`
`NOTE: This disposition is nonprecedential.
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`AZURITY PHARMACEUTICALS, INC.,
`Plaintiff-Appellant
`
`v.
`
`ALKEM LABORATORIES LTD.,
`Defendant-Appellee
`______________________
`
`2023-1540
`______________________
`
`Appeal from the United States District Court for the
`District of Delaware in No. 1:19-cv-02100-MSG, Judge
`Mitchell S. Goldberg.
`______________________
`
`Decided: September 14, 2023
`______________________
`
`TUNG ON KONG, Wilson, Sonsini, Goodrich & Rosati,
`PC, San Francisco, CA, argued for plaintiff-appellant. Also
`represented by WENDY L. DEVINE, KRISTINA M. HANSON;
`KELSEY CURTIS, RICHARD TORCZON, Washington, DC.
`
` TIMOTHY H. KRATZ, Kratz & Barry LLP, Atlanta, GA,
`argued for defendant-appellee. Also represented by
`GEORGE BARRY, III; MICHAEL PATRICK HOGAN, Philadel-
`phia, PA; R. TOUHEY MYER, Wilmington, DE.
` ______________________
`
`
`
`Case: 23-1540 Document: 35 Page: 2 Filed: 09/14/2023
`
`2
`
`AZURITY PHARMACEUTICALS, INC. v.
` ALKEM LABORATORIES LTD.
`
`
`Before DYK, HUGHES, and STOLL, Circuit Judges.
`DYK, Circuit Judge.
`Azurity Pharmaceuticals, Inc. (“Azurity”) appeals a de-
`cision of the United States district court for the District of
`Delaware determining that claims 16, 18, 22, 23, and 28 of
`U.S. Patent No. 10,786,482 and claims 4, 7, 17, and 18 of
`U.S. Patent No. 10,918,621 were invalid. We affirm.
`BACKGROUND
`The ’482 and ’621 patents claim liquid formulations of
`enalapril. Enalapril treats high blood pressure and has
`long been used in tablet form. Children and elderly pa-
`tients can have difficulty swallowing tablets, making the
`liquid form a useful alternative. The difficulty with a liquid
`form is that enalapril degrades in water. The ’482 and ’621
`patents aim to remedy this and claim a liquid formulation
`that “maintains about 95% w/w or greater of the initial en-
`alapril amount at the end of a storage period of at least 12
`months at about 5±3° C.” ’482 patent, col. 42 ll. 21–23.
`Alkem Laboratories, Ltd. (“Alkem”) submitted an Ab-
`breviated New Drug Application (“ANDA”). Azurity
`brought suit claiming the ANDA infringed the ’482 and
`’621 patents. The district court agreed that the ANDA in-
`fringed, and that determination is not challenged on ap-
`peal. However, the district court also found the ’482 and
`’621 patents were invalid due to obviousness and insuffi-
`cient written description. Azurity appeals.
`DISCUSSION
`“Obviousness is a mixed question of fact and law.” No-
`vartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1327
`(Fed. Cir. 2017). The district court’s legal conclusion of ob-
`viousness is subject to de novo review, while “subsidiary
`factual findings are reviewed for substantial evidence.” Id.
`Substantial evidence is “such relevant evidence as a
`
`
`
`Case: 23-1540 Document: 35 Page: 3 Filed: 09/14/2023
`
`AZURITY PHARMACEUTICALS, INC. v.
`ALKEM LABORATORIES LTD.
`
`3
`
`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 sub-
`stantial evidence. Because we affirm the district court’s ob-
`viousness determination, we decline to reach the issue of
`written description.
`
`AFFIRMED
`
`
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