A one-two pulse for Takeda’s dexlansoprazole patent found not infringed and invalid

The Federal Court found Takeda’s Canadian Patent No. 2,570,916 to be invalid for lack of utility and sufficient disclosure and to be not infringed by Apotex. Elsewhere, we have described the Court’s reasons on invalidity (see here). This post will focus on the findings on fact and expert evidence, non-infringement, and costs.

Fact and Expert Evidence

The Court declined to find portions of Takeda’s expert evidence inadmissible. Apotex alleged that Takeda’s formulation expert applied a novel testing methodology in his infringement opinion that did not meet the reliable foundation test (citing R. v. J-L.J). The Court found instead that he adapted known analytical techniques (i.e., area under the curve and trapezoidal method) to a new context—determining whether the dose amounts claimed are found in the Apotex Product.

The Court also considered admissions from Takeda’s gastroenterology expert that he did not read prior art, made inaccurate statements about prior art, and relied on counsel. The Court dealt with these issues as a matter of weight, rather than striking Takeda’s primary validity expert and the only responding expert.

By contrast, the Court found portions of Takeda’s fact evidence inadmissible, which included IQVIA data and third-party recall studies. The Court declined to find the data and studies were business records, because both were conducted outside Takeda, similar to brand awareness surveys that the Court of Appeal has found inadmissible (citing Clorox Company of Canada, Ltd. v. Chloretec SEC). Takeda had not presented sufficient corroborating evidence to establish necessity and reliability for these records and overcome Apotex’s hearsay objections.

The Court also sustained Apotex’s Rule 248 objection to evidence discussing commercial success. Takeda had refused questions about related allegations in its Reply during discovery on the basis that the questions sought opinion evidence.

Non-Infringement

The 916 Patent generally relates to dosage forms of proton pump inhibitors (PPIs) containing multiple doses (i.e. pulsed release dosage forms). The Court found the following essential elements of the Claim 1, on which the other Asserted Claims depended:

1. A dosage form that includes a PPI;
2. The PPI is released as a first and a second dose;
3. The first and second dose are released as discrete pulses;
4. Each pulse of the PPI is sufficient to raise plasma concentrations above a threshold concentration of at least 100 ng/mL;
5. The second dose contains at least 10% more of the PPI than the first dose; and
6. The first and the second dose independently comprise between 5 mg and 300 mg of the PPI.

Takeda did not demonstrate on a balance of probabilities that the Apotex Product contained each of these elements. In particular, Apotex’s formulation details and functional data demonstrated a product that is designed for continuous release and that exhibits a single delayed release profile on dissolution in vitro and when examined in bioequivalence studies. The Apotex Product is not a dosage form with a first and a second dose that has pulsatile release.

Costs

The Court awarded Apotex 40% of its legal fees and 100% of reasonable disbursements. Accepting 37.5% of legal fees as the starting point for lump sum costs under the Patented Medicines (Notice of Compliance) Regulations, the Court increased costs to 40% because Apotex had been successful on both invalidity and infringement.

The Court nonetheless declined to award 50% of legal fees because Apotex pursued eight grounds of invalidity and a Gillette Defence through trial, some of which need not have been pursued and served to add unnecessary complexity to the proceeding. It also declined to award 100% of legal fees for a patent that Takeda ultimately dropped because Apotex had delayed in providing samples.

A copy of the decision can be found here.