VIMOVO Litigation to Continue
MISSISSAUGA, ON, Nov. 11, 2019 /CNW/ - 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--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.
About VIMOVO
VIMOVO (naproxen/esomeprazole magnesium) is the brand name for a proprietary fixed-dose combination of enteric-coated naproxen, a pain-relieving nonsteroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole magnesium, a proton pump inhibitor, in a single delayed-release tablet. VIMOVO was originally developed in collaboration with AstraZeneca. On April 30, 2010, the FDA approved VIMOVO for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is currently commercialized in the U.S. by Horizon Therapeutics plc and Grunenthal GmbH in various rest of world territories, including Canada, Europe and select additional countries.