Secondary Use Patents: An international and Canadian perspective E. Richard Gold James McGill Professor, McGill Faculty of Law Secondary Use Pharmaceutical Patents: Litigation and Trade Policy Briefing June 5, 2014

Context Second use inventions – as all others – must be useful What is particular to second use patents (as well as selection patents) is that the invention is not the compound per se but the compound having some particular, unexpected, function

Argument There exists no international (formal or informal) standard regarding utility or other substantive patent law requirement –The law is so clear on this point that no competent tribunal could rule in Eli Lilly’s favor No distinct ‘promise doctrine’ in Canadian patent law: it is mere shorthand for asserted utility –There is no more a ‘promise doctrine’ than there is an ‘assertion of utility’ doctrine in the US

Argument Promises dispositive in at most 8 cases between 2005 and spring 2013, using Eli Lilly stats –Most patents found to not be valid or not infringed for multiple, independent reasons –Only 2 (both Eli Lilly) of 7 the pharma cases were infringement or impeachment actions, meaning that the pharma still had recourse under Canadian law –Supreme Court has never ruled on this issue

Argument Canada’s utility standard is lower than that in the US –There is no need to have a “specific and substantial” utility (although it must be credible) in Canada The real question is not whether the standard is high or low, but how does patent law deal with a strategic decision (usually to support novelty or non-obviousness) by patentee to assert a higher utility than required

Argument In Canada, asserted utility determined objectively through POSITA reading patent & with general knowledge with eye to validity Canada holds patentees to their asserted utilities –The POSITA, reading the patent as a whole and in combination with general knowledge in the field must be able to find that the logic presented by the applicant supports an expectation (not assurance) of the asserted utility

Argument Similarities with US enablement/utility: –MEPEP (III)(B): “Office personnel must determine if the assertion of utility is credible (i.e., whether the assertion of utility is believable to a person of ordinary skill in the art based on the totality of evidence and reasoning provided).” –Application re Novak (1962): “[U]nless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.”

Conclusion Every jurisdiction deals with strategic patentee who asserts higher utility than can be justified on logic/facts Jurisdictions conduct analysis differently, but all hold patentees to their assertions, objectively identified Differences in results usually come down to evidence, presumptions of validity, patent claim construction, etc. While much to criticize in Canadian patent law (as in US or Europe), must improve law within a holistic understanding of the system, not through artificial and inappropriate comparisons