Multiple sclerosis patients in California and across the country have watched an intellectual property dispute play out in the pharmaceutical arena that could have a major influence on the price of a key drug in MS treatment. Copaxone, patented by Teva Pharmaceuticals, is one of the most widely prescribed treatments for relapsing multiple sclerosis. From August 2017 to 2018, $2.86 billion in 40 mg/mL doses were sold as well as $527 million in 20 mg/mL doses.
Mylan, partnered with the Indian pharmaceutical firm Natco, filed for Food and Drug Administration approval of its own injections of glatiramer acetate, generic versions of Copaxone, and they won approval for their drugs in October 2017. While 20 mg/mL generic versions have been available in the United States for several years, Teva held on to a dosing patent for the 40 mg/mL version of the drug. Mylan and Natco's generic was the first to challenge Teva's grip on that dose. Patent infringement litigation followed Mylan's decision to enter the market, and it began to launch the drug even as the lawsuit continued.
In October 2018, the U.S. Court of Appeals invalidated Teva's dosing patents, saying that they were "obvious." The decision upheld lower court rulings of the U.S. District Court and the Patent Trial and Appeal Board. After Mylan's generics hit the market, Teva's Copaxone sales fell dramatically. The Israeli company said that its sales in the second quarter of 2018 were almost half of what they were one year before.
For inventors and companies involved with scientific research and development, intellectual property rights can be their lifeblood and the key to financial success. A lawyer may help rights holders defend their patents or copyrights and work with innovators to secure a path to success without being held back by dubious claims.