Taft Chicago partners Andrew M. Alul and Roshan P. Shrestha, Ph.D., secured a significant Federal appeals court 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,” formerly Silvergate Pharmaceuticals, Inc.) Epaned®, a prescription drug product used to treat hypertension in children and the elderly. On March 9, 2022, the United States Court of Appeals for the Federal Circuit in Washington, D.C. summarily affirmed a judgment entered last year in Delaware Federal Court that Bionpharma’s generic enalapril product does not infringe certain patents Azurity holds for Epaned®, allowing Bionpharma to continue marketing its lower-cost generic enalapril product to pediatric and elderly hypertension patients.
By way of background, Bionpharma had filed with the United States Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking FDA approval to commercially market its 1 mg/mL enalapril maleate oral solution as generic to Azurity’s Epaned®. In response, Azurity filed actions in the United States District Court for the District of Delaware alleging that Bionpharma’s ANDA and generic enalapril product described therein infringe several of Azurity’s Epaned® patents. Following a five-day bench trial held in February 2021, where Taft partners Alul and Shrestha served as Bionpharma’s trial counsel, Judge Leonard P. Stark of the Delaware court issued an opinion on April 27, 2021, finding that Bionpharma’s ANDA and generic enalapril product do not infringe Azurity’s asserted Epaned® patents on multiple legal and factual grounds. Silvergate Pharm., Inc. v. Bionpharma Inc., C.A. Nos. 18-1962-LPS, 19-1067-LPS, 2021 WL 1751148 (D. Del. Apr. 29, 2021). The Delaware court entered final judgment of non-infringement in Bionpharma’s favor shortly thereafter. The court’s opinion not only exonerated Bionpharma’s ANDA and generic enalapril product from Azurity’s infringement claims, it also rendered moot a subsequent suit filed by Azurity 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 enalapril product, which provides hypertension patients who use Epaned® with a lower-cost generic alternative and addresses 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.
Subsequently, Azurity appealed the Delaware court’s final judgment of non-infringement to the United States Court of Appeals for the Federal Circuit in Washington, D.C., arguing that the Delaware court’s judgment was based on numerous legal and factual errors that required reversal or, at the very least, vacatur of the judgment of non-infringement and remand to the Delaware court so that Azurity could continue pursuing its infringement claims against Bionpharma. After hearing oral arguments on March 7, 2022, the three-judge panel presiding over the appeal (Circuit Judges Pauline Newman, Raymond C. Clevenger, III, and Kara Farnandez Stoll) summarily affirmed the Delaware Court’s judgment of non-infringement in Bionpharma’s favor, allowing Bionpharma to continue marketing its lower-cost generic enalapril product to pediatric and elderly hypertension patients. Azurity Pharm., Inc. v. Bionpharma Inc., Nos. 2021-1926, -1927, 2022 WL 703903 (Fed. Cir. March 9, 2022).
Alul focuses his practice on intellectual property litigation and counseling, particularly pharmaceutical drug patent litigation and regulatory litigation involving the 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.