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18 May 2021BiotechnologyMuireann Bolger

SCOTUS declines patents review on Enbrel drug

A  Novartis unit,  Sandoz, has failed to persuade the  US Supreme Court to review two Amgen-owned patents on the rheumatoid arthritis drug  Enbrel (etanercept), preventing the roll-out of any copies in the US until 2029.

The court delivered its decision to turn down the petition filed by Sandoz yesterday, May 17.

Sandoz had argued that the  US Court of Appeals for the Federal Circuit had erred in affirming the validity of US patent numbers 8,063,182 and 8,163,522 last July, a ruling that prevented it from marketing its generic version, Erelzi.

The patents are directed to the fusion protein etanercept, the active ingredient in the biologic drug Enbrel for treating the symptoms of rheumatoid arthritis.

Enbrel is a blockbuster drug for Amgen,  making up nearly $5 billion of the company’s $24.2 billion in product sales for 2020. The dispute began when Amgen, which exclusively licenses the patents covering Enbrel from  Roche, sued Sandoz for infringement after the German company filed an application for Erelzi.

Biologics maker  Immunex licensed the patents-in-suit from Roche more than 30 years ago and when Amgen acquired Immunex in 2002, it entered into an ‘accord and satisfaction’ agreement with Roche. This gave Amgen the exclusive right to prosecute the patents, as well as the first right to sue for infringement and retain any damages.

But Sandoz accused Immunex of illegally trying to extend the patents by virtue of its 2004 deal in which it took over Roche’s patent applications and amended them to cover Enbrel. The German company claimed that the patents should be invalid under the judicial doctrine of “obviousness-type double patenting”—designed to prevent applicants from filing separate patents that claim obvious variants of the same subject matter, in order to extend the life of their patent protection.

The Federal Circuit, however, rejected Sandoz’s argument, saying that Immunex did not fully take over the Roche patents. The judge argued that Roche’s rights in the patents were therefore “illusory”, and should be considered commonly owned by Amgen, a view upheld by SCOTUS this week.


More on this story

Americas
2 July 2020   Amgen has won a key patent victory over Sandoz in a dispute over biologic Enbrel.
Americas
27 August 2020   Amgen’s subsidiary Immunex has called on the US Court of Appeals for the Federal Circuit to reject Sandoz’s request for an en banc rehearing of a dispute over biologic Enbrel.

More on this story

Americas
2 July 2020   Amgen has won a key patent victory over Sandoz in a dispute over biologic Enbrel.
Americas
27 August 2020   Amgen’s subsidiary Immunex has called on the US Court of Appeals for the Federal Circuit to reject Sandoz’s request for an en banc rehearing of a dispute over biologic Enbrel.