The Patents Act 2013 expressly excludes patents for methods of medical treatment. The rationale is that medical practitioners should not be liable for providing treatment to those in need. Swiss type claims are often used to get around the exclusion, especially where the invention is the new use of a known medicine. However, a recent decision of the English Court of Appeal on the interpretation of Swiss type claims indicates that the exclusion could be ineffective. Doctors and pharmacists can in fact infringe Swiss type claims.
The case concerns Warner Lambert’s patent for a Swiss type claim directed to the use of pregabalin for manufacturing a medicament for treating pain. Pregabalin was also known to be useful for treating anxiety and mood disorders but the patent for these uses had expired. Actavis manufactured pregabalin but the leaflet in the packet indicated that the product was only suitable for treating anxiety and mood disorders, not for treating pain.
Warner Lambert claimed that, although pain was not mentioned in the leaflet, Actavis’s product would still be dispensed for the treatment of pain. This is because doctors did not prescribe by brand or include the condition to be treated on the prescription. Consequently pharmacists would dispense Actavis’s product to patients not knowing that they were using it for pain.
The English Court of Appeal said that if Actavis knew or could reasonably foresee that patients would use its product for the treatment of pain, then Actavis would infringe Warner Lambert’s Swiss type claim. It did not matter whether the doctor knew that Actavis’ drug would be dispensed by the pharmacist, nor that the pharmacist did not know that the drug was being used by the patient to treat pain.
The corollary is that if Actavis infringed the Swiss type claim, doctors and pharmacists also infringed. This is because the UK Patents Act 1977 makes it an infringement to dispose of, keep, or use the product of a patented process and a Swiss type claim is considered to be a claim to the process for manufacturing the drug.
The Court of Appeal also indicated that a pharmacist would be participating in the manufacturing process and infringing the Swiss type claim by applying a label to the package or any similar activity. Perhaps even putting a packet in a paper bag, which pharmacists nearly always do, would be a step in the manufacturing process.
Most of the judgment focused on whether pharmacists infringe Swiss type claims. However, in an earlier decision pertaining to the same matter, the English Court of Appeal expressly said that doctors could infringe Swiss type claims by disposing of a drug.
It is arguable that only pharmacists “dispose of” a drug while doctors only advise which drug a patient should take, and therefore doctors do not infringe Swiss type claims. However, if New Zealand Courts follow the English Court of Appeal, the exclusion of medical treatment claims has not achieved its objective.