Canada's
patent utility requirements and the workability of the promise doctrine are currently before the Supreme Court of Canada in AstraZeneca Canada Inc v Apotex Inc, in litigation over the validity of Astrazeneca's patent for the acid reflux medicine Nexium (esomeprazole).
Following a recent Supreme Court of Canada decision that significantly altered and lessened Canada's
patent utility requirement, Canada ought to adopt the US utility standard of requiring inventions to have a «specific, substantial and credible utility.»
Not exact matches
Lilly claimed that the promise doctrine fundamentally changed Canada's
utility requirement, exceeds patentability
requirements of trading partners, contravenes Canada's international trade obligations and discriminates against pharmaceutical
patents.
This is particularly relevant in the case of pharmaceutical inventions, because the
requirement of
utility means that the drug for which a
patent is sought must achieve the result promised in the specification.
In the past five years, the Canadian Federal Court has invalidated several
patents based on an arguably «technical» deficiency — the «Promise /
utility»
requirement.
Moreover, the specific disclosure
requirements for
patents where
utility is based on sound prediction is the consideration an inventor pays for obtaining a
patent without having proved actual
utility as at the filing date of the
patent application.
Utility is a basic
requirement set out in the
Patent Act, yet Canadian courts over the past year have continued to approach this concept from very different points of view.
Although finding a compound
patent valid based on actual
utility after construing a low Promise, Mr. Justice Rennie recognized (in obiter) there would be problems with a sound prediction of any higher Promise, and referred to the «common view» of the disclosure
requirement of AZT as follows:
The promise doctrine was developed through the Federal Courts» jurisprudence; under it, a judge reviewed a
patent as a whole to identify any «promises» made in it, then assessed whether those promises had been met in order to satisfy the utility requirement of the patent under the Paten
patent as a whole to identify any «promises» made in it, then assessed whether those promises had been met in order to satisfy the
utility requirement of the
patent under the Paten
patent under the
PatentPatent Act.
Such a disgorgement is only permissible if at least one design
patent was infringed (it's impermissible for infringement of
utility patents) and (which is not specific to design
patents but to all
patent damages under 35 U.S.C. § 287 (a)-RRB- if the infringer had «actual or constructive notice of the
patent» (as Judge Koh described the
requirement in her damages order).
The development took place over decades, beginning with the Supreme Court's 1979 decision in Monsanto Company v Commissioner of
Patents, which articulated the principle of sound prediction and prohibited post-filing evidence, and by subsequent decisions over the next 23 years, including the Supreme Court's articulation of the
utility test in Consolboard Inc v MacMillan Bloedel (Sask) Ltd, and a later decision in Apotex Inc v Wellcome Foundation Ltd, which clarified the disclosure
requirement.
The Tribunal characterized the three elements of the promise doctrine as: (i) the identification of a «promise» in the
patent disclosure, against which
utility is measured; (ii) the prohibition on the use of post-filing evidence to prove
utility; and (iii) the
requirement for pre-filing evidence to support a sound prediction of
utility to be included in the
patent disclosure.
Case law has imposed a
requirement that an invention's usefulness be demonstrated or soundly predicted at the time of application, rather than at some later point; though
utility of the subject - matter is a
requirement of
patent validity, a patentee is not required to disclose the
utility of the invention to fulfill the
requirements of s. 2.
The Court unequivocally stated that there was no
requirement to disclose in the
patent the demonstration of the
utility of the invention; but in this case, it was at the patentee's peril.
Contrary to Richard Gold's assertion, the Canadian promise of the
patent doctrine, the requirement to disclose the factual basis for sound prediction in the patent, and the prohibition on using post-filing evidence to establish utility, are not in line with US, UK and EPO jurisprudence, at least: see my articles Must the Factual Basis for Sound Prediction Be Disclosed in the P
patent doctrine, the
requirement to disclose the factual basis for sound prediction in the
patent, and the prohibition on using post-filing evidence to establish utility, are not in line with US, UK and EPO jurisprudence, at least: see my articles Must the Factual Basis for Sound Prediction Be Disclosed in the P
patent, and the prohibition on using post-filing evidence to establish
utility, are not in line with US, UK and EPO jurisprudence, at least: see my articles Must the Factual Basis for Sound Prediction Be Disclosed in the
PatentPatent?
Although the SCC has recently granted leave in Astra's esomeprazole action [12], both parties have acknowledged in their leave materials that the disclosure
requirement is not determinative in this case (as the lower court held there was no sound prediction of the promised
utility relying on material in the
patent as well as Astra's internal tests).
It appears Eli Lilly seeks to: abolish any substantive
utility requirement; and permit a patentee to show
utility based on tests done a decade after they file their
patent.