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9 May 2019Americas

Federal Circuit backs Sandoz in Amgen biosimilar suit

The US Court of Appeals for the Federal Circuit yesterday, May 8, rejected an appeal from Amgen in patent litigation relating to two Sandoz biosimilars.

In a  precedential decision, the Federal Circuit affirmed two decisions of the US District Court for the Northern District of California, which found that Sandoz’s filgrastim biosimilar and its proposed pegfilgrastim biosimilar didn’t infringe Amgen’s IP.

Amgen had developed two related biologic products, filgrastim (marketed as Neupogen) and pegfilgrastim (marketed as Neulasta), indicated for treating neutropenia, a deficiency of white blood cells.

In 2014, Sandoz submitted an abbreviated Biologics License Application (aBLA) to the Food and Drug Administration (FDA) to market a biosimilar filgrastim product.

Although Sandoz’s aBLA referenced Neuopgen, Sandoz didn’t provide Amgen with its aBLA or manufacturing information.

Amgen filed a complaint for a declaratory judgment that Sandoz’s proposed biosimilar would infringe US patent number 6,162,427 patent, which discloses methods of treating “diseases requiring peripheral stem cell transplantation”, in October 2014.

The following year, Sandoz received FDA approval for its filgrastim biosimilar, Zarxio. Following the launch of Zarxio, Amgen amended its complaint to plead infringement of US patent number 8,940,878.

The ‘878 patent discloses methods of “protein purification by adsorbent chromatography”, a method that involves separating the components of a solution based upon their chemical attraction to the molecules or ions that comprise a stationary separation matrix.

Sandoz also submitted an aBLA to market a biosimilar pegfilgrastim product referencing Neulasta in 2015. Amgen responded by filing a complaint in May 2016, alleging infringement of its ‘878 patent.

Amgen appealed against the two district court findings of non-infringement.

Amgen contended that the Californian court had misconstrued the “washing” and “eluting” claim limitations in the ‘878 patent as requiring distinct solutions added to the matrix at different times.

According to Amgen, the claims cover any number of solutions or steps as long as the functions of washing and eluting happen in sequence. But Sandoz argued that the washing and eluting steps required discrete solutions, an argument that the Federal Circuit agreed with.

On the ‘427 patent, Amgen argued that the district court misconstrued the limitation of “disease treating-effective amount” of a chemotherapeutic agent in claim 1 as “an amount sufficient to treat a disease for which at least one chemotherapeutic agent is prescribed”.

Sandoz responded that Amgen’s construction would “read disease treatment out of the claim”.

Circuit Judge Alan Lourie, on behalf of the court, said: “We agree with Sandoz that ‘disease treating’ requires that the chemotherapeutic agent be administered to treat an underlying disease. As an initial matter, the preamble of claim 1, as construed, arguably precludes Amgen’s construction.”

Amgen said it was disappointed with the court's decision.

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