Apotex v. OSI Pharmaceuticals: Beware What You Say To The SEC

February 12, 2018

In a recent IPR between Apotex v. OSI Pharmaceuticals, the PTAB relied on an OSI Securities and Exchange Commission (SEC) filing, a 10-K, to find the challenged claims unpatentable.  (A 10-K is an SEC filing that provides a summary of a company’s financial performance).

So why did the PTAB rely on the 10-K?

The challenged claims in OSI’s patent were directed to methods of treating non-small cell lung cancer (NSCLC) in a mammal  by administering a therapeutically-effective amount of erlotinib. The primary reference (Schnur) disclosed treating lung cancer generally, but not NSCLC. So the issue in the IPR was whether one of ordinary skill in the art would have had a reasonable expectation of treating NSCLC using eroltnib based on secondary references. 

Apotex asserted that OSI’s 10-K was a secondary reference that provided a reasonable expectation of success, arguing that “the preferred use of erlotinib to treat NSCLC is made explicit when Schnur is viewed through the lens of OSI’s 10-K.” 

OSI’s 10-K disclosed:

With its collaborative partner Pfizer, OSI has focused since 1986 on the discovery and development of novel classes of orally active, molecularly targeted, small molecule anticancer drugs based on oncogenes and tumor suppressor genes and the fundamental mechanisms underlying tumor growth. The first of these programs to yield a clinical candidate, [erlotinib], which targets a variety of cancers including ovarian, pancreatic, nonsmall 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.

In response, OSI argued that one of ordinary skill in the art would not have relied on such a financial document to find motivation to treat NSCLC.  OSI also argued that none of the prior art (including the 10-K) “include(d) any evidence of using erlotinib against NSCLC,” and that one of ordinary skill in the art would not have had any reason to treat NSCLC using erlotinib “[g]iven the undisputed lack of data concerning the use of erlotinib in NSCLC as of the time of the claimed invention.”

The PTAB agreed with Apotex.

First, the PTAB found that OSI’s 10-K could be relied upon as a reference, stating that “competitor pharmaceutical companies working in the same area as [OSI] at the time of invention, which would have employed medical oncologists who met the requirements of an ordinary artisan, would have been aware of company filings such as OSI’s 10-K” and that such competitors would have looked to OSI’s 10-K to determine which drugs and treatments pharmaceutical companies were pursuing. 

Second, the PTAB found that “given Schnur’s suggestion of treating lung cancer with erlotinib and related compounds, OSI’s 10-K would have provided the ordinary artisan a reason to use erlotinib to treat non-small cell lung cancer.”  The PTAB did not find the lack of data in OSI’s 10-K to be critical given the breadth of the challenged claims.  The PTAB concluded that the claims did not require administration of a clinically effective amount of erlotinib to a human, so proof of efficacy, such as demonstration of clinical efficacy in human NSCLC patients, was not required to demonstrate obviousness of the claims (only some level of therapeutic benefit, such as alleviating the progress of the disease, was needed).

It will be interesting to see what happens in this case on appeal.  At minimum, however, the case illustrates the potential risk associated with public disclosures in documents filed with governmental agencies prior to filing a patent application for an invention – such disclosures could constitute troublesome prior art to the patent application.  So when preparing filings for the SEC (or other agencies), be careful what you say about your invention!