Criteria for pharmaceutical patent term extensions clarified
Published on 01 Aug, 2016
To compensate patent owners for the time it takes to obtain regulatory and marketing approval for new drugs, the Australian Patents Act provides for patent term extensions of up to five years. However, in order to have an extension of term granted, a number of requirements need to be satisfied.
These requirements include:
(a) that a patent discloses and claims a pharmaceutical substance per se or a pharmaceutical substance produced by a process that involves the use of recombinant DNA technology; and.
(b) that the pharmaceutical substance be listed on the Australian Register of Therapeutic Goods (ARTG) before the patent expires.
Two recent Australian Patent Office decisions, namely the Regents of the University of California & Regeneron, Inc.  APO 33 (10 June 2016) (The Regents of the University of California & Regeneron) and Aventis Pharma S.A.  APO 34 (10 June 2016) (Aventis), considered whether product information included with an ARTG pharmaceutical listing was sufficient to satisfy requirement (b) above to obtain a granted patent term extension.
The issues and findings
The relevant claims of the two patents defined combinations of a VEGF antagonist and another compound, either fluorouracil 5-FU (Aventis) or an anti-proliferative agent (The Regents of the University of California & Regeneron). Patent term extension applications were filed for the two patents on the basis of the ARTG listing of ZALTRAP, which contains only the VEGF antagonist, aflibercept.
The patentees submitted that the claimed combinations are “included in the ARTG” by way of the therapeutic indications for ZALTRAP and by references to the claimed combination in the product information associated with ZALTRAP. Thus, the question considered by the Delegate for the Patent Office was whether the reference to the claimed combination in the ZALTRAP product information satisfied the requirement that the pharmaceutical substance be listed on the ARTG.
Ultimately, the Delegate was not satisfied that the relevant requirement was fulfilled. In reaching this decision, reference was made to precedent case law that confirmed that the requirement necessitated a simple comparison of the claimed pharmaceutical substance with the “ingredients” of the goods listed on the ARTG. As the patentees did not establish that ZALTRAP, as listed on the ARTG, included the claimed combination compositions, the patent term extension applications were refused.
These Patent Office decisions clarify that for a patent to be eligible for a term extension a pharmaceutical substance covered by the claims must be explicitly listed on the ARTG – reference to a claimed pharmaceutical in the product information of an ARTG listed pharmaceutical will not suffice.