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Bivalirudin patents upheld by federal court
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The Medicines Company announced that the U.S. Court of Appeals for the Federal Circuit Court affirmed an earlier district court ruling upholding the validity of two of its patents for bivalirudin.
In 2014, the U.S. District Court of Delaware upheld the validity of the patents for bivalirudin (Angiomax, The Medicines Company), a blood thinner used during PCI, which had been challenged by Hospira. The court also ruled at that time that Hospira, which makes a generic version of bivalirudin, did not infringe upon the patents. Hospira appealed the validity ruling and The Medicines Company appealed the infringement ruling.
In July 2015, the U.S. Court of Appeals for the Federal Circuit Court ruled that The Medicines Company’s patents, which expire in 2028, were invalid. The Medicines Company then filed a petition for en banc review, which was granted in November 2015, temporarily vacating the judgment that the patents were invalid.
According to a press release from the company, the U.S. Court of Appeals for the Federal Circuit Court has now determined that the patents covering Angiomax were valid under the “on sale” bar.
“We are pleased that the district court decision on invalidity has been upheld. We continue to believe that our patents are valid and infringed by the [Abbreviated New Drug Application] filers, and are now considering all of our options with respect to Hospira, Mylan, and other generics,” said Clive Meanwell, MD, PhD, CEO of The Medicines Company, said in the release.
Any remaining appeal issues will be handled by the original Federal Circuit panel, according to the release.
Disclosure : Meanwell is an employee of The Medicines Company.