Eli Lilly and Co. and its partner cannot stop competitors from selling generic versions of testosterone treatment Axiron, a federal judge in Indianapolis has ruled.
U.S. Judge Sarah Evans Barker on Monday concluded that a formulation patent originally granted for the drug was invalidated and therefore would not be infringed by the commercialization of generic versions. The court also ruled the applicator patent is valid but was not infringed.
The drug, a topical solution of testosterone, is marketed to men who have a deficiency or absence of testosterone. It is applied by an underarm applicator.
Indianapolis-based Lilly has the exclusive license to market the drug, which was developed by Acrux of West Melbourne, Australia. Axiron had global sales of $29.3 million in the second quarter.
The two companies had filed a lawsuit last summer against a group of generic drugmakers, including Perrigo Co., Actavis Laboratories and Lupin Pharmaceuticals.
Lilly said Tuesday it would appeal the decision. “We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve,” the company said in a written statement. “These rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs.”
Acrux said in a statement Tuesday that the decision will cause a “material decline” in its net sales and the resulting royalties it receives. The drug contributed 84 percent of Acrux’s sales the first half of this year.