Relief for Natco, as US patent office rules in Mylan favour over Copaxone 40

Natco Pharma agreed to partner with Mylan to challenge Teva’s Copaxone patents. Natco supplies the drug and Mylan markets it in the US

Natco Pharma has said that the US Patent and Trademark Office (PTO) has ruled in favour of its marketing partner, Mylan, in its inter partes review (IPR) proceeding and found all claims of the patent owned by Yeda Research & Development and licensed to Teva Pharmaceuticals Industries, are unpatentable. This is the third patent related to Copaxone 40 mg/mL to be found unpatentable in the last week. Copaxone is an injectable drug to treat relapsing forms of multiple sclerosis which damages the central nervous system.

Natco Pharma agreed to partner with Mylan to challenge Teva’s Copaxone 20 mg and 40 mg patents. As per the agreement, Natco supplies the drug and Mylan markets it in the US and both the companies share the profits.

For Teva Pharmaceutical Industries, which had a third patent on its top-selling multiple sclerosis drug Copaxone, the ruling is a further blow to its bid to block generic versions of a drug that accounts for 20% of its revenue. The board had previously said two other patents regarding the dosage were also invalid. Teva has a total of five patents expiring in 2030 that cover ways to administer the drug in a 40-milligram dosage three times a week.

On August 24, the PTO’s Patent Trial and Appeal Board (PTAB) found Teva’s first two patents, unpatentable in Mylan’s IPR challenge of these patents.

“Through significant investment in research and development and by challenging these invalid patents, we are working to bring a more affordable generic alternative of Copaxone to market. Challenging patents is just one of the ways that Mylan helps to ensure patients access to medicines. In the last few years alone, Mylan’s patent challenges have allowed earlier access to generic competition for brand products equating to nearly $20 billion in annual product brand sales and reducing more than 60 years of patent life that otherwise could have blocked generics from entering the market,” Mylan CEO Heather Bresch said in a statement.

Natco’s marketing partner Mylan believes it is one of the first companies to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a three times per week Glatiramer Acetate Injection 40 mg/mL and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.

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