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3 March 2016Americas

Amgen and Sandoz face off again over biosimilars

Amgen and Sandoz are set to go head to head in another patent case, this time centring on Amgen’s arthritis treatment drug Enbrel (etanercept).

In the lawsuit, filed at the US District Court for the District of New Jersey, Amgen has accused Sandoz, a Novartis subsidiary, of infringing five patents covering the drug through its etanercept biosimilar.

The five patents are US numbers 8,063,182; 8,163,522; 7,915,225; 8,119,605; and 8,722,631.

Two of the patents, numbers ‘182 and ‘522, are owned by pharmaceutical company Roche. Immunex, an Amgen subsidiary, is the exclusive licensee of those patents and is the owner of the remaining patents.

According to the lawsuit, the US Food and Drug Administration (FDA) accepted Sandoz’s abbreviated Biologics License Application (aBLA) which sought approval to market an etanercept biosimilar in September last year.

Sandoz is seeking approval to treat all of Enbrel’s approved indications, including rheumatoid arthritis and psoriatic arthritis.

“If the FDA approves defendants’ aBLA, defendants will also infringe one or more claims of each of the patents-in-suit, should they engage in the commercial manufacture, use, offer for sale, sale, distribution in, or importation into the US of defendants’ etanercept product,” the complaint, filed on February 26, said.

The complaint also claimed that Sandoz has refused to follow the protocol laid out by the Biologics Price Competition and Innovation Act (BPCIA) by failing to “engage in negotiation and exchange of patent lists”.

The BPCIA, which provides a shortened regulatory pathway for biosimilar drugs, includes a mechanism known as the ‘patent dance’, which allows parties to address any patent claims while an applied-for drug is being approved.

Both companies have previously faced off in a separate BPCIA lawsuit centring on Amgen’s drug Neupogen (filgrastim).

Sandoz launched its own biosimilar of Amgen’s Neupogen drug, called Zarxio (filgrastim-sndz), in September last year.

But Sandoz has asked the US Supreme Court to review part of the US Court of Appeals for the Federal Circuit’s interpretation of the BPCIA.

The federal circuit said a biosimilar maker must give 180 days’ pre-marketing notice to the biologic company before launching its product.

In the current lawsuit, Amgen is seeking a judgment of infringement and an injunction to prevent Sandoz from marketing the biosimilar until the last of the five patents expires.


More on this story

Americas
13 August 2019   Sandoz has confirmed that it plans to appeal against a decision that upheld the validity of two of Amgen’s patents for its arthritis treatment Enbrel, effectively blocking the launch of Sandoz’s biosimilar version.
Big Pharma
14 December 2020   Amgen is unlikely to succeed in its bid to revive its patents for the cholesterol drug Repatha, a judge at the US Court of Appeals for the Federal Circuit has told the pharmaceutical company.
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4 May 2023   Lawsuit concerns multibillion-dollar bone-strengthening drugs | Alleged dearth of information provided to patent owner before biologics licence application was approved.

More on this story

Americas
13 August 2019   Sandoz has confirmed that it plans to appeal against a decision that upheld the validity of two of Amgen’s patents for its arthritis treatment Enbrel, effectively blocking the launch of Sandoz’s biosimilar version.
Big Pharma
14 December 2020   Amgen is unlikely to succeed in its bid to revive its patents for the cholesterol drug Repatha, a judge at the US Court of Appeals for the Federal Circuit has told the pharmaceutical company.
Americas
4 May 2023   Lawsuit concerns multibillion-dollar bone-strengthening drugs | Alleged dearth of information provided to patent owner before biologics licence application was approved.