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A federal judge in Delaware ruled in favor of Astellas Pharma Inc. on Tuesday, affirming the validity of the company's patent for Myrbetriq, a bladder medication. U.S. District Judge Joseph F. Bataillon concluded that generic-drug makers Lupin and Zydus Pharmaceuticals failed to prove, by clear and convincing evidence, that Astellas' U.S. Patent No. 10,842,780 should be invalid.

The ruling came after a bench trial, which was focused on the patent's validity. Judge Bataillon found that the generics manufacturers' claims, including the assertion that the patent lacked an adequate written description and did not enable skilled individuals to practice the invention, were not supported by clear and convincing evidence. In particular, the court rejected the argument that the patent was indefinite.

“The court concludes the generics manufacturers did not prove their asserted invalidity defenses by clear and convincing evidence,” Judge Bataillon stated in his 61-page opinion.

The patent in question relates to a hydrogel sustained-release formulation of Myrbetriq, which has been used to treat overactive bladder since 2012. The judge highlighted that a person skilled in the art could reproduce the invention using routine experimentation and that the patent provides sufficient disclosure regarding the structure-function relationship of the formulation.

Astellas' patent claims for Myrbetriq are set to expire in 2029 and 2030, depending on the dosage. The ruling now sets the stage for a jury trial in 2026 to determine issues related to infringement and damages.

“This ruling reaffirms Astellas' position in the ongoing litigation and supports the strength of our intellectual property protecting Myrbetriq,” said a representative from Astellas. "The decision will help ensure that our innovation remains protected as we continue to provide effective treatments for overactive bladder."

The legal battle began after Astellas filed a patent infringement lawsuit against several generic-drug manufacturers, asserting that their products would infringe upon the Myrbetriq patent. The court's decision marks a significant victory for Astellas, as it upholds the validity of the key patent covering the formulation of the drug.

Astellas was represented in the case by a team of attorneys from McCarter & English LLP, Kirkland & Ellis LLP, and McDermott Will & Emery. Zydus and Lupin were represented by legal teams from Young Conaway Stargatt & Taylor LLP, Buchanan Ingersoll & Rooney PC, Phillips McLaughlin & Hall PA, Knobbe Martens Olson & Bear LLP, and Wilson Sonsini Goodrich & Rosati PC.