good faith objections to any request or part thereof,
the specific nature of the objection and whether it applies to the entire request or to a part
of the request should be stated. If there is an objection to any part of a request, then the
part objected to should be identified and documents responsive to the remaining
unobjectionable part should be produced.
3. If Defendant withholds information on the grounds of attorney-client
privilege or work produce immunity, or any other privilege or immunity, Defendant must
identify the nature of the privilege that is being claimed and, if the privilege is governed
by state law, indicate the state’s privilege rule being invoked. As to the information
requested, Defendant must indicate whether any such documents exist and if so,
Defendant must identify the following:
(a) a list of all such non-produced documents or tangible things;
(b) the date of the document;
(c) the type of document (e.g., letter, memorandum, etc.);
(d) the name and title of each person who signed, prepared, or sent the
document;
(e) the name of each addressee and person to whom the document or copies
thereof were given, shown, or sent;
(f) a description of the general subject matter of the document;
(g) the identification of any document or other material transmitted with or
attached to the document; and
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