The Commissioner adopts a hard line on pharmaceutical extensions in Australia

G.D. Searle LLC applied for an extension of term based on the substance darunavir. Another substance (known as amprenavir), which was within the scope of the claims of the Seale’s patent, had an earlier inclusion in the Australian Register of Therapeutic Goods (ARTG). The Delegate held that Searle’s application did not comply with section 71 of the Patents Act as the application was not made within six months of the date of the earliest first inclusion in the ARTG. The goods containing darunavir were included in the ARTG six years after those containing amprenavir.

In reaching his decision Delegate Barker sought guidance from Justice Bennett’s decision in Pfizer Corp v Commissioner of Patents [2006] FCA 1176 in the context of section 77 (the section that calculates the extension term). At [34] Bennett J stated:

“Section 77 refers to the ‘earliest first regulatory approval date’ (emphasis added). This recognises that the patent may cover more than one pharmaceutical substance and provides that the term of the extension is based on the earliest of the approval dates that apply to the patent.”

Having regard to Bennett J’s comments, Delegate Barker held that section 71 must mean that an application for extension of term is to be made within six months of the earliest first inclusion in the ARTG. While this decision seems harsh, particularly as the amprenavir product had been sponsored by a competitor and thus Searle would not gain the full effective patent life of its own product, it is clear that the Commissioner will adopt a hard line with applications for extensions of term. First inclusion in the ARTG means exactly that –the date of first inclusion of any pharmaceutical substance; regardless of the identity of the sponsor.

Delegate Barker also made the following comments concerning the extension of term provisions:

  1.  A patentee is not obligated to search the ARTG for all possible pharmaceutical substances covered by their patent, and all possible first regulatory approvals. Patentees can rely on the regulatory approvals that they are aware of. However, once they become aware that there is an earlier first regulatory approval, they have no option but to amend their application, and if necessary make a request under section 223. To do otherwise would be contrary to section 191 of the Patents Act.
  2. The Commissioner is not required to carry out a search, and will record the extension on the basis of the information provided to her. However, the Commissioner is not prevented from undertaking her own investigation, and if she becomes aware of an earlier inclusion she has no option but to bring that to the patentee’s attention so that the application for extension of term is correctly made. The Commissioner’s obligation to maintain the Register of Patents and to remedy any inaccuracies or misleading particulars is paramount.
  3. Regulation 10.7(7) operates when the full facts were not known to the patentee at the time of granting the extension of term.