Enalapril Maleate – USA

Enalapril Maleate – USA

On Mar. 09, 2022, Federal Circuit affirmed (Rule 36 Judgment) district court and found Bionpharma’s product non-infringing under Doctrine of Equivalents (DOE).

 

Background: Silvergate (Plaintiff) sued Bionpharma (Defendant) for infringement of US 9,669,008; US 9,808,442: US 10,039,745 and US 10,154,987 patents as Defendant filed ANDA under Hatch-Waxman Act. These patents are listed in Orange Book for the product, Epaned® (Enalapril maleate). Later, parties narrowed their disputes leaving only ‘745 and ‘987 patents. The Court held a five-day bench trial in February 2021. Silvergate concedes that Bionpharma does not literally infringe but infringes under the doctrine of equivalents (“DOE”). Bionpharma counters that prosecution history estoppel, disclosure-dedication, and claim vitiation – prevent Silvergate from prevailing on its DOE theories.

On Apr. 27, 2021, district court issued opinion and found the non-infringement. You can read the district court summary “here” on this blog.

 

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