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Judge Sleet issues post-trial opinion in ANDA litigation, finds claims not invalid for lack of patentable subject matter

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In a recent post-trial opinion in this ANDA litigation, Judge Gregory M. Sleet found, inter alia, that (1) all asserted claims of the patents-in-suit are valid; (2) defendant’s proposed products induce infringement of the asserted claims of U.S. Patent No. 8,586,610 (the “’610 Patent”); and (3) defendant’s proposed products do not contributorily infringe the asserted claims the ’610 Patent. Vanda Pharmaceuticals Inc. v. Roxane Laboratories, Inc., C.A. Nos. 13-1973, 14-757-GMS (D. Del. Aug. 25, 2016).

Notably, Judge Sleet found certain claims of the ’610 Patent not invalid for failure to claim patentable subject matter pursuant to § 101. Id. at 16-20. Defendant argued that the ’610 Patent embodies laws of nature that it applies in a way that is routine and conventional. Id. at 17. Specifically, defendant contended that the ’610 Patent was directed to two laws of nature: “(1) that mutations in the CYP2D6 genes can alter enzymatic activity, and (2) that a patient’s CYP2D6 enzymatic activity affects their metabolism of iloperidone.” Id. Although Judge Sleet acknowledged that the ’610 Patent depends on laws of nature, he ultimately concluded that defendant failed to prove “by clear and convincing evidence that the precise test and the discovered results were routine or conventional.” Id. at 18-20. As Judge Sleet observed:

The court finds that while it may have been conventional to investigate for side-effects, Roxane has not proven by clear and convincing evidence that the precise test and the discovered results were routine or conventional. The court finds it persuasive that the dosage step in the ’610 Patent does not apply to all patients, but only a specific patient population based upon their genetic composition. The dosage step requires applying genetic tests in a highly specified way. Moreover, the process of using this genetic test to inform the dosage adjustment recited in the claims was not routine or conventional and amounted to more than a mere instruction to apply a natural relationship. This combination of elements is sufficient to ensure that the claims amount to significantly more than just a natural law.

Id. at 20.

Vanda Pharmaceuticals Inc. v. Roxane Laboratories, Inc., C.A. No. 13-1973, 14-757-GMS (D. Del. Aug. 25, 2016).

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