Azilsartan – USA

Azilsartan – USA

Arbor Pharmaceuticals, LLC et al v. Lupin Limited et al

Case : 20-922

Judge: Judge Maryellen Noreika

Court: District of Delaware

Date: Jul. 20, 2021 – Claim construction – US 9,066,936


Court’s construction of term: “pH control agent” shall be given its plain and ordinary meaning, which is “a substance or combination of substances that adjusts or maintains pH”


Plaintiffs proposed that the term should have its “plain and ordinary meaning, i.e., a substance or combination of substances that adjusts pH when dissolved or suspended in water.” Defendants proposed that it means “an excipient or combination of excipients that stabilizes the claimed compound during storage of the pharmaceutical composition and improves dissolution of the claimed compound from the pharmaceutical composition.” Here, Court mostly agreed with Plaintiffs. Court said that, starting with the term itself, the plain meaning of the words “pH control agent” is an agent that controls pH – i.e., to a person of skill in the art, this suggests that the agent maintains or changes pH. Plaintiffs argued that the “pH control agent” adjusts the pH, and there is some support in the specification that the “pH control agent” is something that “adjusts” pH. Defendants’ construction, however, does not even mention the ability of the “pH control agent” to do anything with the pH. This seems contrary to the plain meaning of the words.


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