- Order of Prohibition Granted in Respect of Crystalline Form I ODV Succinate
- November 3, 2017 | Authors: Adrian J. Howard; Jillian Brenner
- Law Firm: Borden Ladner Gervais LLP - Ottawa Office
Pfizer Canada Inc. v. Apotex Inc., 2017 FC 774
Drug: PRISTIQ o-desmethyl-venlafaxine ("ODV")
This is an application pursuant to the Patented Medicines (Notice of Compliance) Regulations. The Court began by noting a related decision in which a different second person sent a separate Notice of Allegation making different allegations. The Court issued an order of prohibition.
The patent relates to Form I ODV succinate, which the Court accepted is a novel composition of matter. Venlafaxine metabolizes into ODV, and was previously patented and approved to treat depression. The Court set out the invention story, including the experimentation with ODV fumarate and forming a pro-drug.
There were several disputes relating to claim construction, which the Court addressed and then found that Apotex’s allegation of non-infringement was not justified, although some claims were not infringed by all Apotex’s products. In terms of obviousness, the allegation was found not to be justified on the basis of a detailed analysis finding that, although “the new composition of matter being the crystalline Form I ODV succinate, was ‘worth a try’”, and “there were ‘possibilities’ that the Skilled Person would find the invention”, this was not sufficient. With respect to utility, the Court had asked the parties for submissions in light of the Supreme Court of Canada decision in AstraZeneca v Apotex. The Court then indicated that it was applying the approach set out in that decision, proceeding on a claim by claim basis having regard to its previous construction of the claims.
The Court also addressed an argument made by Apotex relating to “overpromising” in relation to subsection 27(3) of the Patent Act. The Court noted:
I also observe that the alleged overpromises resemble the promise arguments advanced by Apotex, which are no longer valid having regard to AstraZeneca. If the Supreme Court intended to say, in effect, that the Promise Doctrine was not good law in terms of utility under s. 2, but was good law in terms of patent specifications under subsection 27(3) it could have done so; it did not.The Court concluded by finding that the specification analysis pursuant to section 27(3) requires the patentee to define the precise extent of the exclusive property claimed. In terms of anticipation, although it filed evidence, Pfizer did not address anticipation in its memorandum of fact and law, arguing that Apotex had not filed evidence in this regard. The sections of the expert evidence that Apotex pointed to were submitted in respect of obviousness not anticipation, and no instructions relating to anticipation were given to Apotex’s experts. The Court did not accept Apotex’s arguments that it could rely on this evidence. However, the Court also did not agree that Pfizer could split its case by failing to deal with anticipation in its memorandum but addressing it in oral reply at the end of the hearing. The Court held that Pfizer could not proceed on the basis that anticipation was not in issue once Apotex filed its memorandum dealing with anticipation. The Court did not accept Apotex’s expert evidence on anticipation. The Court also refused to accept Apotex’s argument that its allegations of anticipation in its NOA were sufficient to displace the statutory presumption of validity. The presumption of validity was found to prevail in this case and the allegation of anticipation not justified. The Court also found Apotex’s allegation of double patenting not to be justified. Costs were awarded to Pfizer.