Docket Nos. 2018-2167, -21696
NEWMAN (D), LOURIE, STOLL
Nov. 20, 2018 (Non-precedential)
Brief summary: DC order granting Invidior’s preliminary injunction reversed and remanded (“‘305 patent expressly disclaimed, through remarks in the specification, solely using conventional top air drying” and “claim preclusion likely bars Invidior’s suit”).
Summary: Dr. Reddy’s (DRL) appealed the DC order granting Invidior’s preliminary injunction regarding US 9,931,305 and 8,603,514 and its Suboxone Film, an opioid dependency treatment including buprenorphine (decreases opioid need) and naloxone (abuse deterrant) as active ingredients. The ‘305 and ‘514 patents relate to “methods of producing films that have drug content uniformity” using “controlled drying techniques that avoid the ‘rippling’ problems produced by conventional drying methods.” The FC panel opinion explains that DRL’s predecessor had submitted two ANDA’s regarding the Suboxone Film and Invidior sued for “infringement of several patents, including the ‘514 patent”. In that case, which is the subject of a separate FC appeal (No. 17-2587), DRL’s ANDAs were found not to infringe the ‘514 claims, of which the claim term “dried” was determined to mean “dried without solely employing conventional convection air drying from the top” (“the ‘514 patent’s specification expressly disclaimed and disparaged these methods, and Invidior was ‘unable to point to a single portion of the specification contemplating the use of top air drying alone”). The FC panel explains that after this decision, Invidior amended the claims that issued as the ‘305 patent to replace “dried” and “drying” with “continuously” and “continuously cast”, and filed a terminal disclaimer to the ‘514 patent. Invidior then filed suit alleging DRL’s ANDAs infringed the ‘305 patent claims, and requested a temporary restraining order (TRO) which was granted, and subsequently granted a preliminary injunction (PI), finding Invdior “likely to succeed on the merits of its infringement claim.” The DC also concluded that “the ‘305 claims do not include a drying limitation” and that its suit “was not barred by claim preclusion under SimpleAir” (FC 2018). The FC panel reviewed the DC grant of the PI under Luminaria (FC 2016) and for an abuse of discretion (Abbott, FC 2008; Nat’l Steel Car (FC 2004)). The FC panel concluded that the DC abused its discretion because “[t]he ‘305 patent expressly disclaimed, through remarks in the specification, solely using conventional top air drying to produce films with the claimed content uniformity…a key feature of the invention” (e.g., “conventional drying methods themselves are unable to provide uniform films” and working examples) (“specification disclaimer” (Phillips, FC 2005 (“the specification may reveal an intentional disclaimer…the inventor’s intention, as expressed in the specification, is regarded as dispositive”, citing SciMed (FC 2001 (disavowel “even though the language of the claims, read without reference to the specification, might be considered broad enough”, “present invention”)); Openwave, FC 2015). And even though the ‘305 claims do not recite “dried” or “drying”, the FC panel found that “the drying limitation has a contextual basis in the term ‘continuously cast film’”. Invidior argued “that it is improper to import drying, a process, into the ‘305 patent’s composition claims because there is an absence of ‘specific process language’”, and the FC panel agreed this is generally correct (Vanguard, FC 2000), “process steps can be treated as part of a product claim if the patentee has made clear that the process steps are an essential part of the claimed invention” (Andersen, FC 2007; Medicines Co., FC 2017) as in this case. The FC panel also held “that claim preclusion likely bars Invidior’s suit as the ‘514 claims and the ‘305 claims are patentably indistinct” (“the same cause of action…a terminal disclaimer is a strong clue that a patent examiner and, by concession, the applicant, thought the claims in the continuation lacked a patentable distinction over the parent”). It therefore vacated and remanded the DC decision. Judge Newman’s dissent argued, e.g., that the FC panel “erroneously apply a decision of the [DC] on a different patent with different claims, although that decision is pending on appeal.”