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Federal Circuit Examines the Analogous Art Test
On May 9, 2023, a Federal Circuit panel consisting of Judges Reyna, Mayer and Cunningham issued a precedential opinion, authored by Judge Cunningham, in Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981. Patent owner Sanofi appealed from an inter partes review (IPR) Board's decision finding Sanofi's U.S. Patent No. RE47,614 (the "614 Patent") invalid as obvious, arguing that Mylan failed to assert that a prior art reference is analogous to the challenged patent and instead asserted that the reference is analogous to another prior art reference. Slip Op. at 2. The Federal Circuit agreed finding that the analogousness test was not based on the challenged patent and, therefore, Mylan did not meet its burden of establishing obviousness. Id. As a result, the Federal Circuit reversed the Board's decision.
Sanofi's 614 Patent relates to a drug delivery device that can be configured to allow setting of different dose sizes by using a "spring washer" that can exert a force on the cartridge and secure the cartridge against movement. Id. at 2-3. All claims of the 614 Patent require a "spring washer" secured by "at least two fixing elements." Id. at 3.
Mylan petitioned for IPR of all claims of Sanofi's 614 Patent based on a combination of three prior art references: Burren, Venezia and de Gennes. Id. Mylan asserted that the combination of Burren and Venezia taught the use of spring washers within drug-delivery devices and de Gennes disclosed "snap-fit engagement grips" to secure the spring washer. Id. at 3-4. Mylan argued that although de Gennes is concerned with a clutch bearing in automobiles, it nevertheless addressed a problem identified in Burren, namely "axially fixing two components relative towards each other." Id. at 4-5. Sanofi argued, among other things, that de Gennes is not analogous art to the 614 Patent because it relates to cars and not drug delivery devices or medical devices and is not reasonably pertinent to the 614 Patent's problem of "secur[ing] a cartridge against movement within a housing" — a problem that is narrower than that of Burren. Id. at 4.
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