A Full Court of the Federal Court has confirmed that patents containing “Swiss-style” claims are outside the scope of the Australian patent term extension regime in its recent judgment of Commissioner of Patents v AbbVie Biotechnology Ltd  FCAFC 129.
What it means:
- Patents which claim methods or processes involving pharmaceutical substances cannot be extended under the patent term extension regime. This includes Swiss-style claims for the use of a compound for the preparation or manufacture of a medicine for the treatment of a particular disease.
- Swiss-style claims, which are common in the pharmaceutical field, particularly in the area of biologics, are therefore limited to 20 year terms.
- The patent term extension regime is not changed for API patents.
The case was an appeal of a decision from the Administrative Appeals Tribunal (AAT), brought by the Commissioner of Patents, in which the AAT found that Swiss-style claims were within the scope of the patent term extension regime. Swiss-style claims protect the use of a compound for the preparation or manufacture of a medicine for the treatment of a particular disease. At issue in this case were patents claiming the use of adalimumab (Humira®) in manufacturing a medicament to treat particular auto-immune diseases.
The Patents Act patent term extension regime is stated to apply to either a “pharmaceutical substance per se” or a “pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology”. The intention of the regime is to acknowledge delays in the regulatory processes for registration of pharmaceuticals; if there is a delay of greater than 5 years between the date of the patent and the first regulatory approval date for the substance, in which case an extension may be granted.
AbbVie had argued that the patents protected a pharmaceutical substance produced by recombinant DNA technology and there had been a delay between the date of filing of the patent and the registration of these new indications on the Register of Therapeutic Goods. The Commissioner of Patents had held that these patents were not eligible for extension on the basis that the claims did not fall within the scope of the regime; the AAT disagreed, but found that the first regulatory approval date should be that of Humira itself, and not the date on which the new indications were registered.
The joint judgment of Justices Besanko, Yates and Beach overturned the AAT decision, and agreed with the Commissioner. The patents were not directed to a pharmaceutical substance (Humira) but rather to methods or processes, by which a substance is used to produce a medicament, and that medicament is used for a specific purpose. It is the substance that must be the subject matter of the claims of the patent, and not the methods or processes concerning or involving the substance. Therefore, the patents could not be extended.