Reasonable expectation of success continues to dominate the headlines in pharmaceutical patent cases. In its latest decision, the United States Court of Appeals for the Federal Circuit reversed a Patent Trial and Appeal Board (“PTAB”) decision to invalidate claims to the treatment of non-small cell lung cancer (“NSCLC”), in OSI Pharm., LLC v. Apotex Inc., No. 2018-1925, 2019 U.S. App. LEXIS 29851 (Fed. Cir. Oct. 4, 2019).
The patent at issue, U.S. Patent No. 6,900,221, claimed:
44. A method for the treatment of NSCLC (non small cell lung cancer), pediatric malignancies, cervical and other tumors caused or promoted by human papilloma virus (H[P]V), Barrett's esophagus (pre-malignant syndrome), or neoplastic cutaneous diseases in a mammal comprising administering to said mammal a therapeutically effective amount of [erlotinib].
The PTAB had invalidated the patent based largely on the following statement in a review article by Dr. Jackson B. Gibbs:
ZD-1839 and [erlotinib], competitive inhibitors of ATP binding to the [EGFR]'s active site, are currently in clinical trials (12, 13). . . . However, these compounds appear to have good anti-cancer activity in preclinical models, with an acceptable therapeutic index, particularly in patients with non-small cell lung cancer.
In addition, OSI made the following statement in its annual report to shareholders:
[Erlotinib], which targets a variety of cancers including ovarian, pancreatic, non-small cell lung and head and neck, achieved a significant milestone with the completion of Phase I safety trials and the initiation of Phase II clinical trials in the United States in cancer patients. [Erlotinib] is a potent, selective and orally active inhibitor of the epidermal growth factor receptor, a key oncogene in these cancers.
According to the PTAB, this evidence supported a "clear inference" that "erlotinib has anti-cancer activity against non-small cell lung cancer."
The Federal Circuit disagreed. As an initial matter, the Gibbs article did not include or refer to any data indicating that erlotinib had activity against NSCLC. OSI submitted a declaration from Dr. Gibbs, the author of the article, who stated:
Based on references 12 and 13, the abstracts from the 1999 ASCO and AACR Conferences, and my own personal recollection, my research at the time of my article did not identify any information suggesting that [erlotinib] exhibited anti-tumor activity in NSCLC. I was (and still am) not aware of any published abstracts or articles describing the clinical or preclinical response of a NSCLC tumor to [erlotinib] that were available as of the time my article was published, and I reviewed no such abstracts or articles in drafting my article.
In addition, the evidence of record merely demonstrated that erlotinib had entered phase II clinical trials, and OSI had submitted proof that 99.5% of drugs entering phase II for NSCLC cancer fail to gain FDA approval. As the Federal Circuit explained.
A great majority of therapies for NSCLC failed in clinical trials. "In non-small-cell lung cancer alone, between 1990 and 2005, a total of 1,631 new drugs were studied in phase II. Only seven of these new agents gained FDA approval."
Without relevant data, and this huge failure rate, the record failed to support a reasonable expectation of success in NSCLC, in spite of the vague rosy predictions in the prior art.