The U.S. Patent and Trademark Office has reversed two patents related to Teva Pharmaceuticals’ MS drug Copaxone, the company announced.
The patents, which had been due to expire in 2030, covered a 40 milligram injection of Copaxone that patients use three times a week. Teva switched its patents over to the 40 mg version from its 20 mg daily dosage, which began facing generic competition last year.
Mylan petitioned the patent office to review the Copaxone patents’ validity last year, saying a less frequently administered drug was obvious and not deserving of legal protection.
Mylan has filed an ANDA with the FDA to sell its own version of the 40 mg drug. If the drug hits the market, it could be worth $3.3 billion annually, according to IMS Health, a healthcare information company.