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RULE 804. DISCLOSURES

1. Cases Involving Claims of Infringement

Unless otherwise ordered by the Court, in all cases other than those arising under the Hatch-Waxman Act (21 U.S.C. § 355), in which a party has asserted a claim of patent infringement, the parties shall make the following disclosures.

a) Initial Disclosure of Infringement Contentions

Twenty-eight (28) days from the date of the Scheduling Order, any party claiming patent infringement shall serve on all parties an Initial Disclosure of Infringement Contentions, separately setting forth for each allegedly infringing party, the following information:

i. Each claim of each patent in suit that is allegedly infringed by each allegedly infringing party, including for each claim the applicable statutory subsections of 35 U.S.C. § 271 asserted;

ii. Separately for each allegedly infringed claim, each accused apparatus, product, device, process, method, act, or other instrumentality ("Accused Instrumentality") of each allegedly infringing party of which the party is aware. This identification shall be as specific as possible. Each product, device, and apparatus shall be identified by name or model number, if known. Each method or process shall be identified by name, if known, or by any product, device, or apparatus which, when used, allegedly results in the practice of the claimed method or process;

iii. A chart identifying specifically where each limitation of each asserted claim is found within each Accused Instrumentality, including for each limitation that such party contends is governed by pre-AIA 35 U.S.C. § 112(6) or post-AIA 35 U.S.C. § 112(f), the identity of the structure(s), act(s), or material(s) in the Accused Instrumentality that performs the claimed function;

iv. For each claim which is alleged to have been indirectly infringed, an identification of any direct infringement, a description of the acts of the alleged indirect infringer that contribute to or are inducing that direct infringement, and an identification of the bases upon which the patentee contends the alleged infringer had knowledge of the patent asserted to be indirectly infringed. Insofar as alleged direct infringement is based on joint acts of multiple parties, the role of each such party in the direct infringement must be described;

v. Whether each limitation of each asserted claim is alleged to be literally present or present under the doctrine of equivalents in the Accused Instrumentality;

vi. For any patent that claims priority to an earlier application, the priority date to which each asserted claim allegedly is entitled;

vii. The date of conception and the date of reduction to practice of each asserted claim;

viii. If a party claiming patent infringement wishes to preserve the right to rely, for any purpose, on the assertion that its own apparatus, product, device, process, method, act, or other instrumentality practices the claimed invention, the party shall identify, separately for each asserted claim, each such apparatus, product, device, process, method, act, or other instrumentality that incorporates or reflects that particular claim; and

ix. If a party claiming patent infringement alleges willful infringement, the basis for such allegation.

b) Document Production Accompanying Initial Disclosure of Infringement Contentions

With the Initial Disclosure of Infringement Contentions, the party claiming patent infringement shall produce to each allegedly infringing party or make available for inspection and copying all documents relating to:

i. Any offers to sell or efforts to market each claimed invention prior to the date of the application for the patent (A party's production of a document as required herein shall not constitute an admission that such document evidences or is prior art under 35 U.S.C. § 102);

ii. The standing of the party alleging infringement with respect to each patent upon which such allegations are based; and

iii. A copy of the file history for each patent in suit.

c) Initial Disclosure of Invalidity Contentions in Defense of Infringement Claims

Fifty-six (56) days from the date of the Scheduling Order, each party opposing a claim of patent infringement shall serve on all parties its Invalidity Contentions, which shall contain the following information:

i. The identity of each item of prior art that allegedly anticipates each asserted claim or renders it obvious. Each prior art patent shall be identified by its number, country of origin, and date of issue. Each prior art publication shall be identified by its title, date of publication, and where feasible, author and publisher. Prior art under 35 U.S.C. § 102(b) shall be identified by specifying the item offered for sale or publicly used or known, the date the offer or use took place or the information became known, and the identity of the person or entity which made the use or which made and received the offer, or the person or entity which made the information known or to whom it was made known. Prior art under 35 U.S.C. § 102(f) shall be identified by providing the name of the person(s) from whom and the circumstances under which the invention or any part of it was derived. Prior art under 35 U.S.C. § 102(g) shall be identified by providing the identities of the person(s) or entities involved in and the circumstances surrounding the making of the invention before the patent applicant(s);

ii. Whether each item of prior art anticipates each asserted claim or renders it obvious. If obviousness is alleged, an explanation of why the prior art renders the asserted claim obvious, including an identification of any combinations of prior art showing obviousness;

iii. A chart identifying where specifically in each alleged item of prior art each limitation of each asserted claim is found, including for each limitation that such party contends is governed by pre-AIA 35 U.S.C. § 112(6) or post-AIA 35 U.S.C. § 112(f), the identity of the structure(s), act(s), or material(s) in each item of prior art that performs the claimed function;

iv. Any grounds of invalidity based on 35 U.S.C. § 101, indefiniteness under pre-AIA 35 U.S.C. § 112(2) or post-AIA 35 U.S.C. § 112(b), or enablement or written description under pre-AIA 35 U.S.C. § 112(1) or post-AIA 35 U.S.C. § 112(a) of any of the asserted claims. This identification must be as specific as possible. For example, each party asserting an enablement defense must set forth with particularity what is lacking in the specification to enable one skilled in the art to make or use the invention, specifically citing information or materials obtained in discovery to the extent feasible. Each party asserting an enablement defense must set forth with particularity what is lacking in the specification to enable one skilled in the art to make or use the invention; and

v. If the claimant has alleged willful infringement, the date and a document reference number for each opinion of counsel upon which the party relies to support a defense to the willfulness allegation, including, but not limited to, issues of validity and infringement of any patent in suit.

d) Document Production Accompanying Initial Disclosure of Invalidity Contentions

With the Initial Disclosure of Invalidity Contentions, the party opposing a claim of patent infringement shall produce or make available for inspection and copying a copy of any prior art identified in the Initial Disclosure of Invalidity Contentions that does not appear in the file history of the patent(s) at issue. To the extent any such item is not in English, an English translation of the portion(s) relied upon shall be produced.

2. Cases Seeking Declaratory Judgment of Invalidity

Unless otherwise ordered by the Court, in all cases in which a party files a complaint or other pleading seeking a declaratory judgment that a patent is invalid, and there are no claims for patent infringement asserted by any party, the parties shall make the following disclosures.

a) Initial Disclosure of Invalidity Contentions

Twenty-eight (28) days from the date of the Scheduling Order, the party seeking a declaratory judgment of invalidity shall serve upon each opposing party its Initial Disclosure of Invalidity Contentions that conform to L.R. 804.1.c.

b) Document Production Accompanying Initial Disclosure of Invalidity Contentions

With the Initial Disclosure of Invalidity Contentions, the party seeking a declaratory judgment that a patent is invalid shall produce or make available for inspection and copying the documents described in L.R. 804.1.d.

3. Cases Arising Under the Hatch-Waxman Act (21 U.S.C. § 355)

Unless otherwise ordered by the Court, in all cases alleging patent infringement based upon a Paragraph IV certification under 21 U.S.C. § 355, the parties shall make the following disclosures.

a) Initial Disclosure of Invalidity Contentions

Twenty-eight (28) days from the date of the Scheduling Order, the Defendant shall serve upon the Plaintiff its Initial Disclosure of Invalidity Contentions that conform to L.R. 804.1.c.

b) Initial Disclosure of Non-Infringement Contentions

With the Initial Disclosure of Invalidity Contentions, the Defendant shall serve upon the Plaintiff its Initial Disclosure of Non-Infringement Contentions for any patents referred to in Defendants Paragraph IV Certification which shall include a claim chart identifying each claim in the patent at issue in the case and each limitation of each claim and shall specifically identify for each claim which claim limitation(s) are literally absent from the Defendants allegedly infringing Abbreviated New Drug Application or New Drug Application.

c) Document Production Accompanying Initial Disclosures of Invalidity and Non-Infringement Contentions

With the Initial Disclosures of Invalidity and Non-Infringement Contentions, the Defendant shall produce or make available for inspection and copying and produce to the Plaintiff or make available for inspection and copying the documents described in L.R. 804.1.d, as well as a complete copy of the entire Abbreviated New Drug Application or New Drug Application that is the basis of the case in question and any document or thing that the Defendant intends to rely on in defense against any infringement contentions by Plaintiff.

d) Initial Disclosure of Infringement Contentions

Fifty-six (56) days from the date of the Scheduling Order, Plaintiff shall serve Defendant with an Initial Disclosure of Infringement Contentions for all patents referred to in Defendants Paragraph IV Certification, which shall contain all disclosures required by L.R. 804.1.a.

e) Document Production Accompanying Initial Disclosure of Infringement Contentions

Plaintiffs Initial Disclosure of Infringement Contentions shall be accompanied by the production of documents required under L.R. 804.1.b.

4. Cases Seeking Correction of Inventors (35 U.S.C. § 256)

Unless otherwise ordered by the Court, in all cases in which a party seeks an order directing the Director of Patents to correct the inventors on a certificate of patent pursuant to 35 U.S.C. § 256, the parties shall make the following disclosures.

a) Initial Disclosure of Contribution Contentions

Twenty-eight (28) days from the date of the Scheduling Order, any party seeking an order directing the Director of Patents to correct a certificate of patent pursuant to 35 U.S.C. § 256 by adding to or replacing the inventors identified on the certificate shall serve the opposing parties a claim chart identifying each claim in the patent(s) at issue in the case to which the party alleges a person or persons, not named as inventor or joint inventor on certificate(s) of patent, made a significant contribution in conception and/or reduction to practice, describing the contribution made by the alleged inventor or joint inventor(s), and identifying the date each such contribution was made.

b) Document Production Accompanying Initial Disclosure of Contribution Contentions.

With the Initial Disclosure of Contribution Contentions, the party seeking correction of a certificate of patent shall produce or make available for inspection and copying and produce to opposing parties or make available for inspection and copying:

i. All documents upon which the party asserts its standing to bring the claim(s) pursuant to 35 U.S.C. § 256; and

ii. All documents reflecting the alleged inventor or joint inventor(s) contribution to the conception and/or reduction to practice of the inventions described in the claims identified in the Initial Disclosure of Contribution Contentions.

c) Documents Reflecting Conception and Reduction to Practice

Sixty (60) days from the date of the Scheduling Order, the opposing parties shall serve upon the disclosing party all documents reflecting or pertaining to the conception and reduction to practice of the inventions described in the claims identified in the Initial Disclosure of Contribution Contentions.

5. Cases Alleging False Marking (35 U.S.C. § 292)

Unless otherwise ordered by the Court, in all cases in which a party alleges false marking pursuant to 35 U.S.C. § 292, the parties shall make the following disclosures.

a) Initial Disclosure of False Marking Contentions

Twenty-eight (28) days from the date of the Scheduling Order, any party asserting a claim of false marking pursuant to 35 U.S.C. § 292 shall serve the opposing parties a chart identifying each item or article that the party claims has been falsely marked, the patent numbers with which the item or article was allegedly marked, the alleged expiration date of each such patent, and, to the extent that the party contends that the item or article is not within the inventions claimed in each such patent, the basis for each such contention.

b) Response to Initial Disclosure of False Marking Contentions.

Fifty-six (56) days from the date of the Scheduling Order, the opposing parties shall serve upon the disclosing party a chart listing each item or article identified in the Initial Disclosure of False Marking, identifying all patent numbers with which those items and articles were marked and the periods of time during which they were so marked, the number of units of each item and article that were sold during each such period, and the basis for the opposing party's contention that the items and articles were within the inventions claimed in each such patent.

6. Amendment to Contentions

A party may amend Contentions described in L.R. 804.1 through 804.5 upon written consent of all parties or, for good cause shown, upon leave of the Court.

7. Advice of Counsel

Unless otherwise ordered by the Court, not later than twenty-eight (28) days after entry of the Court's claim construction order, each party relying upon advice of counsel as part of a patent-related claim or defense for any reason shall:

a. Produce or make available for inspection and copying any written advice and documents related thereto for which the attorney-client and work product protection have been waived;

b. Provide a written summary of any oral advice and produce or make available for inspection and copying that summary and documents related thereto for which the attorney-client and work product protection have been waived; and

c. Serve a privilege log identifying any documents other than those identified in L.R. 804.7.a above, except those authored by counsel acting solely as trial counsel, relating to the subject matter of the advice which the party is withholding on the grounds of attorney-client privilege or work product protection.

d. A party who does not comply with the requirements of this L.R. 804.7 shall not be permitted to rely on advice of counsel for any purpose absent a stipulation of all parties or by order of the Court.