Invidior Inc. et al. v. Dr. Reddy’s Labs. (DRL), Actavis/Watson, Teva, Par, Intelgenx, Alvogen Pine Brook, LLC
Docket Nos. 2017-2587, 2018-1010, -1058, -1062, -1114, -1115, -1176, -1177
Newman, Mayer (D), Lourie
July 12, 2019
Brief Summary: DC findings that Invidior patents relating to its Suboxone® sublingual film are infringed by certain parties and not invalid for obviousness affirmed.
Summary: DRL et al. appealed several DC decisions regarding exclusive licensee (from Aquestive Ther., Inc.) Invidior’s US 8,603,514; 8,900,497; and 8,017,150; relating to Invidior’s Suboxone® sublingual film (combination of the opioid buprenorphine and the opioid antagonist naloxone; previously sold as a tablet; NDA N022410; ‘514 and ‘150 patents on Orange Book (OB), ‘497 is not). The FC panel opinion explains that the parties’ arguments are focused on the OB patents (‘514 and ’150; “the parties do not distinguish” the ‘497 patent, directed to film manufacturing, “from the ‘514 patent with respect to the issues on appeal”). The ‘514 patent requires uniform distribution of active ingredient a “viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity”, and “capable of being dried without loss of substantial uniformity”. The ‘150 patent claims the films by the components therein (e.g., “the water-soluble polymer component comprises greater than 75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer”, including low molecular weight PEO (L-PEO) and high molecular weight PEO (H-PEO)).
Regarding the ‘514 patent, the FC panel agreed with the DC’s conclusion that Invidior “disclaimed drying wet cast films using solely convection air drying from the top…based on the ‘514 patent specification’s express statements of what the invention is, its repeated disparagement of conventional top drying methods, and the patent applicants characterization of the invention during prosecution” (Phillips, FC 2005 (“[t]he specification ‘is the single best guide to the meaning of a disputed term’”); SciMed, FC 2001 (“where it ‘makes clear that the invention does not include a particular feature’”); Openwave, FC 2015 (“A specification may disclaim an embodiment by repeatedly disparaging it.”)). The FC panel also agreed with the DC’s decision that DRL’s and Alvogen’s drying processes do “not meet the drying limitation” and do not therefore infringe the ‘514 patent. The FC affirmed the DC’s decision that Watson infringed the ‘514 patent and disagreed with Watson that the DC should have let it argue its revised process does not infringe (e.g., “Watson acknowledges that it can still seek a judgment of noninfringement based on the amended ANDA process even if it fails to secure Rule 59 relief.”) The FC panel also disagreed with Watson’s ‘514 indefiniteness argument that since “a cast film in its final dosage form is not flowable”, the claim “required a physical impossibility” (i.e., “a product claim ‘comprising’ certain elements must contain those elements simultaneously”), finding that the ‘514 patent properly “makes clear that the matrix is flowable only are a certain time-before drying” (Gemtron, FC 2009 (“the specification made clear that the [claimed] resilience only referred to resilience during assembly”). The FC panel found no error with the DC’s conclusion of no invalidity of ‘514 claims for obviousness (e.g., no error in “adopting a compromise measure of the level of ordinary skill”, reliance on expert testimony regarding what the prior art taught and a motivation to combine (“adjusting the various factors” that affect uniformity “would have been unintuitive, and that that field was still emergent”), Aquestive was first to obtain FDA approval).
Regarding the ‘150 patent, claim 1 recites that the film includes hydrophilic cellulosic polymer (‘HCP’) while DRL used polyvinyl pyrrolidone (PVP). The DC held no infringement under the doctrine of equivalents since the ‘150 patent “disclosed PVP as an alternative to HCP but did not claim it” and “thereby dedicate[ed] it to the public.” The FC panel agreed (Johnson & Johnson, FC 2002; Mahn, US 1884 (“the essential notice function of claims”)). DRL also alleged obviousness, and the FC explained that determination is based on whether the ‘150 patent can properly claim priority to the ‘902 provisional application, which turns on written description (section 112 and Lockwood (FC 1997)). The FC panel agreed with the DC that the provisional application properly described the claimed films and therefore its finding of no obviousness.
Invidior also requested that the DC’s decision finding claims 15-19 of Invidior’s US 8,475,832 obvious be vacated as moot (also held unpatentable in IPR2014-00325, affirmed by the FC). The FC panela greed with Invidior.