Pankhuri Malik is an IPilogue Writer, IP Innovation Clinic Fellow, and an LLM Candidate at Osgoode Hall Law School.
On May 31, 2022, the Federal Court of Canada ruled in favour of the plaintiffs, Janssen and Actelion Pharmaceuticals (“Janssen”) in their action against Sandoz. The Court held that Janssen’s combination therapy patent is valid. Combination therapy is often used to treat ailments and medical conditions where treatment through single-agent therapy has proven to be challenging.
The present case concerns the validity of claims 21 to 31 of Janssen’s Canadian combination therapy patent for treatment of diseases involving vasoconstriction, including pulmonary arterial hypertension (PAH). The patent seeks to treat the ailments through a combination of Macitentan (sold under the brand name Opsumit) and phosphodiesterase type-5 inhibitor (PDE5-1).
Sandoz sought permission from Health Canada to market generic medicine containing 10mg of Macitentan as the active pharmaceutical ingredient (API) for use alone, or in combination with PDE5-Is. Janssen filed an action before the Federal Court claiming that Sandoz’s generic medicine will infringe upon claims 21 to 31 of the plaintiffs’ patent.
Sandoz conceded that its proposed medicine does infringe the alleged claims, but defended against Janssen’s claims by raising four different grounds of invalidity. However, the Court rejected Sandoz’s arguments that the combination therapy invention was obvious, lacked a sound prediction of utility, and that the patent was overbroad, and the specifications were insufficient.
The Court in Beloit Canada Ltd. v Valmet Oy held that whether an invention is “obvious” depends on if the skilled person (without any inventiveness), in view of the state of the art and the common general knowledge on the date of publication, would have directly or without difficulty come to the same conclusion as the patent. Plainly, the test can be understood as:
- Identify the person of skill in the art (“POSITA”), and their common general knowledge;
- Identify the inventive concept;
- Identify the difference between the inventive concept and the “state of the art”; and
- Determine if the difference is obvious or if it requires inventiveness.
The Federal Court followed the test down to the T and held that the available evidence and prior art do not indicate that the POSITA would have considered the combination of Macitentan with PDE5-I to show effectiveness in treatment of ailments involving vasoconstriction, where monotherapies have failed.
Since Sandoz raised the defence of invalidity, Sandoz had the onus to establish obviousness, which it was unable to do.
The requirements to establish a sound prediction of utility were set out in the case of Wellcome v Apotex as:
- A factual basis for prediction;
- An articulable and sound line of reasoning; and
- Proper disclosure.
The Court, having considered the POSITA’s common general knowledge and the test results provided in the patent, concluded that the plaintiffs met the requirements of sound prediction of utility.
Here, Sandoz recycled its argument of utility in claiming that the patent does not disclose a sound line of reasoning and claims overtly broad protections. However, the Court relied on its own analysis under Utility and concluded that a sound line of reasoning is present, thereby invalidating the overbreadth argument.
A patent specification is required to provide sufficient disclosures to enable the POSITA to use the invention. Sandoz claimed that the specification of the patent does not enable the POSITA to put the invention to use. The Court reasoned that Sandoz’s “sufficiency” argument contradicted its “obviousness argument.” Further, Sandoz failed to explain the lacunae in the specification that needed filling for the disclosure to be sufficient.
Unable to find merit in Sandoz’s arguments, the Court declared that Sandoz would infringe the asserted claims if granted permission to market its generic medicine in Canada. As of July 20, 2022 Sandoz has filed an appeal against Federal Court’s judgment.