Background and Context
The litigation between OSI Pharmaceuticals, LLC and Apotex Inc. revolves around the validity of certain claims of U.S. Patent No. 6,900,221 B1, which pertains to the use of erlotinib, a targeted therapy for non-small cell lung cancer (NSCLC), among other conditions. Erlotinib is marketed by OSI under the name Tarceva®.
The Patent and Its Claims
The ’221 patent, issued on May 31, 2005, claims priority to several provisional applications filed between 1999 and 2000. The patent is listed in the Orange Book for Tarceva® and includes claims 44-46 and 53, which are central to the dispute. These claims describe methods for treating various cancers, including NSCLC, using a therapeutically effective amount of erlotinib or its pharmaceutically acceptable salts[1][3][4].
Inter Partes Review (IPR) Proceedings
Apotex Inc. initiated an inter partes review (IPR) challenging the patentability of claims 44-47 and 53 of the ’221 patent. The Patent Trial and Appeal Board (PTAB) instituted the IPR on January 9, 2017, based on a reasonable likelihood that Apotex would prevail in showing the unpatentability of the challenged claims under 35 U.S.C. § 103(a)[2][4].
Prior Art and Obviousness
The PTAB reviewed prior art references, including Schnur and Gibbs, to determine if the claims would have been obvious to a person of ordinary skill in the art. Schnur disclosed the use of EGFR inhibitors for treating various human tumors but did not specifically mention NSCLC. Gibbs and OSI’s 10-K filings indicated that erlotinib had good anti-cancer activity in preclinical models, particularly for NSCLC, and that it had entered Phase II clinical trials[1][3][4].
The PTAB found that a person of ordinary skill would have had a reasonable expectation of success in combining these references to treat NSCLC with erlotinib, thus rendering claims 44-46 and 53 obvious over the prior art[1][3][4].
Appeal to the Federal Circuit
OSI Pharmaceuticals appealed the PTAB's decision to the United States Court of Appeals for the Federal Circuit. OSI argued that the PTAB’s finding of a reasonable expectation of success was not supported by substantial evidence. They also challenged the constitutionality of the IPR process, though this aspect was not the primary focus of the appeal[1].
Federal Circuit Decision
The Federal Circuit overturned the PTAB's decision, finding that the Board’s conclusion of obviousness lacked substantial evidence. The court emphasized that the prior art did not provide reliable data or clinical evidence supporting the efficacy of erlotinib in treating NSCLC. The decision highlighted the high failure rate of EGFR inhibitors in clinical settings despite promising in vitro results, which undermined the PTAB’s assumption of a reasonable expectation of success[1][3].
Implications and Analysis
Fact-Specific Nature of the Decision
The Federal Circuit's decision in OSI Pharmaceuticals v. Apotex is highly fact-specific and may not serve as a broad precedent for overcoming Section 103 rejections in pharmaceutical method of treatment claims. The case underscores the importance of detailed clinical and preclinical data in supporting patent claims, especially in the context of targeted therapies where in vitro success does not guarantee in vivo efficacy[3].
Clinical and Preclinical Data
The decision emphasizes the critical role of clinical and preclinical data in establishing the non-obviousness of a patent claim. The lack of such data in the prior art references was a key factor in the Federal Circuit's reversal of the PTAB's decision. This highlights the need for robust evidence to support the patentability of medical treatment claims[1][3].
IPR Process and Constitutional Challenges
While OSI raised constitutional challenges to the IPR process, the Federal Circuit did not address this issue in detail. The focus remained on the substantive patent law issues, specifically the obviousness determination[1].
Related Proceedings and Context
The ’221 patent was also involved in other litigation, including cases against Mylan Pharmaceuticals and Breckenridge Pharmaceuticals. These proceedings are part of a broader landscape of patent disputes in the pharmaceutical industry, particularly around generic challenges to branded drugs[2][4].
Key Takeaways
- Fact-Specific Decisions: The Federal Circuit's decision in OSI Pharmaceuticals v. Apotex is highly fact-specific and may not be broadly applicable to other pharmaceutical method of treatment claims.
- Importance of Clinical Data: Robust clinical and preclinical data are crucial in establishing the non-obviousness of patent claims, especially in targeted therapies.
- IPR Process: The case highlights the complexities and challenges of the IPR process, particularly in evaluating the obviousness of pharmaceutical patents.
- Patent Litigation Landscape: The dispute is part of a larger context of patent litigation in the pharmaceutical industry, where generic manufacturers often challenge the validity of branded drug patents.
Frequently Asked Questions (FAQs)
What was the main issue in the OSI Pharmaceuticals v. Apotex case?
The main issue was whether claims 44-46 and 53 of U.S. Patent No. 6,900,221 B1, related to the use of erlotinib for treating NSCLC, were obvious over prior art references.
What prior art references were cited in the case?
The prior art references included Schnur and Gibbs, as well as OSI’s 10-K filings.
Why did the Federal Circuit overturn the PTAB's decision?
The Federal Circuit overturned the PTAB's decision because the Board’s finding of a reasonable expectation of success was not supported by substantial evidence, particularly lacking reliable clinical and preclinical data.
What is the significance of the OSI Pharmaceuticals v. Apotex decision for pharmaceutical patents?
The decision emphasizes the importance of robust clinical and preclinical data in supporting the patentability of medical treatment claims and highlights the fact-specific nature of such decisions.
Were there any constitutional challenges raised in the case?
Yes, OSI raised constitutional challenges to the IPR process, but these were not addressed in detail by the Federal Circuit.
Sources Cited
- OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375 - Casetext
- IPR2016-01284, No. 8 Institution Decision - Finnegan
- OSI Pharmaceuticals Decision Has Limited Use in Supporting Patentability of Pharmaceutical Method of Treatment Claims - IPWatchdog
- FINAL WRITTEN DECISION, IPR2016-01284 - Finnegan
