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Federal Court Finds Takeda’s Patent Not infringed and Invalid for Inutility and Insufficiency

The Federal Court (per Furlanetto J.) held that Takeda’s 916 Patent covering aspects of its DEXILANT® capsules is not infringed by Apotex’s proposed generic dexlansoprazole capsules and, in any event, is invalid for inutility (lack of sound prediction) and insufficiency.

Takeda Canada Inc. v. Apotex Inc. – Federal Court (

The Court’s infringement and validity decision turned largely on the facts of the case, especially on the construction of the 916 Patent.

The 916 Patent

The 916 Patent is entitled “Pulsed Release Dosage Form of a PPI”. The construction of two elements of the asserted claims was key to the Court’s decision.

First, the Court construed the claim element “a first and a second dose” as meaning that two distinct amounts of PPI are loaded into the dosage form prior to administration to the patient. These two distinct amounts are then available to be released from the dosage form in separate pulses. The Court held that this interpretation is consistent with another claim element that required that the second dose be at least 10% larger than the first dose.

Second, the claim element “threshold concentration” was construed to mean the plasma concentration level that must be surpassed when the dosage form is administered to a patient. The Court preferred this interpretation because it was consistent across all the claims of the 916 Patent, and consistent with the patent’s disclosure. Takeda’s argument that this element refers to a particular pharmacological effect caused when the dosage form is administered was rejected.

Non-Infringement by Apotex

Having construed these two claim elements, the Court found that Takeda had not met its burden to establish that Apotex’s dexlansoprazole capsules contain both claim elements.

The PPI present in Apotex’s capsules is not loaded as separate first and second doses that provide pulsatile release, wherein the second dose is at least 10% larger than the first dose. Although this portion of the Court’s Reasons is highly redacted, the Court ultimately concluded that Apotex’s capsules contain only one dose in each capsule and that the PPI is released in a single, continuous delayed release fashion.

In its attempt to prove infringement, Takeda relied on the bioequivalence testing of Apotex’s product to show that, for some of the subjects in the study, the plasma concentration-time profile showed a second peak, thus indicating a pulsed release of the PPI. The Court discounted this evidence as “cherry-picking” a few plasma concentration curves while ignoring the majority of the other data and, importantly, while ignoring the mean plasma concentration-time data.

Takeda’s expert also attempted to use the plasma-concentration curves to prove that the PPI released in the second pulse was at least 10% larger than the first pulse. The Court gave no weight to this evidence, in part because such an approach ran contrary to established scientific principles.

Lack of Sound Prediction

The Court began its analysis by noting that utility must be either demonstrated or soundly predicted as of the filing date. To meet the test for sound prediction, there must be a factual basis for the prediction, an articulable line of reasoning from which the desired result could be inferred from the factual basis, and there must be proper disclosure of the factual basis and line of reasoning in the patent. An established exception to the disclosure requirement is that facts or reasoning that form part of the common general knowledge of the skilled person need not be disclosed in the patent.

In the case of the 916 Patent, the Court found that the information provided in the patent, in particular Example 1, was insufficient to form a basis for a sound prediction of utility. Rather, the key information on which the prediction was based was provided by additional modelling simulations that the inventors had done prior to the filing date but had not disclosed in the 916 Patent. The Court held that without these additional simulation data, the skilled person would not have had the necessary line of reasoning to predict that the claimed dosage form would achieve the practical utility. As a result, the asserted claims failed to meet the requirements for sound prediction.


Related to the sound prediction analysis, the Court further found that the information found in Example 1 of the 916 Patent was insufficient for the skilled person to understand how the claimed dosage forms provided the required pharmacokinetic threshold plasma concentration through pulsatile release of drug. The skilled person would have had to undertake a research project in the form of conducting simulation modelling similar to what the inventors had done to arrive at the claimed dosage forms. As a result, the patent was invalid for insufficiency.

Other Invalidity Attacks

Apotex also raised other invalidity allegations, including anticipation and obviousness, but the Court dismissed those attacks.


This decision raises a number of issues that patent practitioners must be aware of when drafting and enforcing patents. For example, Canadian Courts continue to require that a patent must disclose sufficient information that, when combined with the common general knowledge, will allow a skilled person to soundly predict the utility and to put the claimed invention into practice. Further, when proving infringement, Canadian Courts require patentees to adduce evidence that is “sufficiently clear, convincing and cogent to satisfy the balance of probabilities test” – speculative evidence of infringement will not be enough.

Takeda has 30 days from the date of Judgment (February 7, 2024) to appeal to the Federal Court of Appeal.