OSI Pharmaceuticals, LLC v. Apotex Inc, No. 18-1925 (Fed. Cir. 2019)Annotate this Case
Non-small cell lung cancer (NSCLC) was the leading cause of cancer deaths in 2000. The standard for treating NSCLC was chemotherapy, which ameliorated some lung cancer-related symptoms, but was limited in use due to toxicity. In response to a need for a therapy that would effective and well-tolerated, investigators pursued targeted therapies as alternatives to chemotherapy. A great majority of alternative therapies for NSCLC failed in clinical trials. One compound that ultimately gained FDA approval was erlotinib. OSI markets erlotinib under the name Tarceva®, which is covered by the 221 patent, which issued in 2005. On inter partes review, the Patent Board found certain claims unpatentable under 35 U.S.C. 103, in light of prior art and the 10-K disclosure filed by OSI with the Securities and Exchange Commission. The Federal Circuit reversed. Substantial evidence did not support the Board’s finding that the asserted combinations of prior art or prior art and the 10-K disclosures each would have provided a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal.