By Kevin E. Noonan --
There has been some comment in certain quarters regarding the recent penchant for the Federal Circuit to issue Rule 36 summary affirmances instead of full-fledged opinions as had been the Court's practice for much of its 40-year existence (see, e.g., D. D. Crouch, Wrongly Affirmed without Opinion, 52 Wake Forest Law Review 561 (2017)). The Supreme Court has deigned not to review the practice (see, e.g., writs of certiorari in Shore v. Lee (2017) and Broadband ITV v. Hawaiian Telecom (2017)). In its recent decision in Azurity Pharmaceuticals Inc. v. Alkem Laboratories Ltd., the Court handed down a non-precedential opinion that is unlikely to still those voices raised in criticism of cases affirmed without opinion.
The case arose in ANDA litigation as an appeal of a decision by the U.S. District Court for the District of Delaware finding the asserted claims of U.S. Patent Nos. 10,786,482 and 10,918,621 to be invalid for obviousness and insufficient written description. These patents claimed liquid formulation of enalapril, a drug for treating high blood pressure that conventionally was dispensed in tablet form. Some patients (children and the elderly) have difficulties swallowing tablets but liquid formulations had the drawback that the drug degrades in water. The claimed formulation overcame this limitation; claim 16 is set forth here to illustrate the claimed invention:
16. An oral liquid formulation, comprising:
(i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
(ii) a buffer comprising a mixture of citric acid and sodium citrate, wherein the buffer is present at a concentration between about 5 mM and about 20 mM in the oral liquid formulation;
(iii) about 1 mg/ml of a preservative, wherein the preservative is a paraben or a mixture of parabens; and
(iv) water;
wherein the formulation maintains about 95% w/w or greater of the initial enalapril amount at the end of a storage period of at least 12 months at about 5±3° C, wherein the sweetener is sucralose.
(As set forth, the italicized portion of the claim is recited in independent claim 14 and the remainder in dependent claim 16.)
The Federal Circuit affirmed in an opinion by Judge Dyk joined by Judges Hughes and Stoll. The following is the entirety of the discussion portion of the opinion:
"Obviousness is a mixed question of fact and law." Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1327 (Fed. Cir. 2017). The district court's legal conclusion of obviousness is subject to de novo review, while "subsidiary factual findings are reviewed for substantial evidence." Id. Substantial evidence is "such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938).
We see no legal error in the district court's obviousness determination and conclude that it was supported by substantial evidence. Because we affirm the district court's obviousness determination, we decline to reach the issue of written description.
For anyone counting at home, the total word count for the discussion portion of the opinion is 115 words (the entire opinion takes 332 words to be expressed). For comparison, this post is 536 words in length.
Azurity Pharmaceuticals Inc. v. Alkem Laboratories Ltd. (Fed. Cir. 2023)
Nonprecedential disposition
Panel: Circuit Judges Dyk, Hughes, and Stoll
Opinion by Circuit Judge Dyk
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