Highlights from the USPTO Interim Guidance on Subject Matter Eligibility (Dec. 2014) 6 Includes all claims (product and process) “directed to” a judicial exception Step 2A analysis: compare product in the claim to its naturally occurring counterpart to identify markedly different characteristics —Includes structure, function, and/or other characteristics Step 2B analysis: determine if additional elements add significantly more to the exception Streamlined eligibility analysis: claim clearly does not seek to pre- empt all uses of the exception Clear statement that mere possibility that something exists in nature does not bar eligibility Kimya Harris 3.4.2015
Comparison of Patent Eligibility for Diagnostics Worldwide 7 EuropeCanadaJapanAustralia Methods- Patentable - Must have in vitro step - Patentable - “Diagnostic method” or “diagnostically effective amount” - Not patentable - “Method of using X as an indicator for Y” Patentable Compositions & Kits Patentable - Patentable - Composition limited by use Patentable Relevant Court Decisions - Myriad patents opposed - Patents upheld on appeal - Patent eligible subject matter affirmed - No Myriad challenges - CHEO challenged gene patent No Myriad challenges - Myriad upheld by Federal Court of Australia - “Isolated genes are not naturally occurring” - Standard for “invention” is an artificially created state of affairs Kimya Harris 3.4.2015
Case Studies 8 Correlation between a SNP in a certain gene (or SNPs in multiple genes) and diagnosis of a specific disease. Higher levels of phosphorylation at a specific serine position of a certain protein represents a biomarker of patients with bipolar disease who will respond to lithium treatment (patient stratification tool/companion Dx type situation). The inverse correlation between low levels of a specific protein in the tumor microenvironment and the aggressiveness of the tumor.
Case Studies (continued) 9 Identification of a (or more than one) circulating biomarker that is correlated to a disease. Panel of mutations in one or more genes that provide responses to specific clinical questions (e.g. Is the cancer invasive? How to stratify patients or classify the cancer?) Correlation of certain altered methylation patterns with increased probability of carcinogenesis in specific tumor types.