- Eastern District of Texas Adds New Local Patent Rule in Hatch-Waxman Cases
- April 3, 2014 | Author: Joseph E. Cwik
- Law Firm: Husch Blackwell LLP - Chicago Office
Following the lead of the U.S. District Court for the District of New Jersey, the U.S. District Court for the Eastern District of Texas just announced the adoption of a General Order amending the disclosure requirements for cases under the Hatch-Waxman Act, 21 U.S.C. § 355. The new rule takes effect after a notice and comment period ending on April 1, 2014.
Similar to local patent rule 3.6(j) from the District of New Jersey, the new Eastern District of Texas local patent rule 3-8(e) requires the following:
“(e) 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, no later than seven days after the date it sends or receives any such correspondence.”
The stated purposes of the new rule are to help ensure coordination between related FDA proceedings and district court litigation, and also avoid a recurring discovery issue regarding the production of correspondence to and from the FDA both prior to and during litigation. The District of Idaho also has a local patent rule for Hatch-Waxman cases, but has not yet adopted this specific disclosure rule. It will be interesting to see if more District Courts also adopt this new local patent rule.