IP lawyer: Amped-up protection on the cards for recombinant DNA products

The deputy president of the Administrative Appeals Tribunal of Australia (AAT) has overturned a decision from the commissioner of patents to find that the term of a patent with Swiss-style claims can be extended when the claims cover the production of a pharmaceutical substance involving recombinant DNA technology (AbbVie Biotechnology Limited v Commissioner of Patents [2016] AATA 682, September 5 2016).

When a pharmaceutical substance is protected by an Australian patent, the term can generally be extended by up to five years beyond the usual 20-year period – but only if a relevant claim covers a pharmaceutical substance per se. In other words, a patent claim covering a new use of a known pharmaceutical substance protected by a patent claim is generally not extendible. Under Section 70(2)(b) of the Patents Act, the patent term can also be extended where a claim or claims of a patent disclose a pharmaceutical substance “when produced by a process that involves the use of recombinant DNA technology”. Substances produced by recombinant DNA technology are created by bringing together gene sequences from different sources to form molecules which do not ordinarily exist in nature. Swiss-style claims are often found in pharmaceutical patents, whether for recombinant DNA molecules or not, and are usually in the form: “the use of a compound X for the preparation of a medicament Y for the treatment of a disease/condition Z.” Such claims are generally not amenable to patent term extension. For many years, patent claims structured in this way were not permissible in Australia at all.

In AbbVie Biotechnology the relevant patents each related to a pharmaceutical substance sold under the brand name Humira, which is produced using recombinant DNA technology. Humira has had remarkable commercial success. It is an important anti-inflammatory drug and is used for the treatment of a number of conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Global sales of Humira in 2015 exceeded $14 billion. Unsurprisingly, other pharmaceutical companies are keen to supply generic versions of Humira and AbbVie has been a vigilant enforcer of its patents. Just this year, it launched a major suit in the United States against rival Amgen Inc concerning what AbbVie has called a “replica” of Humira.

In Australia, AbbVie sought an extension of the term of three patents each for the treatment of different conditions using Humira. The commissioner argued that to extend the three AbbVie patents would be anomalous, as pharmaceutical substances not produced using recombinant DNA are not extendible for new uses. The AAT rejected this argument, noting that the words “per se” are not found in Section 70(2)(b), which relates specifically to the extension of patents which relate to recombinant DNA technology (Section 70(2)(a) relating to other pharmaceutical substances utilises the expression “pharmaceutical substances per se”). The tribunal found that the only requirement for the extension of a patent for a pharmaceutical substance produced by recombinant DNA technology is that the substance be disclosed in the complete specification and fall within the scope of the claims. It did not matter that the particular patents in question were for new uses of a known pharmaceutical substance.

After applying a strict reading to Section 70(2)(b), which worked to the benefit of the patentee, the tribunal then took a strict reading to the question of when an application for extension of term needed to be filed. Under Section 71(2), an application for an extension of term must be made within six months of the date on which the patent was granted or six months of the first inclusion of the pharmaceutical substance in the Australian Register of Therapeutic Goods (ARTG). Relevant in these cases was that Humira had been first registered for the treatment of other conditions well before the applications for extension of term which had been filed by AbbVie for the three patents under consideration. The AAT observed that the applications for extensions did not relate to a pharmaceutical different from the substance which had been previously registered; and while the uses covered by the patents were different, the substance remained the same as that which was originally registered on the ARTG as Humira.

AbbVie had filed its applications for a term extension within six months of each of the specific ARTG registrations for the treatment of the respective conditions covered by the patents. The AAT found that this was too late. In this respect it was guided by H Lundbeck A/S v Alphapharm Pty Ltd ([2009] FCAFC 70), where the Full Federal Court observed that the relevant enquiry for Section 71(2) does not involve looking at the therapeutic effect of the pharmaceutical substance – rather, it is a simple comparison of the pharmaceutical substance with the ingredients of the goods on the ARTG.

As a result of the decision, the current structure of Section 70 gives preferred status to pharmaceutical substances produced by processes which involve the use of recombinant DNA. Swiss-style claims covering the use of such substances for the treatment of different conditions can be extended by up to five years beyond the standard 20-year patent term. However, an application for an extension must be made within six months of the original ATRG registration in which the pharmaceutical substance was first disclosed for any condition, not the registration relevant to the particular condition addressed in the patent.

The commissioner of patents has filed an appeal against the AAT’s decision.