D.N.J. L. Pat. R. 3.6

The following applies to all patents subject to a Paragraph IV certification in cases arising under 21

U.S.C. § 355 (commonly referred to as “the Hatch-Waxman Act”). This rule takes precedence over any

conflicting provisions in L. Pat. R. 3.1 to 3.5 for all cases arising under 21 U.S.C. § 355.

(a) On the date a party answers, moves, or otherwise responds, each party who is an ANDA filer

shall produce to each party asserting patent infringement the entire Abbreviated New Drug Application or New

Drug Application that is the basis of the case in question.

(b) Not more than seven days after the initial Scheduling Conference, each party asserting patent

infringement shall serve on all parties a “Disclosure of Asserted Claims” that lists each claim of each patent that

is allegedly infringed by each opposing party, including for each claim the applicable statutory subsections of

35 U.S.C. § 271 asserted.

(c) Not more than 30 days after the initial Scheduling Conference, each party opposing an assertion

of patent infringement shall provide to each party asserting patent infringement the written basis for its

"Invalidity Contentions," for any patents referred to in the opposing party's Paragraph IV Certification, which

shall contain all disclosures required by L. Pat. R. 3.3.

(d) Any "Invalidity Contentions" disclosed under L. Pat. R. 3.6(c) shall be accompanied by the

production of documents required under L. Pat. R. 3.4(b) and (c).

(e) Not more than 30 days after the initial Scheduling Conference, each party opposing an assertion

of patent infringement shall provide to each party asserting patent infringement the written basis for its

"NonInfringement Contentions," for any patents referred to in the opposing party's Paragraph IV Certification

which shall include a claim chart identifying each claim at issue in the case and each limitation of each claim at

issue. The claim chart shall specifically identify for each claim which claim limitation(s) is/(are) literally absent

from each opposing party's allegedly infringing Abbreviated New Drug Application or New Drug Application.

(f) Any “Non-Infringement Contentions” disclosed under L. Pat. R. 3.6(e) shall be accompanied by

the production of any document or thing that each party who is an ANDA filer intends to rely on in defense

against any infringement contentions by each party asserting patent infringement.

(g) Not more than 45 days after the disclosure of the “Non-Infringement Contentions” as required by

L. Pat. R. 3.6(e), each party asserting patent infringement shall provide each opposing party with a “Disclosure

of Asserted Claims and Infringement Contentions,” for all patents referred to in each opposing party's Paragraph

IV Certification, which shall contain all disclosures required by L. Pat. R. 3.1. The infringement contentions

shall be limited to the claims identified in L. Pat. R. 3.6(b).

(h) Any “Disclosure of Asserted Claims and Infringement Contentions” disclosed under L. Pat. R.

3.6(g), shall be accompanied by the production of documents required under L. Pat. R. 3.2.

(i) Not more than 45 days after the disclosure of “Invalidity Contentions” as required by L. Pat. R.

3. 6(c), the party defending the validity of the patent shall serve on each other party its “Responses to Invalidity

Contentions” as required under L. Pat. R. 3.4A.

(j) Each party that has an ANDA application pending with the Food and Drug Administration (“FDA”)

that is the basis of the pending case shall: (1) notify the FDA of any and all motions for injunctive relief no

later than three business days after the date on which such a motion is filed; and (2) provide a copy of all

correspondence between itself and the FDA pertaining to the ANDA application to each party asserting

infringement, or set forth the basis of any claim of privilege for such correspondence pursuant to L.Civ.R. 34.1,

no later than seven days after the date it sends same to the FDA or receives same from the FDA. L. Pat. R. 3.7.

Amendments.

Amendment of any contentions, disclosures, or other documents required to be filed or exchanged

pursuant to these Local Patent Rules may be made only by order of the Court upon a timely application and

showing of good cause. The application shall disclose whether parties consent or object. Non-exhaustive

examples of circumstances that may, absent undue prejudice to the adverse party, support a finding of good

cause include: (a) a claim construction by the Court different from that proposed by the party seeking

amendment; (b) recent discovery of material prior art despite earlier diligent search; (c) recent discovery of

nonpublic information about the Accused Instrumentality which was not discovered, despite diligent efforts,

before the service of the Infringement Contention; (d) disclosure of an infringement contention by a Hatch-Waxman Act party asserting infringement under L. Pat. R. 3.6(g) that requires response by the adverse party

because it was not previously presented or reasonably anticipated; and (e) consent by the parties in interest to

the amendment and a showing that it will not lead to an enlargement of time or impact other scheduled

deadlines. The duty to supplement discovery responses under Fed. R. Civ. P. 26(e) does not excuse the need to

obtain leave of Court to amend contentions, disclosures, or other documents required to be filed or exchanged

pursuant to these Local Patent Rules. L. Pat. R. 3.8. Advice of Counsel.

Unless otherwise ordered by the Court, not later than 30 days after entry of the Court’s claim

construction order, or upon such other date as set by the Court, 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 subpart (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.

A party who does not comply with the requirements of this L. Pat. R. 3.8 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.

4. CLAIM CONSTRUCTION PROCEEDINGS