The Australian Patent Office has refused to extend the term of a patent directed to an anti-cancer combination comprising thalidomide and a steroid. In a decision dated 7 October 2011, (The Children’s Medical Center Corporation  APO 80) the patent office refused the extension on the grounds that:
- The extension could not be based on the inclusion in the Australian Register of Therapeutic Goods (ARTG) of Thalomid™ (thalidomide). Even though the entry for thalidomide included a reference in the Product Specific Indications to it being used in combination with certain steroids, the patent office found that this indication was not an element of the therapeutic good. It followed that this entry did not constitute inclusion in the ARTG of the combination of thalidomide and a steroid and, accordingly, the requirement of the act that goods containing, or consisting of, the pharmaceutical substance be included in the ARTG was not satisfied.
- A combination of thalidomide and a steroid provided as separate unit dosages of the individual drugs was not a ‘pharmaceutical substance per se’ within the meaning of the act. It was found that the term ‘pharmaceutical substance per se’ was intended to be a pharmaceutical presented as a single entity, not in the form of a kit or separate dosage forms. The patentee had identified the pharmaceutical substance as a combination of thalidomide and a steroid presented as separate oral dosage forms of the individual drugs to enable the clinician to control the side effects of the drug combination.
According to this decision, a patent for a combination therapy cannot be extended on the basis of inclusion of one of the components in the ARTG. The combination also does not constitute a pharmaceutical substance per se, unless it is in a single unit dosage form. Presumably the outcome would have been different if the combination was produced as a single entity and the combination was registered on the ARTG. It will be interesting to see if this decision is appealed.
Contact: If you have any specific enquiries about this decision, or extensions of term more generally, please contact Debra Tulloch.