Perspective

Pharmaceutical Patent Term Extensions | Not available for second medical use claims

The Australian courts have determined that pharmaceutical patent term extension is not available for second medical use claims.

In Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129, the Full Federal Court determined that patent term extensions for pharmaceutical patents are not available in relation to second medical use claims, such as Swiss style claims.  Traditionally, Swiss style claims are claims that claim a use of a substance in the manufacture of a medicament for the treatment of a disorder.

In the decision, the full federal court considered the operation of section 70(2)(b) of the patents act which governs patent term extensions.  The provision states that a patent term extension is available if the specification discloses a pharmaceutical substance “per se”, or a pharmaceutical substance produced by recombinant technology, and the pharmaceutical substance falls within the scope of the claims.  Section 70(3) stipulates that the pharmaceutical substances must be registered under the Therapeutic Goods Act and the registration must occur 5 or more years after the date of the patent.

The rationale is to allow a patentee to gain an extension of the term of the patent to make up for time lost due to the requirement to obtain regulatory approval of the pharmaceutical which often can take more than 5 years.  As such, the extension granted is equivalent to the amount of time greater than 5 years of the term of the patent that is lost in achieving regulatory approval.  The extension term can be for a period of no longer than 5 years.

The case considered a decision of the Administrative Appeals Tribunal in Re AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682 that patent term extension is available in circumstances where the patent claim is in the form of a second medical use or Swiss Style claim.  The patent in question claimed adalimumab, which is a biologic and TNF inhibitor for use in the treatment of auto-immune disorders such as rheumatoid arthritis, rheumatoid spondylitis, Crohn’s disease and ulcerative colitis.

The Patent Office rejected the initial applications for patent term extension on the basis that a pharmaceutical substances produced by recombinant technology, or a pharmacaceutical substance per se, does not fall within the scope of a secondary medical use claim such as a swiss style claim.  Part of the Office’s reasoning is that to grant such an extension would circumvent the purpose of the provision which is not to grant a patent term extension for a new use of an old substance, as in the case of a second medical use claim, but rather to grant an extension for a new pharmaceutical substance where the inventor has not had the benefit of the full patent term due to the requirement to obtain regulatory approval.

The AAT overturned the Patent Office Decision on the basis that the Act did not explicitly exclude second medical uses of pharmaceuticals produced by recombinant technology as the wording of the section did not include the words “per se” as in the cases of pharmaceutical substances not produced by recombinant technology.

The Federal Court overturned the AAT’s decision and its reasoning.  The Federal Court stated that it is clear the section 70(2)(a) excludes second medical use claims, or any other method of use claim, from patent term extension on the grounds that the extension is only available to a pharmaceutical substance per se, and a claim to a method of use of the pharmaceutical does not include within it’s scope the pharmaceutical substance “per se”.

However, in the case of section 70(2)(b) which applies to pharmaceutical substances produced by recombinant technology, the claim must by definition include more than the pharmaceutical substance “per se” as it is qualified by the requirement to be produced by recombinant technology.  However, this does not mean that a patent term extension extends to methods of use of such pharmaceutical substances.  On the contrary, a claim to a method of use of a pharmaceutical substance produced by recombinant technology, as in the case of the patents in question, does not, in the view of the Federal Court, include within its scope the pharmaceutical substance produced by recombinant technology.

If you have any questions about pharmaceutical patent term extensions in Australia then please contact Daniel McKinley (daniel@gestalt.law).

 

"The rationale is to allow a patentee to gain an extension of the term of the patent to make up for time lost due to the requirement to obtain regulatory approval of the pharmaceutical which often can take more than 5 years."