AbbVie Biotechnology Ltd Commissioner of Patents
[2016] AATA 682
•5 September 2016
AbbVie Biotechnology Ltd Commissioner of Patents [2016] AATA 682 (5 September 2016)
Division
GENERAL DIVISION
File Number(s)
2015/4540-4542
Re
AbbVie Biotechnology Ltd
APPLICANT
And
Commissioner of Patents
RESPONDENT
DECISION
Tribunal The Hon. D Cowdroy OAM QC, Deputy President
Date 5 September 2016 Place Sydney With respect to the Delegate’s decision dated 4 August 2015 refusing the Applicant’s applications for extension of the term of the relevant patents, the Tribunal:
(a) Sets aside and substitutes a decision that a pharmaceutical substance, when produced by a process that involves recombinant DNA technology, in substance falls within the scope of the claims of the patents 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.
(b) Affirms the decision that the first regulatory approval date of the substance adalimumab for the purposes of section 70(3) of the Patents Act 1990 (Cth) is 10 December 2003.
(c) Affirms the decision that the Applicant did not comply with section 71(1) of the Patents Act 1990 (Cth).
...........................[sgd].............................................
The Hon. D Cowdroy OAM QC, Deputy President
CATCHWORDS
INDUSTRY, INNOVATION AND SCIENCE - Patents – request for extension of the term of patents – “Swiss style” claims - whether 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 of the patents which are capable of extension within the meaning of the Patents Act – interpretation of section 70(2)(b) of the Patents Act – origins of the words ‘per se’ – whether Applicant’s applications for extension disqualified on basis that “Swiss style” claims – decision set aside
INDUSTRY, INNOVATION AND SCIENCE - Patents – request for extension of the term of patents – “Swiss style” claims - whether first relevant inclusion of goods in the Australian Register of Therapeutic Goods was inclusion of pharmaceutical substance, rather than first inclusion of pharmaceutical substance characterised by its method of production and intended use – decision affirmed
LEGISLATION
Patents Act 1990 (Cth) ss 70, 71
Therapeutic Goods Act 1989 (Cth)
Patents (World Trade Organisation Amendments) Act 1994 (Cth)
Intellectual Property Laws Amendment Act 1998 (Cth)Acts Interpretation Act 1901 (Cth) s 15AC
CASES
Boehringer Ingelheim International GmbH v Commissioner of Patents (No 2) (2001) 112 FCR 595; [2001] FCA 647
Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (No 4) (2015) 113 IPR 191
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (1998) 41 IPR 467
Astra Lakemadel Aktiebolag v Commissioner for Patents (1995) 56 FCR 208
ThromboGenics NV (2015) 115 IPR 391
Commissioner of Taxation v Energy Resources of Australia Ltd (2003) 135 FCR 346
Re Alcan Australia Ltd; Ex-parte Federation of Industrial Manufacturing and Engineering Employees (1994) 181 CLR 96
H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151
Pfizer Corporation v Commissioner of Patents (No 2) [2006] FCA 1176
Alphapharm Pty Ltd v H.Lundbeck A/S [2008] FCA 559
Pfizer Corp v Commissioner of Patents [2006] FCAFC 190
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1; [2013] HCA 50
SECONDARY MATERIALS
Explanatory Memorandum, Intellectual Property Laws Amendment Act 1998 (Cth)
REASONS FOR DECISION
The Hon. D Cowdroy OAM QC, Deputy President
5 September 2016
The applicant in these proceedings, AbbVie Biotechnology Ltd, seeks review of the respondent’s decision to refuse three applications for extensions of the term of three patents (“the patents”), each of which was held in the name of the applicant. Each patent relates to a pharmaceutical substance known as adalimumab, which is produced (as referred to hereunder) by a process of recombinant DNA technology and marketed under the name HUMIRA. This substance was first registered as a patent on 10 February 1997. Each of the patents the subject of this decision are derived from this parent patent, and by operation of the relevant legislation, so too is their registration date. Accordingly, the 20 year life of the parent patent and the patents the subject of this decision expire on 10 February 2017, as is discussed more fully in the facts set hereunder.
The application for extension of the term of the patents was made pursuant to section 70 of the Patents Act 1990 (Cth) (“the Patents Act”). The respondent rejected the application in each case on the basis that the requirements of ss 70(2), 70(3) and 71 of the Patents Act were not satisfied. The Applicant seeks review of each decision, which all raise identical issues.
It is necessary to have regard to the factual background concerning the registration of the patents and the circumstances concerning their registration under the Australian Register of Therapeutic Goods (ARTG) as established by the Therapeutic Goods Act 1989 (Cth) (“the TGA”) and considered in the facts which follow.
FACTS
The applicant is the registered proprietor of the following patents:
(d)Australian Patent 2013257402, which includes claims to the use of adalimumab in the manufacture of a medicament for the treatment of rheumatoid spondylitis (“the rheumatoid spondylitis patent”). The rheumatoid spondylitis patent was filed on 11 November 2013.
(e)Australian Patent 2013203420, which includes claims to the use of adalimumab in the manufacture of a medicament for the treatment of Crohn’s disease (“the Crohn’s disease patent”). The Crohn’s disease patent was filed on 10 April 2013.
(f)Australian Patent 2012261708, which includes claims to the use of adalimumab in the manufacture of a medicament for the treatment of ulcerative colitis (“the ulcerative colitis patent”). The ulcerative colitis patent was filed on 7 December 2012.
For the purpose of section 77(1)(a) of the Patents Act the date of the patents outlined above is 10 February 1997: see section 65(b) of the Act.
Adalimumab is marketed under the name HUMIRA in the form of an injectable solution for the treatment of diseases including rheumatoid arthritis, rheumatoid spondylitis, Crohn’s disease and ulcerative colitis.
HUMIRA was originally included in the ARTG on 10 December 2003 (“the 10 December 2003 approval”). The 10 December 2003 approval was limited to use of HUMIRA for the treatment of rheumatoid arthritis.
Subsequent to the 10 December 2003 approval, the applicant obtained approvals under the TGA to market HUMIRA for the treatment of a number of further disease or indications:
(a)On 10 August 2006, HUMIRA was approved for the treatment of rheumatoid (ankylosing) spondylitis (“the rheumatoid spondylitis ARTG registration”);
(b)On 29 June 2007, HUMIRA was approved for the treatment of Crohn’s disease (“the Crohn’s disease ARTG registration”); and
(c)On 23 July 2013, HUMIRA was approved for the treatment of ulcerative colitis (“the ulcerative colitis ARTG registration”).
In each case, the approval took the form of an amendment to the original ARTG listing.
There was no marketing approval for the use of HUMIRA in the treatment of:
(a)rheumatoid spondylitis; or
(b)Crohn’s disease; or
(c)ulcerative colitis,
before each relevant approval in paragraph 8 above was given.
On 3 October 2014, the applicant requested an extension of term of the patents:
(a)The extension of the rheumatoid spondylitis patent was based on the rheumatoid spondylitis ARTG registration;
(b)The extension of the Crohn’s disease patent was based on the Crohn’s disease ARTG registration; and
(c)The extension of the ulcerative colitis patent was based on the ulcerative colitis ARTG registration.
In each case, the applicant’s request for an extension of term was made under s 70(2)(b) of the Patents Act. None of the patents had previously been extended under Chapter 6, Part 3 of the Act.
On 4 August 2015, the Delegate of the Commissioner of Patents refused each of the applications for an extension of term.
ISSUES FOR DETERMINATION
The parties identified four issues for determination by this Tribunal. However, the Tribunal is satisfied that only two issues for determination arise and that upon determination of those issues, the remaining issues need not be determined by the Tribunal. Rather they can be resolved by the parties. The issues for determination by the Tribunal are as follows:
(a)Does a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, fall within the scope of the claims of the patents within the meaning of section 70(2)(b) of the Patents Act?
(b)Did the Delegate wrongly conclude that the first relevant inclusion of goods in the ARTG was the inclusion of adalimumab, rather than the first inclusion of adalimumab characterised by its method of production and intended use?
Reference will be made to “product” claims throughout these reasons. Such a claim relates to a therapeutic substance which is patentable without any reference to its use. Reference will also be made to a different category of claims, known by several names, such as “process”, “method”, “application” or “use” claims each of which for convenience is known as and shall be referred to as “Swiss style claims”. These claims are dependent for their specific use or application as a medicament. The origins of such claims are referred to hereunder. The distinction between these two categories of claims is critical in the determination of the issues before this Tribunal.
STATUTORY PROVISIONS
The relevant provisions of the Patents Act are contained in section 70(1) to section 70(5) as follows:
70 Applications for extension of patent
(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.
Meaning of first regulatory approval date
(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.
Certain provisions of the TGA will be referred to whenever relevant.
ISSUE 1: DO SECTION 70(2)(b) AND SECTION 70(3) APPLY TO THE PATENTS?
Applicant’s Submissions
The applicant submits that its applications qualified for extension pursuant to section 70(2)(b) of the Patents Act. The applicant further submits that its pharmaceutical substance, namely HUMIRA, and its use in the particular application for which each patent has been granted, has been disclosed in the complete specification of the patent. Accordingly it submits that the requirements of section 70(2)(b) are satisfied.
In respect of section 70(3) of the Patents Act, the applicant submits that the requirements of subparagraph (a) and (b) are satisfied. HUMIRA as used in the treatment of rheumatoid arthritis was registered on the ARTG on 10 December 2003. On 10 August 2006 HUMIRA was approved for the treatment of rheumatoid spondylitis and registered for this purpose. On 29 June 2007 HUMIRA was registered on the ARTG for the treatment of Crohn’s disease. On 23 July 2013 HUMIRA was registered on the ARTG for the treatment of ulcerative colitis. Each registration was recorded as an amendment to the original registration of HUMIRA, but each application was separately registered as a patent.
As appears from the facts referred to above at paragraph 5, the rheumatoid spondylitis patent, whilst filed on 11 November 2013, is taken to be patented from 10 February 1997, being the date of the parent patent. The same observation relates to the Crohn’s disease patent and the ulcerative colitis patent.
The applicant refers to the definition of a “pharmaceutical substance” set out in Schedule 1 of the Patents Act which provides:
“pharmaceutical substance” means 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;
(c)but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing.
The applicant also refers to the definition of “therapeutic use”, which is contained in the Schedule as follows:
“therapeutic use” 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.
Accordingly the applicant submits that the patents for which it seeks extension are pharmaceutical substances as defined; that they involve the use of recombinant DNA technology; and that the patent is in substance disclosed in the specification. Further, the applicant submits that the requirements of section 70(3) have been satisfied.
The applicant submits that the intention of Parliament is clearly expressed in the provisions of section 70(2). A product which is patentable without regard to its use as a medicament or without any other characteristics may be extended under the provisions of section 70(2)(a). However where a patent is sought to be extended which has as its essential feature its use as a medicament (that is, a Swiss style claim as is more fully described hereunder), such patent may be extended under section 70(2)(b). The applicant submits that the history of the legislative provision makes it plain that this was the very purpose of the extant section, which had been amended from its previous iteration, and that no requirement exists that only product claims are eligible for extension.
Respondent’s Submissions
The respondent submits that the claims made by the applicant in respect of extension of its patents do not qualify for two reasons. Firstly the respondent says that the claims do not relate to pharmaceutical substances, as defined: rather, they relate to process claims or Swiss style claims as opposed to a product claim which is directed to the substance itself. That is, the patents of the applicant relate to the use of pharmaceutical substances as opposed to the actual substances.
Secondly the respondent says that, as with all Swiss style claims, the claims are characterised by reference to the intended therapeutic use of the medicament to be manufactured using the pharmaceutical substance the subject of a patent: that is the claims are characterised by reference to something other than the substance namely the production by recombinant DNA technology.
The respondent submits that such claims are not contemplated by section 70(2)(b). The respondent relies upon the decision in Boehringer Ingelheim International GmbH v Commissioner of Patents(No 2) (2001) 112 FCR 595; [2001] FCA 647. In that decision the Full Federal Court considered an application for an extension of a patent which consisted of a container into which was inserted a particular pharmaceutical substance. In finding that such a patent could not be renewed, the Full Court at [40] referred to the Explanatory Memorandum to the Intellectual Property Laws Amendment Act 1998 (Cth) in respect of the extant section 70 of the Patent Act, which referred to the fact that pharmaceutical substances per se “would usually be restricted to new and inventive substances”.
The respondent states that Swiss style claims were not permitted as patents in Australia until September 1998, namely after the extant section 70(2)(b) was formulated. Accordingly Swiss style claims could not have been within the purview of the legislation as it now exists. The respondent states that the status of such claims in Australia was not settled conclusively until the decision in Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd(No 4) (2015) 113 IPR 191 (see in particular [100] to [121], [166] to [174]).
The respondent submits that the extant relevant provisions of section 70 of the Patents Act constitute a replacement of a former section; that the present iteration of section 70 is fundamentally different from its predecessor; and that the new section does not assist the applicant.
Consideration
Prior to 27 January 1999, a different provision existed for extension of patents under the Patents Act. Relevantly the original provision provided:
70(1) Where:
(a) a pharmaceutical substance is in substance disclosed in the complete specification of a standard patent and in substance falls within the scope of the claim or claims of that complete specification; and
(b) the patentee has requested the issue of a marketing approval certificate in respect of that substance;
the patentee may, by notice in writing in the approved form given to the Commissioner not later than 12 months before the end of the term of the patent, apply for an extension of the term of the patent in respect of that substance and any other pharmaceutical substance which is in substance disclosed in the specification and in substance falls within the scope of the claim or claims of the specification.
In Astra Lakemadel Aktiebolag v Commissioner for Patents (1995) 56 FCR 208, Lee J held that the delegate misdirected himself by determining that a “method-type” claim (i.e. Swiss style), claimed matter other than a pharmaceutical substance.
His Honour noted that the delegate had argued (at p 216C):
“The plain meaning of this clause is that the proposed claims can only claim pharmaceutical substances per se; method-type claims are excluded as they would clearly claim matter other than the pharmaceutical substance-viz the steps of the method. Consequently subsection 75(2)(b) requires that the proposed claims must claims substances per se”.
His Honour concluded that the proposed claims which related to the use of pharmaceutical substances to treat viral infections could be extended, under the prevailing legislation. The protection sought by the claimant was in respect of the pharmaceutical substances so used and fell within the definition of pharmaceutical substance in section 70 (see Astra at page 218D).
In reaching his conclusion that the method type claim was capable of registration, his Honour expressly rejected the delegate’s argument.
It is convenient to observe that section 75(2) of the legislation which prevailed when Astra was decided relevantly provided as follows:
75(2) Where the time for opposing the grant of a extension of the term of the patent has expired, the Commissioner must, if satisfied that:
(a) the application for the extension, the marketing approval certificate and the proposed claim or claims are in accordance with this act; and
(b) the proposed claim or claims do not claim matter other than the pharmaceutical substance or substances to which the application relates;
grant an extension of the term of the patent for a period of four years…”
On 1 July 1995 the Patents (World Trade Organisation Amendments) Act 1994 (Cth) came into operation. Section 5 thereof repealed Division 2 of Part 3 of Chapter 6 of the Patents Act, which included the former sections 70 and 75. Thereafter for a period of almost three years, there was no legislative provisions relating to extension of patents.
On 27 July 1998 the Intellectual Property Laws Amendment Act 1998 was assented to. Section 3 of such Act introduced extension of term provisions into Part 3 of Chapter 6 to the Patents Act. On 27 January 1999 the amending Act commenced and for present purposes introduced the extant relevant provisions.
The applicant relies upon the fact that the words “per se” now appear in section 70(2)(a) and that the identical words, “per se” were used by Lee J in Astra to distinguish between those products which were the subject of a product only patent compared to those pharmaceutical substances which were the subject of a process patent. The use of the word “per se” is confined to those pharmaceutical substances which are described as “product claims”. Accordingly the applicant submits that section 70(2)(b) was intended specifically for extension of patents relating to pharmaceutical products produced by a process that involves recombinant DNA technology and which, as part of their specification, include a particular application. The respondent submits that the current legislation constitutes a replacement of the former provisions and that interpretive assistance can be drawn between the current provisions and the former provisions. Further, the respondent submits that the decision of Lee J involving the use of the word “per se” cannot be relied upon in support of the proposition that the current legislation resulted from Astra.
In the course of the hearing, evidence was tendered by the applicant in support of its submissions that “Swiss style” claims, whilst not being recognised widely in Australia at or about the date of the relevant legislative amendment, must have been known to the legislative drafts persons at about the time that the current legislative provisions were enacted.
The applicant relied upon an affidavit of Steven David Barker, sworn 27 May 2016. Such affidavit establishes that whilst there was doubt, as at 1994 and as expressed in the ‘Australian Patent Office Manual of Practice and Procedure, whether method or application claims possessed the requisite clarity such that they could be regarded as a definition of a novel process and accordingly registered as a patent, the practice of the Commissioner of Patents changed in September 1998. As a result of such change Swiss style claims were permitted, as is evidenced in a publication of the Commissioner of Patents entitled Australian Patent Office Manual of Practice and Procedure, Volume 2 - National Amendments (September 1998) (“the Manual”). Accordingly “use claims” namely the use of a compound X for the preparation of a medicament Y for the treatment of a disease/condition Z (commonly known as a Swiss style claim) was expressly recognised.
Dr Barker opines that such change occurred in consequence of a decision of the Federal Court of Australia in Bristol-Myers Squibb Co v FH Faulding & Co Ltd (1998) 41 IPR 467. Such decision was delivered on 22 July 1998. It held that a method of medical treatment was not a “manner of manufacture” and could not be patented as an invention. Dr Barker states that it was in consequence of such decision that the Commissioner allowed Swiss style claims as an alternative means to protecting inventions involving second medical uses.
An extract from the Manual referred to in the evidence of Dr Barker shows that as at September 1998 the changes as described in the amendment sheet for the Manual include the following:
“change in office practice regarding “Swiss form” claims. These no longer automatically attract a lack of clarity of objection…”
Michael James Caine, registered Australian patent attorney, provided evidence of the history of Swiss style claims in Australia. Mr Caine was first registered as a patent attorney in 1994. Mr Caine said that prior to August 1998, and certainly prior to when the Intellectual Property Laws Amendment Act 1998 (Cth) received its consent on 27 July 1998, the Australian Patent Office was aware of Swiss style claims and of the objection which was taken to the registration of such claims. However he states that prior to August 1998 many Australian patent applications included Swiss style claims. He also stated that the Australian patent office changed its practice in respect of Swiss style claims in July or August 1998, as has been referred to in the evidence of Dr Barker.
Prior to 1998 the Commissioner had issued an Official Notice which stated as follows:
“Practice of the Commissioner with regard to “Swiss” style claims
A “Swiss” claim is of the form “The use of compound X for the preparation of a medicament for the treatment of disease Y”, and is a common form of claim in Europe.
For several months the Commissioner has been reviewing his practice of routinely objecting to “Swiss”-style claims during examination, on the basis of lack of clarity.
The Commissioner has concluded that objections to lack of clarity of such claims are inappropriate where these are taken merely on the basis that the claim is drafted in this form. Accordingly such objections will no longer be taken during examination.”
Mr Caine also referred in his evidence to the decision in Bristol-Myers Squibb Company v FH Faulding and Co Ltd (1998) 41 IPR 467 in which the Court concluded that patentability denied an alleged invention which is comprised nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. Such decision was delivered on 22 July 1998, and reflected the practice of the Commissioner which was stated in the Manual in March 1994, an extract of Part 10.8.9.7 provided:
“iii Use of compound X for the preparation of Y, for treatment of disease Z
These claims are interpreted as method claims. However, it is not clear whether it is a method of preparing Y (which is suitable for treating Z), or a method of treating Z. An objection of lack of clarity should be taken. If the invention relates to the second pharmaceutical indication of Y, then the first interpretation probably does not define a novel process”.
Mr Caine also referred to the Amendment to the Manual published as at September 1998 as extracted from Part 10.8.9.7 concerning “use claims”. It provides:
“iii Use of compound X for the preparation of medicament Y for treatment of disease/condition Z
Such claims, and certain variations along similar lines, are colloquially known as Swiss form claims. Notwithstanding that methods of treatment of the human body are excluded from patentability under the European Patent Convention, Swiss form claims are allowed by the European Patent Office, apparently on the basis that there scope is construable as excluding treatment of a patient by a medical practitioner. Given that, and the absence of any judicial determination in Australia of the meaning of that type of claim, it is considered not appropriate for a lack of clarity objection to be taken merely because of the “Swiss form” wording of the claim.
In determining novelty or inventive step issues in relation to a Swiss form claim it is to be assumed that the claim embodies the inventive concept expressed in the specification e.g. a potentially commercially useful new compound or a new use of a known substance”.
Mr Caine opined that “the practice of the Commissioner of Patents was changed so as to permit Swiss style claims as nought it means of protecting inventions involving second medical uses”, and expressed the opinion that the change in practice resulted from the decision in the Bristol Myers Squibb proceedings.
The respondent relies upon the decision of Yates J in Otsuka and submits that this decision settled authoritatively the status of Swiss style claims in Australia. The decision at [96] to [121] discusses Swiss style claims. At [101] his Honour said:
“The generalised form of such a claim is “the use of compound X in the manufacture of a medicament for a specified (and new) therapeutic use…”
At [120] his Honour said:
“In my view, an invention defined by a Swiss type claim is appropriately characterised as method or process. For the purpose of this analysis, no useful distinction exists between the words “method” and “process”. In the Act, the words “method” and “process” are not defined. In my view, neither word has a meaning that is different from its ordinary English signification.”
The decision in Otsuka clarifies the judicial interpretation of a Swiss style claim. However it is plain that the Commissioner was well aware of the nature of such claims at least from 1998 and gave recognition to them as being claims for patents which would no longer automatically be rejected for registration on the basis of the lack of definition.
In Boehringer, the Full Court referred to the Explanatory Memorandum relating to the amending Bill. At [40] the Full Court observed that the Memorandum stated that claims to “pharmaceutical substances per se, would usually be restricted to new and inventive substances” [emphasis in original]. The Court continued:
“The Explanatory Memorandum excludes the application of the new provisions to “new processes of making pharmaceutical substances or new methods of using pharmaceutical substances, where the substances themselves are known”.”
The respondent submits that such observation was applied in ThromboGenics NV (2015) 115 IPR 391. In that decision the Commissioner, applying the observations of the Full Court in respect of the Explanatory Memorandum, found that a substance 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 therapeutic use.
Findings
Whilst the respondent has submitted that the decision in Astra has had no bearing upon the current version of section 70, the Tribunal must decide whether the use of the word “per se” in section 70(2)(a) has its origins in the decision of Lee J. It must be remembered that the decision in Astra was published two years before the Intellectual Property Laws Amendment Bill 1997 was introduced before the House of Representatives. The question is whether the Tribunal is entitled to infer that, on the balance of probabilities, the drafter of the legislation who formulated such amending Bill had regard to the specific constraint referred to by Lee J.
In Commissioner of Taxation v Energy Resources of Australia Ltd (2003) 135 FCR 346, the Full Federal Court observed at [13] that Parliament is deemed to know the law and that, with respect to taxation legislation, those responsible for the drafting of the legislation must be taken to be familiar with the law relating to that topic. At [14] their Honours (Ryan, Finkelstein and Allsop JJ) said:
“This proposition applies not only in cases where Parliament has repeated the words which have been construed, but also where the relevant provision has been amended and Parliament has not seen fit to override the effect of judicial decisions which construe that provision: Platz v Osborne (1943) 68 CLR 133 at 141 , 146–7.”
The Tribunal sees no reason not to conclude that, at least with such a specialised area of the law such as patent law, the same principle should not be extended so as to interpret section 70 of the Patent Act, as having its genesis in the Astra decision. Otherwise it would be an extraordinary coincidence that the drafter of the legislation used the term “per se” without any regard or knowledge of the decision in Astra. The Tribunal finds, on the balance of probabilities, that the decision in Astra has resulted, at least in part, in the formulation of the current section 70. Such a conclusion is reinforced by the decision of the High Court of Australia in Re Alcan Australia Ltd; Ex-parte Federation of Industrial Manufacturing and Engineering Employees (1994) 181 CLR 96 at 106 where the Court observed in relation to the legislation in question before it:
“Parliament re-enacted, in s 4(1) of the Act, words which are almost identical with those considered in R v Portus. There is abundant authority for the proposition that where the parliament repeats words which have been judicially construed, it is taken to have intended the words to bear the meaning already “judicially attributed to [them]’’…”
The respondent refers and relies upon the provisions of section 15AC of the Acts Interpretation Act 1901 (Cth) in support of its submission that the current version of section 70 is to be interpreted in the same manner as the former version. Section 15AC provides:
Where:
(a) An Act has expressed an idea in a particular form of words; and
(b) a later act appears to have expressed the same idea in a different form of words for the purpose of using a clearer style;
the ideas shall not be taken to be different merely because different forms of words were used.
The Tribunal is satisfied that the legislation, as it currently exists, should not be constrained by reference to the former iteration of section 70. It is clear that, by virtue of the legislative change, Parliament considered that it was necessary to bring clarity to the question of the extension of patents and to the type of patents which were eligible for extension. By virtue of the inclusion in the present circumstances, of subparagraphs (a) and (b) to section 70, this object has been achieved. The clarity was necessary as a result of the decision in Astra. The substantial revision brought about by the amendment indicates that section 15AC of the Acts Interpretation Act 1901 (Cth) should be given little weight in the interpretation of the new provision.
INTERPRETATION OF SECTION 70
It is now necessary to consider the interpretation of section 70 of the Patents Act. Clearly the applicant’s patents do not qualify for extension under the provisions of section 70(2)(a). Such subsection only applies to pharmaceutical substances per se.
The Commissioner relied upon the decision in Boehringer in support of the finding made in Thrombogenics. This decision was in turn relied upon in support of the decision to refuse the applicant’s extension of its three patents. It must be remembered that in Boehringer, the Full Court found that the applicant’s patent comprised a container. A particular pharmaceutical substance, namely a nasal spray, was inserted into the contained. The Court found and that such patent was not one which was a pharmaceutical substance “per se”. The decision obviously turned on the fact that the container in which the nasal spray was contained, comprised the patent and that the patent therefore included more than the mere pharmaceutical substance. The Full Court concentrated on the use the words “per se” in reaching its decision.
As was observed in H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 at [238], the definition of “pharmaceutical substance” contained in the dictionary to the Patents Act focuses on the ingredient for therapeutic use that involves “the relevant type of interaction”. So construed, the fact that in Boehringer a container was included in the patent disqualified the application for extension of the patent. As was noted by Middleton J in Lundbeck at [242]:
“In my view, s 70 recognises that the pharmaceutical substance per se may not equate with the subject matter of the claim of the patent in terms. For example, a chemical compound claimed in a patent may not have the necessary therapeutic use or enable the required physico-chemical interaction unless formulated. It is sufficient if the pharmaceutical substance is in substance disclosed in the specification and in substance falls within the scope of the claim or claims. At that point in the scheme of s 70, the satisfaction of s 70(2), the necessary definition of the pharmaceutical substance by reference to the patent ceases”.
The Tribunal now addresses the issue of the extension of the applicant’s patents under section 70(2)(b). Each of the patents represents a Swiss style claim, associated with a pharmaceutical substance produced by a process that involves the use of recombinant DNA technology.
Significantly, the extant section 70(2) does not indicate that Swiss style claims are to be excluded from eligibility for extension. The fact that such patent is characterised by its specified therapeutic use as a medicament does not, on its face, suggest that there is a legislative barrier to eligibility for extension of the patent.
In Thrombogenics, the delegate considered that the decision in Boehringer supported the finding that neither the product nor the process of its manufacture was required to be, and was usually not, new and inventive.
The Tribunal observes that at [40] of Boehringer, the Full Court referred to the Explanatory Memorandum and particularly to the portion (referred to above) which stated “pharmaceutical substances per se, would usually be restricted to new and inventive substances” [emphasis in original].
Their Honours continued (at [40]):
“The Explanatory Memorandum excludes the application of the new provisions to “new processes of making pharmaceutical substances or new methods of using pharmaceutical substances, where the substances themselves are known”” [emphasis in original].
Significantly, it should be observed that such extract referred to process claims generally; it did not refer to process claims made, for example, of a container for a substance produced by recombinant DNA technology. The Full Court was considering an application for registration of a container for a substance, which did not include a pharmaceutical substance (see [38]). Accordingly the patent was ineligible for an extension because it was not registered in respect a substance per se. It was not considering the type of patent of a Swiss style claim which is the subject of the application now before this Tribunal. However it is plain that the purpose of the legislation was to ensure that patents were registrable in Australia in the same manner as they were registrable in other countries. In respect of pharmaceutical patents, the Explanatory Memorandum states, inter alia:
“A decision to provide patent protection comparable with that available in many developed countries would contribute positively to perceptions that Australia values an innovative pharmaceutical industry”.
The Explanatory Memorandum also stated:
“A strong patent system is an important contributor to the competitiveness of Australia’s investment climate. This was confirmed by the Industry Commission, which agreed that, in most circumstances, it would be undesirable for Australia to be out of step with the periods of protection offered to most other developed countries. To do otherwise would send a highly visible and particularly strong negative signal about the Australian climate for innovation and research and development.”
In applying Boehringer to Thrombogenics, the Delegate appears to have construed the Boehringer decision to the provisions of section 70(2)(b), namely to construe section 70(2)(b) as only applicable to a pharmaceutical substance, produced by a process that involves the use of recombinant DNA technology, “as such”, or “per se”. The Explanatory Memorandum, in relation to the amendment to section 70 states:
“The extension of term provisions will be available for patents that include claims to pharmaceutical substances per se (provided that the other criteria are met) [i.e. a product claim]. These claims to pharmaceutical substances per se would usually be restricted to new and inventive substances. Patents that claim pharmaceutical substances when produced by a particular process (product by process claims) will not be eligible unless that process involves the use of recombinant DNA technology. Claims which limit the use of a known substance to a particular environment, for example claims to pharmaceutical substances when used in a new and inventive method of treatment, are not considered to be claims to pharmaceutical substances per se” [emphasis added].
Arising from the words emphasised in the Explanatory Memorandum, it is apparent that eligibility for extension of a patent would be applied to product claims and to process claims but only where such claims were made in respect of a substance produced by a process of recombinant DNA technology. If a process claim is made in respect of a substance not so produced, the patent for that substance does not qualify for extension.
The extract of the Explanatory Memorandum quoted by their Honours when reference is made to “new methods” does not suggest that such reference is intended to refer to substances produced by a process of recombinant DNA technology. The terminology of section 70(2)(b) does not contain such words.
Section 70(2)(b) only refers as a qualification for extension, to the requirement that the substance be produced by recombinant DNA technology. An interpretation which would incorporate into the plain reading of section 70(2)(b) an exclusion of Swiss style claims based upon a substance produced by recombinant DNA technology is unwarranted. The manner in which this subsection has been construed by the delegate overlooks the express requirement which qualifies process claims based upon a substance produced by recombinant DNA technology. No exclusion is incorporated. If the legislature intended to exclude such claims, then the plain reading of the subsection does not achieve this object. Had Parliament intended to exclude such claims, it would have been a simple matter to include the words “per se” after the word “process” and to make no reference to description of the pharmaceutical substance produced by recombinant DNA technology. Parliament did not do so. Whilst the Explanatory Memorandum at [9] refers to limiting the use of a known substance to a particular environment, “when used in a new and inventive method of treatment”, the legislation does not address such a limitation and does not use terminology to state that “Swiss style” claims are not included in the eligibility for extension. The only requirement, for extension of a patent for a substance produced by recombinant DNA technology, is that it be disclosed in the complete specification of the patent and fall within the scope of the patent. The patents sought to be extended satisfy such criteria.
For these reasons the Tribunal considers that there is no mandate for so construing the subsection. In the Tribunal’s consideration, the Delegate erred in the interpretation of section 70(2)(b). The Tribunal finds that the applicant’s applications for extension are not disqualified from extension under section 70(2)(b) because the patents are of a “Swiss style”, in addition to them being made in respect of a substance produced by a process of recombinant DNA technology.
ISSUE 2: FIRST REGULATORY APPROVAL DATE
Applicants submissions
The Tribunal now turns to the second issue for determination, namely the further requirement to be satisfied to enable registration of the patents as set out in the provisions of section 70(3) of the Patents Act.
The applicant submits that the Commissioner has misapplied established authority concerning the interpretation of the phrase “first regulatory approval date for the substance”. The applicant submits that, consistent with the regulatory scheme for the supply of therapeutic goods, such date is the first regulatory approval date for the pharmaceutical substance approved for the patented indication, i.e. the therapeutic use.
The phrase “first regulatory approval date” is defined in section 70(5) (set out above at [16]).
The applicant submits that in order to determine an extension for a patent it is necessary to determine the first regulatory approval date of the pharmaceutical substance, that being the first inclusion in the ARTG of goods that contain or consist of the pharmaceutical substance. Section 9A of the TGA makes provision for the ARTG. It permits therapeutic goods to be registered. The applicant contends that the word “good” or “goods” as referred to in section 70(3) of the Patents Act takes its meaning from the definition in the TGA since the term “good” is not defined in the Patents Act. Section 3 of the TGA relevantly defines therapeutic goods as follows:
therapeutic goods means goods:
(a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the manufacture of therapeutic goods…
The applicant submits that the reference to “goods” in section 70 of the Patents Act should be read consistently with other provisions which characterise a therapeutic good under the TGA and that these characteristics apply equally to a “pharmaceutical substance”. The applicant contends that “goods” for a particular indication or therapeutic use is separate and distinct to a good for another indication or all use. The date of the first regulatory approval for a good containing a particular pharmaceutical substance is the date of the first regulatory approval of a good containing that substance for that indication, or therapeutic use.
The applicant contends that if this construction is adopted in the context of a Swiss style claim, the first regulatory approval date means the first regulatory approval date of the substance for a particular therapeutic use. If that substance is approved for another use it is deemed under the TGA to be a different good and its registration does not constitute the first regulatory approval date which allows the exploitation of the patent.
The applicant refers to the decision of Bennett J in Pfizer Corporation v Commissioner of Patents (No 2) [2006] FCA 1176 in which her Honour was required to determine the meaning of “first inclusion in the ARTG” in section 70(5) and earliest first regulatory approval date” in section 77 of the Patents Act. Relevantly her Honour referred to the fact that under the amended legislation (regarding section 70 of the Patent Act), the extension or renewal scheme was introduced in recognition of the need “to compensate for the time before which a patentee of a pharmaceutical substance can exploit the invention” at [64]. Similarly, the applicant refers to the decision in Alphapharm Pty Ltd v H.Lundbeck A/S [2008] FCA 559 wherein Lindgren J found that ARTG registration should “mark the beginning of exploitation”.
Respondent’s submissions
The respondent submits that the “substance” is the pharmaceutical substance contained in the claims of the patent’s namely the antibody known as adalimumab. This was first registered on the ARTG on 10 December 2003, being the date on which the product HUMIRA was first listed. The respondent submits that the later registrations were merely amendments to that listing by the addition of further indications or uses.
The respondent submits, firstly, the amendments were not listings of new products in the ARTG but additions to the approved indications or uses for the existing HUMIRA. Secondly, it submits that the dates of such amendments were not relevant to “the date of the first inclusion” of HUMIRA in terms of section 70(5)(a) of the Patents Act. The respondent submits neither section 70(3) nor section 70(5) of the Act make reference to the indications or the goods concerned: rather they refer simply to the inclusion of goods “containing, or consisting of, the substance”.
Findings
The Full Court in Lundbeck said at [239]:
“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.”
The pharmaceutical substance which was first included on the ARTG register is HUMIRA. The current applications for extension do not relate to a different pharmaceutical substance, as it is agreed that the pharmaceutical substance in each case is identical. Their applications may be different, but the substance remains the same as that which was originally registered on the register as HUMIRA. It follows that there are no new substances registered after the date of registration of HUMIRA.
The applicant made submissions concerning the need to exploit the product which is a subject of the patent. In PfizerCorp v Commissioner of Patents [2006] FCAFC 190, the Full Court considered and recognised the time taken to register and market a new product and thereafter to permit the patentee who holds a monopoly on such patent to reap the benefit of the patent. At [68] their Honours stated:
“Until goods are included in the Therapeutic Register, they cannot be supplied or marketed in Australia or exported and, therefore, cannot be exploited commercially.”
The patents the subject of the present applications were registered for the purposes of section 67 of the Patents Act on 10 February 1997. The pharmaceutical substance was first registered on the ARTG register on 10 December 2003. The subsequent registrations on 10 August 2006 for rheumatoid spondylitis; 29 June 2007 for Crohn’s disease and 7 December 2012 for ulcerative colitis were added as indications for HUMIRA. However the fact remains that, in view of the Full Court’s decision in Lundbeck (as set out above), the therapeutic effect of the pharmaceutical substance is to be ignored when the question arises of the date of first registration of the pharmaceutical substance.
It follows that, when considering the provisions of section 70(5) of the Patents Act, the critical matter for consideration is the registration of the substance and that any uses to which the substance maybe later be put is irrelevant for the purposes of this subsection. That is, registration of therapeutic substances for particular applications are irrelevant for consideration.
The applicant referred to the decision of the High Court of Australia in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1; [2013] HCA 50 , where at [296] the High Court referred to the following:
“Therapeutic goods which are entered on the ARTG are taken to be “separate and distinct” from other therapeutic goods if they have “a different name”, “different indications”, or “different directions for use” amongst other things”.
The High Court was not referring to the interpretation of the subsection now in question. The specific provisions of section 70(5) require consideration of the date of the first registration of goods that contain, or consist of the substance. In this instance, HUMIRA is the “goods”. In respect of the subsequent registrations, the “goods” are identical. Only their application or use is different.
It follows that the Tribunal finds the decision of the Delegate of the Commissioner on this issue to be correct. Since the application for extension in each case is dependent upon satisfaction of the requirements of section 70(2) and of section 70(3) which requires consideration of the definition of “first regulatory approval date” as contained in section 70(5), the first regulatory approval date is 10 December 2003, being the date of the registration on the ARTG.
DECISION
For the reasons outlined above, the Tribunal decides as follows:
(c)With respect to Issue 1, the Tribunal sets aside the Delegate’s decision and substitutes a decision that a pharmaceutical substance, when produced by a process that involves recombinant DNA technology, in substance falls within the scope of the claims of the patents within the meaning of section 70(2)(b) of the Patents Act where such patent is granted in respect of a particular therapeutic use.
(d)With respect to Issue 2, the Tribunal affirms the Delegates decision that the first regulatory approval date of the substance adalimumab for the purposes of section 70(3) of the Patents Act is 10 December 2003.
In view of the finding made above in relation to the second issue for determination in this matter, the parties are in agreement that the Delegate’s decision that the Applicant did not comply with section 71(1) of the Patents Act should be affirmed. The applications for extension refer and relate to dates of the subsequent amendments to add indications to the listing of HUMIRA (adalimumab) on the ARTG, rather than the correct date of the first inclusion of those goods on the ARTG on 10 December 2003.
NOTES TO DECISION
The Tribunal notes that the parties reached a further agreement that the maximum extension available to the applicants if the patents are able to be extended is to 10 December 2018 according to the formula in section 77 of the Patents Act. However, because the applications which have been made under section 71(1) would be taken to have identified the wrong registration date by reason of the determination as set out in the decision above at [87], the applicant would not be entitled to an extension on the basis of the extension of term applications which have been filed and are the subject of the present proceedings. The applicant can however apply to correct the error.
I certify that the preceding 92 (ninety -two) paragraphs are a true copy of the reasons for the decision herein of The Hon. D Cowdroy OAM QC ..........................[sgd]..............................................
Associate
Dated 5 September 2016
Date(s) of hearing 2 May and 1 June 2016 Counsel for the Applicant Mr B Caine QC and Ms C Cunliffe Solicitors for the Applicant Davies Collison Cave Counsel for the Respondent Mr C Dimitriadis SC and Ms M Gaven Solicitors for the Respondent Australian Government Solicitor
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