The Australian Patent Office recently refused an application for an extension of term of a pharmaceutical patent that claimed a combination of active ingredients for the treatment of cancer. This case serves as a reminder that a combination of pharmaceutical substances as separate dosage forms is ineligible for a patent term extension and that the relevant claim(s) must be aligned with the description of the goods in the ARTG.
The patent in question
The patent in issue, AU2005202596, was granted to The Children's Medical Center Corporation on 4 February 2010 for a pharmaceutical anti-cancer combination. The patentee subsequently filed an application for a patent term extension in a submission dated 17 June 2010, which was refused at first instance by the Examiner. The matter was then set for hearing.
Requirements for grant of a patent extension
The key question before the Delegate of the Commission of Patents was whether the patent met the conditions for the grant of a patent term extension. Section 70 of the Australian Patents Act 1990 sets out several conditions that must be met before a patent term extension can be granted. The two conditions at issue in this case were:
70(2)…(a): one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
70(3)…(a): goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods [ARTG];
The claims under consideration were directed to the pharmaceutical combination comprising thalidomide and (i) a steroid (claim 1), (ii) dexamethasone (claim 4) or (iii) prednisone and melphalan (claim 5).