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23 November 2017Americas

Federal Circuit paves way for Eli Lilly testosterone generics

Eli Lilly experienced a setback yesterday at the US Court of Appeals for the Federal Circuit when it affirmed that a patent owned by the company is invalid.

The Federal Circuit backed a decision made by the US District Court for the Southern District of Indiana, which found that claim 20 of US patent number 8,435,944 was invalid for obviousness.

The ‘944 patent, called “Method and composition for transdermal drug delivery”, covers Eli Lilly’s Axiron testosterone applicator. The treatment is used for men with testosterone deficiency.

Claim 20 of the patent recites a “transdermal delivery method of applying testosterone to the axilla [armpit] of a patient”.

Eli Lilly had sued Actavis, Lupin, Watson, Perrigo and Amneal over the companies’ filings of Abbreviated New Drug Applications for generic versions of Axiron, claiming patent infringement.

After a nine-day bench trial, the district court issued a 200-page judgment which, according to the Federal Circuit, was a “thorough, well-considered opinion”.

The Indiana court found that claim 20 was obvious in light of prior art, which taught and suggested that applying testosterone to the armpit will “increase a patient’s testosterone level with a reasonable expectation of success”.

The Federal Circuit agreed with the lower court’s decision, adding that Eli Lilly’s arguments against those references “lack merit and/or are based on a misreading of the lower court’s opinion”.

Circuit Judge Raymond Chen, on behalf of the court, said: “As an initial matter, it is premised on Eli Lilly having provided weighty objective indicia of non-obviousness. We agree with the district court, however, that Eli Lilly’s proffered objective indicia lacked probative weight.”

Eli Lilly had put forward two bases of secondary considerations: that the prior art teaches away from applying testosterone to the armpit due to “concerns over causing an undesired elevated level of dihydrotestosterone”, and that the claimed method yielded unexpected results.

“Eli Lilly’s expert, however, did not point to any teaching in the prior art that suggested avoiding the axilla as a location for applying and delivering testosterone,” noted Chen.

He added that the company had made “no meaningful” argument contesting the district court’s rejection of Eli Lilly’s theory of unexpected results.

Aside from the ‘944 patent, the Federal Circuit was also dealing with Amneal’s cross-appeal against the district court’s opinion that claims 9 and 10 of US patent number 8,807,861 were valid and infringed by Amneal’s applicator.

But Chen said: “Because we find no fault in the district court’s opinion, we affirm on all grounds.”

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