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Shire, LLC v. Amneal Pharmaceuticals, LLC

Representative Claim(s)

  1. A composition comprising an amount of from 25 to 75 mg of L-lysine-d-amphetamine or a salt thereof and having an amphetamine base amount of from 7.37 to 22.1 mg of said amphetamine, said L-lysine-d-amphetamine or a salt thereof providing a mean AUC0-12 h (ng h/mL) from 205.4±42.5 to 611.5±104.5, a mean AUClast (ng h/mL) from 396.7±84.8 to 1237.0±194.0, a mean AUCinf (ng h/mL) from 415.0±80.1 to 1259.5±191.3, a mean Cmax (ng/mL) from 25.0±5.6 to 74.0±12.9, a mean Tmax (hours) from 3.1±0.876 to 3.9±1.0, and a mean T1/2 (hours) from 9.68±1.43 to 10.3±1.7 of amphetamine when orally administered to a human subject.

Posture:

Motion for Summary Judgment

Exception Category: None

After addressing other potential grounds for invalidity, the court addressed the Defendant’s position that the claims at issue were similar to the method claims in Mayo, in that they effectively preempt a law of nature.  [Note: the claims are actually directed to compositions.  As such, if the compositions were naturally-occurring, they would implicate the judicial exception of natural phenomena, rather than laws of nature as the Defendants asserted.]

“[Defendant’s argument], however, fails because of the distinction that Mayo involved a method patent and the patents at issue on this motion are composition patents.”

“The claims at issue on this motion are not process claims.  The claims are directed to a composition.  Defendants make no persuasive argument that these claims are directed to a process which attempts to monopolize the laws of nature.”