On August 8, 2024, the Federal Court (per Furlanetto J.) held that a patent directed to nintedanib for use in the prevention or treatment of idiopathic pulmonary fibrosis (“IPF”) was valid and infringed, while a patent directed to formulations of nintedanib was not infringed.
Boehringer Ingelheim (Canada) Ltd. et al v. Jamp Pharma Corporation, 2024 FC 1198
Background
Boehringer Ingelheim International (“BII”) owns Canadian Patent Nos. 2,591,083 (“083 Patent”) and 2,726,267 (“267 Patent”). Boehringer Ingelheim Canada (“BI”) markets and sells nintedanib capsules in Canada under the brand name OFEV for, inter alia, the treatment of IPF. JAMP Canada (“JAMP”) holds a Notice of Compliance allowing it to sell generic nintedanib capsules for the treatment of IPF, but it has not yet begun sales in Canada.
BI brought an infringement action under subsection 6(1) of the Patented Medicines (Notice of Compliance Regulations) alleging that JAMP’s nintedanib capsules infringe, and induce infringement of, claims of the 083 Patent and the 267 Patent. JAMP denied infringement and asserted that the 083 Patent is invalid for anticipation, double patenting, lack of sound prediction of utility, or in the alternative to lack of sound prediction, obviousness, and that certain claims (not all) of the 267 Patent are invalid for obviousness or overbreadth.
Claim Construction
The Court construed the claims before assessing infringement or validity. The Court recognized that the focus of claim construction is on the language of the claims when read in context with the other claims and the patent’s description, while considering the purpose of the claimed invention.
The 083 Patent
The sole construction issue relating to the 083 Patent was the meaning of the phrase “prevention or treatment” of IPF. It was common general knowledge at the time that IPF was a rare and serious disease of unknown etiology that was without an effective treatment. In view of this knowledge, and with the aid of the expert evidence adduced at trial, the Court held that the skilled person would have understood “prevention” to mean secondary prevention, namely, prevention of the progression of the disease state and the development of symptoms arising from IPF, while “treatment” would have been understood to be referring to treating the existing disease state and stalling further progression after symptoms have already manifested.
The 267 Patent
The main construction issue raised in respect of the 267 Patent was whether lecithin (and its amount) is a non-essential element of each of the asserted claims. This issue was key to the infringement analysis because there is infringement only if JAMP’s nintedanib capsules contain all the essential elements of the claim (a non-essential element need not be present).
The Court began by noting that claim elements are presumed to be essential and the party alleging otherwise bears the onus of establishing non-essentiality. In the case of the 267 Patent, the Court focused on the specific language of the claims when read in view of the patent’s disclosure and held that “it is clear from the language of the 267 Patent claims that lecithin was intended to be an essential element of the claimed invention.” In support of this conclusion, the Court emphasized that no other options were provided in the patent’s claims or in the patent’s disclosure.
BI also argued that the skilled person would have considered that lecithin could be readily substituted with another surfactant so that lecithin was, in this respect, non-essential. The Court dismissed this argument, finding that the expert evidence showed that this was not a “plug in play” scenario where another surfactant could easily be used in a nintedanib formulation instead of Lecithin.
Finally, the Court referred to correspondence between BII and the Patent Office during prosecution of the patent application in which BII had argued that the claims were not anticipated or rendered obvious by prior art because the prior art formulations did not include lecithin. These representations showed that BII considered lecithin to, in fact, be essential to the formulation claimed.
Infringement
The 267 Patent
Once the Court found that lecithin was an essential element of the claims of the 267 Patent, it became clear that JAMP’s nintedanib capsules do not infringe any claims. JAMP’s capsules contain the surfactant PG3D instead of lecithin.
The 083 Patent
The only infringement issue regarding the 083 Patent was whether JAMP’s actions would constitute direct infringement of claims 2, 3 and 4 of the 083 Patent. JAMP had stipulated that it would induce infringement of the other claims of the patent if those claims were valid.
The claims at issue are directed to nintedanib esylate (claim 2), and a pharmaceutical composition of nintedanib esylate (claims 3 and 4) for use in the prevention or treatment of IPF. The Court found that claims 2, 3 and 4 are product claims rather than use claims, and as such, JAMP will directly infringe them. JAMP’s capsules contain nintedanib esylate and excipients in gelatin capsules, and if JAMP launches in Canada, it will import the capsules and sell them in accordance with the indication in the product monograph (that is, to treat IPF). As a result, JAMP’s importation and sale of JAMP’s nintedanib capsules constitutes direct infringement of claims 2-4 of the 083 Patent.
Validity
The Court did not need to assess JAMP’s invalidity allegations in respect of the 267 Patent because none of the claims were infringed. Thus, only the validity of the 083 Patent was considered by the Court.
Anticipation
JAMP alleged that the claims of the 083 Patent were anticipated by WO 948, a PCT patent application published prior to the relevant date. BI argued WO 948 did not disclose the claimed invention because it referred to a large number of compounds (including nintedanib) for use in the treatment of a number of diseases, some of which give rise to lung fibrosis.
The main disclosure issue turned on whether the treatment of “lung fibrosis” in WO 948 encompassed the treatment of IPF. On this point, the Court preferred the evidence of BI’s expert, who opined that the term “lung fibrosis” in WO 948 would have been understood by the skilled person to refer to lung fibrosis arising from a number of autoimmune diseases believed to be associated with inappropriate T-cell activation. In contrast, IPF was known not to be an autoimmune or T-cell mediated disease. The Court also noted that there is no reference to IPF in WO 948 and, while lung fibrosis is characteristic of IPF, not all lung fibrosis is associated with IPF. In fact, lung fibrosis was known to be associated with upwards of 150 different diseases.
As a result, the use of nintedanib for the treatment of IPF was not disclosed by WO 948.
Double Patenting
JAMP alleged that the claims of the 083 Patent were invalid for “obviousness-type double patenting” because the claims were said to be an obvious and uninventive extension of the claims of a prior BII patent (the 350 Patent). The doctrine of obviousness-type double patenting prohibits the same patentee from claiming subject-matter that is an obvious extension of an earlier claimed invention.
The prior BII patent asserted by JAMP (the 350 Patent) was the Canadian equivalent of WO 948. As discussed in the section on anticipation, the Court held that going from the use of a number of compounds that included nintedanib to treat lung fibrosis (the claims of the 350 Patent) to the use of nintedanib to treat IPF (the claims of the 083 Patent) was not obvious. There was a patentable distinction between treatment of “lung fibrosis” and the treatment of IPF.
The Court also dismissed JAMP’s assertion that, because BI had listed the 350 Patent on the Patent Register in respect of its OFEV capsules, this constitutes an admission against interest that the 350 Patent claims the use of nintedanib to treat IPF.
Utility
JAMP also argued that the claims of the 083 Patent were invalid for inutility because they did not meet the test for sound prediction.
In Canada, the utility requirement in section 2 of the Patent Act is met if the inventors had demonstrated the utility as of the filing date, or they could soundly predict the utility. It is settled law that, for sound prediction to be established, three factors are required: 1) there must be a factual basis for the prediction, 2) the inventor must have an articulable line of reasoning, and 3) there must be proper disclosure.
The Court held that the first two factors are subjective in that it is the inventors who must have a factual basis and a sound line of reasoning to support the invention as claimed. Thus, evidence of what the inventors did and knew prior to the filing date was relevant. On the other hand, the third factor (proper disclosure) was objective and must be viewed from the perspective of the skilled person as they are the intended recipient of the patent’s disclosure.
In this case, JAMP argued that the inventors had not made full disclosure of all the facts and reasoning necessary to make the prediction that nintedanib can be used to treat IPF. That is, the inventors had not satisfied the quid pro quo required in exchange for patent rights. The Court disagreed, holding that, by disclosing the positive results of testing using the preventative regimen, the skilled person was given the data from the leading in vivo model, thereby establishing nintedanib as a compound of interest in treating IPF. This was sufficient to establish a sound prediction of utility. It was more than mere speculation or hypothesis because it was grounded in the accepted in vivo model for evaluating potential efficacy.
Obviousness
The Court quickly dealt with JAMP’s allegation of obviousness. The evidence established that IPF was poorly understood at the time and many different types of treatment strategies were under investigation with uncertain prospects of success. The skilled person was looking in a variety of different directions for treatments for IPF. Nothing pointed to nintedanib, and even if there was a compound that seemed interesting, efficacy would not have been self-evident.
Disposition
JAMP’s nintedanib capsules were found to infringe the valid claims of the 083 Patent, but not to infringe the claims of the 267 Patent. An injunction issued enjoining JAMP from making, using, selling and otherwise dealing with its nintedanib capsules in Canada until the expiry of the 083 Patent.
JAMP has 30 days from the date of the Judgment to appeal to the Federal Court of Appeal.