Mylan NV's generic version of Eli Lilly and Co.'s lung cancer drug Alimta received tentative approval from the U.S. Food and Drug Administration.
Tentative approvals by the U.S. regulator signify that the drug meets all safety, efficacy and manufacturing quality standards for marketing. However, full approval is subject to the resolution of all patent issues.
While Alimta, or pemetrexed, itself is no longer subject to patent, Lilly has a remaining patent on a delivery method for the drug — an injection of the medicine, along with certain vitamins and other additives that reduce the drug's side effects. The patent expires May 2022.
Canonsburg, Pa.-based Mylan rose 3.92% to close at $19.90 on Aug. 29.
Alimta is approved in combination with Merck & Co. Inc.'s Keytruda and platinum chemotherapy as an initial treatment for nonsquamous non-small cell lung cancer with a certain gene mutation that has spread.
Lilly has been involved in a multicase patent battle as it seeks to protect the cancer therapy from copycat versions by generic-drug makers.
Earlier in August, the U.S. Court of Appeals for the Federal Circuit ruled that other companies — Dr. Reddy's Laboratories Ltd. and Pfizer Inc.'s unit Hospira Inc. in the immediate case — cannot sell an alternative version of Alimta before the patent expires in 2022.
In April, the federal appeals court also ruled in Lilly's favor in a patent lawsuit regarding the Alimta vitamin regimen. The appellate court upheld an October 2017 decision by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office declaring the vitamin regimen patent valid — a ruling appealed by Mylan and other drugmakers.
The U.S. District Court for the Southern District of Indiana, in June 2018, also ruled that Lilly's patent would be violated if Dr. Reddy's markets alternative salt forms of Alimta prior to the patent's expiration in 2022. In a separate trial, the District Court also ruled in favor of Lilly's patent, preventing Hospira from launching an alternative salt form of Alimta until the patent expires.
