Sanofi, et al. v. Watson Laboratories, Sandoz Inc.


Docket No. 2016-2722, -2726

PROST, WALLACH, TARANTO
November 9, 2017

Brief summary: DC decision finding inducement to infringe based on proposed drug label, no obviousness in view of prior art clinical trial documents, or prosecution history estoppel affirmed.

Summary: Sanofi and Watson appealed various portions of a DC decision regarding Sanofi’s US Pat. Nos. 8,318,800 (2018 expiration) and 8,410,167 (2029 expiration) listed on the Orange Book for Sanofi’s Multaq® (the antiarrhythmic drug dronedarone). Of note, US Pat. Nos. 7,323,493, 8602215 and 9107900 are also listed on the OB, expiring in 2018, 2031, and 2029, respectively. The FC opinion explains that “[t]he ‘167 patent claims methods of reducing cardiovascular hospitalization by administering dronedarone to patients meeting conditions mirroring those” described in a clinical trial (“ATHENA”) (i.e., the patient “does not have” defined “severe heart failure” and has a form of atrial fibrillation (“AF”), as well as “at least one” of six “cardiovascular risk factor[s]”), “the rationale and design” of which, but “not the results”, is prior art.

The DC found inducement to infringe under § 271(b) (Commil, US 2015 (defendant must know of the patent and “the induced acts” must constitute patent infringement, “[n]either” of which “is disputed here”)), the “induced act” being “the administration of dronedarone by medical providers to patients meeting the criteria set forth in the ‘167 patent claims.” The FC panel explained its position that “to find induced infringement, ‘[i]r must be established that the defendant possessed specific intent to encourage another’s infringement” (DSU, FC 2006 (“knew or should have known his actions would induce actual infringement” and “circumstantial evidence may suffice”); Takeda, FC 2015 (a drug “label must encourage, recommend, or promote infringement”)). The FC panel found no clear error with the DC’s decision (AstraZeneca, FC 2010) since “[t]he label…directs medical providers to information identifying the desire benefit for only patients with the patent-claimed risk factors” (including claim 4, see FN2). The FC panel was not persuaded by Watson and Sandoz’s argument that the DC erred because there are “substantial noninfringing uses not forbidden by the proposed labels” because “[s]ection 271(b), on inducement, does not contain” that limitation (Grokster, US 2005); that limitation is found in § 271(c) on contributory infringement; and unlike Vita-Mix, FC 2009).

The DC also found the disputed claims not to be invalid for obviousness. The obviousness issues center around whether prior art clinical trial studies (EURIDIS, ADONIS, ANDROMEDA, PALLAS, and ATHENA) render the claims obvious. Multaq®’s label relies on the clinical trial studies (“indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent” AF, the same as that proposed by Watson and Sandoz. “[A] centerpiece of the obviousness challenge in this case” is the statement in that prior art document that “[s]ince it was shown that dronedarone” can maintain sinus rhythm and atrial fibrillation relapse, “it is expected that treatment with this compound will result in a significant reduction in the need of rehospitalization for cardiovascular reasons.” Watson and Sandoz argued the DC erred “by applying too high a standard for proving a reasonable expectation of success” but the FC panel disagreed. This is because, e.g., “[t]he EURIDIS/ADONIS pair of studies…were not designed to investigate reduced hospitalization, let alone to do so for the patient population covered by the patent claims” (“[a] post-hoc analysis of the results suggested a potential reduced-hospitalization benefit… ‘potential,’ no more”) and “the ANDROMEDA showed dangers of” the drug and was terminated. Regarding the ATHENA article describing “the benefit of reduced hospitalization as ‘expected’”, the FC panel noted “there was an evidentiary dispute about how that statement would be understood by a person of ordinary skill in the art” (see FN4; unlike PharmaStem (FC 2007) in which expert testimony did not comport with the specification; “[t]he record contains evidence about the unreliability of post-hoc analysis generally”; “no evidence that…documents containing ‘it is expected’ language were ever actually given to patients in the ATHENA trial” (FN5)).

Watson and Sandoz also argued, in their only point raised regarding the ‘800 patent, the the DC “erred by failing to limit the claims…to exclude polysorbate surfactants” based on prosecution history estoppel (PHE) during prosecution of the parent application (now US 7,323,493). The FC panel reviewed the DC’s decision de novo (Shire, FC 2015), finding no error since disclaimers in parent applications do not apply to subsequent applications when not present “or materially altered” (Saunders, FC 2007; Univ. Minn. FC 2013).

This entry was posted in Contributory Infringement, Inducement to Infringe, Obviousness, Prosecution History Estoppel. Bookmark the permalink.

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