The Federal Court (FC) has upheld the validity of a patent concerning treatment of idiopathic pulmonary fibrosis (IPF) and granted injunctive relief against the generic in an infringement action under section 6 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations). In reaching its conclusion, the FC dismissed arguments including double-patenting and failure to meet the disclosure requirement for sound prediction of utility. The FC also dismissed infringement allegations regarding a second patent relating to formulations.

Background

Boehringer Ingelheim (Canada) Ltd. (BI) markets OFEV® (nintedanib) for the treatment of IPF. This litigation concerned two patents listed on the Patent Register in association with OFEV®: Canadian Patents No. 2,591,083 (083 Patent) and 2,726,267 (267 Patent). The 083 Patent claims, inter alia, the compound nintedanib for use in the prevention or treatment of IPF. The 267 Patent claims formulations of nintedanib comprising medium chain triglycerides, hard fat, and lecithin.

JAMP Pharma Corporation (JAMP) sought to market a generic version of the 150 mg strength of OFEV® (the JAMP Product). In response, BI commenced this infringement action under section 6 of the Regulations.

Notably, BI renounced the 24-month stay in this action. As a result, the JAMP Product was approved on September 6, 2023, prior to the hearing of the action – although JAMP had not acted on the approval by selling the JAMP Product or offering it for sale. BI did not renounce the stay in a separate action against JAMP relating to the 100 mg strength (Court File No. T-352-24).

The 083 Patent would be infringed

083 Patent: infringed. JAMP did not dispute that with the JAMP Product, it would induce infringement of any claims of the 083 Patent that were held valid. With respect to this patent, the only infringement issue was whether JAMP would also directly infringe certain claims relating to “[Nintedanib esylate], for use in the prevention or treatment of [IPF].” The FC agreed with BI that these were ‘product claims’ that would be directly infringed, as the “approved and intended use of JAMP Nintedanib includes use of nintedanib esylate for the treatment of IPF”.

267 Patent: no infringement. Conversely, JAMP was successful in designing around the asserted claims of the 267 Patent by adopting a particular formulation that did not contain lecithin. The non-infringement issues with respect to this patent were determined by claims construction:

  • The test is conjunctive. The FC’s non-infringement finding turned on the construction that lecithin is an essential element of the claims of the 267 Patent. Here, the FC agreed with JAMP that it is necessary – but not sufficient – to show “that at the date of publication of the patent, the skilled addressees would have appreciated that a particular element could be substituted without affecting the working of the invention”. It must also be shown “that on a purposive construction of the words of the claim it was clearly not intended to be essential”. BI conceded that it could not meet this prong if the test if it were required to do so.
  • Prosecution history is relevant. In deciding that lecithin was indeed essential to the claimed formulations, the FC also noted that the applicant had overcome anticipation and obviousness rejections during prosecution of the patent on the basis that the prior art did not include the composition of the claimed formulation – including lecithin. The FC agreed with JAMP that although the relevant correspondence was not about the construction of the patent per se, it was admissible under section 53.1 of the Patent Act.
  • Variability is not permitted. The FC also found that JAMP would not infringe certain claims because they required precise weight amounts of certain formulation ingredients (to two decimal places). The FC rejected the argument that a range was permitted in these claims, noting that the inventors did not use the word “about” to qualify the amounts and other claims of the 267 Patent did have ranges.

The 083 Patent is valid

The FC rejected JAMP’s arguments that the 083 Patent is invalid for anticipation, obviousness, double-patenting, and inutility.

Anticipation, obviousness, double-patenting. The FC’s conclusions on anticipation, obviousness, and double-patenting all turned on its appreciation of prior art publications that disclosed 38 compounds – one of which was nintedanib – in the context of treating “lung fibrosis”. The skilled person would have understood that the teaching related to “autoimmune disorders, Lck inhibition and T-cell mediated diseases”. As there was no “established view that IPF was a T-cell mediated disease or one that would be regulated by Lck”, the FC was not persuaded that the skilled person would have considered treatment of “lung fibrosis” to encompass the treatment of IPF. Nor would it have been obvious to the skilled person to use (or try to use) nintedanib as a treatment for IPF.

Notably, the earlier Canadian patent cited by JAMP in its double-patenting argument had previously been listed on the patent register in respect of OFEV®. JAMP argued that in listing the patent, BI had made an admission against interest that the patent encompassed a treatment for IPF. In deciding that there was no double-patenting, the FC rejected JAMP’s argument.

Utility. The FC’s utility finding turned on whether the 083 Patent disclosed a factual basis and line of reasoning to support a sound prediction, as utility was not demonstrated by the filing date. The FC held a patent does not need to disclose all studies, but must disclose the information that made the prediction sound. JAMP argued that certain studies omitted from the 038 Patent were foundational. The FC disagreed, concluding that they were merely corroborative. The disclosure in the 083 Patent and its line of reasoning were sufficient to provide the skilled person with a sound prediction of utility for the use of nintedanib in the treatment of IPF.

Immediate release of decision in English

The FC held that the timing of its decision was relevant to other proceedings concerning the same patents, including BI’s action against JAMP concerning the 100 mg strength. The FC found that it was justified in publishing this decision first in English, with a French translation to follow as soon as it became available. In doing so, the FC invoked the exception to a recently amended provision of the Official Languages Act requiring certain decisions to be published simultaneously in both official languages. Given the potential for translation to delay the release of lengthy and complex patent decisions, we anticipate this exception to be cited more frequently in the future.

Link to decision

Boehringer Ingelheim (Canada) Ltd. v. Jamp Pharma Corporation, 2024 FC 1198