Richard Edward Naiberg

The Court allowed AstraZeneca’s appeal and held the patent ‘promise doctrine’ is not the correct approach to utility under s. 2 of the Patent Act.

It found the doctrine improperly imports disclosure obligations into the utility requirement and wrongly invalidates patents when one of multiple promised uses is unproven.

The correct test asks whether the claimed subject-matter has at least one practical use related to that subject-matter, demonstrated or soundly predicted at filing.

Applying that test, the ‘653 patent had sufficient utility and was not invalid.

Apotex appealed a prohibition order preventing the Minister of Health from issuing a notice of compliance for its generic version of Plavix.

Apotex alleged that Sanofi's selection patent for clopidogrel bisulfate was invalid on the grounds of anticipation, obviousness, and double patenting.

The Supreme Court of Canada dismissed the appeal, clarifying the tests for anticipation and obviousness in Canadian patent law.

The Court adopted a two-step approach for anticipation (prior disclosure and enablement) and a four-step approach for obviousness, including a flexible 'obvious to try' consideration.

The Court found the selection patent was not anticipated, not obvious, and did not constitute double patenting.

Apotex Inc. sought judicial review of the Respondents' decision to remove the designation of its generic drug, Apo-Flavoxate, as an interchangeable drug product under the Drug Interchangeability and Dispensing Fee Act (DIDFA) and to delist it from the Comparative Drug Index.

The Divisional Court found that the decision to delist the drug under DIDFA was not rationally connected to the decision to delist it as an eligible benefit under the Ontario Drug Benefit Act.

The majority held that the circumstances surrounding the decision constituted a denial of natural justice and quashed the regulation, restoring the drug's interchangeable status.

A dissenting opinion would have upheld the decision as a valid exercise of public interest discretion.

The appellants challenged the validity of the respondents' patent for the use of AZT in the treatment and prophylaxis of HIV/AIDS.

The appellants argued that the patent lacked utility at the time of application, claimed more than was invented, and failed to name NIH scientists as co-inventors.

The Supreme Court of Canada dismissed the appeal, holding that the utility of AZT was established through the doctrine of sound prediction at the time of the patent application.

The Court also found that the prophylactic claims were soundly predicted and that the NIH scientists were not co-inventors because they merely verified the respondents' inventive concept.

Apotex appealed a trial judge's decision allowing Bayer to elect an accounting for profits as a remedy for patent infringement and directing a referee to count all infringing capsules sold by Apotex.

Apotex argued that the trial judge reversed the burden of proof, misconstrued the patent, and erred in finding a causal link between the infringement and all profits.

The Court of Appeal dismissed the appeal, finding no error in the trial judge's exercise of discretion to award an accounting for profits or in the direction to the referee, as Apotex's product infringed the patent in its entirety.

The respondents on an application for leave to appeal sought to include the costs of expert evidence and related travel expenses as disbursements in their bill of costs after the leave application was dismissed.

The Registrar disallowed these expenses, ruling they were not covered by Part II of Schedule B of the Rules of the Supreme Court of Canada.

The respondents brought a motion to review the Registrar's decision.

The Supreme Court of Canada dismissed the motion, holding that expert fees are not specifically authorized as disbursements under the Rules and can only be allowed if expressly authorized by the Court under Rule 58.

Apotex applied for a Notice of Compliance (NOC) to market the patented drug Norfloxacin, alleging non-infringement because it would obtain the drug from Novopharm under a supply agreement.

Novopharm held a compulsory licence that prohibited sublicensing.

The patentee and its licensees sought an order prohibiting the Minister from issuing the NOC, arguing the supply agreement was an invalid sublicence and the application was premature.

The Supreme Court of Canada held that the supply agreement was not a sublicence.

Furthermore, the Court determined that the proper date for assessing the justification of a Notice of Allegation is the date of the hearing, not the date it was issued.

Since Novopharm was legally entitled to produce the drug for the Canadian market by the hearing date, the allegation was justified.

The appeal was allowed and the prohibition order was dismissed.

Novopharm held a compulsory licence for the patented medicine nizatidine, owned by Eli Lilly.

Novopharm and Apotex entered into a supply agreement whereby Novopharm would obtain the medicine and supply it to Apotex.

Eli Lilly sought to terminate Novopharm's licence, arguing the agreement constituted an impermissible sublicence, and sought prohibition orders against the issuance of Notices of Compliance to both Novopharm and Apotex.

The Supreme Court of Canada held that the supply agreement did not constitute a sublicence, as it did not grant Apotex the independent right to exercise Novopharm's licensed rights.

The Court also held that Apotex's proposed reformulation of the bulk medicine into final-dosage form would not infringe Eli Lilly's patents.

The appeals by Novopharm and Apotex were allowed.

The appellants appealed a judgment of the Federal Court of Appeal that affirmed an order granting mandamus to compel the Minister of National Health and Welfare to issue a notice of compliance respecting a generic version of a drug.

The Supreme Court of Canada dismissed the appeal substantially for the reasons of the Federal Court of Appeal.