Bendamustine – USA

Bendamustine – USA

On Oct. 25, 2022, Delaware district court found defendants NDA non infringing as their products were not “ready to use”.

 

This is a patent infringement case under Hatch-Waxman Act brought by Plaintiff (Eagle pharmaceutical) against defendants (Slayback & Apotex). Defendants filed NDA for approval to manufacture and sell bendamustine
hydrochloride drug products based on plaintiff’s approved product, BELRAPZO® (bendamustine hydrochloride) Injection, I 00 mg/ 4 mL (25mg/mL). Eagle alleged in its complaint that defendants’ submissions of their NDAs
constitute infringement of claims 2 and 4 of U.S. Patent No. 11,103,483. Both claims cover a “ready to use
liquid bendamustine-containing composition. The only disputed infringement issue was whether defendants’ proposed products are “ready to use.” The parties stipulated that “ready to use” means “able to be dispensed with minimal if any effort or preparation; prepackaged.”

 

Court said that the dispensing of defendants’ proposed products requires more than minimal effort and preparation. Moreover, Dr. Graham Sewell (Eagle’s expert), admitted at trial that defendants’ proposed products were not prepackaged. Bendamustine is a cytotoxic drug having narrow therapeutic window. The dispensing of a liquid concentrate form of bendamustine involves many critical steps. None of the undisputed steps in the dispensing process requires minimal effort or preparation. Each step must be performed with more than minimal effort and preparation because “there’s nothing minimal or trivial about compounding a highly toxic cancer chemotherapy.” Defendants’ proposed products are packaged in a multi-dose vial and each patient receives dose according to body surface area and considering other conditions such as kidney function, blood type, blood count. Therefore, dispensing defendants’ proposed products involves more than minimal if any effort or preparation. Thus, it is not “ready to use” composition. Accordingly, Eagle failed to establish that defendants’ filing of their NDAs constituted infringement of the asserted claims of the #483 patent.

 

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