DC decision affirmed as safety and efficacy “wherein” clauses are limiting

Allergan, Inc. et al. v. Sandoz, Inc., Alcon Laboratories

Docket No. 2018-2207
August 29, 2019

Brief Summary: DC grant of a preliminary injunction to Allergan affirmed since the “wherein” clauses relating to safety and efficacy were found to be limiting to the claims.

Summary: Sandoz appealed DC grant of a preliminary injunction regarding Sandoz’s ANDA No. 91-087 for generic Combigan® eye drops (combination of brimonidine tartrate, timolol maleate) and Allergan’s US 9,770,453; 9,907,801; and 9,907,802 (three of 11 Orange Book-listed patents for Allergan’s NDA N021398). The DC based its decision on its determination that the “wherein” clauses in the patents were limiting (“wherein the method is as effective”, “wherein the method reduces the incidence of one o[r] more adverse events”). The FC panel agreed, looking first at “the language of the claims, followed by the language of the specification and prosecution history” (Amgen, FC 2006; Phillips, FC 2005; Home Diagnostics, FC 2004; Wi-Lan, FC 2016). The FC panel also explained that while “[a] whereby [or wherein] clause in a method claim is not given weight when it simply expresses the intended result of a process step” (Minton, FC 2003; Bristol-Myers, FC 2001), the claims must be “read…in view of the ‘entire specification’” (Sinorgchem, FC 2007; Columbia Univ., FC 2016). Here, the FC panel found, “[t]he specification…demonstrates that the claimed invention is ultimately a formulation (and methods of using that formulation) that allows for increased efficacy and safety, i.e., a decreased risk of adverse events” (e.g., from the specification, “it is well known that many of such topically-applied ophthalmic agents cause systemic side effects”, “comparative study of the ‘safety and efficacy’” in examples; “[t]hese benefits are described throughout the specification with reference to prior art topical ophthalmic treatments”, including the composition “as recited in the claims…the specification demonstrates that Allergan believed the increased efficacy and safety of the claimed methods to be material to patentability”). Further, “Allergan relied on the efficacy and safety of the claimed methods during prosecution…in responding to the examiner’s rejections” (e.g., “the prior art ‘does nothing to teach of suggest that the claimed fixed combination…administered twice daily would be as effective as…three times per day, nor that [it] would cause an unexpected reduction in adverse events…’unexpected results’”; “the Examiner specifically relied on the ‘wherein’ clauses in explaining why the claims” were allowed; clauses “were expressly relied on to define the claimed methods and distinguish them from the prior art”) (Southwall, FC 1995; Hoffer, FC 2005 (“[W]hen [a] ‘whereby’ [or ‘wherein’] clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.”); see also Griffin (FC 2002) referred to in the concurrence (“giving ‘meaning and purpose to the manipulative steps’”); unlike Bristol-Myers (FC 2001), Copaxone (FC 2018), or Georgetown (FC 2017)). The DC decision was therefore affirmed. Judge Prost concurred but followed “a slightly different path”, writing that the FC panel could have relied on “the claim language on its face” and, e.g., “Sandoz provides no basis for us to conclude with any certainty that the safety and efficacy requirements of the ‘wherein’ clauses would always result from two doses of (1) any formulation of the combination at (2) any interval in a 24-hour period.”

This entry was posted in Claim Construction, Uncategorized, Wherein. Bookmark the permalink.

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