APOTEX APPEAL


“THE SUPREME


COURT NO LONGER HAS AN OPPORTUNITY, IN THIS CASE, TO GIVE GUIDANCE AND CLARIFICATION ON THE EXISTING UTILITY REQUIREMENTS


FOR PATENTABILITY IN CANADA.”


led to valuable patents on several top-selling drugs being found invalid, therefore making it easier for pharmaceutical patentees generally to show utility.


Perhaps with this in mind, Apotex decided to pull the plug on its appeal the day before the hearing. T e late discontinuance was not only a surprise, but a disappointment to many.


A lack of utility has been one of the most popular attacks on the validity of pharmaceutical patents in Canada in recent years. In assessing utility, a court typically begins by analysing whether the inventor has made an explicit “promise” of a specifi c result in the patent. If there is such a promise, utility is measured against that promise. But if there is no promise, the test for utility is a “mere scintilla” of utility.


If there is a promise, the patentee must have demonstrated that promised utility by the Canadian fi ling date; if not, the patentee must have had a sound prediction of utility by that date. Where promised utility has not been demonstrated, the doctrine of sound prediction requires: (i) a factual basis; (ii) a sound line of reasoning; and (iii) proper disclosure. T e courts have held that proper disclosure requires that both the factual basis and sound line of reasoning be disclosed in the patent.


T e promise doctrine and the disclosure requirement for a sound prediction have both been particularly challenging for pharmaceutical patentees in recent years.


Generic drug manufacturers typically allege a promise of elevated utility—for example the


28 Life Sciences Intellectual Property Review eff ectiveness of the drug treatment against a


particular disease in humans—even in the case of compound patents such as the one protecting Plavix.


However, actual utility in humans is normally confi rmed only by clinical studies that are completed well aſt er the fi ling of


the patent application.


Consequently, the problem for patentees in Canada is that the current law requires any utility promised by a patentee to be demonstrated or soundly predicted by the Canadian fi ling date, at which time only in vitro or in vivo animal studies have, typically, been completed.


Combined with the current sound prediction requirement, that has put Canada’s utility standard out of step with those in other jurisdictions.


Background to the discontinued appeal


While Sanofi , the patentee, ultimately won this case, it illustrates the potential problems with the utility test in Canada.


T e Canadian patent relevant to Plavix in this


dispute, no. 1,336,777 (‘777), relates to clopidogrel bisulfate, which is a dextrorotatory enantiomer. T e racemic mixture had been disclosed earlier.


In 2003, Apotex unsuccessfully made invalidity and non-infringement allegations regarding the ‘777 patent under the Patented Medicines (Notice of Compliance) Regulations, which are similar to those of the US Hatch-Waxman Act. T e company’s appeals to the Federal Court of Appeal and Supreme


Volume 2, Issue 1


Court were unsuccessful. Accordingly, the minister of health was prohibited from approving Apotex’s clopidogrel product for sale in Canada until the ‘777 patent expired.


To try to get around the prohibition, Apotex started a court action in which it claimed the ‘777 patent was invalid. Sanofi disputed this and alleged infringement.


T e trial judge found that based on the language in the patent, the invention “can be described as a compound which is useful in inhibiting platelet aggregation, has greater therapeutic eff ect and less toxicity than the other compounds” and makes an “explicit promise for use of the compound in humans”.


T e judge then evaluated whether this promised utility had been either demonstrated or soundly predicted by Sanofi by the Canadian fi ling date. Sanofi , the judge found, had neither demonstrated nor soundly predicted the promised utility in humans by the relevant date.


Although Sanofi had obtained results in studies to factually show a prediction that the invention could be used in humans, and there was a “track record” of information which, in turn, provided a sound line of reasoning for such a prediction, the underlying factual basis and line of reasoning that grounded the prediction were not disclosed in the patent. T erefore, the claims were found invalid for lack of utility.


T e case came down to the twin problems of a high promise of usefulness and the disclosure


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