Trial Win Paves Way for Lower-Cost Generic Hypertension Drug

Taft Chicago partners Andrew M. Alul and Roshan P. Shrestha secured a trial win for client Bionpharma Inc., paving the way for the company’s lower-priced generic alternative to Silvergate Pharmaceuticals Inc.’s Epaned® prescription drug product. 

Bionpharma had filed with the United States Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking FDA approval to commercially market a 1 mg/mL enalapril maleate oral solution as generic to Silvergate’s Epaned®, a prescription drug product used to treat hypertension in children and elderly. In response, Silvergate filed actions in the United States District Court for the District of Delaware alleging that Bionpharma’s ANDA and the generic product described therein infringe several of Silvergate’s patents covering Epaned®.

Following a five-day bench trial held in February 2021, Chief Judge Leonard P. Stark of the Delaware court on April 27, 2021, issued an opinion finding that Bionpharma’s ANDA and the generic product do not infringe Silvergate’s Epaned® patents on multiple legal and factual grounds, and entered judgment in Bionpharma’s favor shortly thereafter. The court’s opinion also essentially rendered moot a subsequent suit filed by Silvergate asserting infringement of additional, later-issuing patents relating to Epaned®, and a preliminary injunction motion filed in connection with that subsequent suit, paving the way for Bionpharma to secure final FDA approval and launch its generic alternative to Epaned®, which will provide hypertension patients who use Epaned® with a lower-priced generic alternative and address a financial burden on families who rely on Epaned®. The need for generic options for drugs used by children, such as Epaned®, was featured in the Washington Post article “The dilemma of kid-friendly pharmaceuticals:  Safety comes at a steep price,” on April 21, 2017. 

Alul focuses his practice on intellectual property litigation and counseling, particularly pharmaceutical drug patent litigation and regulatory litigation involving the U.S. Food and Drug Administration (FDA). He has extensive experience litigating cases brought under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act for pharmaceutical products and under the Administrative Procedures Act.

Shrestha focuses his practice on all aspects of intellectual property law, including patent litigation, prosecution and opinion work in the chemical, pharmaceutical and electronic material arts. He has a broad scope of pharmaceutical and life sciences capabilities, including Hatch-Waxman litigation and inter partes review proceedings at the USPTO. Before practicing law, Shrestha was a research scientist at Los Alamos National Laboratory in New Mexico, where his investigation on materials for hydrogen storage technology received several patents.

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