A federal appeals court has ruled four patents by Teva Pharmaceutical Industries’ invalid for its top-selling drug Copaxone (glatiramer acetate), a multiple sclerosis drug and Teva’s top-selling product. The US Court of Appeals for the Federal Circuit declared four of Teva’s Copaxone 40 mg/mL dosing patents invalid based on obviousness. The ruling follows Teva’s appeal of a federal district court ruling that invalidated the four patents in February 2017 and opens the entry of generic competitors for the 40-mg/mL formulation.

Teva had applied a generic defense strategy for Copaxone when it launched a 40-mg formulation of the product with a three-times a week dosing regime following the patent expiration of its first-generation 20-mg formulation with more frequent dosing. Patents covering Copaxone 20 mg/mL expired in May 2014, and in most of the rest of the world in May 2015. The 40-mg/mL Copaxone was launched by Teva in the US in January 2014 and was approved in Europe in December 2015. Teva’s business strategy for Copaxone relies heavily on the continued migration of a substantial percentage of Copaxone patients using the 20-mg formulation to the 40-mg, three-times-a-week version.

Copaxone is Teva’s top-selling drug with 2017 global revenues of $3.8 billion, down from $4.2 billion in 2016. Copaxone had total US brand sales of approximately $3.3 billion, with the 20-mg formulation accounting for $527 million and the 40-mg formulation for $2.86 billion for the 12 months ending August 31, 2018, according to IQVIA, and as reported by Mylan, one company with a generic version of Copaxone.

Copaxone 40 mg/mL is protected by five US Orange Book patents that expire in 2030, which have been challenged in proceedings in the US. Copaxone 40 mg/mL is also protected by one European patent expiring in 2030. This patent is being challenged in Italy and Norway and has been opposed at the European Patent Office. The U.K. High Court found this patent invalid and Teva’s application for permission to appeal this decision was rejected, according to information from Teva’s 2017 annual filing.

The appeals court ruling that invalidated four of Teva’s patents for the 40-mg/mL formulation (US Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776) opens the market for generic entries. Several companies have been progressing generic versions of Copaxone, including Mylan, Novartis, and Pfizer. Mylan received FDA approval for both the 40-mg and 20-mg formulations of glatiramer acetate injection in October 2017. The four patents that were invalidated were the last remaining patent infringement cases Mylan was defending in the US relating to glatiramer acetate Injection 40mg/mL.

Novartis received US Food and Drug Administration (FDA) approval and launched its 40-mg formulation of Copaxone called Glatopa in February 2018. Novartis and Pfizer previously launched generic versions of the Copaxone 20 mg/ml formulation in 2015.

Source: Mylan and US Court of Appeals for the Federal Circuit