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Friday, August 25, 2017

Full Federal Court confirms 'Swiss-style' claims are not eligible for PTE

By Claire Gregg, Associate and Lauren John, Senior Associate

The Full Federal Court of Australia has unanimously confirmed that 'Swiss-style' claims involving recombinantly produced products for a new medical use are not eligible for patent term extension (PTE) under the Patents Act 1990 (Cth) (the Act), in Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129.

Australia’s PTE provisions are found in s 70 of the Act and provide for an extension of term of pharmaceutical patents of up to five years where one or both of the following substances are in substance disclosed in the complete specification and fall within the scope of the claim or claims of the patent:

  1. a pharmaceutical substance per se (s 70(2)(a)); or
  2. a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology (s 70(2)(b)).

Goods containing, or consisting of, the pharmaceutical substance must also be included on the Australian Register of Therapeutic Goods (ARTG), and at least five years must have elapsed between the date of the patent and the 'first regulatory approval date' of such goods (s 70(3)).

This appeal decision, which overturns last year's decision of the Administrative Appeals Tribunal (AAT) in AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AAT 682, marks the first time the Federal Court has considered the scope of s 70(2)(b). The decision means that, to be eligible for PTE under s 70(2)(b), it is not enough merely to show that a pharmaceutical substance has been produced by a process involving recombinant DNA technology and that the pharmaceutical substance is an integer of the claim(s) upon which the PTE application is based. When properly construed, s 70(2)(b) means that 'it is the pharmaceutical substance that must be the subject matter of the claim or claims, not methods or processes (beyond recombinant DNA technology) concerning or involving the pharmaceutical substance'.

Implications


This decision confirms that it is not possible to obtain PTEs for patents directed to a second or subsequent medical use of a known pharmaceutical substance simply because that substance happens to be the product of a process involving recombinant DNA technology. To support an application for PTE, a patent involving recombinant DNA technology must include at least one claim covering the relevant pharmaceutical substance. This may be a product claim per se, or, for products made by a process involving recombinant DNA technology, a process claim which implicitly covers the product of the process under Australian law.

Previous Patent Office decisions have also provided some guidance on the scope of s 70(2)(b). Thus, in considering whether to apply for PTE of a pharmaceutical patent with claims that involve recombinant DNA technology, the following should be kept in mind:

  • The relevant claims need not specifically recite recombinant process steps, provided that the pharmaceutical substance that is the subject of the claim can only be produced using recombinant DNA technology.
  • The claims need not necessarily be in 'product-by-process' format; a claim to a process involving recombinant DNA that would inevitably produce a pharmaceutical substance may suffice.
  • The specific recombinant DNA processes need not be the novel and inventive.

Background


AbbVie Biotechnology Ltd (AbbVie) is the registered proprietor of three 'second medical use' patents, which include claims to the use of adalimumab in the manufacture of a medicament for the treatment of rheumatoid spondylitis, Crohn's disease, and ulcerative colitis, respectively. Such claims are known as 'Swiss-style' claims.

The relevant pharmaceutical substance, adalimumab, is an antibody produced by a process involving recombinant DNA technology and marketed under the name HUMIRA® in the form of an injectable solution. HUMIRA® was originally included in the ARTG on 10 December 2003 for the treatment of rheumatoid arthritis. Subsequently, AbbVie obtained approval to market HUMIRA® for additional therapeutic indications: rheumatoid spondylitis (10 August 2006), Crohn's disease (29 June 2007), and ulcerative colitis (23 July 2013).

AbbVie applied for PTE for each patent under s 70(2)(b) based on the ARTG registration dates for the relevant subsequent therapeutic indications, not the original ARTG registration date of goods containing adalimumab (ie, the first regulatory approval of HUMIRA® on 10 December 2003).

Earlier decisions of the Full Federal Court dealing with s 70(2)(a) determined that the words 'per se' have been used in the legislation for good purpose. The Court held that claims directed to the use of a pharmaceutical substance when used in a particular device (as in Boehringer [2001] FCA 647), and claims directed to a method of administering a pharmaceutical substance (as in Prejay [2003] FCAFC 77) do not relate to a 'pharmaceutical substance per se' because they are qualified by their environment (ie, they include integers other than the substance itself). Put another way, in each case the pharmaceutical substance was not, itself, the subject of the claim.

The decisions below – AbbVie victorious (almost) 


The Commissioner initially refused each of the PTE applications on the basis that the reference in s 70(2)(b) to a 'substance when produced by a process involving recombinant technology' means 'that product as such, not characterised by its therapeutic use, mode of delivery or features other than its process of production'. The Commissioner considered that Swiss-style claims are characterised by a therapeutic use and therefore do not fall within the ambit of s 70(2)(b).

The AAT overturned the Commissioner's decision that the claims in issue are not eligible for PTE. After considering the Explanatory Memorandum which accompanied the legislation that brought about s 70 of the Act, the AAT said that an interpretation which would incorporate into the plain reading of s 70(2)(b) an exclusion of Swiss-style claims based upon a substance produced by recombinant DNA technology is unwarranted. The AAT determined that the only qualification for extension present in s 70(2)(b) is the requirement that the substance be produced by recombinant DNA technology.

The Commissioner also considered that AbbVie had failed to file the PTE applications in the correct form as prescribed under s 71, because, in each case, AbbVie had not based the PTE application on the first regulatory approval date of HUMIRA® (being 10 December 2003), regardless of its therapeutic indication. The AAT affirmed this aspect of the Commissioner’s decision, and so, AbbVie would not be entitled to a PTE on the basis of the applications as filed.

The appeal 


Despite the AAT upholding the Commissioner's decision to refuse the PTE applications, the Commissioner appealed the AAT’s decision in relation to the eligibility of 'Swiss-style' claims for PTE to the Full Federal Court. Since the decision of the Full Court would not alter the AAT's finding that the PTE applications were not in the correct form, AbbVie took no active role in the appeal, and no other contradictor was forthcoming.

The Full Federal Court, comprised of Besanko, Yates and Beach JJ, observed that the Act divides inventions into two categories, being either products, or methods or processes, and that the definition of 'pharmaceutical substance' plainly indicates that such a substance is a product. According to their Honours, 'it is the character of pharmaceutical substances as products that gives meaning to the 'scope of the claim or claims' in [s 70(2)(a)]', and that this interpretation is assisted by the express use of the term 'per se' in s 70(2)(b). For this reason, the courts have readily recognised that s 70(2)(a) is concerned with inventions that are products (rather than methods or processes).

As to the construction of s 70(2)(b), which does not expressly include the term 'per se', their Honours emphasised the explanations given in earlier decisions dealing with s 70(2)(a) that the policy intended to be achieved by s 70(2) is 'primary research and development in inventive substances, not the way they are made or the way they are used, with the sole (and important) exception of recombinant DNA techniques, this being an area particularly worthy of assistance for research and development'. Relevantly, it was noted by the Full Court in Prejay at [25] that:

This conclusion is not negatived by the terms of s 70(2)(b) of the Act…that paragraph does not require disclosure of a process. Rather, it requires the disclosure of “one or more pharmaceutical substances” that are produced by a particular process.

This observation was said to be significant 'because it acknowledges that s 70(2)(a) and s 70(2)(b) address the same concern', namely extensions of term in relation to claims directed to pharmaceutical substances. Although s 70(2)(b) represents an exception where pharmaceutical substances can be produced by a process that involves recombinant DNA technology, their Honours stated that the subject matter of the claims must still be the pharmaceutical substance or substances so produced, not other methods or processes involving those substances, in order to be eligible for PTE.

The Full Court indicated its agreement with the Commissioner's submission that it would not be appropriate to include the term 'per se' in s 70(2)(b) 'because the “one or more pharmaceutical substances” in s 70(2)(b) are further characterised by the fact that they must be produced by a particular process—one involving recombinant DNA technology', but that this was not to imply that the ss 70(2)(a) and 70(2)(b) could not be construed has operating conformably and harmoniously with one another.

Considering the claims in issue, their Honours noted that Swiss-style claims are not claims to pharmaceutical substances at all; rather, they are method or process claims. Although adalimumab is a pharmaceutical substance produced by a process that involves recombinant technology, the Swiss-style claims in issue are not directed to adalimumab produced by recombinant DNA technology. Instead, the claims are directed to a method or process in which adalimumab is used to produce a medicament and to the use of such a medicament for specific therapeutic purposes. Thus, when s 70(2)(b) is properly construed, adalimumab does not in substance fall within the scope of the claims and Swiss-style claims necessarily cannot fall within the ambit of s 70(2)(b).


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