Taft Chicago partners Andrew M. Alul and Roshan P. Shrestha, Ph.D., secured a significant litigation victory for generic drug client, Bionpharma Inc. (Bionpharma). Bionpharma markets a 1.0 mg/mL enalapril maleate oral solution as generic to Azurity Pharmaceuticals Inc.’s (Azurity) Epaned®, a prescription drug product used to treat hypertension in children and elderly.
Earlier this year, Bionpharma prevailed against Azurity after a five-day bench trial in the U.S. District Court for the District of Delaware, where the Delaware court found that Bionpharma’s generic product would not infringe Azurity’s patents covering Epaned®. Subsequent to Bionpharma’s trial victory, Azurity secured additional patents covering Epaned®, with considerably broader claim coverage, and instituted a new suit against Bionpharma in Delaware Federal court, Azurity Pharmaceuticals, Inc. v. Bionpharma Inc., C.A. No. 21-1286-LPS (D. Del.), alleging that Bionpharma’s generic product fell literally within the scope of the claims of Azurity’s new Epaned® patents. Bionpharma secured final FDA approval for its generic product on Aug. 10, 2021, and commercially launched its product on Aug. 17, 2021. On Aug. 19, 2021, Azurity moved for a preliminary injunction seeking to remove Bionpharma’s generic product from the market.
Following a hearing on Azurity’s motion on Nov. 10, 2021, Judge Leonard P. Stark of the Delaware court denied Azurity’s motion, finding that Bionpharma had come forward with “persuasive evidence” that Azurity’s new Epaned® patents failed to adequately describe and enable its broader claim coverage, raising a “substantial questions” of invalidity. Judge Stark also found that the balance of hardships and public policy favored denial of Azurity’s motion because Bionpharma’s launch was lawful, and because patients were now depending on Bionpharma’s lower-priced generic product. As such, Bionpharma was permitted to keep its generic product on the market pending resolution of the case, providing hypertension patients who use Epaned® with a lower-priced generic alternative and addressing 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.