Ruxolitinib – USA

Ruxolitinib – USA

Decision on IPR: Apr 08, 2019

AIA Review
Filing Date
Institution Date
Petitioner
US Patent
Respondent
FINAL WRITTEN DECISION
IPR2017-01256
04/07/2017
04/09/2018
Incyte Corporation
9,249,149
Concert Pharmaceuticals, Inc.
 Claims 1–15 are unpatentable
US 9,249,149 (Concert Pharma.; Exp: Jun 14, 2033) – non OB

1. A compound of Formula A: ##STR00018## or a pharmaceutically acceptable salt thereof, wherein: Y.sup.1 is hydrogen; each Y.sup.2 is selected from hydrogen and deuterium, and each Y.sup.2 is the same; each Y.sup.3 is selected from hydrogen and deuterium, and each Y.sup.3 is the same; Y.sup.4 is selected from hydrogen and deuterium; each Y.sup.5 is the same and is selected from hydrogen and deuterium; and Y.sup.6, Y.sup.7, Y.sup.8 , Y.sup.9 and Y.sup.10 are each independently selected from hydrogen and deuterium; provided that: each Y.sup.2 is deuterium; or each Y.sup.3 is deuterium; or each Y.sup.2 and each Y.sup.3 is deuterium.
9. A compound of Formula I: ##STR00020## or a pharmaceutically acceptable salt thereof, wherein: Y.sup.1 is hydrogen; each Y.sup.2 is selected from hydrogen and deuterium, and each Y.sup.2 is the same; each Y.sup.3 is selected from hydrogen and deuterium, and each Y.sup.3 is the same; Y.sup.4 is selected from hydrogen and deuterium; each Y.sup.5 is the same and is selected from hydrogen and deuterium; and Y.sup.6, Y.sup.7 and Y.sup.8 are each independently selected from hydrogen and deuterium; provided that: each Y.sup.2 is deuterium; or each Y.sup.3 is deuterium; or each Y.sup.2 and each Y.sup.3 is deuterium.
The ’149 patent is entitled “Deuterated Derivatives of Ruxolitinib.”
PTAB in summary concluded that the challenged claims of the ’149 patent are unpatentable as obvious over Rodgers, Shilling, and the Concert Backgrounder. Specifically combined teachings of Rodgers, Shilling, and the Concert Backgrounder would have provided a person of ordinary skill in the art a reasonable expectation of successfully deuterating Rodgers’s ruxolitinib compounds at their metabolic “hot spots,” as identified by Shilling, and in the manner taught by the Concert Backgrounder. Person of ordinary skill in the art would have understood from Shilling that Rodgers’s ruxolitinib compounds feature the metabolic “hot spots” targeted by the Concert Backgrounder for deuteration, and that the Concert Backgrounder teaches that such deuteration has the potential to improve the safety, tolerability, and efficacy of those compounds. PTAB also concluded that Petitioner has established by a preponderance of the evidence that a skilled artisan would have had a reasonable expectation that the synthesized ruxolitinib analogs “may display” superior ADME properties, based upon the combined teachings of Shilling and the Concert Backgrounder.
Interestingly, Patent Owner argued that Petitioner has failed to carry its burden of proving that the “Concert Backgrounder” is a prior art printed publication. Patent Owner asserted that Petitioner has failed to meet its burden by relying “on a ‘cached WebCite® page’ to demonstrate public accessibility,” because “availability on the internet alone is not sufficient to show public accessibility.” Patent Owner asserted that Petitioner has not provided “evidence that WebCite® was catalogued or indexed such that POSAs would have been able to access the Concert Backgrounder on WebCite®, whether through search engine results or by a search of WebCite® itself.” Patent Owner further argued that Petitioner’s evidence establishes only that the Concert Backgrounder was available on WebCite® in 2009, and that the author of the law review article and the examiner who completed the International Search Report both “possessed the full WebCite address for the Concert Backgrounder.” With respect to the admissibility of “Concert Backgrounder”  as prior art PTAB determined that Petitioner’s evidence demonstrating publication of the Concert Backgrounder on the internet, along with the dissemination of the website to patent examiners and an author of a law review article directed to the subject matter of the reference, provides “a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Indeed, the Federal Circuit has recognized that “a published article with an express citation to the potentially invalidating reference would similarly provide the necessary guidance.”

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