This relates to a Federal Court Decision in Canada Boehringer Ingelheim (Canada) Ltd. v. Jamp Pharma Corporation, issued on Aug. 8, 2024, Citation 2024 FC 1198, which is a recent decision involving interpretation of numerical data in claims (including single numbers and number ranges).
See document.do
We discuss here only one of the patents encompassed in the decision and the issue of interpretation of numeric data in claims which was part of the decision: CA 2,726,267 [267 Patent] Espacenet - Originaldokument
The 267 Patent describes the invention of the patent as relating to a suspension formulation containing the active substance Nintedanib esylate, a capsule containing the formulation, a process for preparing the formulation and capsule, and packaging material for the capsule (267 Patent, Ex2, 1:4-9). More particularly, the invention is described as relating to formulations of Nintedanib esylate (Nintendanib hereinafter) containing lipid suspensions of the active substance in 1 to 90 wt.% medium chain triglycerides [MCT], 1 to 30 wt.% of hard fat, and 0.1 to 10 wt.% of lecithin (267 Patent, Ex2, 1:11-15). The lecithin is described to be “surprisingly” useful to improve dissolution behaviour of the finished capsules containing the active substance.
Boehringer Ingelheim (BI) markets and sells Nintedanib capsules in strengths of 100 and 150 mg (equivalent to 120.40 mg and 180.6 mg, respectively) under the tradename OVEF®. Nintendanib is indicated, inter alia, for the treatment of the rare lung disease idiopathic pulmonary fibrosis (IPF). The disease is chronic and incurable and typically leads to respiratory failure and death, due to formation of fibrotic material deposits and accumulates so that gas exchange function is disturbed.
JAMP Pharma Corporation (JAMP) obtained approval for the treatment of IPF but had not yet offered Nintedanib for sale or sold it Canada.
In the litigation, one of the issues, the one which is selected here, was whether and to what extent there was any permitted variability in the weight percentages relevant to a claim (claim 5, referring to claim 3). (Actually other important issues were also treated in the decision, involving seven expert witnesses and two fact witnesses). In claim 5, the amounts of the ingredients in a formulation named Formulation B, given in weight percent (wt.-%) were:
Formulation B:
Active Substance 43.48 wt.-%
Triglycerides, medium chain: 37.38 wt.-%
Hard fat 18.26 wt.-%
Lecithin 0.43 wt.-%
For this formulation, neither a weight percentage range nor the word about were included in the claim, only the specific weight percent amounts.
BI argued that the Person skilled in the art (PSA) would understand that Formulation B allows for minor variability of up to 5% of the specified wt.%, namely 41.31-45.65 wt.% for the active ingredient, 35.94-39.72 wt.% for MCT, and 17.35-19.173 wt.% for hard fat.
The court, however, disagreed on the basis that a fair reading of the evidence and the patent supports the interpretation of Formulation B as being limited to the precise weight percentage amounts claimed: “where the inventors wanted to claim ranges for the components of the formulation, they knew how and did so, for example in claims 1 and 2 of the 267 Patent.” However, “the inventors did not claim a weight percentage range for Formulation B. Nor did they use the word “about” to qualify the precise weight percentage amounts claimed.”
The judge concludes: “In view of my earlier finding that there is no accepted variability in the weight percentage amounts for Formulation B, JAMP Nintedanib does not infringe claim 5 or any claim that depends from claim 5 for this additional reason.”
The specifics of the case at issue are more intricate, but here only the question whether the ingredient amounts may be regarded as variable around the concrete amounts in Formulation B is discussed.
The JAMP Nintendanib did not include the precise weight percentages for medium chain triglycerides and hard fat (and not even lecithin).
In the end, no infringement of the 267 Patent was found and the judge stated he will not go on to consider the additional invalidity defences raised by JAMP.
So it may always be helpful to add “about” before any representation of numeric features (e.g. weight share, weight, volume, voltage, ...) by single numbers, at the same time including a definition in the specification (that might later, during prosecution, be added to the claims) of “about”, for example: “Where “about” is used before a number, this preferably relates to the subsequent number ± 10 %, more preferably ± 5 %, most preferably ± 2 %”.
The same applies to “approximately” or “circa”.
In addition, it is advisable to also defined number ranges (e.g. “5 to 35 wt.-%) where appropriate. In several countries different attitudes prevail with regard to “about”, so it is good to have all options as shown above.
We are experienced and ready to provide appropriate wordings like these for supporting appropriate interpretation and claiming of your inventions.
http://10.23.100.88/mediawiki/images/3/3c/Deepl_translator.pdf
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
