In Australia, it is possible to extend the term of a patent beyond 20 years provided that certain conditions are met. The Administrative Appeals Tribunal’s (AAT) decision in AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682 has clarified that term extensions are available for a broader class of patents for biologic pharmaceutical products than non-biologic pharmaceuticals. This decision could be very lucrative to patentees of biologic pharmaceutical products.

Biologic Pharmaceutical Products

AbbVie applied to extend the terms of several patents that claimed the use of a biologic product, adalimumab, for the manufacture of a pharmaceutical composition for the treatment of rheumatoid spondylitis, Crohn’s disease or ulcerative colitis (commonly referred to as a “Swiss style claim”).

It is well-settled in relation to nonbiologic pharmaceutical products that term extensions are only available for the product itself, not methods of manufacture or therapeutic uses. The Commissioner of Patents applied this reasoning in relation to AbbVie’s biologic patents and refused the term extension. AbbVie appealed this decision to the AAT.

The AAT upheld AbbVie’s appeal, finding that the position for biologic and non-biologic pharmaceutical products is different. The AAT relied heavily on the fact that the section that addresses nonbiologic pharmaceutical products requires that the patent claim a “pharmaceutical substance per se”. Earlier cases have established that a “pharmaceutical substance per se” is limited to pharmaceutical products.

In comparison, the section for biologic pharmaceutical products only requires that the claims relate to a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology. The AAT considered this section broad enough to encompass Swiss-style claims (and other method claims), provided that a pharmaceutical substance produced by recombinant DNA technology is disclosed in, and falls within the scope of, the patent. As a result, AbbVie was entitled to an extension of term for its Swiss-style claims.

ARTG Registrations for New Indications

AbbVie also argued that its extension of term should be calculated from the date that the rheumatoid spondylitis, Crohn’s disease and ulcerative colitis indications were registered on the Australian Register of Therapeutic Goods (ARTG). Adalimumab was first registered on the ARTG for rheumatoid arthritis. If the subsequent registrations were the relevant registrations, AbbVie would be entitled to a longer term extension.

However, the AAT disagreed with AbbVie’s argument, and confirmed that, when calculating the length of a term extension, the relevant point in time is the date on which the therapeutic product was first registered on the ARTG, irrespective of the indication. The subsequent registration of a new indication for that product cannot be taken into account.

Conclusion

The AAT’s decision could have dramatic consequences in the field of biologic pharmaceuticals, as it indicates that the scope for obtaining a term extension might extend to methods of production, therapeutic uses and other methods. This is much broader than the term extensions available for patents claiming non-biologic products (such as traditional small molecules), and presents patentees of biologic pharmaceutical products with a very lucrative opportunity.

Next steps – key action required

As there are time limits that apply to obtaining an extension of term, we strongly advise that all patents relating biologic pharmaceuticals are reviewed immediately to determine whether a term extension is available.