Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC


Docket No. 2017-1671 (several others) (IPR2015-00545-48, -00551, -00554, -01903)

NEWMAN, LOURIE, REYNA
July 13, 2018

Brief summary: Board obviousness decision in several final written decisions affirmed (“no reason to exercise any discretion to remand the non-instituted claims or grounds sua sponte”, FDA materials publicly accessible printed publication, KSR does not provide “mandatory formula”).

Summary: Jazz appealed six IPR decisions regarding seven patents relating to “[a] computerized method of distributing a prescription drug” (a “sensitive drug”) “under exclusive control of an exclusive central pharmacy…requiring entering of” prescribing information ”into an exclusive computer database” and “generating…periodic reports via the exclusive computer database to evaluate potential diversion patterns”. The system is meant “to ‘reveal potential abuse of the sensitive drug, such as early refills.’” The FC panel opinion explains that “[o]ne such sensitive drug is Xyrem®” (gamma-hydroxybutyrate (“GHB”)) which Jazz exclusively markets for narcolepsy, but which “may also be illicitly used as a ‘date-rape drug’”. Par Pharmaceuticals was originally a party to the IPRs but Jaz and Par reached a settlement (FN3). The PTAB’s obviousness determations were based on FDA Advisory Committee background materials, minutes, transcript, and slides (“ACA materials”). The parties disputed whether the ACA materials were publicly accessible prior to the December 17, 2001 critical date. The Board determined the materials were available on the FDA’s website as of October 4, 2001, and would have been accessible to a person of ordinary skill (e.g., pharmacist, computer scientist). The Board also construed “periodic reports” to ‘refer to reports that are generated at regular intervals or intermittently” (Jazz argued for “regular intervals” only) and that the “information” is “not limited to the information listed in the specification or requiring all types of information.” Based on these constructions, the Board held all instituted claims…unpatentable as obvious over the ACA materials alone or in combination with” the Korfhage reference. The FC panel first explained that while the Board did not institute all of the claims and grounds raised by Amneal, the decisions satisfied “the finality requirement” of § 1295(a)(4)(A) (thus, the FC has jurisdiction) and neither party requested any SAS-based action; therefore, the FC panel saw “no reason to exercise any discretion to remand the non-instituted claims or grounds sua sponte” (“any error committed by the Board…in partially instituting IPR” is “waivable”) (SAS, US 2018; PGS, FC 2018). The FC panel also determined the Board correctly determined the ACA materials to be a “printed publication” under § 102(b), specifically “publicly accessible” (e.g., “no reasonable expectation of confidentiality”, “indexing or searchability is unnecessary”, “Federal Register was meaningfully indexed”) (In re NTP, FC 2011; MIT, FC 1985 (paper distributed “to no more than six other persons, without restrictions” corresponding to oral presentation was prior art); In re Klopfenstein, FC 2004 (slides presented at scientific meetings prior art “sufficiently publicly accessible” even though “never distributed” or “indexed”); Cordis, FC 2009 (medical resident’s “scientific monograph” given to approximately six teachers not prior art as “academic norms gave rise to an expectation” of confidentiality); Medtronic, FC 2018 (video distributed on CD as scientific meeting was prior art printed publication)). The FC panel also agreed with the Board’s claim construction and obviousness determinations. On obviousness, the FC panel found the Board’s conclusions to be consistent and explained that KSR “did not set forth…factors” such as “a design need or market pressure to solve a problem and…a finite number of identified, predictable solutions” “as part of a mandatory formula”. The FC panel also found no error with the “Board’s finding of a motivation to modify” (“would have been a predictable use of a known distributed data system according to its established function”), about which Jazz did not argue. The Board decision was therefore affirmed.

This entry was posted in Anticipation (35 USC 102), Claim Construction, Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

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