Pfizer Inc v Commissioner of Patents
(CA 22/03, 28th June 2004)
On the 28th June 2004, the New Zealand Court of Appeal delivered a unanimous judgement rejecting Pfizer Inc’s appeal against a High Court judgement that concurred with the Assistant Commissioner of Patents rejection of two applications to patent methods of medical treatment. The patentability of methods of medical treatment was first substantially tested in New Zealand in Wellcome Foundation Ltd v Commissioner of Patents (1983 FSR 593). The Court of Appeal in Wellcome overturned the High Court judgement, and held that methods of medical treatment cannot be patented on policy grounds. The Court held that the patentability of such subject matter can only be decided by the legislature. Wellcome was recently refined by the Court of Appeal in Pharmaceutical Management Agency Ltd v Commissioner of Patents (2000 RPC 257).
In the current appeal Pfizer initially argued the Pharmac decision overruled Wellcome with respect to the patentability of methods of medical treatment. The Court of Appeal rejected this argument, finding that Pharmac only overruled Wellcome in finding that Swiss-type claims are patentable.
Pfizer also sought to argue that Wellcome should be overruled on account of subsequent developments. Namely; Pharmac acknowledged that methods of medical treatment could qualify as an invention under the Act. The Court also raised doubts in Pharmac about the Commissioner’s ability to refuse an application on the basis of being generally inconvenient. Further, it was argued that there is no specific exclusion from patentability for methods of medical treatment in the Patents Act. If such an exclusion was intended, then it should have been enacted in the 1994 amendments to the Act, which implemented New Zealand’s obligation to the TRIP’s agreement.
However, in the present case the Court of Appeal held that while a method of medical treatment can qualify as an invention, it could still be excluded from patentability by s. 6 of the UK Statute of Monopolies 1623, which constrains the nature of patentable inventions in New Zealand. The Court also held that the Statute of Monopolies is not overruled by New Zealand’s obligations to the TRIP’s agreement. The Court clarified the scope of the Commissioner’s ability to refuse an application on the basis of being generally inconvenient, holding that methods of medical treatment fall within that scope.
Pfizer’s last argument was that its applications should be granted subject to an explicit disclaimer that it would not sue any medical practitioner. This option was considered by the Court of Appeal in Pharmac as a possible strategy to satisfy the “generally inconvenient” objection to patentability that has its basis in the Statute of Monopolies. However, it was held that Pfizer’s proposed disclaimer is inadequate and that the allowability of any such disclaimer needs to be made by the legislature rather than the judiciary.
Assistant Commissioner’s (AC) decision P1-2007 overruled part of a practice note relating to Swiss type claims. In particular, the AC’s decision endorsed the decision by the EPO Technical Board of Appeal in Genentech (T 1020/03). It held that a different dosage regime can confer novelty for Swiss-style claims on account of the problems solved by the use of the dosage regime.
Assistant Commissioner’s decisions P23-2007 and P24-2007 held that there can be novelty in a Swiss-type claim even if there is prior publication of the same use but relating to a different stage of treatment. Hence, the fact that a pharmaceutically active ingredient is known in the treatment of cancer does not mean that it is known to treat all cancers or all stages of any particular cancer. There may well be invention in finding that an anti-cancer drug known for treating one stage of breast cancer is also effective for treating a different stage of what might appear to some to be the same cancer.