Boehringer Ingelheim International Gmbh
[2000] APO 18
•3 March 2000
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 530174 in the name of BOEHRINGER INGELHEIM INTERNATIONAL GMBH
Title: Pharmaceutical Compositions
Action: Application for extension of term of a pharmaceutical patent under section 70 of the Patents Act.
Decision: Issued .
Abstract
The patentee requested an extension of term of the patent on the basis of marketing approval in relation to ATROVENT NASAL, which is a container adapted for nasal administration comprising an aerosol or spray composition of the active ingredient ipratropium bromide.
Claims 1 to 5, 11 and 12 define the combination of the container with the active agent composition and were not considered to define a pharmaceutical substance per se within the meaning of section 70(2)(a) nor were they considered to define a mixture or compound of substances. Claims 6 to 10 define a method of treatment, not a pharmaceutical substance. Claims 14 to 16, inserted as a result of amendment dated 28 September 1999, define an aerosol or spray composition as claimed in claim 1 when used in the container of claim 1. Such "when used" type claims have conventionally been construed as disguised process claims but, as such, they would not provide the basis for an extension of term of the patent. It was argued that they should be interpreted as product claims when used in the environment of the container. However, if this interpretation is accepted, in construing the claims as complying with section 102, they can only be to a product which is within the scope of the accepted claims and such claims have been found not to define a pharmaceutical substance per se.
Thus, it was found that none of the claims define a pharmaceutical substance per se as required by section 70(2)(a) and the application for extension of term was refused.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 530174 by Boehringer Ingelheim International GmbH and an application under section 70 for an extension of term of a patent relating to pharmaceutical substances.
BACKGROUND
This matter concerns a request by the patentee, Boehringer Ingelheim International GmbH (hereafter referred to as Boehringer), for an extension of term of patent number 530174 under section 70 of the Patents Act 1990. Boehringer filed their request on 2 July 1999 indicating that this was in relation to the pharmaceutical substance ATROVENT NASAL (Ipratropium Bromide). The request was supported by a copy of the certificate of registration, showing the date of first regulatory approval (30 August 1995) and a printout showing that the substance was included in the Australian Register of Therapeutic Goods (ARTG). The 20 year term of the patent expired on 4 July 1999.
Boehringer were advised by letter from the Examiner dated 28 July 1999 that the identified substance did not meet the requirements of section 70(2)(a). They filed statements of proposed amendments dated 23 July 1999 and 28 September 1999. Leave to amend was granted on 1 October 1999. Despite these amendments and lengthy submissions from Boehringer dated 28 November 1999, Boehringer were informed by letter from a Supervising Examiner dated 22 December 1999 that their request for extension of term still did not meet the requirements of section 70(2)(a) and the matter was set for hearing.
The hearing was held on 2 February 2000 in Canberra. Boehringer was represented by Ms Virginia Beniac-Brooks, patent attorney of Callinan Lawrie, assisted by Mr Michael Houlihan, Dr Elizabeth Sutherland and Ms Julie Wilkie, also patent attorneys from Callinan Lawrie.
THE CLAIMS
The specification, as amended by the proposed amendments dated 23 July 1999 and 28 September 1999, comprises 16 claims. Claims 1 to 5, 11 and 12 define a container comprising an aerosol or spray composition, claims 6 to 10 define a method of treating nasal hypersecretion and claims 14 to 16 define an aerosol or spray composition when used in the container of claim 1. Thus the claims of interest to this decision are claims 1, 6 and 14:
A container comprising an aerosol or spray composition for nasal administration which composition comprises as active ingredient a quaternary tropane alkaloid derivative with atropine-like activity, the container being provided with a nozzle adapted for nasal administration of the composition.
A method of treating nasal hypersecretion which comprises the nasal administration of an effective amount of a pharmaceutical composition for nasal administration comprising as active ingredient at least one quaternary tropane alkaloid derivative with atropine-like activity to a patient suffering from nasal hypersecretion.
An aerosol or spray composition as claimed in claim 1 when used in the container of claim 1 comprising as active ingredients:
1) a quaternary tropane alkaloid derivative selected from N-isopropyl nortropine tropic acid ester methobromide, N-ethyl-norscopolamine methobromide, N-methyl-scopolammonium bromide, N-ethyl-scopolammonium bromide, N-ethyl-o-benzoyl-norscopolamine methobromide and N-norscopolamine ethobromide; and
2)fenoterol or beclomethasone dipropionate;
together with a carrier or excipient for nasal administration.
I note from the specification that the compound N-isopropyl nortropine tropic acid ester methobromide is a quaternary tropane alkaloid derivative which is also known as ipratropium bromide.
I also note that the specification does not contain any claim to the compound ipratropium bromide or a pharmaceutical composition comprising it which is not in some way limited to the container. However, I am aware that AU 548186 is a divisional of present patent AU 530174 and that AU 548186 claims a pharmaceutical composition as is claimed in present claim 14 but without the limitation of its use in the container. Boehringer made an application to extend the term of AU 548186, based on the same marketing approval certificate as for AU 530174, but their application was made out of time and the Hearing Officer found that section 223 was not available to remedy this. Boehringer has now applied for a review of the Hearing Officer's decision on this matter by the Administrative Appeals Tribunal. Although I am aware of these facts, I do not consider that they are relevant to my decision here.
THE RELEVANT LAW
The Intellectual Property Laws Amendment Act 1998 was introduced to provide for an extension of term scheme for pharmaceutical patents. An extension of up to 5 years is available for a standard patent relating to a pharmaceutical substance that is the subject of first inclusion on the Australian Register of Therapeutic Goods (ARTG). As stated in the Explanatory Memorandum, the object of these changes was to "provide an 'effective patent life' -or period after marketing approval is obtained, during which companies are earning a return on their investment- more in line with that available in other fields of technology."
The relevant parts of the Act concerning extension of time of patents relating to pharmaceutical substances are sections 70 to 79A. As summarised in the Manual of Practice and Procedure, Volume 3 (hereafter referred to as the Manual) at 25.1:
"Essentially, to obtain an extension of the term of a patent:
a)The patent must contain at least one claim covering a pharmaceutical substance per se;
b) That pharmaceutical substance must be included in the ARTG; and
c)First regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent."
The only objection raised to this request for extension of term is that it does not meet the requirements of section 70(2)(a). I am satisfied that all other requirements of sections 70 and 71 have been met and so do not need to give those any further consideration. Section 70(2)(a) provides that:
"(2)(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;"
A definition of "pharmaceutical substance" is given in the Patents Act 1990 Schedule 1-Dictionary:
"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."
A definition is also given for "therapeutic use":
"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 person to a disease or ailment."
DECISION
I will now turn to the substantive issue of whether the provisions of section 70(2)(a) have been satisfied in regard to any of the claims. In order for me to be satisfied that the requirements of section 70(2)(a) have been met, I must find at least one claim to a pharmaceutical substance per se. Claims 6 to 10 define a method not a pharmaceutical substance. No representations concerning these claims were made and so I do not need to consider them further.
Claims 1 to 5, 11 and 12
In regard to claim 1 which defines a container comprising an aerosol or spray composition (and the dependent claims 2 to 5, 11 and 12), Ms Beniac-Brooks made the following submissions which I will summarise:
In the claims of patent AU 530174, the pharmaceutical substance per se is the composition of the pump activated, metered dose container containing the active ingredient (ATROVENT NASAL), not the aerosol or spray composition.
ATROVENT NASAL has a therapeutic use.
Part 25.2.1 of the Manual states "If a substance is listed on the ARTG, there is a prima facie assumption that the substance is a pharmaceutical substance- and therefore the Commissioner is unlikely to query whether a substance is a pharmaceutical substance within the meaning of the Patents Act without good reason." ATROVENT NASAL is listed on the ARTG and its very listing should be sufficient to assure the Commissioner that the composition of the container containing the active ingredient is a pharmaceutical substance within the meaning of the Act.
An extension of term under the previous scheme was granted, after appeal, on patent 510809 which claimed "a pharmaceutical preparation…………….when used for ……….."(see Astra Lakemedal Aktiebolag v Commissioner of Patents 31 IPR 1). At page 6 of the specification it says that "examples of pharmaceutical preparations may be ….tablets, drops such as nasal drops, preparations for topical application such as ointments, jellies, creams and suspensions, aerosols for inhalation, nasal spray, liposomes etc." Thus, 510809 provides precedence for extension of term of claims directed to "a container comprising" as presently claimed.
Examples of patents which have recently had extension of term requests either accepted or granted include AU 576889, AU 599988 and AU 547007. In AU 576889 and AU 547007, all claims are directed to transdermal therapeutic systems for sustained release and in AU 599988, the claims are directed to an intravaginal device, a method of preparing the device and a method of treatment. This demonstrates that the Patent Office considers a composition of a device and an active ingredient to be a pharmaceutical substance within the meaning of the Act.
The definition of a pharmaceutical substance includes a mixture or compound of substances. As stated in the Manual at 25.2.3, "a typical ARTG registration might refer to an active ingredient in a particular carrier or excipient. In this situation, the pharmaceutical substance is the active ingredient in the carrier or excipient, not the active ingredient alone." In the case of the present patent AU 530174, the pharmaceutical substance is the composition of the pump activated, metered dose container containing ipratropium bromide.
Thus, the pharmaceutical substance per se is in substance disclosed in the complete specification and in substance falls within the scope of the claims.
I believe that the crucial issue I must decide in relation to claims 1 to 5, 11 and 12 is whether the container comprising the aerosol or spray composition of ipratropium bromide is "a pharmaceutical substance per se" within the meaning of the Act. The notice of deficiency dated 22 December 1999 indicates that the Supervising Examiner considers the pharmaceutical substance to be the aerosol or spray composition (not including the container) but this composition itself does not fall within the scope of any of the claims.
I agree with Ms Beniac-Brooks that ATROVENT NASAL has a therapeutic use and is listed on the ATRG. However, I do not agree that the fact of the ARTG listing means necessarily that this product is a "pharmaceutical substance per se" within the meaning of the Act. In my view, listing on the ARTG shows only that the product is a pharmaceutical which has therapeutic use. I believe that part 25.2.1 of the Manual is consistent with this view and note the emphasis given in the heading to the word "pharmaceutical".
In any case, although I will take into account Ms Beniac-Brooks' submissions concerning the guidance given in the Manual, ultimately I must make my decision based on the wording of the Act itself. As pointed out by Ms Beniac-Brooks in her submissions, the Acts Interpretation Act 1901 allows me to make reference to extrinsic material such as the Explanatory Memorandum or a dictionary in order to assist in understanding a word or phrases in the Act, provided the construction given results in promoting the purpose or object underlying the Act.
In the present situation, I can find no guidance as to the meaning of the words "substance" or "per se" in either the Act or the Explanatory Memorandum so will look to a dictionary for assistance in this matter. In doing so I need to consider the meaning in terms of the context in this Act. In addition, since the Act defines a pharmaceutical substance as "including a mixture or compound of substances", I believe it will be useful also to obtain definitions for "mixture" and "compound".
The Macquarie Dictionary gives the following definitions (these being the definitions which I believe are the most relevant in the present context):
Substance:1. That of which a thing consists; matter or material. 2. A species of matter of definite chemical composition.
Per se: By or in itself, intrinsically.
Compound:4. Something formed by compounding or combining parts, elements, etc. 5. A substance, consisting of two or more elements joined chemically in fixed proportions, which has properties different from those of the original elements.
Mixture:1. A product of mixing. 3. An aggregate of two or more substances which are not chemically united, and which exist in no fixed proportion to each other. 7. An added element or ingredient; an admixture.
Mixing:1. To put together (substances or things, or one substance with another) in one mass or assemblage with more or less thorough diffusion. 2. To put together indiscriminately or confusedly.
In light of these definitions, I do not see how the combination of a container or device containing a composition of the active ingredient as defined in claim 1 could be construed as being a pharmaceutical substance per se as required by section 70(2)(a). While the composition containing ipratropium bromide inside the device could be considered to be a substance or mixture of substances, I do not believe that this extends to the combination of a container with active agent composition. This combination does not comprise a species of matter of definite composition, nor does it comprise a mixture or compound of substances falling within the definitions of "compound" or "mixture" as given above. The container and aerosol or spray composition are two quite separate entities which are not assembled indiscriminately and are not joined chemically.
As stated above, Ms Beniac-Brooks referred me to part 25.2.3 of the Manual which is concerned with the situation where the pharmaceutical substance is a mixture or compound of substances, including where the ARTG registration refers to an active ingredient in a carrier or excipient. The Manual states that in this case "the pharmaceutical substance is the active ingredient in the carrier or excipient". However, I cannot be bound by the direction given in the Manual. In any case, I believe that a mixture of active ingredient and carrier would constitute a pharmaceutical substance per se only where the carrier and active agent constitute a proper mixture or compound of substances falling within the definitions given above. In the present case I have found that the carrier or device containing the active agent together do not constitute a proper mixture or compound.
I note Ms Beniac-Brooks submissions concerning other patents which have had extensions of term requests either accepted or granted already (either under this scheme or the previous extension of term scheme), but I must make my decision on the facts before me in the present case. Each request must be considered on its own merit and I do not think it is appropriate for me to comment on the facts surrounding these other patents. I acknowledge that, in some instances, it will be quite difficult to determine whether a combination of components constitutes a true mixture, but I believe that there is no doubt in the present patent that they do not.
At the start of the hearing, Ms Beniac-Brooks drew my attention to section 74(1) which states:
"If a patentee of a standard patent makes an application for an extension of term of the patent, the Commissioner must accept the application if the Commissioner is satisfied that the requirements of sections 70 and 71 are satisfied in relation to the application."
In her view, this is unclear as it is not apparent whether the words "is satisfied" and "are satisfied" are being used in the discretionary or mandatory sense. She submitted that: "unlike the words 'is' or 'are', the word 'must' imposes an obligation that the specific requirements must be totally complied with. Accordingly, the phrases 'is satisfied' or 'are satisfied' are directory only and carry with them an element of discretion such that the benefit of the doubt will lean in favour of accepting the application." In the present situation and after considering all the relevant facts, I do not have any doubt that the combination of the container comprising an aerosol or spray composition of ipratropium bromide does not constitute a pharmaceutical substance per se.
In summary, I find that claims 1 to 5, 11 and 12 do not define a pharmaceutical substance per se within the meaning of section 70(2)(a).
Claims 14 to 16
Ms Beniac-Brooks also made a number of submissions relating to claims 14 to 16. They define an aerosol or spray composition as claimed in claim 1 when used in the container of claim 1. The active ingredients defined comprise a quaternary tropane alkaloid derivative (selected from 6 named compounds including ipratropium bromide) and another nasally active compound comprising either fenoterol or beclomethasone dipropionate together with a carrier or excipient.
The construction of such "when used" claims was discussed at the hearing. These types of claims have caused some difficulty in construction in the past but they have conventionally been construed as disguised process claims - see Wellcome v Commissioner of Patents, 30 ALR 510 and Bernard Joos' Application (1972) AOJP 3429.
However, according to Ms Beniac-Brooks, these particular claims should be interpreted as product claims which are used in the environment of the container of claim 1. Ms Beniac-Brooks submitted that the term "pharmaceutical substance" is defined in the dictionary to the Act and not "pharmaceutical substance per se" which is the wording used in section 70(2)(a). She directed my attention to part 25.2.2. of the Manual which interprets the words "per se" as requiring that the claim to the substance be unqualified by process, temporal or environmental components. However, it is her view that this interpretation is only applicable where the substance itself is known. In the present case, the "substance" is not already known. She stated that "nowhere in the Act, Regulations or Explanatory Memorandum is there any indication that this interpretation should extend to all substances regardless of whether they are new or inventive."
She referred to point 9 of the explanatory memorandum where it says:
"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."
and to part 10:
"An extension of term will not be available for claims to new processes of making pharmaceutical substances or new methods of using pharmaceutical substances where the substances themselves are already known."
In her view, claims 14 to 16 are not examples of claims which are excluded by the wording of the explanatory memorandum since both ipratropium bromide and the composition of the pump activated container containing ipratropium bromide were novel and inventive at the earliest priority date of the patent and thus they do not limit the use of a known substance to a particular environment.
In interpreting these claims I need to take into account the fact that they were inserted by amendment dated 28 September 1999. I believe I should construe the claims as if they do comply with section 102 rather than take a construction which would render the amendments not allowable by virtue of them not in substance falling within the scope of the claims before amendment. Since the only claims at acceptance defined either a container comprising an aerosol or spray composition (present claim 1 and its dependent claims) or a method of treating nasal hypersecretion (present claim 6 and its dependent claims), I can only interpret claims 14 to 16 as defining either a method of treatment or a container including the nasal composition.
If present claims 14 to 16 are interpreted as to a method of treatment, they would not provide the basis for an extension of term of the patent as they would not be claims to a pharmaceutical substance per se but claims to a method.
If I accept the interpretation of Ms Beniac-Brooks that this claim is a product claim, it can only be to a product which is within the scope of the accepted claims. There was no claim at acceptance to a composition comprising ipratropium bromide and either fenoterol or beclomethasone dipropionate, only to a container comprising such a composition as defined in claim 3. However, I have concluded above that claims 1 to 5, 11 and 12 are not directed to a pharmaceutical substance per se within the meaning of the Act and, consequently, do not provide the basis for extending the term of the patent.
Furthermore, the marketing approval certificate provided is not in relation to a composition which contains either fenoterol or beclomethasone dipropionate. These are both said to be nasally active substances but do not appear on the extract of the ARTG as either active ingredients or excipient ingredients of ATROVENT NASAL.
Thus, in my view, whether claims 14 to 16 are construed as method type claims or as product type claims they do not provide a proper basis for an extension of term of the patent.
CONCLUSION
I have found above that none of the claims of patent AU 530174 define a pharmaceutical substance per se. If the Commissioner is not satisfied that the requirements of section 70(2)(a) are satisfied in relation to the application, under section 74(3) she must refuse to accept the application for extension of term. Consequently, I refuse the section 70 request.
Gillian Jenkins
Delegate of the Commissioner of Patents
Patent attorneys for the patentee : Callinan Lawrie, Kew, Victoria
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