Novopharm v. Janssen-Ortho; June 7, 2007; Appeal of Infringement Proceeding – levofloxacin

The Court of Appeal upheld the decision that the patent was valid and infringed.

The Court of Appeal upheld the findings of the Trial Judge regarding the construction of the claim at issue and that the claim is not ambiguous.

On the issue of obviousness, the Court of Appeal upheld the findings of the Trial Judge. The Court stated that the Trial Judge had not changed the test of obviousness, and adopted an edited version of the Trial Judge's list of factors that is helpful to guide the inquiry and analysis that must be undertaken in assessing obviousness.

The full text of this decision can be found at:

Pfizer v. Apotex; May 31, 2007; 55.2 Proceeding; Appeal of a decision on the merits of a 55.2 proceeding – quinapril

The Federal Court of Appeal overturned the decision of the Trial Judge and issued an order prohibiting the Minister of Health from issuing an NOC to the generic company until the expiry of the two patents at issue (a genus and a species patent for quinapril).

The Court of Appeal held that the Trial Judge had erred in law by failing to construe the claims of the genus patent prior to determining infringement.

The Court of Appeal found that when one construed the claims in light of the specification with a mind "not bent on finding a way to circumvent the inventor's invention, but one desirous of understanding the invention", the claim of the genus patent would be infringed by the generic company's product.

The Court of Appeal determined that the Trial Judge had erred in applying the test for determining whether a patent is invalid for overbreadth. When properly construed, the patent was not invalid for overbreadth and Court of Appeal indicated that the applicant had met its burden on that issue.

The Court of Appeal then upheld the Trial Judge's decision with respect to obviousness, anticipation, double patenting and utility. The Court of Appeal also clarified the test with respect to burden in NOC proceedings.

The full text of the decision can be found at:  

Eli Lilly v. Novopharm; June 5, 2007; 55.2 Proceeding – olanzapine

The Trial Judge dismissed the application for an order of prohibition.

In an earlier decision regarding the same patent but with a different generic company as respondent, the Trial Division had found the patent to be valid and issued an order of prohibition on that basis. The Trial Judge in this proceeding found that the evidence was similar with respect to the allegations of anticipation, obviousness and double patenting, and thus, the same conclusion should be reached as in that previous proceeding.

However, on the issue of insufficiency, which was not raised in the previous case, the Trial Judge held that the patent at issue was a selection patent but that the patent did not contain sufficient comparative data to prove the advantages disclosed in the patent. On this basis, the Judge found that the allegation of insufficiency was justified. 

The Court also held that the generic company's allegation with respect to s. 53 of the Patent Act was not justified. The Court determined that it was not necessary to make findings as to utility as, if the specification does not sufficiently set out the invention or its intended results, then no proper assessment can be made as to whether the utility promised for those results can be achieved.

The full text of the decision can be found at:

Sanofi-Aventis v. Riva; May 28, 2007; 55.2 Proceeding - ramipril

The Court, after a full hearing on the merits of the proceeding, as well as a section 6(5) motion to dismiss the application, granted the motion to dismiss and dismissed the application for prohibition on the basis of recent jurisprudence from the Court of Appeal.

As another generic company had been successful in obtaining an order declaring its allegation to be justified on the basis of invalidity due to a lack of sound prediction, and a second generic had been successful in having the Court of Appeal find that the applicants could not pursue a further NOA, this third case where the generic had alleged lack of sound prediction was thus entitled to dismissal of the proceeding brought against it.

Thus, the proceeding was dismissed. Notwithstanding the dismissal, the Court went on to state in obiter that on the evidence before the Court, that the patent was not invalid for a lack of sound prediction. An appeal is pending.

The full text of the decision can be found at:

Abbott v. Novopharm; June 11, 2007; Interlocutory Motion; s. 6(5) – lansoprazole

The generic company brought a motion to have the proceeding dismissed under s. 6(5) of the Regulations. The Court accepted the argument that the patent at issue was improperly listed on the Patent Register and dismissed the proceeding.

As the patent was listed prior to the amendment of the Regulations, the Court applied case law from prior to the amendment of the Regulations and found that, as the patent claimed a delivery system rather than a pay load, it did not contain a "claim for the medicine itself" or "claim for the use of the medicine" and was thus ineligible for listing on the Patent Register.

The full text of the decision can be found:

Altana v. Novopharm; June 14, 2007; Interlocutory Decision re: s.7 of the Canada Evidence Act 55.2 proceeding – pantoprazole

This interlocutory motion deals with the number of expert affidavits that can be tendered in a 55.2 proceeding. Specifically, the Court found that infringement was one issue in the proceeding and could not be divided into sub-issues. This was despite the Notice of Allegation that related to two patents with both use and formulation claims.

The Court refused the argument that prescribing practices were relevant for each province in order to show the infringing use. The Court limited the applicant to five experts dealing with the issue of whether the generic company would infringe the patents in suit.

The full text of the decision can be found at: