Teva suffers defeat as Copaxone claims invalidated
The English High Court has invalidated two patent claims protecting Copaxone (glatiramer acetate), a billion-dollar drug marketed by Teva.
Mr Justice Arnold ruled yesterday, October 26, that claims 1 and 3 of European patent (UK) number 2,949,335 were obvious, providing a setback to the blockbuster treatment for multiple sclerosis.
Mylan and Synthon had sought to revoke the patent, called “Low frequency glatiramer acetate therapy”, while Teva (the licensee) and the patent’s owner Yeda Research and Development counterclaimed for infringement.
The plaintiffs were looking to clear the way for a generic version of 40mg glatiramer acetate, with Arnold noting that a large proportion of prescriptions containing the compound have been written for the 40mg version since that amount was authorised for administration.
Arnold added that the reason for the current litigation “is not hard to find”—by the end of 2016, worldwide sales of Copaxone totalled $4.2 billion, which was nearly a fifth of Teva’s global sales.
The judge said Teva’s and Yeda’s closing written submissions extended to 306 paragraphs, while Mylan’s and Synthon’s were 191 paragraphs long, “even though the issues are, with one exception, fairly straightforward”.
The two challenged claims were ultimately felled by obviousness, as Arnold said they were novel, but he added that if claim 3 was not obvious then it would have lacked plausibility and therefore be invalid anyway.
He said that a 40mg administration was obvious to try and that the “skilled person would have had a fair expectation of success, both in the sense that the regimen would be efficacious compared to placebo and in the sense that it would be comparable in efficacy to 20mg”.
This is the third round of litigation between the parties surrounding glatiramer acetate.
In the first case, from 2012, Arnold rejected Mylan’s attempt to revoke a patent covering the compound in a low molecular weight form, as well as a declaration of non-infringement. The English Court of Appeal later dismissed Mylan’s appeal.
The second round saw Synthon try to revoke two patents covering another form of glatiramer acetate, but the claim was mostly rejected, as Mr Justice Birss only upheld it against three claims. Both Synthon’s and Teva’s appeals were later dismissed, although a European Patent Office board did go on to revoke one of the patents.
In April 2018, a fourth wave of litigation will start, this time focusing on an improved process for preparing glatiramer acetate.
Mylan and Synthon had also requested an Arrow declaration in this case, but Arnold gave five reasons for rejecting it, including being unclear “how an Arrow declaration would provide the claimants will greater certainty than this judgment”.
In such cases, a party will seek a declaration that the product/process in question would have been obvious to the skilled person at a given date.
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