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27 August 2020AmericasSarah Morgan

Amgen urges Fed Circuit to deny Sandoz petition

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 (etanercept).

“The gamesmanship story on which Sandoz’s petition rests lacks any factual foundation,” claimed Amgen, in a response to the petition, filed yesterday, August 27.

In July this year, the Federal Circuit issued a decision upholding Amgen’s two patents and preventing Sandoz from selling a version of its rheumatoid arthritis drug Enbrel.

Later that month, Sandoz requested an en banc rehearing of the decision, arguing that the ruling meant that Amgen, which “has already enjoyed a full patent term” on the drug, would experience “an unpreceded 31 years” of patent exclusivity.

Amgen hit back at the petition in its response, claiming that Sandoz’s “tale of gamesmanship founders on the facts”.

“Sandoz’s theory holds that a patent valid in the hands of its original owner can spontaneously become invalid when licensed to someone else more than a decade after invention,” it added.

The patents-in-suit were first licensed from Roche by Immunex more than 30 years ago.

Amgen acquired Immunex in 2002, and it subsequently entered into an ‘accord and satisfaction’ agreement with Roche, giving Amgen the exclusive right to prosecute the patents, as well as the first right to sue for infringement and retain any damages.

Before the Federal Circuit in July, Sandoz argued that the two asserted patents should be invalid under the judicial doctrine of “obviousness-type double patenting” theory in light of two other Immunex patents, not asserted in the suit.

The doctrine only applies to patents which are “commonly owned” by the same party and is designed to prevent applicants from filing separate patents that claim obvious variants of the same subject matter.

Sandoz claimed that the ‘accord and satisfaction’ agreement transferred “all substantial rights” in the IP to Amgen, meaning that the patents were all commonly owned by Amgen.

But the Federal Circuit sided with Amgen, on the basis that Roche retained a secondary right to sue for infringement and a veto over the assignment of the patents to an unrelated third party.

In its response to the petition, Amgen claimed: “For its part, Sandoz attempts to manufacture importance with atmospherics that have little to do with this case. For example, Sandoz repeatedly invokes ‘gamesmanship’.

“But the district court—after hearing ten days of testimony, reviewing the patents’ file histories, and examining the A&S—found that there was no gamesmanship.”

Finally, Amgen noted that, even if there was some need to clarify the all-substantial-rights doctrine, “this unusual double-patenting case would be an exceptionally poor vehicle for doing so”.

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Americas
1 September 2020   Anacor Pharmaceuticals has unsuccessfully challenged the invalidation of four patents covering Kerydin, an antifungal treatment for nails.
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23 October 2020   The English High Court has lifted a stay on Amgen’s lawsuit which accused Sanofi-Aventis and Regeneron of infringing a patent covering pharmaceuticals which treat elevated cholesterol levels.
Biotechnology
18 May 2021   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).

More on this story

Americas
1 September 2020   Anacor Pharmaceuticals has unsuccessfully challenged the invalidation of four patents covering Kerydin, an antifungal treatment for nails.
Big Pharma
23 October 2020   The English High Court has lifted a stay on Amgen’s lawsuit which accused Sanofi-Aventis and Regeneron of infringing a patent covering pharmaceuticals which treat elevated cholesterol levels.
Biotechnology
18 May 2021   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).