Post-Grant Review PGR2017-00034 (U.S. Pat. No. 9,662,335 B2)
Decision not to institute PGR
January 11, 2019
Brief summary: Concert’s Petition to institute PGR of Incyte’s US 9,662,335 B2 regarding deuterated ruxolitinib was denied.
Summary: Concert filed a Petition to institute PGR of claims 1-6 of Incyte’s US 9,662,335 B2, alleging lack of written description (WD), lack of enablement, and anticipation by the prior art (Silverman). The ‘335 patent relates to deuterated ruxolitinib but is not listed on the Orange Book for Incyte’s ruxolitinib Janus kinase (JAK) inhibitor (NDA 202192), but may relate to Concert’s pipeline product CTP-543 (deuterated ruxolitinib). The Board decision indicates that “[t]he ‘335 patent discloses that labeled compounds of the invention are useful for imaging techniques and ‘also in assays, both in vitro and in vivo, for localizing and quantitating JAK”. Independent ‘335 claim 1 claims ruxolitinib “wherein one or more hydrogen atoms are replaced by deuterium; or a pharmaceutical salt thereof” while independent claims 3 and 5 encompass R- and S- enantiomers of deuterated ruxolitinib, respectively. The Board explained that PGR is available for patents with “at least one claim with an ‘effective filing date’…or or after March 16, 2013. The ‘335 patent was filed on June 3, 2016 from continuations dating back to December 12, 2006. But Concert asserted “that none of the challenged claims were adequately enabled or described in any parent application” and that “each challenged claim has an effective filing date of June 3, 2016”. However, the Board concluded “that the challenged claims are entitled to a priority date of at least December 12, 2006” and, “[t]herefore…the ‘335 patent is not eligible for post-grant review.” The claims were interpreted under the broadest reasonable construction standard (“‘ordinary and customary meaning,’ as would be understood by one of ordinary skill at the time of the invention” (In re Translogic, FC 2007; Phillips, FC 2005). “[O]ne or more hydrogen atoms” was construed to mean “any one or combination of the 18 hydrogen atoms of ruxolitinib may be replaced by deuterium” as suggested by Concert, and not objected to by Incyte. On written description challenge, the Board agreed with Incyte that Concert failed to show a lack of WD, finding “the ‘335 patent describes ruxolitinib as a compound of the invention with great particularity, including by name, chemical structure, and exemplary synthesis” and “deuterium isotopes of the ‘compounds of the invention’” (e.g., “can also include all isotopes of atoms…For example, isotopes of hydrogen include tritium and deuterium…The present invention further includes isotopically-labeled compounds of the invention.”) The Board also rejected Concert’s lack of enablement arguments since “deuteration of compounds was a known process and the accompanying disclosure in the specification need only be sufficient to enable those skilled in the art to achieve deuterated ruxolitinib, a compound of the invention that was described with great particularity” and “a person of ordinary skill in the art would have been able to make or carry out the claimed invention without undue experimentation” (Hybritech, FC 1986 (“[A] patent need not teach, and preferably omits, what is well known in the art.”)) This is so, the Board noted, “even if some deuterated ruxolitinib compounds were difficult or impossible to make” (Atlas Powder, FC 1984; In re Ding-Nguyen, CCPA 1974 (“It is not a function of the claims to specifically exclude…possible inoperative substances….”)). The anticipation argument was based on the alleged June 3, 2016 effective filing date, with which the Board disagreed, therefore finding the Silverberg reference was not shown to be prior art. Concert’s Petition was therefore denied.