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23 April 2020AmericasSarah Morgan

Fed Circuit rejects Biogen’s plea in MS drug dispute

The US Court of Appeals for the Federal Circuit has affirmed a lower court’s decision which found that  Banner Life Sciences wasn’t infringing a  Biogen patent with its bioequivalent version of a multiple sclerosis drug.

In a  precedential ruling, handed down on Tuesday, April 21, the Federal Circuit concluded that Banner hadn’t infringed the extended portion of US patent number 7,619,001 which was extended under the patent term restoration provisions of the Hatch-Waxman Act.

The ‘001 patent—called “Utilisation of dialkylfumarates”—covers Biogen’s blockbuster drug Tecfidera (Dimethyl fumarate), a twice-daily pill indicated “for the treatment of patients with relapsing forms of multiple sclerosis”.

Originally set to expire in April 2018, the patent’s term was extended by 811 days under the provisions of 35 USC section 156 to compensate Biogen for the period during which the Food and Drug Administration reviewed its Tecfidera application. It is now set to expire on June 20, 2020.

In 2018, after the five-year data exclusivity period for Tecfidera had expired, Banner submitted an application to market its generic version, a monomethyl fumarate (MMF) pill.

Soon after, Biogen asserted patent infringement. Banner immediately moved for judgment of non-infringement, arguing that section 156(b)(2) limits the scope of the ‘001 patent’s extension to methods of using the approved product, dimethyl fumarate, and that MMF was none of those things.

Biogen claimed that section 156 doesn’t limit extension of a method of treatment patent to uses of the approved product, but instead only to uses of any product within the original scope of the claims.

The US District Court for the District of Delaware sided with Banner, finding non-infringement.

Biogen subsequently appealed against the decision to the Federal Circuit, arguing that the district court misinterpreted “product” in section 156 as not encompassing a de- esterified form of an approved product.

But yesterday, the Federal Circuit affirmed the lower court’s finding.

It said: “Because the scope of a patent term extension under 35 USC section 156 only includes the active ingredient of an approved product, or an ester or salt of that active ingredient, and the product at issue does not fall within one of those categories, we affirm the judgment of the district court.”

Circuit Judge Alan Lourie, on behalf of the court, noted that the active ingredient of a given drug product is defined by what is approved and is specified on the drug’s label.

“MMF is not the approved product, nor is it specified as the active ingredient on the Tecfidera label. Esters are included in the statutory definition of what can be extended, but MMF is the de-esterified form of dimethyl fumarate, not an ester of Dimethyl fumarate. Thus, it is not the same product under section 156(f) and does not fall within the scope of the ‘001 patent’s term extension,” said Lourie.

Biogen’s first argument, that section 156 is only limited to approved uses of any approved product, was also rejected by the court.

Lourie said: “Patent term extension exists to compensate an New Drug Application (NDA) holder for time consumed during regulatory review of the product. But it would make little sense for an extension—whether for a product patent or a method of treatment patent—to apply to a different product for which the NDA holder was never subjected to a regulatory review period.”

In a  release, Banner said it was pleased with the Federal Circuit’s decision.

Franck Rousseau, CEO of Banner, said: “This ruling clears the way for us to proceed with our commercial strategy and move closer to making this important medicine available to physicians and patients in the US.”

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