Arch Dev. Corp., Dana-Farber Cancer Inst., Inc. v. OSI Pharm., LLC and Genentech, LLC

Docket 2018-1485 (IPR2016-01034)
May 9, 2019

Brief summary: PTAB IPR final written decision finding Arch’s claims invalid for obviousness affirmed.

Summary: The PTAB (“Board”) granted OSI’s IPR Petition and issued a final written decision (FWD) finding Arch’s claims 1-3, 5, and 6 of US 7,838,512 B1 (expired as of April 8, 2015) directed to a “method of improving chemotherapeutic intervention” using “a chemotherapeutic DNA damaging agent” (“chemotherapeutic” being added by Certificate of Correction, see FN10 of FWD) and a “therapeutically effective amount of a low molecular weight tyrosine kinase inhibitor” invalid for obviousness on two different combinations of references. The FC panel affirmed the Board’s FWD without opinion. In the FWD, the Board construed “therapeutically effective amount” as “an amount that would be sufficient to have a desired therapeutic effect” (expired patent reviewed under Phillips (FC 2005), ordinary and customary meaning in light of the claim language, specification and prosecution history) (“[W]e are not convinced that the inventors’ express definition of ‘therapeutically effective amount’ applies to the tyrosine kinase inhibitor…as opposed to the combination of inhibitor and DNA damaging agent”). The Parties disagreed as to whether “the terms ‘enhanc[ing] cell death’ and ‘enhancing apoptosis’ encompass inducing an otherwise immortal cancer cell to differentiate and, eventually, die”, and the Board found that it does based on the ‘512 specification and prosecution history which, “read in the context of the Specification”, “makes clear that inducing differentiation is not the same a cell killing” (Retractable, FC 2011 (“we strive to capture the scope of the actual invention, rather than…allow the claim language to become divorced from what the specification conveys is the invention”)). The Parties agreed “that the preamble of each challenged claim, as well as the ‘thereby’ clause of claims 1-3…are non-limiting.” On obviousness, the Board first found that claims 1-3 and 5 were not shown by a preponderance of the evidence to be invalid for obviousness in view of the first combination of references (e.g., “On balance, we are not convinced that Petitioner has shown, by a preponderance of the evidence, that Honna teaches or suggests cell death or apoptosis as opposed to antiproliferative activity and differentiation.”) But the Board found claim 6, which “recites that the” drugs “act in combination to alter the cell’s response to the [DNA damaging] agent”, invalid in view of that combination and the Board’s construction of “therapeutically effective amount”. The Board also found claims 1-3, 5 and 6 were shown by a preponderance of the evidence to be invalid for obviousness based on the second combination of references (e.g., “a strong indication for combining both drugs”, expert testimony, claims do not “specify that ‘tyrosine kinase inhibition itself causes any particular effect’”, “Patent Owner’s unsupported assertion” (Meitzner, CCPA 1977)).

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Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.