Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI, OTCQX:NRIFF), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, today announced that the United States District Court for the District of New Jersey has denied a motion for summary judgment filed by Dr. Reddy's Laboratories Inc. (DRL). As a result, the patent infringement litigation against DRL, involving Nuvo Pharmaceuticals (Ireland) DAC's (Nuvo Ireland) U.S. Patent Nos. 8,858,996 and 9,161,920 (the '996 and '920 patents), will continue.
The parties have mutually agreed on a pre-trial litigation schedule with the court through to April 2021. The term of the '996 and '920 patents extends to May 31, 2022.
While the litigation is pending, DRL may still launch its generic version of VIMOVO "at risk" upon approval by the U.S. Food and Drug Administration (FDA). If an "at risk" launch occurs, Nuvo Ireland and its U.S. partner can continue to enforce the '996 and '920 patents against DRL and seek damages. As of the close of business on Friday, November 8, 2019, the FDA had not issued final approval of DRL's generic VIMOVO abbreviated new drug application (ANDA).
DRL was the first filer of an ANDA for a generic version of VIMOVO in the U.S., and thus, was eligible for a 180-day period of marketing exclusivity vis-à-vis other generic applicants of VIMOVO . The U.S. regulations provide a number of conditions under which the first filer may forfeit eligibility of this 180-day exclusivity, including failure to market. The FDA has not yet determined whether DRL has forfeited this exclusivity, but it is the Company's understanding of the regulations that because DRL did not commence commercial activity in the U.S. prior to October 20, 2019, they may have forfeited this exclusivity. Consequently, if DRL launches a generic version of VIMOVO in the U.S., then other generic companies that have final FDA approval may also launch.
"We are pleased with Judge Chesler's decision," stated Tina Loucaides, Nuvo's Vice President, Secretary and General Counsel. "We believe these patents are valid and enforceable and will continue to enforce Nuvo Ireland's rights against DRL."
A launch of a generic version of VIMOVO in the U.S. does not impact the Company's global VIMOVO business in markets outside of the U.S. Nuvo will continue to receive royalty payments from its global partner, Grunenthal GmbH on global net sales of VIMOVO.