PRE JAY HOLDINGS LTD and WOCO INVESTMENTS LTD
[2001] APO 18
•24 April 2001
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Patent: No. 582540 in the name of PRE JAY HOLDINGS LIMITED and WOCO INVESTMENTS LTD
Title: A Method of Hormonal Treatment of Perimenopausal, Menopausal and Post-menopausal Disorders and Multi-preparation Pack therefor.
Action: Application for an extension of term of a pharmaceutical patent under section 70 of the Patents Act.
Decision: Issued .
Abstract
It was found that the pharmaceutical substance, PREMIA 2.5 CONTINUOUS, per se was in substance disclosed in the complete specification. However, all the claims are to methods of treatment and it was found that the 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 582540 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. 582540 by Pre Jay Holdings Limited and Woco Investments Ltd and an application under section 70 of the Patents Act for an extension of term of a patent relating to pharmaceutical substances
BACKGROUND
This decision concerns an application filed on 27 July 1999 by Pre Jay Holdings Limited and Woco Investments Ltd (hereafter referred to as "the patentee") for an extension of term of their patent number 582540. The patent was granted on 28 July 1989 and its 20 year term is due to expire on 1 August 2004.
The information supplied with the application for extension of term indicated that goods containing the substance PREMIA 5 were listed on the Australian Register of Therapeutic Goods (ARTG) but no certificate of registration was provided. The first regulatory approval date for this product was given as 12 June 1997. Subsequently, the patentee realised that the section 70 application had been based on the wrong product and that the correct product should have been PREMIA 2.5, which also has a first regulatory approval date of 12 June 1997. A second section 70 application, accompanied by the certificate of registration for PREMIA 2.5, was then made on 24 December 1999. In order to comply with the timing requirements set out in section 71(2), the patentee applied for, and was granted, an extension of time under section 223 for making the section 70 application.
An examiner's notice of deficiency on the second section 70 application was issued on 6 July 2000 in which the examiner indicated that the application does not comply with the requirements of section 70(2). Following further correspondence between the examiner and the patentee's attorney, the matter was set for hearing. The patentee chose not to appear but instead relied on 2 pages of written submissions dated 26 February 2001 from their patent attorney, Mr David Gibson from Freehills Carter Smith Beadle.
THE SPECIFICATION
The specification describes the invention as relating to a method of hormonal treatment for menopausal (including perimenopausal and post-menopausal) disorders in women and, particularly, a treatment involving the continuous administration of a progestogen in conjunction with an estrogen. The specification ends with 24 claims, all of which define a method of hormonally treating perimenopausal, menopausal or post-menopausal disorders in women. The claims of interest are:
The method of claim 14 or 15 wherein said estrogen is a synthetic estrogen.
A method of hormonally treating menopausal or post-menopausal disorders in a woman, comprising administering to said woman continuously and uninterruptedly both progestogen and estrogen in daily dosage units of progestogen equivalent to laevo-norgestrel dosages of from about 0.025mg to 0.05mg and of estrogen equivalent to estradiol dosages of about 0.5mg to 1.0mg.
A method of hormonally treating perimenopausal, menopausal or post-menopausal disorders in a woman, comprising:
A. continuously and uninterruptedly administering a progestogen to said woman in daily dosage units of progestogen equivalent to laevo-norgestrel dosages of from about 0.025mg to 0.075mg, and
B. cyclically administering an estrogen to said woman by repetitively using a dosage regimen comprising:
i) administering said estrogen continuously for a period of time between about 20 and 120 days in daily dosage units of estrogen equivalent to estradiol dosages of from about 0.005mg to 2mg, followed by
ii) terminating administering said estrogen for a period of time between about 3 and 7 days.
All other claims are dependent on these claims and all clearly define methods of treatment. I note in passing that claim 1 is unusual in that it is not an independent claim but is dependent on claim 14 or 15.
DECISION
As indicated in the examiner's letter to the patentee dated 12 January 2001, the six month time period specified in regulation 6.11(3) had expired without the examiner being satisfied that the requirements of section 70(2) had been met. I am satisfied that all other requirements of sections 70 and 71 have been complied with and so do not need to give those any further consideration. Section 70(2) provides that:
"(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."
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."
Section 70(2)(b) is concerned with a pharmaceutical substance "when produced by a process that involves the use of recombinant DNA technology". There is no suggestion that the pharmaceutical substance in this case is produced by recombinant DNA technology and so I need give no consideration to the requirements of section 70(2)(b), as this is not relevant here.
Thus, the two key issues that I need to determine are those given in section 70(2)(a). That is, whether a pharmaceutical substance per se is in substance disclosed in the specification and whether a pharmaceutical substance per se in substance falls within the scope of the claims or claims.
Patent 582540 is directed towards the combined use of an estrogen and a progestogen to treat menopausal disorders. The certificate of registration relates to the product PREMIA 2.5 CONTINUOUS, which Mr Gibson identifies as a combined dose of 2.5mg medroxyprogesterone acetate and 0.625mg oestrogen-conjugate. This product is listed on the Australian Register of Therapeutic Goods (ARTG) and appears to be a tablet comprising a combined dosage of the two hormones. Thus, I believe that PREMIA 2.5 CONTINUOUS is the pharmaceutical substance.
Mr Gibson indicates in his submissions that PREMIA 2.5 CONTINUOUS is disclosed in the specification. I note that table 1A on page 8 shows preferred dosages, minimum unit dosages and maximum unit dosages for the estrogen component and table 1B on page 9 shows the corresponding information for the progestogen. I am satisfied that these tables disclose that both medroxyprogesterone acetate and oestrogen-conjugate may be used in the invention and that the amounts of each in PREMIA 2.5 CONTINUOUS fall within the ranges indicated in the tables. Lines 16 to 35 on page 12 of the specification list especially preferred combinations of estrogens and progestogens, with the very last line on page 12 indicating the combination of conjugated equine estrogen with medroxyprogerterone acetate. Thus, I am satisfied that PREMIA 2.5 CONTINUOUS is disclosed in the complete specification but I need to consider whether this substance per se is disclosed.
The meaning of the term "pharmaceutical substance per se" was discussed in my decision in relation to the request by Boehringer Ingelheim International GmbH for an extension of term of patent 530174, see 49 IPR 505. This decision was appealed to the Federal Court and the appeal dismissed by Heerey J (Boehringer Ingelehim International v Commissioner of Patents [2000] FCA 1918). However, Justice Heerey's decision has now been appealed to the Full Bench of the Federal Court. Since the Full Bench has not yet heard this matter, I think it appropriate to take guidance from Justice Heerey's decision.
Heerey J agreed that the words "per se" "have an accepted meaning as an expression in English, namely "by or in itself", "intrinsically" or "essentially" (Macquarie , new Shorter Oxford)" and he rejected the patentee's submission that the words "per se" confer no special or different meaning on the expression "pharmaceutical substance".
With regard to patent 582540, I am satisfied that the pharmaceutical substance (PREMIA 2.5 CONTINUOUS) per se is in substance disclosed in the complete specification. Although the invention is directed to the use of PREMIA 2.5 CONTINUOUS, I believe that there is disclosure in the specification of the pharmaceutical substance by itself.
The next consideration I must give is whether PREMIA 2.5 CONTINUOUS in substance falls within the scope of the claims. Further on in his decision, Heerey J states:
"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 s70 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."
Thus, it seems clear to me from this decision that Heerey J is saying that section 70(2)(a) is only available to extend the term of a patent when there is at least one claim to a pharmaceutical substance by itself, which is unqualified by process or method components. The intent of the legislation is only to provide an extension of term for a patent in certain circumstances and that such an extension is not available in relation to method claims.
As noted above, patent 582540 has 24 claims, all of which are method claims. There are no claims to a pharmaceutical substance per se and the patentee has not disputed this. Mr Gibson submitted that there is no requirement in the Act that there must be a claim to a pharmaceutical substance per se, only that a pharmaceutical substance per se must in substance fall within the scope of the claim or claims of the specification. However, in light of the above I must disagree.
Mr Gibson also made the following comments in his submissions in regard to section 70(2)(a):
"The phrase "in substance falls within the scope" has been interpreted in the context of amendments in the Distillers Co Ltd's Application (1953) 70 RPC 221 at page 223 as meaning whether the amendment would make "anything an infringement which would not have been an infringement before the amendment".
In most cases of claims for pharmaceutical substances being directed towards a particular medical use the pharmaceutical substance is not new and has been disclosed for some other medical use. These usual method claims are directed towards second and subsequent medical use. In these usual circumstances the sale of the pharmaceutical substance for the first medical use would not be an infringement of a claim for the method of use for the second and subsequent medical treatment. Accordingly, the pharmaceutical substance per se would not is [sic] substance fall within the scope of the second or subsequent medical use claim as its sale would not necessarily amount to infringement of that claim. Ordinarily for a pharmaceutical substance per se to be an infringement of patent claim it would be necessary for that claim to be unqualified by process, temporal or environmental components.
We submit that the pharmaceutical substance per se in the present case does not fall into the ordinary category. There have been no products registered with the ARTG for these two active ingredients at the stated dosage levels other than PREMIA 2.5 CONTINUOUS. As set out in the Distillers' case, the critical issue is whether sale of a pharmaceutical product having the two active ingredients at the defined dosage rates would infringe one or more of the method claims of the present patent. In Australia sale/use of pharmaceutical products is rigorously controlled by the TGA and the only pharmaceutical sale allowed with those two active ingredients at the defined levels is PREMIA 2.5 CONTINUOUS. As submitted in our response of 25 August 2000, the sale of PREMIA 2.5 CONTINUOUS would infringe one or more of claims 3, 4, 5, 14, 16, 17 and 23. In these special circumstances we submit that the pharmaceutical substance in the present case does in substance fall within the scope of the claims of the patent."
Although the test in Distillers (supra) was applied to the allowability of amendments under section 102(2), the wording of section 70(2)(a) is very similar to that of section 102(2). Although this is not the test used by Heerey J in his decision, it would seem to be relevant to the consideration of whether the pharmaceutical substance per se in substance falls within the scope of the claims. The Distillers test is referred to in section 25.2.4 of the patent Office Manual of Practice and Procedure, Volume 3, in this context and this section was quoted by Heerey J in his decision. He states that he found the material in the Manual to be of assistance and that it "can be used in the same way as counsel's submissions or text books or articles in learned journals."
Having said that, I do not agree with the way Mr Gibson has applied this test to the current claims. The test has always been an academic question concerned with whether an infringement could theoretically occur, not whether it has occurred. I believe that to correctly apply the test in the context of pharmaceutical extensions of term, I need to determine whether a hypothetical amendment resulting in claims to the pharmaceutical substance per se could make anything an infringement that could not have infringed the current claims. The present claims of the patent are all directed to one method of treatment. However, a claim to PREMIA 2.5 CONTINUOUS per se would include the substance itself as well as all methods of use of that substance. Clearly, such an amendment would fail the Distillers test.
Consequently, I do not believe that the request for extension of term of patent 582540 satisfies the requirements of section 70(2)(a) since the pharmaceutical substance per se does not in substance fall within the scope of the claim or claims of the specification.
CONCLUSION
In conclusion, I find that the pharmaceutical substance (PREMIA 2.5 CONTINUOUS) per se does not fall within the scope of the claims of the complete specification and thus fails to satisfy section 70(2)(a). As a result, I must refuse the section 70 request for extension of term of the patent under the provisions of section 74(3).
Gillian Jenkins
Delegate of the Commissioner of Patents
Patent attorneys for the patentee : Freehills Carter Smith Beadle, Melbourne
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