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OSI Pharms., LLC v. Apotex Inc.

United States Court of Appeals for the Federal Circuit

October 4, 2019, Decided

2018-1925

Opinion

 [*1377]  Stoll, Circuit Judge.

OSI Pharmaceuticals, LLC appeals the decision of the Patent Trial and Appeal Board holding claims 44-46 and 53 of U.S. Patent No. 6,900,221 unpatentable as obvious. We conclude that the Board's finding of reasonable expectation of success is not supported by substantial evidence and reverse the Board's obviousness determination.

Background [**2] 

I. Non-Small Cell Lung Cancer and the '221 Patent

Non-small cell lung cancer (NSCLC) was the leading cause of cancer deaths in 2000, claiming more than 1 million lives. The standard for treating NSCLC at the time was chemotherapy, which ameliorated some lung cancer-related symptoms, but was limited in use due to toxicity. Chemotherapy nonspecifically kills normal proliferating cells in addition to cancerous cells, and can result in the patient experiencing side effects such as nausea, vomiting, hair loss, and neuropathy.

By the late 1990s, there was a recognized need for a new therapy that would be both effective and well tolerated. In response, investigators pursued targeted therapies as alternatives to chemotherapy. One avenue of research involved investigating agents that inhibit the epidermal growth factor receptor (EGFR). Activation of the EGFR triggers a cascade of events leading to cell reproduction, and it was hypothesized that inhibiting the EGFR would be beneficial in treating tumor cells. EGFR inhibitors were investigated as potential agents for treating NSCLC, but many of these compounds failed in clinical trials.

Cancer treatment is highly unpredictable. Even though the EGFR was identified [**3]  in some cancers as a drug target, the in vitro (i.e., in a test tube) effectiveness of a drug in inhibiting the EGFR turned out to be a poor proxy for how effective that drug actually was in treating cancer in vivo (i.e., in the body). Numerous EGFR inhibitors that showed promising in vitro activity failed for a variety of reasons.  [*1378]  These included poor pharmacokinetics due to poor absorption or rapid metabolism (or both), undesirable drug-drug interactions, drug toxicity due to drug binding onto healthy cells, drug toxicity due to binding onto other receptors, and metabolite toxicity. Some drug candidates were limited by one or more of these shortcomings, further underscoring the unpredictable nature of cancer treatment.

A drug compound must pass three phases of human clinical trials in order to obtain FDA approval. A threshold step is to gain the FDA's permission to test the compound in humans in the first place. After a drug developer has conducted preclinical studies, i.e., tested the compound in vitro (in a test tube; outside of a living organism) and in animals, it submits an Investigational New Drug (IND) application to the FDA. An IND submission includes an investigator's brochure, [**4]  which discloses information such as animal safety and preclinical efficacy data, clinical trial proposals, and toxicology data. If the FDA approves the IND, then Phase I studies can commence. Phase I studies involve administering the compound to a small group of healthy volunteers or advanced cancer patients with a variety of tumor types. Phase I studies are conducted primarily to evaluate safety, to determine a safe dosing range, and to identify any side effects.

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939 F.3d 1375 *; 2019 U.S. App. LEXIS 29851 **; 2019 U.S.P.Q.2D (BNA) 379681; 2019 WL 4892078

OSI PHARMACEUTICALS, LLC, Appellant v. APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS HOLDINGS INC., APOTEX HOLDINGS INC., Appellees UNITED STATES, Intervenor

Prior History:  [**1] Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2016-01284.

Disposition: REVERSED.

CORE TERMS

erlotinib, reasonable expectation, cancer, Phase, compounds, cell, references, preclinical, efficacy, studies, clinical trial, lung cancer, tumor, substantial evidence, discloses, treating, non-small, patients, anti-cancer, skill, effective, ordinary person, therapeutic, targeted, Patent, animal, mammal, combinations, inhibiting, inhibitors

Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, Substantial Evidence, Infringement Actions, Summary Judgment, Nonobviousness, Elements & Tests, Evidence, Fact & Law Issues