PTAB IPR decision finding OSI’s Tarceva® patent obvious reversed (e.g., “unpredictability in cancer treatment generally”, reasonable expectation of success only with hindsight)

OSI Pharmaceuticals, LLC v. Apotex Inc. et al.

Docket No. 2018-1925 (IPR2016-01284)
October 4, 2019

Brief Summary: PTAB’s IPR decision holding OSI’s OB ‘221 patent obvious reversed (e.g., the PTAB “misinterpreted the asserted references”, “NSCLC treatment was highly unpredictable”).

Summary: OSI appealed PTAB IPR decision holding claims 44-46 and 53 of OSI’s Orange Book (OB) patent US 6,900,221 (listed for the epidermal growth factor receptor (EGFR) inhibitory Tarceva® (erlontinib HCl, along with one other unexpired patent; NDA 021743)) directed to methods for treating non-small cell lung cancer (NSCLC). The ‘221 patent specification describes “treating” as “reversing, alleviating, inhibiting the progress of, or preventing the disorder or condition”. The PTAB concluded that the ‘221 claims would have been obvious in view of Schnur (erlotinib for treating “lung cancer”, but not NSCLC as “one of the many conditions that could be treated”) in view of Gibbs (a review article describing erlotinib as being in clinical trials and referring to two other references, not referring to NSCLC) or OSI’s 10-K (mentioning but not disclosing data regarding NSCLC). The FC panel reviewed the PTAB’s legal conclusions (obviousness) de novo and its underlying fact findings for substantial evidence (Intelligent Bio-Sys., FC 2016; Consol. Edison, US 1938; Intel. Vent., FC 2017 (“[m]ere speculation’ is not substantial evidence”)). The FC panel disagreed with the PTAB’s decision, finding it “misinterpreted the asserted references to teach more than substantial evidence supports”, and that it did not “provide a reasonable expectation of success”. The FC panel explained that “the claims require only treatment of a mammal…efficacy in humans is not required”, “the asserted references do not disclose any data or other information about erlotinib’s efficacy in treating NSCLC” (e.g., evidenced by Gibbs’s declaration to the PTAB), “[t]he record does not contain any clinical (human) data or preclinical (animal) data” (e.g., “i]t does not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC”), and “it is undisputed that NSCLC treatment was highly unpredictable with an over 99.5% rate of failure for drugs entering Phase II clinical studies” (e.g., “it is undisputed that a drug’s success in treating one type of cancer does not necessarily translate to success in treating a different type of cancer, which underscores the unpredictability in cancer treatment generally”, “99.5% failure rate of the other 1,630 drugs entering Phase II trails for the treatment of NSCLC”, reasonable expectation of success “only with the benefit of hindsight”). OSI also challenged the constitutionality of IPRs but the FC panel disagreed (“Following oral argument in this case, we issued multiple decisions holding that the application of IPR to pre-AIA patents does not violate the Constitution.” Celgene, FC 2019; Arthrex, FC 2019). Thus, the PTAB’s IPR obviousness decision was reversed.

This entry was posted in Claim Construction, Generics / ANDA, Inter Parties Review (IPR), IPR, Method claims, Obviousness, Uncategorized. Bookmark the permalink.

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