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17 May 2019Americas

Federal Circuit invalidates Nuvo’s Vimovo patents

The US Court of Appeals for the Federal Circuit has delivered a blow to Nuvo Pharmaceuticals by reversing a decision which had upheld the validity of the Canadian company’s pain relief drug Vimovo (naproxen/esomeprazole magnesium).

The Federal Circuit delivered the decision on Wednesday, May 15.

Nuvo’s US patent numbers 6,926,907 and 8,557,285 cover Vimovo, a medication used for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and stomach ulcers. Nuvo licenses the patents to Irish biopharmaceutical company Horizon Pharma.

Generic drug company Dr Reddy’s Laboratories claimed that the patents are invalid, and filed three Abbreviated New Drug Applications in efforts to bring a generic version of Vimovo to market.

In response, Nuvo filed a patent infringement suit against Dr Reddy’s.

In 2017, the US District Court for the District of New Jersey upheld the claims of both patents as non-obvious. However, it also granted summary judgment of non-infringement to Dr Reddy’s after finding that one of its proposed products would not infringe the ‘907 patent.

Dr Reddy’s appealed against the former part of the ruling, and Nuvo cross-appealed against the latter.

Dr Reddy’s argued that claims of the two Vimovo patents are invalid for lack of sufficient written description.

Meanwhile, Nuvo claimed that the patent specifications satisfy the written description requirement, that being that they teach how to make and use the claimed invention.

On Wednesday, the Federal Circuit sided with Dr Reddy’s and said that “teaching how to make and use an invention does not necessarily satisfy the written description requirement”.

According to the Federal Circuit, a written description must be sufficient to establish that the inventor was in possession of the claimed invention, but there is nothing in the specification of the Vimovo patents to show that the inventor actually invented the claimed invention.

Nuvo cannot “reasonably dispute” this point, the Federal Circuit added, as the patents’ specification is “fatally flawed”.

For example, the patents sought to claim the therapeutic effectiveness of an uncoated proton pump inhibitor, which reduces the production of acid in the wall of the stomach.

However, this was not “adequately described” so as to enable ordinarily-skilled persons to realise that the inventor possessed and actually invented this, the court said.

Accordingly, “the patent claims are invalid for lack of adequate written description”, the Federal Circuit concluded.

As a result of this finding the court held Nuvo’s cross-appeal to be “moot”.

Jesse Ledger, president and CEO of Nuvo, said: “We are disappointed by the court's decision, as we continue to believe that our US Vimovo patents are valid.  We are reviewing the decision with our partner Horizon and will consider all future options.”

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More on this story

Americas
17 July 2017   A New Jersey judge has ruled today that Dr Reddy’s Laboratories infringed a patent owned by Horizon Pharma.
Americas
12 August 2016   Horizon Pharma has filed a complaint against Actavis accusing it of infringing three of patents for the Vimovo (naproxen/esomeprazole magnesium) drug.

More on this story

Americas
17 July 2017   A New Jersey judge has ruled today that Dr Reddy’s Laboratories infringed a patent owned by Horizon Pharma.
Americas
12 August 2016   Horizon Pharma has filed a complaint against Actavis accusing it of infringing three of patents for the Vimovo (naproxen/esomeprazole magnesium) drug.