LTS Lohmann Therapie-Systeme GmbH & Co KG - [2002] APO 12

OFFICIAL NOTICE
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Patent: No. 678408 in the name of LTS Lohmann Therapie-Systeme GmbH & Co. KG

Title: Transdermal therapeutic system for the release of 17-beta-estradiol and process for its production

Action: Request for an extension of term (s.70) and objections of the Commissioner thereto.

Decision: Issued : 11 April 2002.
Abstract
In the dictionary definition of “pharmaceutical substance” the reference to ‘substance’ is reference to ‘a species of definite chemical composition’. The reference to ‘including a compound or mixture of substances’ implies that the reference to ‘substance’ is a reference to a chemical entity that is usually defined by itself. To the extent that a “pharmaceutical substance” may contain more than one chemical entity, it must be by way of being a compound or mixture of substances. A mixture of substances implies an uncontrolled spatial configuration of the entities in the mixture. A substance characterised by features of spatial configuration is not a mixture of substances, but an arrangement of substances characterised by that configuration. It follows that such a claim would not normally include within its scope a “pharmaceutical substance per se”.
The invention of the patent concerns a transdermal patch to deliver a particular drug. The claim defines an arrangement of chemical entities that make up the patch (the active drug, various layers, etc.) It does not claim a chemical entity per se, nor a compound or mixture of chemical entities. Accordingly a pharmaceutical substance per se does not fall within the scope of any claim, and the requirements of s.70(2) are not met. Request refused.

PATENTS ACT 1990
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Re:Patent No. 678408 in the name of LTS Lohmann Therapie-Systeme GmbH & Co. KG, a request under s.70 for an extension of term, and objections of the Commissioner thereto

BACKGROUND

This matter concerns a request for an extension of the term of patent no. 678408 in the name of LTS Lohmann Therapie-Systeme GmbH & Co. KG (LTS). The invention involves a transdermal patch for hormone replacement therapy. The patent was applied for on 27 October 1993. Accordingly its 20-year term will expire on 27 October 2013. If an extension of the term of the patent is granted, I understand the term would be extended to 22 September 2015.
Following the application, a delegate of the Commissioner reported that he considered the patent does not include any claim to a pharmaceutical substance per se, and questioned whether there was any substance in the relevant Goods listed on the ARTG that fell within the scope of the claims. Following further information and submissions, the delegate maintained his objection that a pharmaceutical substance per se does not in substance fall within the scope of the claims. The matter was subsequently heard in Sydney on 1 Feb 2002. LTS was represented by Dr P. Stearne, patent attorney of Davies Collison Cave.
DISCUSSION
The patent relates to what is commonly referred to as a transdermal patch. The drug that is being delivered is 17-b-estradiol, for use in hormone replacement therapy. That drug is per se known. The invention relates to an arrangement for ensuring correct administration of the drug. The key aspect of the invention is that 17-b-estradiol needs to be delivered in a controlled manner; that variability of water vapour tension affects the solubility of 17-b-estradiol – and therefore the capacity for physico-chemical interaction with the human body; and 17-b-estradiol is subject to undesirable re-crystallisation. The invention seeks to solve these problems with a transdermal patch having certain structural features. Claim 1 is directed to a ‘Transdermal therapeutic system’. Claims 2 to 5 are dependent thereon. Claim 6 is to a ‘Process for the production of the transdermal therapeutic system according to claims 1 to 5’. Whilst it is the first claim to a ‘process’, it is nevertheless limited by the features of claim 1. The remaining claims are dependant upon claim 6, and therefore upon claim 1. Having regard to the requirement that a pharmaceutical substance per se must in substance fall within the scope of a claim, and the fact that dependant claims add features to claims, I am satisfied that if claim 1 does not provide the necessary justification for an extension of term of the patent, none of the remaining claims is capable of providing that justification. Accordingly I can limit my considerations to Claim 1.
Claim 1 is in the following terms:
Transdermal therapeutic system containing the active substance 17-b-estradiol and optionally further active substances, with a laminated structure comprising a backing layer which is substantially impermeable to moisture and impermeable to active substance, one or more matrix layers and, where non-adhesive matrix layers are present, an adhesive layer, characterised in that the concentration of the dissolved estradiol in all matrix layers and, where an adhesive layer is present, in the adhesive layer, lies between its saturation concentration in dry condition and its saturation concentration in moist condition, whereby the term “dry condition” is understood to mean that the base material is in equilibrium with a gas phase with less than 10% relative humidity, and the term “moist condition” is understood to mean that the base material is in equilibrium with a gas phase with more than 90% relative humidity.
Of particular relevance, the claim defines a layered structure, with the active substance present in a specified amount in certain layers.
Dr Stearne noted that the specification was originally drafted in German, and that as a result phraseology may be somewhat unusual or unconventional. While I accept that due allowance should be made to such issues when construing the specification, none of the considerations regarding the extension of term of this patent depend on this issue.
The relevant statutory requirement that must be met is set out in s.70(2), which is as follows:
(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.
As the current invention does not involve the use of recombinant DNA technology, only subparagraph (a) is relevant.
The proposition argued by the attorney is that claim 1 defines a ‘substance’. That is, the transdermal patch as a whole is a pharmaceutical substance per se. Dr Stearne argues that when the treated in this manner, the patent meets all the requirements for the grant of an extension of term. The delegate disagreed with this interpretation. Accordingly, the dispute involves a short point concerning the proper interpretation of the term “pharmaceutical substance” as defined in the dictionary to the Act.
This term “pharmaceutical substance” is defined in the Dictionary to the Act, as:
“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 a physico-chemical interaction, with a human physiological system; or
(b)action on an infectious agent, or 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.
Interestingly, the definition is based on the word “substance” itself, so that to understand the term “pharmaceutical substance” it is necessary to understand the meaning of “substance” as used in the definition. The Macquarie dictionary ascribes 10 meanings to the word ‘substance’ when used as a noun. They are:
1.That of which a thing consists; matter or material.
2.A species of matter of definite chemical composition.
3.The matter of which thought, discourse, study, or the like, is occupied; subject matter.
4.The actual matter of a thing, as opposed to the appearance or shadow; reality.
5.Substantial or solid quality: claims lacking in substance.
6.Body: soup without much substance.
7.The meaning or gist, as of speech or writing.
8.Something that has a separate or independent existence
9.Philos.a. that which exists by itself, and in which accidents or attributes inhere; that which receives modifications, and is not itself a mode; that which is causally active; that which is more than an event. b. the essential part, or essence, of a thing. c. the thing, as a continuing whole.
10.Possessions, means or wealth: to squander one’s substance.
Definitions 3 to 7, 9 and 10 are plainly inappropriate to the context of the definition of a pharmaceutical substance. I also think that the 8^th meaning (in the context of a pharmaceutical substance) is parallel to the 2^nd meaning – except that it perhaps better equates to the situation where the chemical composition of an entity is unknown but that entity has, in practical terms, a separate and independent existence. However, it could equally be said to be parallel to the 1^st meaning – in the sense that a transdermal patch has an independent existence. The issue is therefore whether the reference to ‘substance’ in the definition is a reference to whatever is said to make up the ‘pharmaceutical substance’ (in this case, the transdermal patch as a whole) as per the 1^st meaning above, or a reference to a species of matter of definite chemical composition, as per the 2^nd meaning above.
The full Federal Court considered the meaning of the term ‘pharmaceutical substance per se’ in Boehringer Ingelheim International GmbH v Commissioner of Patents 52 IPR 529. That decision was focussed on the significance of the qualification ‘per se’, rather than the scope of the term ‘substance’. However, it is noteworthy that the present applicant’s desired construction of the word ‘substance’ would, in the context of Boehringer, be a reference to the aerosol can containing the drug – an approach not followed in that decision. Indeed, when discussing the phrase ‘pharmaceutical substance per se’, the court observed at paragraph 39 [contrary to the present applicant’s desired interpretation]:
‘The second reading speech 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.’
(my emphasis added.)
The definition of ‘pharmaceutical substance’ qualifies ‘a substance’ with the phrase ‘(including a mixture or compound of substances)’. It could be (as was suggested by Dr Stearne) that this qualification is by way of mere clarification or explanation. However, if the intention of the drafter was for ‘substance’ to be whatever the entity is made up of [i.e. the 1^st meaning above], it is difficult to ascertain any reason for specifically identifying, out of all possible arrangements for making up such an entity, just mixtures or compounds of substances. On the other hand, applying a presumption against redundancy leads to a clear purpose for the qualification. With ‘substance’ being used in the sense of the 2^nd meaning above [i.e. of definite chemical composition] the qualification makes clear that ‘substance’ is not limited to single chemical entities, but extends to mixtures and compounds of chemical entities. It follows that a ‘pharmaceutical substance’ is a chemical entity, or a mixture or compound of chemical entities; it is not a reference to whatever the ‘substance’ is made up of.
In further support of this interpretation, it is instructive to refer to the Explanatory Memorandum accompanying the amending legislation. In the introductory part under the heading ‘Problem or issue identification’, it is stated:
‘The development of a new drug is a long process, estimated to average around 12 years, which requires a new chemical entity to be patented early in the process in order to secure its intellectual property rights. However, considerable research and testing is still required before the product can enter the market. As a consequence, patentees of new drugs usually have considerably fewer years under patent in which to maximise their return.’
which shows that the scheme has a focus on new chemical entities. Then in the part dealing with the specific amendments made by Item 3 of the Schedule 1 of the amending Bill, it states:
7.‘Section 70 sets out the substantive conditions that must be satisfied for a patent to be eligible for an extension of term. Extensions of term will be available only for patents containing claims to pharmaceutical substances per se or claims to pharmaceutical substances when produced by recombinant DNA technology. Paragraph 70(2)(a) requires that one or more pharmaceutical substances per se must be both in substance disclosed in the complete specification and in substance fall within the scope of the claim or claims of that specification. Paragraph 70(2)(b) requires that one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology must be both in substance disclosed in the complete specification and in substance fall within the scope of the claim or claims of that specification.
8.‘A “pharmaceutical substance” is defined in Schedule 1 of the Patents Act 1990 and may comprise combinations of active ingredients or single active ingredients.
9.‘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). 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.
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.’
It may be noted that the text refers generally to pharmaceutical substances – the phrase used in the legislation. I think the general tenor of the text is consistent with an interpretation that ‘substance’ is used in the definition of ‘pharmaceutical substance’ in the sense of the 2^nd meaning above – i.e. definite chemical composition. I do not consider it to be consistent with an interpretation that a pharmaceutical substance is whatever ‘it’ is made up of (with the only limitation being that of having a ‘therapeutic effect’) – such that a ‘pharmaceutical substance’ would extend to things like acupuncture needles, bandages, delivery systems etc.
A further important point arises in relation to the phrase ‘including a mixture or compound of substances’. I take this qualification as meaning that whenever there are plural entities involved in the ‘pharmaceutical substance’, they must be involved by way of being a mixture or compound. A compound involves some form of chemical association governed by the laws of chemistry. A ‘mixture’ does not involve any chemical association. I take the term ‘mixture’ as being used in this context of the third definition in the Macquarie dictionary – viz. “An aggregate of two or more substances which are not chemically united, and which exist in no fixed proportions to each other.” In particular, I think that the term ‘mixture’ involves a concept, at least at the macroscopic level, of an uncontrolled spatial configuration of the entities in the mixture. By way of example, pouring salt onto the top of a bowl of sugar will create a quantity of sugar covered by a layer of salt. It is not a mixture of salt and sugar, but a layered arrangement. Vigorously shake the bowl, and a mixture of salt and sugar will result – with there being no controlled spatial arrangement of the salt and sugar.
Accordingly, I think the definition of ‘pharmaceutical substance’ is necessarily limited to:
·     Chemical entities per se
·     Compounds of chemical entities; and
·     Mixtures of chemical entities – noting that mixtures entail an uncontrolled spatial configuration of the entities in the mixture.
Consequently, if a claim to an alleged pharmaceutical substance includes features specifying the spatial configuration of the entities in the substance, it is not a claim to a pharmaceutical substance per se but a claim to an arrangement of substances characterised by that spatial configuration.
In the present application the claim includes a number of entities. While 17-b-estradiol is the pharmacologically active element of the system claimed, the system includes a range of other entities. Dr Stearne argued that the whole ‘system’ is a ‘pharmaceutical substance’, noting that as a whole it interacts with the human physiological system in the manner required by the definition of ‘therapeutic use’. However the ‘system’ is clearly not a compound or single-entity substance – it is comprised of a number of known entities. Further, an essential part of the claim is the definition of spatial requirements on the entities in the ‘system’. That is, the ‘system’ claimed is not a mixture or compound of chemical entities, but an arrangement of entities. The presence of the macro spatial requirements on the entities demonstrates that the claim does not claim a pharmaceutical substance per se, but is a claim to substances qualified by a spatial arrangement. Accordingly, I consider that a pharmaceutical substance per se is not in substance within the scope of the claim 1. As previously indicated, the remaining claims are in one form or another dependant upon claim 1, and add further features. It follows that a pharmaceutical substance per se is not in substance within the scope of any of the remaining claims in the specification. Accordingly, the requirements of s.70(2) cannot be met with this patent.
At the hearing Dr Stearne identified a number of patents similar to the present where the Commissioner has previously granted an extension of the term of the patent. A similar argument arose in the Boehringer case (supra). In that case, the full Federal Court stated:
"20 Heerey J referred to submissions by Boehringer that Ms Jenkins' approach was inconsistent with the granting of extensions for other patents. His Honour did not think this a fruitful line of argument. We agree. When the argument was put to us, we pointed out to counsel that, even if it was possible to show inconsistency, that would not mean Ms Jenkins erred; the decisions in the other cases may have been wrong. Counsel saw the point and did not press the argument."
I think these comments of the Federal Court fully dispose of this submission.
CONCLUSION
The specification does not include any claim where a pharmaceutical substance per se is in substance within the scope of the claim. As a consequence the requirements of s.70(2) cannot be met. Accordingly I refuse the request to extend the term of patent 678408.
D Herald
Deputy Commissioner of Patents
Patent attorneys for the patentee : Davies Collison Cave, Sydney