Euro-Celtique, S.A.
[2007] APO 13
•26 March 2007
ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : Patent No. 774779 in the name of Euro-Celtique, S.A.
Title: Method of providing sustained analgesia with buprenorphine
Action :Request under s 70 of the Patents Act for an extension of term and objections of the Commissioner thereto
Decision: Issued 26 March 2007.
Abstract
The patent relates to a sustained-release formulation of buprenorphine, a known opioid analgesic used in the relief of moderate to severe pain. The patentee requested an extension of term of the patent based on the inclusion of NORSPANTM, a transdermal delivery system comprising buprenorphine, on the Australian Register of Therapeutic Goods.
Claims 22 to 59 are directed towards “A pharmaceutical formulation…in a transdermal delivery system…”. Though the claims did not define an arrangement characterised by features of spatial configuration as in LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12, a transdermal system, by its very nature, suggests the presence of a backing layer or patch upon which the mixture of chemical entities is applied. It was found that the use of the phrase “transdermal delivery system”, in the context of the patent, does represent a separate physical integer unrelated to the mixture of chemical entities.
It was found that a pharmaceutical substance per se does not in substance fall within the scope of the claim or claims of the specification. As a result, the section 70 application for extension of term of patent 774779 was refused for failing to comply with section 70(2)(a).
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re: Patent No. 774779 in the name of Euro-Celtique, S.A., a request under s 70 of the Patents Act 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. 774779 in the name of Euro-Celtique, S.A. The patent relates to a "Method of providing sustained analgesia with buprenorphine". The patent is a divisional of 61841/98 (743071) and has a filing date of 24 February 1998. Accordingly its 20-year term will expire on 24 February 2018. An application for extension of term of the patent was lodged on 9 November 2005, and if an extension of the term of the patent is granted, the term would be extended to 9 May 2020.
The basis for the request for an extension of term was the inclusion in the Australian Register of Therapeutic Goods (ARTG) of NORSPANTM, a buprenorphine transdermal drug delivery system which was subject to an ARTG registration commencing on 9 May 2005. Following the filing of the request, a delegate of the Commissioner reported that he considered the patent did 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 did not in substance fall within the scope of the claims.
The matter was subsequently heard in Canberra on 17 January 2007. Ms Shahnaz Irani, patent attorney of Spruson & Ferguson represented the patentee. Dr John Whitlam, Director of Medical Affairs, Mundipharma Pty Ltd was also in attendance to discuss the relevant clinical trial data. Mundipharma is the manufacturer of NORSPANTM in Australia, and is also the sponsor of the goods registered on the ARTG.
THE SPECIFICATION
The patent relates to sustained-release formulations of buprenorphine, a known opioid analgesic used in the relief of moderate to severe pain. Such formulations have the advantage that less drug may be used compared with normal dosage regimes over the same time period. This is particularly important in opioid analgesic formulations since the level of opioid in the blood must be maintained at an appropriate level in order to achieve effective pain relief.
The specification ends with eighty claims, which fall into one of three categories. The first category comprises claims 1 to 21, which define methods of treatment involving the administration of buprenorphine. The second category includes claims 60 to 80, which are “Swiss-style” claims which define the use of buprenorphine in the manufacture of a medicament for treating pain. The third and most relevant category for the purposes of s 70 comprises claims 22 to 59, which are directed to “A pharmaceutical formulation for treating pain…”. Claim 22 is representative of this third category, and is as follows:
“22. A pharmaceutical formulation for treating pain in a human patient comprising a pharmaceutically effective amount of buprenorphine in a transdermal delivery system containing buprenorphine as the active ingredient together with instructions for applying said transdermal delivery system onto the skin of a human patient to provide a substantially first order plasma level increase of buprenorphine over a first three-day dosing interval, such that a mean plasma concentration from about 20 pg/ml to about 1052 pg/ml is attained, about 72 hours after application of said transdermal delivery system; and maintaining said transdermal delivery system on the skin of a human patient for at least an additional two-day dosing interval, such that a mean relative release rate from about 0.3 μg/hr to about 9 μg/hr is maintained over said at least two‑day additional dosing interval and a human patient experiences analgesia throughout the at least two-day additional dosing interval.”
Claims 23 to 58 primarily differ from claim 22 by specifying different parameters for the mean plasma concentration.
Claim 59 is an omnibus claim that defines a monopoly by reference to the whole body of the specification. It reads:
“59. A pharmaceutical formulation for treating pain in a human patient substantially as hereinbefore described with reference to any one of the examples.”
THE RELEVANT LAW
Part 3 of Chapter 6 of the Patents Act provides a statutory framework for the extension of the term of standard patents relating to pharmaceutical substances. Section 70 relevantly provides:
"(1) The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.
(2) Either or both of the following conditions must be satisfied:
(a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
(b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification."
The patent under consideration in these proceedings falls into the first category, s 70(2)(a). Section 70(2)(b) is therefore of no relevance.
10. The expression "pharmaceutical substance" is defined in Schedule 1 of the Act to mean:
"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."
11. The term "therapeutic use" is also defined in Schedule 1. It means:
"use for the purpose of:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
(b) influencing, inhibiting or modifying a physiological process in persons; or
(c) testing the susceptibility of persons to a disease or ailment."
12. Section 70(3) provides that the following conditions must be satisfied in relation to at least one of the pharmaceutical substances referred to in s 70(2):
"(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."
13. Section 70(4) requires that the patent must not have been previously extended under Part 3.
14. There is no argument that NORSPANTM is on the ARTG and that the patent has not been previously extended under Part 3 of the Patents Act. I am therefore satisfied that the patent meets the requirements set out in ss 70(3) and (4). The only issue that must be resolved is whether it also satisfies the requirements set out in s 70(2)(a).
15. There are two questions that arise under s 70(2)(a):
- is “A pharmaceutical formulation…in a transdermal delivery system…” a pharmaceutical substance per se? and
- is NORSPANTM "in substance disclosed in the complete specification of the patent?" and does it "in substance fall within the scope of the claims of the patent?"
DECISION
Are the claims to a pharmaceutical substance per se?
16. The meaning of the expression "pharmaceutical substance per se" in s 70(2)(a) has been authoritatively considered by the Federal Court in Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 (‘Boehringer’), Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77 (‘Prejay’) and most recently in Pharmacia Italia SpA v Mayne Pharma Pty Ltd [2006] FCA 305 (‘Pharmacia’). In Boehringer, the Full Court referred with approval, at [34] and [37], to the submission of the respondent that the introduction of the words "per se" by the 1998 amendments to the Patents Act indicated a clear intention, on the part of the legislature, to limit the operation of s 70 to patents disclosing and claiming a pharmaceutical substance "by or in itself, intrinsically, essentially" (New Shorter Oxford English Dictionary), or "taken alone; essentially; without reference to anything else" (Butterworth’s Australian Legal Dictionary).
17. This approach was approved in Prejay, in which the Full Court held that the qualification per se requires that the pharmaceutical substance is itself the subject of a claim. It is not sufficient for a substance to appear in a claim only in combination with other products or integers or as part only of the description of a method or process that is the subject of a claim. The Court noted at [24] that extensions of the patent term are confined to patents that claim invention of the substance itself.
18. Under the Patents Act, a pharmaceutical substance is limited to “…a substance (including a mixture or compound of substances) for therapeutic use…”. There is no dispute that NORSPAN, being a transdermal formulation of buprenorphine, is for therapeutic use and that its application involves a chemical interaction, or physico-chemical interaction, with a human physiological system. The issue is whether it falls within the scope of the phrase “a substance (including a mixture or compound of substances)”.
19. This phrase has been discussed in LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12 (‘Lohmann’). The patent in that case related to a transdermal patch which delivered a known drug, 17-[beta]-estradiol. Claim1 was defined in the following terms:
“Transdermal therapeutic system containing the active substance 17-[beta]-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.”
20. In that decision, the Hearing Officer concluded that the qualification “including a mixture or compound of substances” to the definition of “a substance” in Schedule 1 makes clear that “substance” is not limited to single chemical entities, but extends to mixtures and compounds of chemical entities. He went on to state at [16] that 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. It was concluded at [17] that “....if a claim to an alleged pharmaceutical substance includes features specifying 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.”
21. It was submitted by the patentee that:
“Specifically, the claims of the patent do not include features specifying spatial configuration of the entities in the substance, they simply define any formulation which meets particular pharmacokinetic parameters, those parameters being dependent on the claim being assessed. Such a formulation could be any transdermal formulation meeting those parameters including a buprenorphine gel or cream - both of which are topically applied. See page 18 lines 17-21 of the patent where it is stated that ‘Any type of transdermal delivery system may be used provided the desired pharmacokinetic and pharmacodynamic responses are attained over at least 3 days…Preferable transdermal delivery systems include eg., transdermal patches, transdermal plasters, transdermal discs, iontophoretic transdermal devices and the like.’
In conclusion, the claims do not define an arrangement of entities or a layered arrangement and therefore can be distinguished from the claims in the LTS Lohmann decision as not being claims to substances qualified by a spatial arrangement. Accordingly, a pharmaceutical substance per se is in substance within the scope of claims 23-59 of the patent and the requirement of s 70(2)(a) is met.”
22. I am satisfied that the relevant claims may be distinguished from Lohmann. In that patent, the claims are clearly characterised by features of spatial configuration, whereas the claims of the present patent do not upon any conceivable interpretation define an arrangement of substances characterised by configuration, other than the existence of a pharmaceutically effective amount of buprenorphine “…in a transdermal delivery system…”.
23. Although successfully distinguished from Lohmann, this is not determinative of whether claims 22 to 59 meet the requirements of s 70(2)(a). Is the reference to a “transdermal delivery system” sufficient to take the claimed invention outside the ambit of “a substance (including a mixture or compound of substances)”?
24. The decisions of the Federal Court in Boehringer, Prejay and Pharmacia have not addressed this specific issue. In Boehringer, a Full Court (Wilcox, Whitlam and Gyles JJ) had to consider a patent where the pharmaceutical substance was contained in a container. The court concluded that as the pharmaceutical substance, in itself, was not a thing claimed in the patent sense, it did not fall within the scope of a claim. In Prejay, another Full Court (Wilcox, Cooper and Allsop JJ) considered a patent where the claims were to a method of treatment by administering a pharmaceutical substance. The court concluded that the substance was not itself the subject of such a claim. In Pharmacia, Weinberg J considered claims to a pharmaceutical substance in the form of an injectable solution. The issue centred on whether elements of claim 1 were attributes of the solution claimed or process elements. The court concluded that the claim was not to a method, and that the mixture was a pharmaceutical substance.
25. It is clear from these cases that the present claims lie somewhere on the spectrum which encompasses Pharmacia on the one hand and Boehringer and Prejay on the other. The patentee submitted that the pharmaceutical formulation claimed is exactly analogous to the preparation of a mixture of entities which is then tabletted except that once the mixture of entitles is prepared it is then formulated into a dermal delivery formulation. NORSPAN is a dermal dosing form which may be considered equivalent to a controlled release orally delivered formulation but which is absorbed through a different membrane (the skin rather than the gastro mucosa), and should not be distinguished from such other pharmaceutical substances. The NORSPANTM formulation was developed because the extremely low bioavailability of the active makes oral administration inefficient.
26. The analogy is not without merit. I agree with the patentee that in a purely therapeutic sense, with all other factors being equal, there is no difference between a pharmaceutical delivered orally from one delivered dermally. However, unlike a simple tablet which merely consists of a mixture of chemical entities in tablet form, a “transdermal delivery system”, by its very nature, suggests the presence of a backing layer or patch upon which the mixture of chemical entities is applied. In my view, the phrase “tablet” merely represents the intrinsic form or shape in which the mixture of chemical entities exists. It is nothing more than a description of the broad characteristics of the mixture and does not represent the presence of a separate physical integer. The use of the phrase “transdermal delivery system”, in the context of the patent, does represent a separate physical integer unrelated to the mixture of chemical entities. In essence, the example of a “tablet” and the “transdermal delivery system” of the claims cannot be considered as equivalent delivery mechanisms.
27. The patentee’s argument has paid insufficient regard to the approach espoused in Prejay that the patent must claim a pharmaceutical substance in itself, not in combination with other integers or as a part of a process. I believe the only sensible conclusion open to me is that a claim to “A pharmaceutical formulation…in a transdermal delivery system…” is not a claim to “a substance (including a mixture or compound of substances)”. Accordingly, the claims are therefore not directed to a pharmaceutical substance per se.
28. I certainly have some sympathy for the patentee’s assertion that a new formulation of an old or known drug may require as much investment, research and testing as the development of new chemical entities. Nevertheless, as was noted by the Full Court in Pharmacia at [99], the rationale for implementing the extension of term provisions relating to pharmaceutical substances per se was to encourage the development of new drugs, not drugs in combination with other elements. The explanatory memorandum to the Intellectual Property Laws Bill of 1997, in particular, excluded the application of the new provisions to “new methods of making pharmaceutical substances or new methods of using pharmaceutical substances, where the substances themselves are known”.
29. Even if my conclusion on this matter is incorrect, I believe the claims fail to meet the requirements of s 70(2)(a) for another reason. I note that each of claims 22 to 58 recite “A pharmaceutical formulation…comprising a pharmaceutically effective amount of buprenorphine in a transdermal delivery system…with instructions for applying said transdermal delivery system…” [Emphasis added].
30. As a matter of first impression, and notwithstanding the fact that these claims are couched in terms of “A pharmaceutical formulation…”, one would not expect to see such a limitation in a claim to a pharmaceutical substance per se. In my opinion, claims 22 to 58 are clearly directed towards commercial packaging aspects of the pharmaceutical. If the patentee had intended to refer to a pharmaceutical substance per se, then, given the simplicity of the requirement, it would have been easy to simply omit the reference to “instructions for applying”. This step was not taken by the patentee. It must be borne in mind that patent claims are the result of considered and deliberate choice, encompassing all the complexities and nuances of the written language, to delimit the boundaries of the claimed monopoly. They are usually not drafted by inexperienced or unqualified authors. I therefore find that claims 22 to 58 of the patent do not provide the necessary justification for an extension of term of the patent.
31. Claim 59 is an omnibus claim. By referring to “A pharmaceutical formulation…as hereinbefore described with reference to any one of the examples”, the claim is limited to the essential integers of the invention as described and claimed. The patentee contends that the integer “…with instructions for applying…” is not an essential integer of the invention, and is therefore not encompassed by claim 59. From Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 212 ALR 1, the relevant inquiry is what the body of the specification as a whole discloses as the invention. In my opinion, and after a fair reading of the specification as a whole, it is apparent that the “instructions for applying” is described as an essential integer of the pharmaceutical formulation claimed. Claim 59 therefore cannot be relied upon for an extension of term of the patent.
Is NORSPANTM in substance disclosed and does it fall within the scope of the claims?
32. S 70(2)(a) stipulates that 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. In the report of 21 November 2005 the delegate noted that the evidence provided by the patentee did not demonstrate that NORSPANTM has the pharmacokinetic parameters defined in claims 22 to 59.
33. The pharmacokinetic properties of NORSPANTM were observed and reported on during the various clinical trials that took place. Evidence from these trials, which include dose proportionality and single dose safety and pharmacokinetic studies, was presented at the hearing by Dr Whitlam.
34. Based on the extensive regulatory materials and discussion which ensued I am satisfied that NORSPANTM is in substance disclosed within the complete specification and that it in substance falls within the scope of claims 22 to 59. Nevertheless, these claims fail to define a pharmaceutical substance per se despite NORSPANTM possessing the required pharmacokinetic properties.
CONCLUSION
35. The specification does not include any claim where a pharmaceutical substance per se is in substance within the scope of the claim or claims of the specification. As a consequence the requirements of s 70(2)(a) cannot be met. Accordingly I refuse the request to extend the term of patent 774779.
R. W. J. Finzi
Delegate of the Commissioner of Patents
26 March 2007
Patent attorneys for the patentee: Spruson & Ferguson, Sydney
5
0