Promised utility must be clearly and unequivocally found in the express language of the specification.

Eli Lilly Canada Inc. V. Hospira Healthcare Corp.
2016 CarswellNat 2355
Federal Court

Intellectual property --- Patents — Validity of patent — Utility — Broad claims

Applicant held license from patentee to sell anti-folate drug useful in treatment of some cancers — Patent claimed thousands of compounds, including compound in drug, that were not made or tested at time of patent filing — Applicant applied under Patented Medicines (Notice of Compliance) Regulations for order prohibiting Minister of Health from issuing Notice of Compliance (NOC) to respondent for generic version of its drug until patent expired — Application dismissed — Applicant failed to establish that promised utility of untested compounds would have been soundly predicted by person of skill from results obtained from testing of some of compounds falling within claims — Person of skill would construe patent as promising use of compounds as antitumour agents — Promise of antitumour activity would be understood by person of skill to mean in vivo activity in relation to abnormal tissue such that in vitro testing would not, absent sound prediction, establish efficacy against tumour masses — There was threshold level of measurable in vitro antifolate activity to satisfy promise of being antifolate agent with antitumour effects — Where utility was based on sound prediction, factual basis and sound line of reasoning supporting prediction had to be disclosed in patent such that applicant was not entitled to rely on its in-house test data or upon sound line of reasoning not found in patent to establish utility — Patent disclosed in vitro test results for small number of compounds and provided no line of reasoning from which person of skill could draw prima facie reasonable inference that thousands of untested claimed compounds would be useful as antitumour agents in vivo or even in vitro — Patent did not disclose any line of reasoning from which person of skill could extrapolate in vivo antitumour effect from reported in vitro data — Respondent's experts' evidence about significant barriers to predicting antifolate activity for untested compounds based on data for another compound was accepted — Patentee's attempt to monopolize such huge class of compounds on strength of highly discrete test data was clear case of over-reaching and it fell squarely within concerns about stockpiling of stables of chemical compounds before their utility had been shown or predicted.