Novartis Pharm. Corp. v. Accord Healthcare, et al. and HEC Pharm Co., Ltd. et al.
Docket No. 2021-1070 (https://cafc.uscourts.gov/opinions-orders/21-1070.OPINION.1-3-2022_1887614.pdf)
Original Panel: MOORE (D), LINN, O’MALLEY (January 3, 2022)
Rehearing Panel: MOORE, LINN (D), HUGHES (June 21, 2022)
Update (June 21, 2022): HEC petitioned for rehearing of prior FC affirmance of DC finding that Novartis’ ‘405 claims were not invalid for failing to describe a negative limitation (“absent…[a] loading dose”). This FC panel found the prior decision erroneous and reversed. This opinion explained that “[i]t is not enough that a claimed invention is ‘an obvious variant of that which is disclosed in the specification’” (Lockwood, FC 1997) and “[d]isclosure is essential; it is ‘the quid pro quo of the right to exclude’” (Kewanee, US 1974; Enzo, FC 2002). It also wrote that “[f]or negative claim limitations, like the no-loading-dose limitation at issue here, there is adequate written description when, for example, “the specification describes a reason to exclude the relevant [element]” (e.g., “‘statements in the specification expressly listing the disadvantages of using’ that element”, “the specification ‘distinguishes among’ the element and alternatives to it”, “[s]ilence is generally not disclosure”; Santarus, FC 2015; Inphi, FC 2015; Nike, FC 2016; In re Johnson, CCPA 1977; Seabed, FC 2021; MPEP 2173.05(i)). It explained that WD could be satisfied even if the specification is silent as long as “the record established that in a particular field, the absence of mention of a limitation necessarily excluded that limitation” (Tronzo, FC 1998; Cont’l Can, FC 1991; In re Roberston, FC 1999). This FC panel found the evidence did not support a clear and convincing conclusion that the no loading dose negative limitation was sufficiently described (e.g., “the disclosure of a daily dosage cannot amount to a disclosure that there can be no loading dose, because such a finding is at odds with the prosecution history”, “there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure”). This FC panel also wrote that this opinion does not “create a heightened standard for negative claim limitations” and the specification need not “use the same words as the claims” (Santarus; Lockwood; Eiselstein, FC 1995). Judge Linn’s dissent argued, e.g., that Santarus “did not hold that a specification must describe a reason to exclude a negative limitation”, all that is required is a reasonable conveyance that “that the inventor had possession of the claimed subject matter as of the filing date”, and that such conveyance was found here (Ariad, FC 2010; In re Bimeda, FC 2013).
Brief Summary of original FC panel decision (now reversed): DC finding Novartis patent not invalid for lack of written description of negative limitation affirmed.
Summary of original FC panel decision (now reversed): HEC appealed DC bench trial decision that Novartis’ US 9,187,405 is not invalid for lack of written description and that HEC’s ANDA infringes. The Novartis product is a 0.5 mg daily dose of fingolimod hydrochloride (FH) sold as Gileyna for treatment of relapsing-remitting multiple sclerosis (RRMS), and the ‘405 patent is one of three patents listed on the Orange Book. Independent claim 1 of the ‘405 patent claims “[a] method for reducing or preventing or alleviating relapses in [RRMS]…comprising orally administering” a daily dosage of 0.5 mg FH including the negative claim limitation “absent an immediately preceding loading dose regimen.” The dependent claims include methods for “slowing progression of” RRMS. The ‘405 patent claims priority to a British application filed in 2006, which HEC argued “does not contain adequate written description of the ‘405 claims”. The FC panel explained that the 2006 application and the ‘405 patent “identify [FH] as a particularly preferred compound”, “describe the results of an Experimental Autoimmune Encephalomyelitis (‘EAE’) experiment” using FH (e.g., “disease relapse was completely inhibited” using a 0.3 mg daily dose, “a prophetic human clinical trial…in which patients would receive 0.5” PH without mentioning “a loading dose”, and “a wide range of potential doses” including “0.5 to 30 mg”. HEC appealed the DC’s “findings as to written description for the 0.5 mg daily dose and no-loading-dose limitations”. The DC relied upon Novartis’s expert witness testimony regarding “mak[ing] the leap from a 0.3 mg/kg weekly rat dosage to a 0.5 mg daily human dosage” and that “the 0.5 mg daily dose is also illustrated in the Prophetic Trial.” Regarding the “absent an immediately preceding loading dose” limitation, the DC “found sufficient written description in the EAE model and the Prophetic Trial” as “[n]either…recite a loading dose” and does not otherwise describe the use of loading doses (e.g., “thus, the patent provides sufficient written description of the negative limitation”). The FC panel reviewed the DC decision for “clear error” (Allergan, FC 2015) and explained that the WD requirement is met if a specification “reasonably conveys to those skilled in the art possession of the claimed subject matter” (Ariad, FC 2010). In FN6, the FC panel also notes that even if the 2006 application lacked WD, “the ’405 patent’s claims are not automatically rendered invalid; they are merely deprived of the 2006 priority date” (35 USC 119; Paice, FC 2018). The FC panel disagreed with HEC and found no clear error with the DC’s decision as to the 0.5 mg dose (e.g., “[t]he Prophetic Trial and the EAE model”, expert testimony). The FC panel explained that “[t]he ’405 patent does not contain the laundry-list-type disclosures that we have found require guidance to direct a skilled artisan to the claimed species” (Snitzer, CCPA 1972; Novozymes, FC 2013 (“blaze marks”); “efficacy is not a requirement of the claims” (Nuvo, FC 2008)). The FC panel also explained that “[i]t is well established that there is no “new and heightened standard for negative claim limitations” (Inphi, FC 2015 (“specification’s disclosure of alternative features was sufficient to satisfy the written description standard for the negative limitation”); Nike, FC 2017; Santarus, FC 2012 (“[n]egative claim limitations are adequately supported when the specification describes a reason to exclude the relevant limitation”); In re Bimeda, FC 2013 (“a negative limitation which is inconsistent with the disclosure is not adequately described”); Erfindergemeinschaft, ED TX aff’d by FC 2018 (“the law does not require that the disclosure explain a negative limitation” unless “contrary to the thrust of the invention”). And while MPEP 2173.05(i) states that “[t]he mere absence of a positive recitation is not a basis for an exclusion”, as does Judge Moore’s dissent, the FC panel wrote that both “ignore[] that it is how a skilled artisan reads a disclosure that matters” (Enzo, FC 2002 (WD inquiry “will ‘necessarily vary depending on the nature of the invention claimed’”; MPEP § 2163 (“newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure”)) and that it “reject[s] the invitation to create a heightened written description standard for negative limitations.” The FC panel also explained that while an issued patent “is presumed valid” and “to have a complete written description” (Nat’l Recovery, FC 1999), the same is not true of non-patent prior art (e.g., here, the Kappos 2006 abstract is also “silent on the presence or absence of a loading dose”) and found no clear error with the DC’s analysis (Teva, FC 2015). The DC decision was therefore affirmed.