thedesign
13 August 2018Americas

AbbVie escalates Humira battle with Sandoz

AbbVie has taken Sandoz to court over its biosimilar version of Humira (adalimumab), heightening the dispute between the pair.

In a claim filed on Friday, August 10 at the US District Court for the District of New Jersey, AbbVie alleged that Sandoz was infringing a number of patents and claimed that while Sandoz can “delay justice, it cannot prevent it”.

The US Patent and Trademark Office has granted more than 100 patents relating to Humira, which is an antibody used to treat Crohn’s disease, arthritis and psoriasis, said AbbVie.

According to the claim, numerous biosimilar companies have attempted to make copycat versions of Humira.

“When confronted with AbbVie’s patents, these companies took their best shots, filing 20 inter partes review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB),” it added, explaining that the PTAB has rejected the “overwhelming majority” of these challenges.

AbbVie noted that Sandoz has lost six IPR proceedings relating to Humira.

“Despite its repeated, failed attacks, Sandoz has elected to put off confronting the vast majority of AbbVie’s patents for another day, substantially delaying resolution of the parties’ dispute,” added the claim.

Under the Biosimilar Price Competition and Innovation Act (BPCIA), AbbVie can bring patent infringement litigation before Sandoz launches a biosimilar.

AbbVie identified 84 patents that would be infringed, which reportedly includes those that Sandoz unsuccessfully challenged at the PTAB. However, Sandoz had the option to limit the number of patents that AbbVie can assert at this stage.

“Sandoz has chosen to take advantage of those provisions of the BPCIA to avoid litigating all but two of AbbVie’s 84 patents at this time,” said the suit.

AbbVie is now seeking an injunction to prevent Sandoz from infringing the two patents, which it said reflect “years of innovation and research”.

It added: “AbbVie also reserves its right to assert the remaining patents infringed by Sandoz in a second wave when Sandoz provides a notice of commercial marketing.”

In July, AbbVie granted generics company Mylan a non-exclusive licence to the Humira patents and, in return, Mylan will pay royalties once it launches the biosimilar product.

Earlier this year, in April, AbbVie  secured a settlement with biopharmaceutical company Samsung Bioepis relating to litigation over Humira.

In September last year, AbbVie  announced that it had settled a patent dispute with Amgen over the latter’s proposed biosimilar version of Humira.

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More on this story

Americas
18 July 2018   US-based biopharmaceutical company AbbVie entered into a patent licensing agreement with generics company Mylan yesterday.
Americas
29 September 2017   AbbVie has settled its patent dispute over Amgen’s proposed biosimilar for Humira (adalimumab), a drug used to treat multiple types of arthritis as well as psoriasis.
Americas
12 October 2018   AbbVie has announced yet another settlement relating to litigation over Humira, a drug used to treat multiple types of arthritis as well as psoriasis.

More on this story

Americas
18 July 2018   US-based biopharmaceutical company AbbVie entered into a patent licensing agreement with generics company Mylan yesterday.
Americas
29 September 2017   AbbVie has settled its patent dispute over Amgen’s proposed biosimilar for Humira (adalimumab), a drug used to treat multiple types of arthritis as well as psoriasis.
Americas
12 October 2018   AbbVie has announced yet another settlement relating to litigation over Humira, a drug used to treat multiple types of arthritis as well as psoriasis.

More on this story

Americas
18 July 2018   US-based biopharmaceutical company AbbVie entered into a patent licensing agreement with generics company Mylan yesterday.
Americas
29 September 2017   AbbVie has settled its patent dispute over Amgen’s proposed biosimilar for Humira (adalimumab), a drug used to treat multiple types of arthritis as well as psoriasis.
Americas
12 October 2018   AbbVie has announced yet another settlement relating to litigation over Humira, a drug used to treat multiple types of arthritis as well as psoriasis.