Celgene Corporation and Commissioner of Patents
[2013] AATA 55
[2013] AATA 55
Division GENERAL ADMINISTRATIVE DIVISION File Numbers
2011/2584
2011/4765
Re
Celgene Corporation
APPLICANT
And
Commissioner of Patents
RESPONDENT
And Children’s Medical Center Corporation
JOINED PARTY
DECISION
Tribunal Deputy President RP Handley
Senior Member Dr T NicolettiDate 1 February 2013 Place Sydney Decision Summary: The decisions under review are affirmed.
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Deputy President RP Handley
Catchwords
PATENTS – Application for extension of patent terms – Whether each patent specification disclosed a pharmaceutical substance per se – Meaning of pharmaceutical substance per se – Timing of applications for extension of patent – Decisions under review affirmed
Legislation
Patents Act 1990 (Cth)
Therapeutic Goods Act 1989 (Cth)
Cases
Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595
H Lundbeck A/S and Another v Alpharpharm Pty Ltd and Another (2009) 177 FCR 151
LTS Lohmann Therapie Systeme AG & Scharz Pharma Ltd and Commissioner of Patents (2010) 118 ALD 425
Prejay Holdings Ltd and Another v Commissioner of Patents (2003) 57 IPR 424
REASONS FOR DECISION
Deputy President RP Handley
Senior Member Dr T Nicoletti
Celgene Corporation (the Applicant) has applied for the review of decisions of delegates of the Commissioner of Patents (the Respondent) to refuse to extend the terms of three of Celgene’s patents. These decisions are as follows:
(1) a decision dated 3 June 2011 refusing to extend the terms of Australian patents 2003228508 (patent 508) and 2004270211 (patent 211); and
(2) a decision dated 7 October 2011 refusing to extend the term of Australian patent 2005202596 (patent 596).
BACKGROUND
Patent 508
Celgene is the patentee of patent 508 which is entitled “Methods of using and compositions comprising immunomodulatory compounds for the treatment and management of myelodysplastic syndromes” (MDS). MDS “are a diverse group of blood-cell related malignancies which affect cells in the bone marrow”: Applicant’s Statement of Facts and Contentions (SOFC) at [14]. The complete specification for the patent was filed on 13 April 2003 which, pursuant to s 65 of the Patents Act 1990, is the date of the patent. The term of the patent will, pursuant to s 67, run for 20 years from that date (until 13 April 2023) unless an extension is granted.
An application to extend patent 508 was filed by Celgene on 27 September 2010. On 3 June 2011, the Respondent refused the application on the ground that no pharmaceutical substance per se was disclosed in the complete specification of patent 508 as required by s 70(2)(a) of the Patents Act. Further, the application had not been made within the time specified in s 71(2) of the Patents Act. On 1 July 2011, Celgene applied to the Tribunal for a review of this decision.
Patent 211
Celgene is also the patentee of patent 211 which is entitled “Polymorphic forms of 3-(4-amino-1-oxo-1,3dihydro-isoindol-2-yl)-piperidene-2,6-dione”. The complete specification for the patent was filed on 3 September 2004, which is the date of the patent. Unless an extension is granted, the term of 20 years will expire on 3 September 2024.
An application to extend patent 211 was filed by Celgene on 27 September 2010. On 3 June 2011, the Respondent refused the application on the ground that the application had not been made within the time specified in s 71(2) of the Patents Act. On 1 July 2011, Celgene applied to the Tribunal for a review of this decision in conjunction with the review in respect of patent 508.
Patent 596
Celgene is the licensee of patent 596 which is entitled “Methods and compositions of inhibition of angiogenesis”. Patent 596 describes angiogenesis as “the generation of new blood vessels into a tissue or organ”. The complete specification for the patent was filed on 15 June 2005. Patent 596 is a divisional of Australian patent 780296, which is in turn a divisional of Australian patent 746713, the complete specification for which was filed on 4 November 1997. That is the date which is taken to be the relevant date of the 596 patent. The term of the 596 patent will therefore expire on 4 November 2017, unless the term is extended.
An application to extend patent 596 was filed by the patentee (and joined party), Children’s Medical Center Corporation, on 17 June 2010. On 7 October 2011, the Respondent refused the application on the ground that no pharmaceutical substance per se was disclosed in the complete specification of patent 596 as required by s 70(2)(a) of the Patents Act. The delegate found that a ‘combination’ of thalidomide and a steroid provided as separate unit dosages of the individual drugs was not a ‘pharmaceutical substance per se’.
On 4 November 2011, Celgene applied to the Tribunal for a review of this decision.
LEGISLATIVE BACKGROUND
Section 70 of the Patents Act 1990 states:
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.
Note: Section 65 sets out the date of a patent.
(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.
Section 71 states:
Form of application
(1) An application for an extension of the term of a standard patent must:
(a) be in the approved form; and
(b) be accompanied by such documents (if any) as are ascertained in accordance with the regulations; and
(c) be accompanied by such information (if any) as is ascertained in accordance with the regulations.
For this purpose, document includes a copy of a document.
Timing of application
(2) An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:
(a) the date the patent was granted;
(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3);
(c) the date of commencement of this section.
‘Pharmaceutical substance’ is defined in the dictionary that appears in Schedule 1 of the Act:
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;but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing.
ISSUES
There are two decisions under review, that of 1 July 2011 in respect of patents 508 and 211 (file number 2011/2584) and that of 7 October 2011 in respect of patent 596 (file number 2011/4765). The issues for the Tribunal to decide are:
Patent 508
(1) whether the application to extend patent 508 disclosed a ‘pharmaceutical substance per se’ in the complete specification of the patent as required by s 70(2)(a) of the Patents Act and, if so
(2) whether the application for an extension of term was made within the time specified in s 71(2) of the Patents Act.
Patent 211
(1) whether the application for an extension of term was made within the time specified in s 71(2) of the Patents Act.
(The Respondent accepts that the application to extend patent 211 does disclose a ‘pharmaceutical substance per se’ in the complete specification of the patent as required by s 70(2)(a).)
Patent 596
(1) whether the application to extend patent 596 disclosed a ‘pharmaceutical substance per se’ in the complete specification of patent as required by s 70(2)(a) of the Patents Act.
(The Respondent accepts that the application to extend patent 596 was within the time specified in s 71(2) of the Patents Act.)
DISCUSSION
The Application of s 70(2)(a)
The Applicant submits that the meaning of the words ‘pharmaceutical substance per se’ should be construed according to the words of the legislation, noting:
(a)A ‘pharmaceutical substance’ is defined in the dictionary appearing in Schedule 1 of the Patents Act as a substance ‘for therapeutic use’ and whose application involves “a chemical interaction, or physico-chemical interaction, with a human physiological system” or “action on an infectious agent, or on a toxin or other poison, in a human body”.
(b)Accordingly, a ‘pharmaceutical substance’ is one that after administration interacts with the body or a toxin, poison or infectious agent in the body, and is used for the purpose of preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury, of influencing, inhibiting or modifying a physiological process, or testing the susceptibility of persons to a disease or ailment.
(c)The use of the words ‘per se’ in s 70(2)(a) indicates that the pharmaceutical substance must in and of itself be claimed in the specification of the patent.
(d)The definition indicates that a ‘pharmaceutical substance’ may be a mixture of substances, meaning an aggregate of two or more substances that are not chemically united and exist in no fixed proportion to each other.
The Applicant submits that its approach is not foreclosed by the decision of the Full Federal Court in Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595 (Boerhinger) and Prejay Holdings Ltd and Another v Commissioner of Patents (2003) 57 IPR 424 (Prejay Holdings) which were decided on materially different facts. In Boehringer, the claim related to a container for a nasal spray and not a substance, and in Prejay Holdings the claim was in relation to a method of treatment. The Applicant submitted that these decisions were not directly on point and should not be followed. Mr Dimitriadis also sought to distinguish the decision of the Tribunal in LTS Lohmann Therapie Systeme AG & Scharz Pharma Ltd and Commissioner of Patents (2010) 118 ALD 425 (Lohmann), which involved a transdermal patch for the delivery of a drug. He noted that in H Lundbeck A/S and Another v Alpharpharm Pty Ltd and Another (2009) 177 FCR 151 (Lundbeck), a majority decision in the Full Federal Court, the construction given to the claim included “some additional integers” (Transcript, 17 December 2012, p 48).
The Applicant contends that the relevant claim 36 for patent 508 is “directed to a pharmaceutical composition (used for treating MDS) which contains a therapeutically effective amount of an active ingredient (lenalidomide) together with a pharmaceutically acceptable carrier, diluent, excipient and/or adjuvant” (SOFC at [77]). The pharmaceutical composition “will interact with a human physiological system to prevent, cure or alleviate a disease as required by the definition of ‘pharmaceutical substance’ in Schedule 1 of the Patents Act” (SOFC at [81]).
With regard to patent 596, the Applicant contends that the combination of thalidomide and dexamethasone (SOFC at [88]):
gives rise to a chemical interaction with a human physiological system which causes inhibition of angiogenesis and ultimately results in a reduction in a particular disease state, such as multiple myeloma. Again, such a description reflects the definition of ‘pharmaceutical substance’ as used in Schedule 1 to the Patents Act.
The Respondent submitted that in Boehringer, the Court distinguished between a pharmaceutical substance that is the subject of a product claim (which it held to be within the terms of s 70(2)(a)) and a substance that forms part of a method or process claim (which it held not to be within s 70(2)(a)). Ms Gleeson said the definition of ‘pharmaceutical substance’ in the dictionary in Schedule 1 requires, first, that there is a substance and, second, that the application of the substance involves doing something (Transcript, p 49).
Ms Gleeson contended that in relation to patent 596, which appears to involve the administering of a dose of thalidomide and a dose of dexamethasone, which are claimed to mix inside the body in some way to create an effective treatment, there is no single substance and no separate application (Transcript, p 49): “[t]he patent is better understood as a new method of using known substances.” She submitted that s 70(2) does not contemplate a mixture wherein two unit dosages comprising two different substances become a mixture upon administration to a patient.
Ms Gleeson characterised patent 508 as a known substance, lenalidomide, being used for the treatment of another, different condition, in this case MDS. She said, in essence, that the claim is for the method involved in using a known substance for the treatment of MDS.
The Tribunal considers that the Full Court’s decision in Boehringer provides an answer to the issues raised by the Applicant in relation to patents 508 and 596 and whether a ‘pharmaceutical substance per se’ is disclosed. At [37], the Court cited with approval Heerey J’s reasons at first instance which it set out at [17]:
Heerey J went on, in [13] to [16] of his reasons, to set out his conclusions about the critical issue:
"The 1990 Act in its present form manifests a policy which draws a distinction between, on the one hand, a pharmaceutical substance that is the subject of a patent claim and, on the other hand, a pharmaceutical substance that forms part of a method or process claim. The specific exception to the latter (an exception which proves the rule) is the provision for recombinant DNA technology in s 70(2)(b).
Broadly speaking, a claim in relation to a pharmaceutical substance can be made in three ways
(i) a new and inventive product alone;
(ii) an old or known product prepared by a new and inventive process;
(iii) an old or known product used in a new and inventive mode of treatment.
What is clear in s 70 is that only the first type of claim to a pharmaceutical product is to be subject to extension rights. So far as a new process is concerned, it is only when the new process answers the particular description in s 70(2)(b) (recombinant DNA process) that it can be the subject of an extension. As counsel for the Commissioner submitted, the policy to be deduced in the light of the legislative history is that Parliament has decided that what is intended to be fostered 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.
In the light of this history, the relevance of the expression `per se' becomes clear. Section 70(2)(a) is only to make extension rights available when the claim is for a pharmaceutical substance as such, as opposed to a substance forming part of a method or process.”
The Court referred, at [39], to the Second Reading Speech which:
… speaks about the "development of a new drug" and the research and testing required before "the product" can enter the market. This is plainly a reference to the drug itself; not to the drug in combination with other elements.
And, at [40], to:
… the Explanatory Memorandum [which] says that claims to "pharmaceutical substances per se, would usually be restricted to new and inventive substances". 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". (Original emphasis.)
Thus, the Court concluded that s 70(2)(a) only makes extension rights available when the claim is for a pharmaceutical substance per se and not for a substance forming part of a method or process.
Turning to the present case, and patent 508, described in the patent as “Methods of using and compositions comprising immunomodulatory compounds for the treatment and management of myelodysplastic syndromes”, and involving the use of an effective amount of lenalidomide in conjunction with a carrier, we are not satisfied that the relevant patent identifies a new ‘pharmaceutical substance per se’. In our view, the patent discloses a new method of using lenalidomide in conjunction with a carrier for the treatment of MDS. Thus, in accordance with the Full Court decision in Boehringer, extension rights are not available to the patentee under s 70(2)(a). The Tribunal followed this decision in Lohmann.
While it is true that the facts of Boehringer concerned the use of a container for the delivery of a nasal spray and the facts of Lohmann concerned the use of a transdermal patch, the facts of Prejay Holdings concerned a patent relating to the treatment of menopausal or post-menopausal disorders, which the Full Federal Court found to be a method claim and not a product claim. Referring to the decision in Boehringer, Wilcox and Cooper JJ ( with whom Allsop J agreed) said:
24 … the Full Court was saying that, for a substance to fall within s 70(2)(a) it must itself be the subject of a claim in the relevant patent. It is not enough that the substance appears in a claim in combination with other integers or as part of the description of a method (or process) that is the subject of a claim. The policy adopted in s 70 was to confine extensions to patents that claim invention of the substance itself.
Similarly, in the case of patent 596, what we find is a method for treating angiogenesis using a composition of Thalidomide Pharmion and Dexamethasone, and not a new pharmaceutical substance per se, with the result that extension rights are not available to the patentee.
Thus, the Tribunal concludes that s 70(2)(a) cannot apply to either patent 508 or 596. We find the Respondent’s decision to refuse to extend the term of those patents to be correct.
The Application of s 70(3)
It also follows that because neither patent 508 nor 596 involves a ‘pharmaceutical substance per se’, s 70(3) of the Patents Act also does not apply.
In relation to patent 211, the Respondent contends that the date of the first inclusion of the relevant substance in the ARTG was on 20 December 2007. The Applicant states that this inclusion was specifically for the combination of Revlimid (the brand name of a pharmaceutical product that includes the relevant substance as the active ingredient) and Dexamethasone in the treatment of relapsed/refractory multiple myeloma (RRMM).
The Applicant referred to the first inclusion of Revlimid (alone) in the ARTG (for the treatment of MDS) on 21 May 2010. According to the affidavit of Michael Riffkin dated 2 December 2011, the Therapeutic Goods Administration (TGA) stated that pursuant to s 16(1) of the Therapeutic Goods Act 1989 (the TG Act), it considered Revlimid (alone) for the treatment of MDS to be a separate and distinct good from the previous inclusion of a combination of Revlimid and Dexamethasone in the treatment of RRMM. The Applicant therefore contends that the first inclusion of goods containing or consisting of lenalidomide (alone) in the ARTG was on 21 May 2010 and not on 20 December 2007.
The Respondent submits that s 16 of the TG Act is not relevant to the meaning of s 70(3)(a) of the Patents Act.
Section 16(1) of the TG Act states:
(1) For the purposes of this Part, therapeutic goods (other than medicine of the kind to which subsection (1A) applies) are to be taken to be separate and distinct from other therapeutic goods if they have:
(a) a different formulation, composition or design specification; or
(b) a different strength or size (disregarding pack size); or
(c) a different dosage form or model; or
(d) a different name; or
(e) different indications; or
(f) different directions for use; or
(g) a different type of container (disregarding container size).
The Respondent notes that the subsection commences with the words “For the purposes of this Part”. The relevant Part, Part 3-2, is concerned with the registration and listing of therapeutic goods in the ARTG. The Respondent contends that this is different from the question of when a pharmaceutical substance is first included in the ARTG for the purposes of the Patents Act and cites the Full Federal Court decision in H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 in support of its contention. In that decision, at [239] – [240], Bennett J (with whom Middleton J agreed), said:
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. …
There is no requirement in s 70(3) to compare or contrast the effectiveness of the pharmaceutical substance with the goods with ARTG approval, nor to consider the purity of the pharmaceutical substances. There is no suggestion from the words of s 70(3) that the relevant "goods" could or must include no more than one pharmaceutical substance. What is required is an analysis of whether there are goods containing or consisting of [the pharmaceutical substance] and, if so, which of those goods had the first regulatory approval date.
Ms Gleeson noted that to apply s 16(1)(d) of the TG Act to the Patents Act provisions would permit the same therapeutic good but with a different name to be treated differently.
The Tribunal agrees with the Respondent’s submissions on this issue. We should follow Bennett J’s exposition of the law which accords with an interpretation of s 16(1) of the TG Act, limiting the meaning given to ‘therapeutic goods’ to Part 3-2 of that Act. The consequence of doing so is that the relevant date, for the purposes of s 71(2), is when Revlimid was first registered in the ARTG, which was when a combination of Revlimid and Dexamethasone in the treatment of RRMM was registered on 20 December 2007.
The Application of s 71(2)
First, in relation to patent 211, our finding, above, is that the date of the first inclusion in the ARTG is 20 December 2007. Section 71(2) of the Patents Act provides for the date by which an application for an extension of term must be made. Given that the date of the commencement of s 71 was 27 January 1999 (s 71(2)(c)) and the date of the relevant patent was 3 September 2004 (s 71(2)(a)), the latest of the relevant dates is the date of commencement of the first inclusion in the ARTG, namely 20 December 2007 (s 71(2)(b)). Thus, pursuant to s 71(2), an application for an extension of term had to be made within six months of 20 December 2007. Since the application was made on 27 September 2010, the application was out of time.
In relation to patent 508 and patent 596, because we have determined that no pharmaceutical substance per se is in substance disclosed in the complete specifications for those patents, the extension of term provisions do not apply and there is therefore no requirement to further inquire as to whether the applications for extension of term in respect of patents 508 and 596 were made in time.
We note, nevertheless, that the date of grant of patent 508 is 13 April 2003. The date of the first inclusion of the pharmaceutical goods in the ARTG was, as is the case with patent 211, when a combination of Revlimid and Dexamethasone in the treatment of RRMM was registered on the ARTG on 20 December 2007. The application for an extension of term was made on 27 September 2010 and was, therefore, out of time.
The date of the grant of patent 596 was 4 February 2010. The date of the first inclusion of the pharmaceutical goods – Thalidomide Pharmion – in the ARTG was 10 October 2003. The application for an extension of term was made on 17 June 2010 and was, therefore, in time (within 6 months of the date of grant of the patent, as provided for in section 71(2)(a)), as the Respondent acknowledges.
CONCLUSION
In summary, neither patent 508 nor patent 596 disclose a pharmaceutical substance per se in the complete specification of the patent as required by s 70(2)(a) of the Patents Act, and, therefore, the extension of term provisions in the Act do not apply to those patents. In the case of patent 211, the application for an extension of term was made outside the time provided for in 71(2) of the Patents Act and cannot therefore be entertained.
DECISION
The decisions under review are affirmed.
I certify that the preceding 41 (forty one) paragraphs are a true copy of the reasons for the decision herein of Mr RP Handley, Deputy President and Dr T Nicoletti, Senior Member.
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Associate
Dated 1 February 2013
Date of hearing 17 December 2012 Date final submissions received 17 December 2012 Counsel for the Applicant C Dimitriadis Solicitors for the Applicant Jones Day Counsel for the Respondent J Gleeson Solicitors for the Respondent Australian Government Solicitor
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