Benjamin Appelbaum, Attorney at Law

Copaxone dosing patents ruled invalid by appeals court

In the pharmaceutical industry, patents can be the key to financial success. Multiple sclerosis patients in New Jersey and across the country have made Teva Pharmaceuticals' Copaxone a high-earning drug. The treatment for relapsing MS had brand-only sales of $527 for the 20 mg/mL dose from August 2017 to August 2018; the 40 mg/mL dose brought in $2.86 billion in sales for the Israeli company in the same period of time. While multiple generics have been introduced into the market to compete with Teva's 20 mg/mL original, the company has kept competitors out of the market with dosing patents on the higher-volume injection.

Pharmaceutical company Mylan, working in partnership with Natco, began to challenge those dosing patents after it sought Food and Drug Administration approval for its 20 mg/mL and 40 mg/mL generics. The FDA approved the glatiramer acetate injections in October 2017, and Mylan brought them to market despite the pending intellectual property issues. Mylan has prevailed against Teva's claims on several occasions, and it scored a major victory as the U.S. Court of Appeals for the Federal Circuit ruled Teva's patents invalid on grounds of obviousness.

The ruling upheld prior decisions by the Patent Trial and Appeal Board and the U.S. District Court for the District of Delaware. The costs could be substantial for Teva; the company claimed that its income from 40 mg/mL Copaxone dosage was nearly halved in the second quarter of 2018 in comparison to the same quarter in 2017.

For pharmaceutical companies and other science and technology innovators, intellectual property can form the backbone of the business. However, rights holders can also abuse patents to keep real competition out of the market unfairly. An intellectual property lawyer may represent a client throughout a copyright or patent dispute, working to protect their rights and uphold their innovations.

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Benjamin Appelbaum, Attorney at Law - Intellectual Property

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