A U.S. based appeal court declared that Mylan N.V. (NASDAQ:MYL) proposed generic version of blood thinner Angiomax will not in any way infringe The Medicines Company (NASDAQ:MDCO) patents.
The ruling from the appeal court
The Court of Appeal for the Federal Circuit reversed the decision declared by a federal judge in Illinois who had ruled in favor of The Medicines Company. Angiomax is the main product for the Medicines Company and accounts for $121.8 million of the company’s reported revenue in 2016 out of the total revenue of $167.8 million.
The larger share of the Angiomax revenue, $71.2 million, is derived from royalties on the authorized generic version which is a product of Sandoz Inc, a generic arm of Novartis AG.
In the ruling, the Federal Circuit stated that the generic version of Angiomax is not likely to infringe The Medicines Company’s patents. However, they did not address if the the patents were valid. Both the company and The Medicines Company declined to make any comments related to the matter.
Previous ruling by the Illinois Federal Court
The Medicines Company had sued Mylan for infringing patent rights with the introduction of its new version of generic Angiomax. The Federal Court ruled in Favor of The Medicines Company stating that Mylan proposed version of the anticougulant Angiomax indeed infringed one of the plaintiff’s patents on the drug.
Mylan had not adequately proven that the patent was invalid. In an 8o page ruling, Amy J. St. Eve the District Judge, found that the company’s application for a different version of the generic Angiomax produced by The Medicines Company, led to the infringement of the drug’s pharmaceutical Patent Number 7,582,727.
Judge Eve also put it on the table that Mylan had failed to indicate how a variety of the claims in the patents were not valid due to the anticipation, obviousness, non-enablement or even were unenforceable enough for inequitable conduct.
As a result of the ruling Mylan was left with an option of successfully appealing the ruling or the company risked being barred from acquiring approval for its version of generic Angiomax from U.S. Food and Drug Administration.