IP Law Daily PTAB erred in invalidating as obvious claims of patent for lung cancer treatment drug Tarceva®
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Friday, October 4, 2019

PTAB erred in invalidating as obvious claims of patent for lung cancer treatment drug Tarceva®

By Cheryl Beise, J.D.

The Board misinterpreted two prior art references to find a reasonable expectation of success.

The U.S. Court of Appeals for the Federal Circuit has reversed a Patent Trial and Appeal Board inter partes review decision finding that four claims of a patent claiming use of the compound erlotinib for treating non–small cell lung cancer were unpatentable as obvious over a combination of three prior art references. Substantial evidence did not support the Board’s interpretation of the cited references or its finding of a reasonable expectation of success for use of erlotinib for treating non–small cell lung cancer in a mammal (OSI Pharmaceuticals, LLC v. Apotex Inc., October 4, 2019, Stoll, T.).

OSI Pharmaceuticals, LLC("OSI") owns U.S. Patent No. 6,900,221 ("the ’221 patent"), issued on May 31, 2005, in connection with non-chemotherapy drug compounds for treatment of non–small cell lung cancer (NSCLC) using N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazo-linamine, also known as erlotinib. The’221 patent claims priority to three provisional applications (filed on November 11, 1999, March 30, 2000, and May 23, 2000) and is listed in the Food and Drug Administration Orange Book for OSI’s erlotinib treatment drug, marketed under the brand name Tarceva®.

Apotex, Inc. filed a petition for inter partes review. The Board instituted review and held claims 44–46 and 53 of the ’221 patent unpatentable on the asserted ground of obviousness over U.S. Patent No. 5,747,498 ("Schnur"), in view of Jackson B. Gibbs, Anticancer Drug Targets: Growth Factors and Growth Factor Signaling, 105 J. CLINICAL INVESTIGATION 9, 9–13 (2000) ("Gibbs’) or OSI Pharmaceuticals, Inc., Annual Report (Form 10-K) (Sept. 30, 1998) ("OSI 10-K"). OSI appealed.

Constitutionality of IPR. OSI challenged the constitutionality of the Board’s IPR decision. Following oral argument in this case, the Federal Circuit noted that it issued multiple decisions holding that the application of IPR to pre-AIA patents does not violate the Constitution. OSI conceded that these decisions foreclosed its constitutional challenge at this point.

Obviousness. OSI challenged the Board’s obviousness determination, arguing that the Board’s finding of a reasonable expectation of success was not supported by substantial evidence. The Board determined that the asserted combinations of Schnur with Gibbs and Schnur with OSI’s 10-K each would have provided a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal. Schnur broadly discloses at least 105 compounds for the treatment of twelve different types of cancer, but it does not suggest the use of erlotinib treat NSCLC. According to the Board, Schnur discloses all of the limitations of claims 44 and 53 except for the treatment of NSCLC. The Board found a "clear inference" in Gibbs that "erlotinib has anti-cancer activity against non–small cell lung cancer." The Board also reasoned that the disclosures in OSI’s 10-K—that erlotinib targeted a variety of cancers including NSCLC, and that erlotinib had entered Phase II clinical trials—would have provided a person of ordinary skill with a reasonable expectation of success in light of Schnur’s teachings.

The Federal Circuit held that the Board’s finding was not supported by substantial evidence. First, the Board misinterpreted the asserted references. None of the references discloses anydata or other information about erlotinib’s efficacy in treating NSCLC. Gibbs is a review article that collects, reviews, and analyzes other research studies, but none of the publications cited in Gibbs discussed erlotinib’s effect on NSCLC. Dr. Gibbs himself confirmed in a declaration before the Board that he was not aware of any such publications. In addition, there was nothing in OSI’s 10-K suggesting the existence of erlotinib preclinical efficacy data that was specific to NSCLC. "Even if a skilled artisan could presume that some preclinical data exists, there is no basis for assuming that the data pertains to NSCLC as opposed to other cancers," the court said.

The Federal Circuit found no basis for concluding that the combination of Schnur and either Gibbs or OSI’s 10-K provided a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal. "The record does not contain any clinical (human) data or pre-clinical (animal) data. It does not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC," the court said. The lack of erlotinib-NSCLC efficacy data or other indication of success is particularly significant in view of the undisputed fact that that NSCLC treatment was highly unpredictable, with an over 99.5% rate of failure for drugs entering Phase II clinical studies. "Given this high failure rate, a fact finder could not reasonably find that the 10-K statement combined with Schnur would have been sufficient to create a reasonable expectation of success," the court said.

On this record, the Board’s finding of a reasonable expectation of success was not supported by substantial evidence. Board’s obviousness determination was accordingly reversed.

This case is No. 2018-1925.

Attorneys: Thomas Saunders (Wilmer Cutler Pickering Hale and Dorr LLP) for OSI Pharmaceuticals, LLC. William Blake Coblentz (Cozen O'Connor PC) for Apotex Inc., Apotex Corp. and Apotex Pharmaceuticals Holdings Inc.

Companies: OSI Pharmaceuticals, LLC; Apotex Inc.; Apotex Corp.; Apotex Pharmaceuticals Holdings Inc.

MainStory: TopStory Patent FedCirNews

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