Beware of earlier inclusions in the ARTG
Re: G.D Searle LLC  APO 31
A delegate of the Commissioner of Patents has rejected an application for an extension of patent term by G.D Searle LLC on the basis that the application was not made within 6 months of the earliest inclusion in the Australian Register of Therapeutic Goods (ARTG) of a relevant pharmaceutical substance.
Facts of the case
Searle G.D Searle LLC (Searle), applied for a patent term extension for Patent No 680635 on the basis of the inclusion of goods containing darunavir (as goods called PREZISTA) in the ARTG (sponsored by Janssen-Cilag Pty Ltd). During examination of the application for extension, it was noted that goods containing another substance within the scope of the claims of the patent, amprenavir, had an earlier inclusion in the ARTG (as goods called AGENERASE and sponsored by GlaxoSmithkline Australia Pty Ltd). As a consequence, the Senior Examiner held that Searle’s application for extension had not been made within the statutory six months from the first inclusion in the ARTG of goods that contain the substance. Searle requested a hearing.
The relevant provision under consideration was subsection 71(2)(b) which requires that an application for an extension must be made within six months of the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, any of the pharmaceutical substances (which must in substance be disclosed in the complete specification and in substance fall within the scope of the claim or claims).
The Senior Examiner placed emphasis on the expression “the first inclusion”, taking the view that this required an application to be made within six months of the earliest inclusion in the ARTG of a good that contained or consisted of a relevant pharmaceutical substance. In contrast, Searle was of the view that the relevant phrase was “any of the pharmaceutical substances,” “and that” first inclusion” referred to the first inclusion of goods consisting of a particular substance, reflecting the recognition that a substance can have several entries in the ARTG with respect to different goods or listings. As a consequence, it was asserted by Searle that the six month period is started afresh by each first inclusion in the ARTG.
Acknowledging that either interpretation could be fairly read and that the matter at hand was an issue of construction, the Delegate examined the relevant provisions and noted that section 77, which determines the extension term, refers to the earliest first regulatory approval. The Federal Court, in Pfizer Corp v Commissioner of Patents (no 2)  FCA 1176, had previously made clear that this refers to the earliest inclusion in the ARTG and accordingly, the Delegate favoured an interpretation in which the expression “the first inclusion” refers to the inclusion of the first pharmaceutical substance.
In doing so, the Delegate rejected Searle’s contention that such a construction operates unfairly to the patentee when the first inclusion of relevant goods in the ARTG is sponsored by another party, particularly as in this instance the term of extension based on AGENERASE would be some two years shorter than that based on PREZISTA. The Delegate held that it is not open to the Commissioner to calculate the term of extension only on the basis of goods sponsored by the patentee, and that in any event, the goods on which Searle relied were also sponsored by another party. It was acknowledged that it was not incumbent on the patentee to search the ARTG for all possible goods containing or consisting of substances covered by their patent, however, once aware of an earlier regulatory approval of relevant goods, the patentee has an obligation to inform the Commissioner of this fact and the application must be amended, and if appropriate, an extension of time must be sought in which to make the application. Indeed, the Delegate noted that failure to inform the Commissioner of an earlier relevant inclusion could be an offence under section 191, punishable by imprisonment, for the making of a false entry in the (Patent) Register. Likewise, the Commissioner is not required to carry out a search of the ARTG, however, the Commissioner is not prevented from undertaking a suitable investigation, and if aware of an earlier inclusion, must bring that to the patentee’s attention so that the application can be correctly made.
Although it is not clear from the decision whether the sponsor of the first registered product was a licensee of Searle, this decision does serve as a warning to patentees to remain alert to activities undertaken by a licensee to register or list a licensed pharmaceutical substance in the ARTG, particularly where the patentee intends to register a different pharmaceutical substance under the same patent. If it is anticipated that a patent may encompass more than one pharmaceutical substance intended for inclusion into the ARTG, then consideration should be given to filing one or more divisional applications prior to grant so that an extension of term may be sought in respect of each first inclusion of a pharmaceutical substance.
The decision also has the effect that a listing or registration in the ARTG by an unauthorised third party may reduce or even nullify the term of extension to which a patentee might otherwise be entitled. Whilst the Delegate expressed the view that appropriate redress could be sought in an action for infringement, under section 119A the mere act of seeking and obtaining registration is in itself no infringement, and in the absence of any further unauthorised exploitation of the invention, no redress would appear available. In any event, even if subsequent to registration the activities of the unauthorised party amount to infringement, a remedy of damages as a result of a reduced period of monopoly may be difficult to assess or quantify, particularly if a patentee does not obtain marketing approval until towards the end of the standard twenty year patent term.