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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.
After a protracted intellectual property battle spanning the period of a few years, on June 18, 2015 Teva’s patent for Copaxone (glatiramer acetate) was determined to be invalid by a US Court of Federal Appeals. The same day, Momenta Pharmaceuticals announced that Sandoz has initiated its US launch of once-daily Glatopa (glatiramer acetate injection), a generic equivalent of daily Copaxone 20 mg, developed under a collaboration agreement between Momenta and Sandoz. Momenta and Sandoz’s version of the drug was approved by FDA in April 2015. FDA accepted Mylan's abbreviated new drug application (ANDA) for generic Copaxone (20 mg/mL) in September 2014.
In 2012, Teva won a patent infringement lawsuit against Momenta/Sandoz, but the US Court of Appeals for the Federal Circuit reversed the district court ruling on the patent in 2013, resulting in the drug's patent protection being shortened. The US Supreme Court later ruled on Jan. 20, 2015 that a federal appeals court had erred in invalidating the patent covering Copaxone. The new ruling again has found Teva's “‘808 patent" for Copaxone to be invalid.
Copaxone has record annual revenues of $4.3 billion, which represents approximately half of Teva’s revenue. Teva has estimated that generic entry of Copaxone could reduce operating income by $30 to $50 million per month. Mylan's CEO Heather Bresch seemingly took jabs at Teva’s sustainability, saying in a press release that Mylan believes the recent ruling “underscores concerns with Teva's ongoing financial prospects, as Teva's Copaxone franchise has historically been its largest and most significant revenue driver."
The comments from Bresch may serve to strengthen the tension between Mylan and Teva, who have been squabbling over takeover attempts and public criticism of each others’ business operations. In April 2015, Mylan's board of directors unanimously rejected Teva's unsolicited takeover proposal valued at approximately $40.1 billion.
Despite concerns that Teva will lose significant market share now that generic versions of the drug will be available-potentially by more than one other manufacturer-Teva has already managed to convert nearly 70% of current patients to its new 40-mg/mL formulation, which has patent protection until 2030. The new version also has a lower price than Teva's older formulation and only needs to be administered three times a week, instead of once daily, as with the 20 mg formulation. Both of the generic versions of Copaxone-including Momenta/Sandoz’s Glatopa and Mylan’s version in development-come in a 20-mg/1-mL daily injection, which, arguably, could be correlated with lower adherence rates than Teva’s new formulation, which would require four fewer injections per week.