In a decision handed down on 18 August 2017, the Full Federal Court has overturned a decision of the Administrative Appeals Tribunal, finding that patents which rely on Swiss-style claims are incompatible with extension of term (EoT) provisions. These provisions enable the term of a patent claiming a pharmaceutical substance to be extended on the basis of regulatory delay. In particular, the court determined that Swiss-style claims are to methods of production, not to a product, and as such do not comply with the EoT provisions.
Background
The original decision of the Deputy Commissioner of Patents was handed down on 4 August 2015. That decision found that the three patents in question, Patent No. 2012261708 (the 708 patent); Patent No. 2013203420 (the 420 patent) and Patent No. 2013257402 (the 402 patent), were not directed to pharmaceutical substances, and thus the EoT could not be granted (1). Each of the patents includes Swiss-style claims, directed to the use of a substance (Adalimumab) in the manufacture of a medicament for the treatment of a disease. The Adalimumab was produced using recombinant DNA technology. The 708 patent was directed to the treatment of ulcerative colitis, the 420 patent to the treatment of Crohn’s disease and the 402 patent to the treatment of rheumatoid spondylitis.
This patentee applied to the Commissioner of Patents, under s 70(2) of the Patent Act, for an extension of term for each patent. Section 70(2) of the Patents Act requires that:
‘Either or both of the following conditions must be satisfied:
(a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
(b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.’ (2)
The delegate of the Commissioner found that in each EoT application, section 70(2)(b) had not been satisfied. In particular, it was found that a pharmaceutical substance, when produced with recombinant DNA technology, does not fall within the scope of a claim which is characterised by the therapeutic use of that product, ie. a Swiss style claim (3. ) As such, all three extensions were refused by the Deputy Commissioner (4).
This decision was appealed to the Administrative Appeals Tribunal (AAT), which overturned the decision of the Deputy Commissioner. The AAT held that a product, when produced by a process that involves recombinant DNA technology, in substance falls within the scope of the claims of a patent within the meaning of section 70(2)(b) of the Patents Act 1990 (Cth) where such patent is granted in respect of a particular therapeutic use (5).
The tribunal decision reasoned that, had the intent of the s70(2)(b) been to exclude Swiss type claims, this would have been done so by simply including ‘per se’ after the word process and excluding a description of pharmaceutical substance produced by recombinant DNA technology.
Full Federal Court Decision
The AAT decision was appealed to the Full Federal Court, which overturned the AAT finding, reverting to the decision of the Deputy Commissioner. The Full Federal Court found that Swiss-style claims are methods or processes for the production of a medicament for a specified therapeutic purpose. As Swiss-style claims are not directed to a pharmaceutical product per se, it was found that they could not meet the requirements of s 70(2)(b) of the Patents Act.
The Court determined that the only exception, as stated in s70(2)(b), is a pharmaceutical product which is produced by a process which involves recombinant DNA technology. Although the Court went on to establish that the matter claimed must only be the pharmaceutical substance, not methods or processes which involve those substances. Therefore, the production of a product for the use in the preparation of a medicament (ie. a Swiss-style claim) is not a claim which could be considered to fall within the scope of s70(2)(b), and thus, a patent relying on such a claim should not be granted an EoT.
Conclusion
This decision confirms that EoT are only available for novel pharmaceuticals and for known pharmaceutical substances produced using a novel recombinant DNA technique, for example a product by new rDNA process. Given that the number of biologics n the pharmaceutical landscape of Australia continues to grow, EoT applications for these treatments are likely to become a major contentious focal point in the future.
It is not known as yet whether there will be a further appeal against this decision. However, an appeal to Australia’s highest court, the High Court, would require special leave of that Court to proceed.
This article was written by Benjamin Clearly and Rosemary Manhire-Heath
If you have any specific enquiries about the Pharmaceutical Benefits Scheme listing decision in Australia, please contact Debra Tulloch or Paul Jones.
References
- AbbVie Biotechnology Ltd [2015] APO 45
- Patents Act, 1990 – s 70(2)
- Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 [22]
- AbbVie Biotechnology Ltd (2015) 115 IPR 398; [2015] APO 45.
- AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682).