AbbVie Biotechnology Ltd
[2015] APO 45
•4 August 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
AbbVie Biotechnology Ltd [2015] APO 45
Patent No.:2012261708, 2013203420, 2013257402
Title:Human antibodies that bind human TNFalpha
Patentee: AbbVie Biotechnology Ltd
Hearing Officer: P M Spann, Deputy Commissioner of Patents
Decision Date: 4 August 2015
Hearing Date: 12 June 2015 Melbourne; supplementary written submissions completed 17 July 2015
Catchwords: PATENTS – extensions of term – Swiss claims – whether a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, falls within the scope of the claims – first inclusion in the ARTG of goods that contain or consist of the substance – whether application made in time – extension application refused.
Representation: Mr B Caine, QC
Mr M Caine, patent attorney,
Dr S Khosa,
Davies Collison Cave
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent No’s.: 2012261708, 2013203420, 2013257402
Title:Human antibodies that bind human TNFalpha
Patentee: AbbVie Biotechnology Ltd
Date of Decision: 4 August 2015
DECISION
The requirements of section 70 and 71 are not satisfied and pursuant to subsection 74(3) I refuse to accept the applications for extensions of term.
REASONS FOR DECISION
Background
This matter concerns applications for extensions of the term of patent numbers 2012261708 (‘708), 2013203420 (‘420) and 2013257402 (‘402) all in the name of AbbVie Biotechnology Ltd (AbbVie). Patent ‘402 is a divisional of patent ‘420 which is a divisional of patent ‘708. These patents are in a larger chain of divisional patents including 2009202707 (’707), 2006241387, 2004202769, 775499 and 722077 (‘077). ‘077 and ‘707 have already been granted an extension of term on the basis of the listing of HUMIRA adalimumab on the Australian Register of Therapeutic Goods (ARTG) with the extended terms expiring on 10 December 2018.
It follows that all 3 of the present patents are related. The date of the patents is 10 February 1997 and the maximum 20-year term will therefore expire on 10 February 2017. The applications for extensions of term were all made on 3 October 2014 and, if granted on the basis asserted by the patentee, the extended terms of the patents will expire on 10 August 2021 (‘402) and 10 February 2022 (‘420 and ‘708).
The grounds for the extension applications are various inclusions in the ARTG for HUMIRA adalimumab, differing relevantly in the product specific indications. For present purposes it is sufficient to say that HUMIRA was subject to the first inclusion on the ARTG on 10 December 2003 with indications for Rheumatoid Arthritis. Subsequent inclusions added indications for other conditions being Ankylosing Spondylitis (10 August 2006), Crohn’s Disease (29 June 2007) and Ulcerative Colitis (23 July 2013). The present patents include claims of the “Swiss” type characterised by manufacture of a medicament for use in the treatment of the latter three conditions.
The examiner has objected that, as the Swiss claims are purpose limited, they are not directed to substances when produced by a process that involves the use of recombinant DNA technology. She has also objected that the applications do not correctly identify the first regulatory approval date for the relevant substance, that is, adalimumab (rch) as opposed to the date of the inclusions for the relevant indications. The patentee ultimately requested a hearing and provided written and oral submissions to which I will refer as appropriate in my reasons below.
The Specifications
The specifications are similar and begin by highlighting that tumour necrosis factor α (TNFα) is a cytokine implicated in the pathophysiology of various human disorders. Accordingly therapies have been sought to inhibit human TNFα (hTNFα) and particularly antibodies that bind to and inhibit hTNFα activity. The invention then relates to the provision of human and preferably recombinant human antibodies that bind to hTNFα. Suitable antibodies or antigen binding portions are identified including apparently adalimumab.
As indicated above the claims are of the Swiss type and similar between the patents except for the condition treated. For current purposes I will refer to claim 1 of the ‘708 patent:
“1. Use of an isolated human antibody, or antigen-binding portion thereof, that dissociates from human TNFα with a Kd of 1 x 10-8 M or less and a Koff rate constant of 1 x 10-3s-1 or less, both determined by surface plasmon resonance, and neutralises human TNFα cytotoxicity in a standard in vivo L929 assay with an IC50 of l x 10-7 M or less, in the manufacture of a medicament for the treatment of ulcerative colitis, wherein the human antibody or antigen-binding portion thereof is produced by a process that involves the use of recombinant DNA technology.”
Law
Part 3 of Chapter 6 of the Patents Act provides a statutory framework for the extension of the term of standard patents relating to pharmaceutical substances. Section 70 relevantly provides:
“(1)The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.
(2)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.
(3)Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:
(a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;
(b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.
(4)The term of the patent must not have been previously extended under this Part.
(5)For the purposes of this section, the first regulatory approval date, in relation to a pharmaceutical substance, is:
(a) if no pre-TGA marketing approval was given in relation to the substance—the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, the substance; or
(b) if pre-TGA marketing approval was given in relation to the substance—the date of the first approval.
(6)For the purposes of this section, pre-TGA marketing approval, in relation to a pharmaceutical substance, is an approval (however described) by a Minister, or a Secretary of a Department, to:
(a) market the substance, or a product containing the substance, in Australia; or
(b) import into Australia, for general marketing, the substance or a product containing the substance.”
The expression "pharmaceutical substance" is defined in Schedule 1 of the Act. It is:
“a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:
(a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or
(b) action on an infectious agent, or on a toxin or other poison, in a human body;
but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing.”
The term "therapeutic use" is also defined in Schedule 1. It means:
“use for the purpose of:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
(b) influencing, inhibiting or modifying a physiological process in persons; or
(c) testing the susceptibility of persons to a disease or ailment.”
10. If an extension of term is granted section 77 provides:
“(1)If the Commissioner grants an extension of the term of a standard patent, the term of the extension is equal to:
(a) the period beginning on the date of the patent and ending on the earliest first regulatory approval date (as defined by section 70) in relation to any of the pharmaceutical substances referred to in subsection 70(2);
reduced (but not below zero) by:
(b) 5 years.
Note: Section 65 sets out the date of a patent.
(2)However, the term of the extension cannot be longer than 5 years.”
Consideration
11. The first issue that arises in this matter is whether, in substance, the specification discloses and claims a pharmaceutical substance “when produced by a process that involves the use of recombinant DNA technology”. While I can accept for current purposes that such a substance is disclosed in the specification I do not agree that it in substance falls within the scope of the claims.
12. I considered the application of subsection 70(2)(b) to Swiss and method claims in my recent decision in ThromboGenics NV [2015] APO 44 concluding:
“…. in my view, the reference in subsection 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. Consequently a substance when produced by a process that involves the use of recombinant DNA technology will not fall within the scope of a claim that is characterised by a therapeutic use in the same way as a pharmaceutical substance per se does not fall within the scope of such claims. Otherwise extensions of term will be granted that are clearly inconsistent with the purpose of the Act. In particular it seems clear that patents covering new therapeutic uses of old substances produced by old processes should not be extended even if they involve recombinant DNA technology.”
13. It is not necessary to restate the basis for my reasoning on this question. It is sufficient to point out that, while notionally directed to a method or process of manufacturing a medicament, the claims are characterised by a therapeutic use. Consequently, on the basis of my reasons in ThromboGenics I do not find that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, in substance falls within the scope of the claims. I must therefore refuse the application for an extension of term.
14. I would add that had the requirements of subsection 70(2)(b) been met I would have found that the relevant earliest first regulatory approval date is 10 December 2003. That is, the date of the first regulatory approval for HUMIRA not the date of subsequent inclusions for various different indications. Consequently the maximum extension granted would be to 10 December 2018, the same date as for the related ‘077 and ‘707 patents.
15. The submissions on this point appear to assume a policy intent that methods of treatment are extendable if in some way associated with recombinant techniques. As in ThromboGenics I find no support for this in the Explanatory Memorandum to the Intellectual Property Laws Amendment Bill 1997 nor in any judicial consideration of the legislative scheme (see for example Justice Heerey’s analysis at first instance in Boehringer lngelheim International v Commissioner of Patents [2000] FCA 1918 at [12] – [15]). On the contrary, the intention seems clearly to exclude therapeutic methods and to provide extensions only for new and inventive pharmaceutical substances per se and, as an exception, substances produced by new and inventive processes involving recombinant technology.
16. More particularly it is asserted that the substance referred to in subsection 70(3) is not adalimumab but adalimumab characterised both by it method of production and its intended use. Then it is submitted that ‘Goods’ in the context of the ARTG includes the pharmaceutical product adalimumab together with its indications. Therefore it is said, for example, that adalimumab with an indication for the treatment of rheumatoid arthritis is a Good that does not contain or consist of adalimumab claimed for the treatment of ulcerative colitis.
17. However, nothing in normal usage of the term or the context of the legislation requires a reference to a pharmaceutical substance to be taken to include its use. Neither for the purpose of the comparison required by subsection 70(3) is it sensible to say Goods on the ARTG somehow include different dosages, indications, names or any other distinguishing feature mentioned in subsection 16(1) of the Therapeutic Goods Act (TGA). Different indications may result in Goods being treated as distinct for the purpose of listing in the ARTG but this does not mean the composition of the ‘Goods’ is necessarily different. The TGA for example recognises that goods are separate from their therapeutic use (“"indications", in relation to therapeutic goods, means the specific therapeutic uses of the goods”) - see Celgene Corporation [2011] APO 37.
18. The comparison required by subsection 70(3) was considered by the Full Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70. Bennett J at [239] pointed out:
"The level of the inquiry required by s 70(3) does not look to 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."
19. I do not agree with the patentee’s submissions that Lundbeck is distinguishable and the Court’s conclusion on subsection 70(3) remains apt whether subsection 70(2)(a) or (b) is being considered. On this basis, the relevant substance for the purpose of subsection 70(2)(b) is adalimumab and I find that first relevant inclusion in the ARTG of goods that contain, or consist of adalimumab, is that made on 10 December 2003. For this reason, as pointed out by the examiner, the applications do not refer to the correct information and do not comply with the requirements of section 71.
Conclusion
20. The requirements of sections 70 and 71 are not satisfied and pursuant to subsection 74(3) I refuse to accept the applications for extensions of term.
P M Spann
Deputy Commissioner of Patents
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