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3 April 2017Americas

AbbVie fights to invalidate Novartis patents

AbbVie has filed a declaratory judgment against Novartis, alleging that its patents covering the treatment of hepatitis C virus (HCV) are invalid.

Filed on Friday, March 31 at the US District Court for the Northern District of California, the lawsuit claimed that the patents are invalid because of recent US Supreme Court decisions focusing on patent-eligible subject matter.

These cases include Mayo v Prometheus, Association for Molecular Pathology v Myriad Genetics, and Alice v CLS Bank.

AbbVie said in its complaint: “The Supreme Court opinions exclude from patent-eligible subject matter claims that are directed to ‘natural laws’ (including products of nature) because these discoveries are not patentable inventions.”

In 2001, AbbVie started a programme to develop novel therapies to treat HCV.

At the time, AbbVie was aware that Novartis, then Chiron, was engaged in an “aggressive” licensing programme and demanding that any company seeking to undertake research in the area of HCV therapies obtain a licence to a portfolio of HCV-related patents.

AbbVie had entered into a licence agreement with Novartis in 2002.

The company told the court that Novartis’s sole inventive contribution was the identification of the “genomic sequence of naturally occurring HCV”.

According to AbbVie, “in Novartis’s own words regarding three patents at issue in this case, which are representative of those in its portfolio: ‘The novel aspect of the invention of these three patents is the genomic sequence of HCV.’”

AbbVie claimed that Novartis’s patents do not cover its HVC treatments Viekira Pak (ombitasvir, paritaprevir and ritonavir), Viekira XR (ombitasvir, paritaprevir, ritonavir and dasabuvir) and Technivie (ombitasvir, paritaprevir and ritonavir).

According to AbbVie, at the time it entered into the agreement with Novartis, the US Patent and Trademark Office was granting patents covering naturally occurring protein and nucleic acid sequences, as well as conventional methods for working with them.

However, after the Supreme Court’s rulings, the patents are now invalid because they are related to a “natural product”, AbbVie said.

It added: “They are instead basic tools of scientific and technological work. Allowing patents on such natural products would discourage the very scientific activity that the patent laws are meant to encourage.”

AbbVie has asked the district court to enter a judgment that the patents-in-suit are invalid due to obviousness.

The patents involved are US numbers 6,472,180; 5,712,088; 5,714,596; 5,863,719; 6,074,816; 6,096,541; 6,171,782; 6,027,729; 7,790,366; 5,922,857; and 6,057,093.

AbbVie has also asked the court for costs covering its attorneys’ fees.


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More on this story

Big Pharma
18 August 2020   In a win for Novartis Pharmaceuticals, the US District Court for the district of Delaware has upheld the patent on its top-selling multiple sclerosis drug Gilenya.
Americas
15 July 2021   Novartis should pay a Daiichi Sankyo subsidiary, Plexxikon, $47 million in overdue IP royalties, according to an argument presented before a federal court in California this week.
Americas
4 January 2022   Novartis Pharmaceuticals has prevailed against China’s HEC Pharm at the US Court of Appeals for the Federal Circuit, after a majority panel of judges held that a patent covering the multiple sclerosis drug Gilenya was valid.