Effective March 18, 2011, the United States District Court for the District of New Jersey amended Local Civil Rule 9.3, i.e., the Court's Local Patent Rules, as recommended by the Local Patent Rules Committee. The order adopting the amendments is available on the Court's website or by clicking here.
The Report of the Local Patent Rules Committee includes Explanatory Notes for the 2011 Amendments that provide a concise summary of all of the changes. This alert focuses on the changes to Local Patent Rule 3.6, which specifically governs litigations arising under the Hatch-Waxman Act. Here are the more important changes:
- Newly Required "Disclosure of Asserted Claims." The party asserting infringement must now provide, within seven days of the initial Scheduling Conference, a "Disclosure of Asserted Claims" listing "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." L. Pat. R. 3.6(b). This change eliminates the inefficiency caused by the previous rules requiring the ANDA filer to speculate as to which claims would be asserted in providing their non-infringement and invalidity contentions, which effectively required the ANDA filer to provide contentions for each claim of each asserted patent.
- Newly Required "Responses to Invalidity Contentions." The patent holder, or party defending the validity of the patent, is now required to serve "Responses to Invalidity Contentions" within 45 days of the disclosure of the ANDA filer's invalidity contentions. L. Pat. R. 3.6(i). This new rule also applies to cases outside the Hatch-Waxman context and is intended to provide parity between the parties and focus the invalidity challenge. This is a positive change for ANDA filers as they will have advance notice of the patent holder's positions on validity and need not anticipate them.
- Earlier Production of ANDA. The ANDA filer must now produce its entire ANDA on the date it answers, moves, or otherwise responds to a party asserting patent infringement. L. Pat. R. 3.6(a). Previously, the rules required that the ANDA be produced at or before the initial Scheduling Conference. The Explanatory Notes indicate that the change was meant to recognize that the ANDA is a fundamental element of the Hatch-Waxman action. This change obviously moves up the time frame in which the ANDA filer needs to be ready to produce its ANDA.
- Timely Disclosure of FDA Communications. The ANDA filer is now required to (1) notify the FDA of any motion for injunctive relief within three business days after any such motion is filed, and (2) produce, or set forth the basis of any claim to privilege, copies of all correspondence between itself and the FDA pertaining to its ANDA within seven days after sending or receiving such correspondence. L. Pat. R. 3.6(j). The purpose of this change, according to the Explanatory Notes, is to keep the FDA and parties apprised of any proceedings that may impact the ongoing litigation. This change creates an additional burden on the ANDA filer.
Overall, these changes are positive ones. Requiring a disclosure of asserted claims and a response to the invalidity contentions will be very helpful to the ANDA filer and outweighs the potentially negative aspects of the new earlier disclosure of the ANDA and timely disclosure of FDA communications requirements. ANDA filers may now need to better coordinate their responses to the FDA in advance between their in-house regulatory department, in-house counsel, and litigation counsel so that communications can be produced in a timely manner. Even so, the 7-day time period may not allow for adequate communication between these various groups, and thus, the ANDA filer may also wish to consider proposing a stipulation during the early stages of the litigation that would allow it more time to produce this information.