(commonly referred to as “the Hatch-Waxman Act”)
The following provisions apply 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”).
These provisions take precedence over any conflicting provisions in LPR 3.1-3.8 for all cases
arising under 21 U.S.C. § 355.
(a) Production of New Drug Application. At or before the Patent Scheduling
Conference, Defendant(s) shall produce to Plaintiff(s) the entire Abbreviated New
Drug Application or New Drug Application that is the basis of the case in
question.
(b) Invalidity Contentions. Within 14 days after the Patent Scheduling Conference,
Defendant(s) shall provide to Plaintiff(s) written Invalidity Contentions for any
patents referred to in Defendant(s) Paragraph IV Certification. At a minimum,
these Invalidity Contentions should include those items required by LPR 3.5(a)-
(d).
(c) Production of Materials Supporting Invalidity Contentions. Any Invalidity
Contentions disclosed under LPR 3.10(b) shall be accompanied by the production
of any document or thing that each Defendant intends to rely on to show
invalidity. At a minimum, this disclosure should comply with LPR 3.6(a).
(d) Non-infringement Contentions. Within 30 days after the Patent Scheduling
Conference, Defendant(s) shall provide to Plaintiff(s) the written basis for their
Non-infringement Contentions for any patents referred to in Defendant(s)
Paragraph IV Certification, which shall include a claim chart as required by LPR
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Local Patent Rules - Western District of Tennessee
3.3(a) 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) are literally absent from the Defendant(s) allegedly infringing
Abbreviated New Drug Application or New Drug Application.
(e) Production of Materials Supporting Non-infringement Contentions. Any Non-
infringement Contentions disclosed under LPR 3.10(d) shall be accompanied by
the production of any document or thing that each Defendant intends to rely on in
defense against any infringement contentions by Plaintiff(s), including those items
required by LPR 3.4(a).
(f) Infringement Contentions. Within 45 days after the disclosure of the Non-
infringement Contentions as required by LPR 3.10(d), Plaintiff(s) shall provide
Defendant(s) with Infringement Contentions for all patents referred to in
Defendant(s) Paragraph IV Certification, including, at a minimum, those items
required by LPR 3.1.
(g) Production of Materials Supporting Infringement Contentions. Any Infringement
Contentions disclosed under LPR 3.10(f) shall be accompanied by the production
of documents required under LPR 3.2.
3.11. Amending and Supplementing Contentions
Unless otherwise ordered by the Court, the parties’ contentions and responses shall have
the same binding effect on a party as a response to an interrogatory made under Rule 33 of the
Federal Rules of Civil Procedure. The parties’ disclosures and responses may be amended or
supplemented without leave of Court until the Final Contentions are due under LPR 3.8(a)-(c);
provided, however, that after submission of the exchange of claim terms under LPR 4.1(c),
additional claims in the patent(s) in suit may not be asserted without obtaining leave from the
Court for good cause shown.
3.12. Final Date to Seek Stay Pending Reexamination
Absent exceptional circumstances, no party may file a motion to stay the lawsuit
pending reexamination in the United States Patent Office after the due date for service of that
party's Final Contentions.
IV. CLAIM CONSTRUCTION PROCEEDINGS
