Clarus succeeds in invalidating four Lipocine testosterone patents
Clarus Therapeutics has convinced a US court to invalidate four Lipocine testosterone booster patents it was accused of infringing.
The US District Court for the District of Delaware handed down the summary judgment on June 1, siding with Clarus’ argument that 24 of the asserted claims in the patents were invalid insufficient written description and enablement requirements.
Judge William Bryson agreed with Clarus’ argument that the patent claims were “very broad” and “although lengthy, and discursive, provides only limited and narrowly circumscribed support for the claims”.
Initially, Lipocine had accused Clarus of infringing on its patents through the sale of its testosterone replacement drug Jatenzo (testosterone undecanoate). Clarus fired back with a counter-claim that the patents were invalid, seeking a summary judgment.
The four patents in suit were US patent nos. 9,034,858, 9,205,057, 9,480,690, and 9,757,390. All the patents share the same specification.
This ruling renders Lipocine’s claims of infringement and Clarus’ counterclaims of non-infringement moot.
Both parties were ordered to file a joint report within 21 days of the order to establish how they recommend the court should proceed with the case.
‘Meaningful specificity’
Bryson said in the summary judgment: “Only one of the 24 asserted claims provides any meaningful degree of specificity regarding the identity of the excipients [substances included alongside the active ingredient of a medication but has no therapeutic action] claim 21 of the ‘690 patent… yet even that claim is not highly specific with respect to its formulation.”
A skilled artisan, Clarus argued, would need to test thousands of formulations to determine which excipients would be preferred.
Bryson, in response to Clarus’ claims, said: “I agree... The effect of the claims is to cover any oral method using almost any formulation administered within that broad range of doses, followed by titration if needed, as long as the method works. But that kind of functional claiming runs afoul of the written description requirement.”
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