Generic versions of Teva Pharmaceutical Industries’ multiple sclerosis drug Copaxone are to go on the US market a year earlier than expected, with major financial consequences expected for the company.
The news comes as the result of a ruling in the US Court of Appeals for the Federal Circuit on 26 July, which upheld only four of nine patent claims to Copaxone asserted by the company.
The four patents upheld have an expiry date in May 2014, whereas one of those dismissed had an expiry date in 2015.
The effect of the ruling is that generics producers—including Teva’s opponents in the dispute, Mylan Pharmaceuticals and Novartis subsidiary Sandoz—will be able to release rival versions of the drug a year earlier than many industry members had expected.
Mylan CEO Heather Bresch said in a statement: “We expect that it will allow Mylan to launch its generic version of Copaxone on May 25, 2014.”
Since Copaxone reportedly accounts for 20 percent of Teva’s sales and around 50 percent of its profit, the financial results of the decision may be substantial for the company.
A statement from Teva following the US decision to invalidate patents related to Copaxone read: “Teva is disappointed with the court’s decision with respect to four of the 2014 patents and the 2015 patent and will appeal today’s decision.”
Nevertheless, despite having several related patents invalidated in the US by Mylan, Yeda’s European patent EP0762888 for the multiple sclerosis drug Copaxone which is licensed exclusively to Teva has been upheld in the UK High Court, successfully shaking off a threat from Generics (UK) Limited which is the UK trading arm of Mylan, who challenged the patent on grounds of non-inventiveness and ambiguity.
On 29 July, Lords Justice Alan Moses, David Kitchin and Christopher Floyd in the High Court of Justice for England and Wales ruled in Teva’s favour and held that the patent to be valid. They also refused to grant a non-infringement declaration to Mylan, since Mylan failed to demonstrate technical differences between their products and Copaxone. The ruling by the High Court affirms the conclusion of a 104-page ruling by Justice Richard Arnold in the UK Patents Court in July 2012.
Teva CEO said in a statement following the ruling: “Thousands of patients in the UK and elsewhere depend on Copaxone for relief in relapsing-remitting multiple sclerosis, and we are pleased that the English Court of Appeal has upheld the validity of the patent until its expiry in 2015.”
The UK ruling in favor of Teva upholds the patent in the UK, whereas in the US where Mylan managed to invalidate some of Teva’s patents, generic players such as Mylan will be able to market alternatives from May 2014.
Teva maintains that Copaxone is difficult to manufacture and so the generic equivalents should have to satisfy stringent FDA approval. They are considering appealing the US decision to the Supreme Court, but the chances of the appeal being heard are slim. Unless Mylan and TEVA coordinate their actions, which could be seen as delaying a generic launch, the discrepancy may lead to a price differential between the US and Europe and to smuggling of the generic equivalent.