In Pharmascience Inc. v. Janssen Inc., 2024 FCA 10, the Federal Court of Appeal dismissed Pharmascience’s appeal of a Federal Court decision that found Pharmascience’s sale of a generic version of a drug for treating schizophrenia would infringe Janssen’s patented dosage regimen for the drug, even if some of the doses in the regimen had to be sourced from Janssen.
Janssen’s patent specifies a regimen of: a first dose of 150 mg-equivalent (mg-eq.) of the drug on day 1, a second dose of 100 mg-eq. on day 8, and monthly maintenance doses of 75 mg-eq. thereafter. Pharmascience sells products that provide the first two doses (the 150 mg-eq. and 100 mg-eq. doses) but not the 75 mg-eq. doses.
The Federal Court had found that Pharmascience would induce infringement of Janssen’s patent by selling its products. Pharmascience argued that the Federal Court erred in its assessment of the first prong of the three-prong inducement test, namely that there was direct infringement by a third party.
Pharmascience argued that, in the absence of any limitations imposed by Janssen at the time of sale, the sales by Janssen of its 75 mg-eq. doses would include an implied license to use the 75 mg-eq. doses in any way the purchaser or prescribing physician chooses, such as using them as part of the claimed dosage regimen by combining them with other doses obtained from other sources (from, for example, Pharmascience). The Federal Court was not persuaded and held that any implied license related to a patented invention itself, and the 75 mg-eq. dose alone was not a patented invention. Instead, it was only one component of a patented invention.
The Federal Court of Appeal found no error in the Federal Court’s analysis. The Federal Court of Appeal further commented that there was no reason to conclude that either Janssen or its customers would have understood that the purchase of the drug in a single dose from Janssen would include an implied licence to use the entire dosing regimen of the product in combination with other doses obtained from other sources in order to practise the patented invention.
A copy of the decision is available here.