SCHERING AKTIENGESELLSCHAFT

[1990] APO 1

In the Matter of the Patents Act 1952

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In the Matter of Patent Application No. 48275/85 in the Name of SCHERING AKTIENGESELLSCHAFT

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In the Matter of Examiner's Objections thereto and a Request under Regulation 19D.

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS:
Background
         Application No. 48275/85, which was lodged on 1 October 1985 in the name of Schering Aktiengesellschaft is entitled "Antigestagens, Glucocorticoids and Prostaglandins for Induction of Labour or for Termination of Pregnancy".  The examiner has maintained an objection that proposed claims 37 to 49 were directed to a mere collocation of known integers which do not have a have working interrelationship to produce a new or improved result, even though a number of proposed amendments have been lodged.  Thus the applicant's attorney, Mr G.H. Gordon of Arthur S. Cave & Co, requested a decision upon the written record relating to this objection.
Specification
         The specification, as presently proposed to be amended relates to a combination product for use in induction of labour or termination of pregnancy.

The specification states that it is known to use prostaglandins or antigestagens alone to either induce labour or terminate pregnancy however there are a number of major disadvantages in using either of these chemicals alone.  The specification also states that it is known that many of these disadvantages can be avoided by joint use of a prostaglandin and a antigestagen.  The specification goes on to state that it has now been found that a further increase in the success rate can be surprisingly achieved by administration of a glucocorticoid in addition to the prostaglandin and antigestagen.  A statement on page 2 of the specifications reads as follows:

"With this three‑component product comprising a prostaglandin, antigestagen and glucocorticoid, means is available for therapeutic termination of pregnancy or induction of labour with the highest rates of success, e.g. in mammals including humans.  It permits methods of treatment that can be better standardized and which facilitate clinical application.

.....

The antigestagen and glucorticoid are preferably used separately and simultaneously and/or chronologically staggered (sequentially).  The prostaglandin, antigestagen and glucocorticoid can also be used together in one dosage unit."

The specification states that the amounts of prostaglandin and antigestagen used in the present application are generally lower than the amounts customary for termination of pregnancy.  The antigestagen and glucocorticoid can be applied locally, topically enterally or parenterally.  The specification on page 6, lines 11 to 16 states as follows:

"Joint treatment with prostaglandin, antigestagen and glucocorticoid usually takes place for 1 to 4 days, preferably 1 to 2 days, it being possible to apply antigestagen and glucocorticoid preferably separately and simultaneously or chronologically staggered (sequential) with antigestagen and glucocorticoid."

It seems to me that this statement is in error as it appears that the word "(sequential)" should be followed by a reference to a prostaglandin.  The three active ingredients can also be applied in combination in one unit dose.
         Then follows a description of a number of formulation examples.
         The specification as proposed to be amended includes 49 claims, however only claims 37 to 49 are relevant to this decision.  Claim 37 reads as follows:

"37.A pharmaceutical preparation for inducing abortion or labour in a pregnant subject comprising a labour or abortion inducing prostaglandin, a labour or abortion inducing antigestagen and a glucocorticoid, wherein at least one of the prostaglandin, antigestation and glucocorticoid are contained in separate dosage units, and wherein the total amount (sic) of the combination of the prostaglandin, the antigestagen and the glucocorticoid is effective to induce labour or an abortion."

Claims 38 to 49 are appended to claim 37 and only further define features of claim 37 thus I will restrict my comments to claim 37 while at the same time recognising that these comments also apply to claims 38 to 49.
Objection and Submissions
         The examiner's reports argue that claims 37 to 49, and earlier versions of these claims on which the present claims are based, are directed to a mere collocation of known integers and thus do not constitute a manner of new manufacture within the meaning of the Act.  The examiner also referred to the decision of the hearing officer in the National Research Development Corporation case (Re Application by National Research Development Corporation 11 IPR 666).
         The attorney's written submissions include arguments which can be summarised as follows:

1.The words "effective to induce labour or an abortion" in claim 37 mean the amounts of each substance, and hence also, the number of separate dosage units present in the pharmaceutical preparation must be carefully selected to fulfil this requirement.  This is an actual working interrelationship between the components present in the pharmaceutical preparation.

2.The form the pharmaceutical preparation would take is the form commonly used in the art, such as a blister pack.  The case law relied on by the examiner relates to glues and assay kits, and in this prior art, the amounts in which the components are presented is not critical to the performance of the invention.  In the pharmaceutical art the selection of specific dosage units for treating a patient is critical to the performance of the invention.  By bringing together the three essential ingredients in the correct amounts to induce labour or abortion the applicants have made an invention, whether the ingredients are combined in a single capsule or are in separate dosage units in a blister pack.

3.The definition of "manner of new manufacture" given by the High Court in the NRDC case (National Research Development Corporation v Commissioner of Patners 102 CLR 252) refers to an artificially created state of affairs providing economic utility. The present claims 37 to 49 define an artificially created state of affairs as there is nothing "natural" in bringing three components together in a pharmaceutical preparation provided that the total amount is effective for inducing labour or abortion.

The attorney also suggested that if claim 37 was found to be unpatentable that consideration be given to a new version of the claim in which the words "at least" were deleted from line 4 of the present text.  The attorney also requested that consideration be given to a second version of claim 37 which commences "A blister pack containing ..." and continues with the present text of claim 37.
Decision
         The pharmaceutical preparation which is defined in claim 37 and appended claims is patentable if the packaging of the preparation is novel or if the preparation includes a novel chemical or a novel composition or if the preparation includes patentable subject matter.  The present specification does not disclose that the packaging of the preparation is novel and the attorney's submissions in this regard refer to knowledge in the art, e.g. blister packs.  The present specification admits that the prostaglandin, the antigestagen and the glucocorticoid are all known compounds.  However claim 37 and appended claims also include within their scope a pharmaceutical preparation in which any two of the components are combined in one dosage unit and the remaining component is in another dosage unit.
         The paragraph which bridges pages 1a and 2 of the present specification admits that a prostaglandin and an antigestagen can be used jointly for termination of pregnancy.  The Australian patent corresponding to this reference (patent No. 572569) is in the name of the present applicant and describes a composition containing both these components.  Australian patent No. 550334, which was published in Australia before the present priority date corresponds to the reference in the present specification at page 4a, line 26.  This Australian patent describes a combination of an antigestagen and a glucocorticoid wherein the antigestagen is used to control the side effects of the glucocorticoid.  A search report, compiled by the European Patent Office in respect of the application which corresponds to the present application, cites EP application No. 82201569 which was published in Australia before the present priority date.  This application relates to a medicine having transplant rejection and/or immunological inflammation inhibiting activities and comprises a combination of a prostaglandin and an immunosuppressive drug such as a corticosteroid.  I note from US patent No. 4452794, which corresponds to this European patent application, that the term "corticosteroid" describes the same compounds as the term "glucocorticoid".  I do not propose to analyse these specifications in detail to determine if they describe labour or abortion inducing prostaglandins and antigestagens as defined in claim 37, because, in my view, the present specification describes all three components of the pharmaceutical preparation as essential features of the invention.  Consequently the pharmaceutical preparation which is defined in claim 37 and appended claims will only be patentable if the assembly of separate dosage units constitutes patentable subject matter.
         Turning to the first point in the attorney's written submissions I think the words "effective to induce labour or an abortion" in claim 37 merely specifies the minimum amount of the ingredients and not the maximum amount.  For example the preparation may be effective at inducing labour or abortion with 1mg or 100g of a particular prostaglandin however the latter preparation may have other undesirable side effects.  However, even if the claims were redrafted to specify that the preparation contained just a sufficient amount of all the components to induce labour or an abortion, I do not think that this would be adequate in itself to imply that the separated components of the pharmaceutical preparation have an actual working interrelationship (British Celanese Ltd v Courtaulds Ltd 52 RPC 17) because the actual working interrelationship only takes place when all the components of the preparation are present in the body of the patient in which labour or abortion is being induced. However the separated components of the pharmaceutical preparation which is defined in claim 37 may have a potential working interrelationship (Cobianchi's Application 1953 RPC 199 at page 200).
         The potential working interrelationship between a collection of separated chemical compositions, which have been assembled so that the collection may be conveniently used in the performance of a new method, has been considered in two recent Office decisions, namely the National Research Development case to which the examiner referred, as well as the Bristol‑Myers case (Bristol‑Myers Co v L'Oreal 12 IPR 275). However the attorney in his submissions attempts to distinguish the present situation from those considered in these, and other earlier decisions of this Office, on the basis that the present claims refer to compositions for use in a pharmaceutical treatment of a patient and such treatment requires specific amounts of the active ingredients in each separate dosage unit.
         I think it is apparent that the specific form and quantity in which each chemical composition appears in a collection of separate chemical compositions assembled with a particular use in mind, depends upon that end use.  Thus, in my view, the particular form and quantity of the separate chemical compositions is irrelevant to the basic question, which is, is the collection of separate chemical compositions limited to the inventive concept?  I consider that the separate chemical compositions will have a potential working interrelationship if they are limited to the inventive concept.
         It seems to me that the inventive concept of the present invention is the introduction into the body of a patient a prostaglandin, an antigestagen and a glucocorticoid, either jointly or chronologically staggered in order to induce labour or an abortion.
         The applicant intends the pharmaceutical preparation, which is defined in claim 37 to be used in a single patient to induce labour or an abortion.  However it seems to me that this claim does not include a physical construction which ensures that in normal use the separate dosage units are applied to a single patient (Blendax‑Werke's Application 1980 RPC 491 at page 506). The blister packs which are mentioned in the second point in the attorney's submissions and which are also well known in the art do not include a physical construction which ensures that in normal use the separate dosage units are applied to the same patient.
         The applicants intended use may be described on written instructions associated with the pharmaceutical preparation but the High Court decided that the association of written instructions with a chemical composition in a container was not patentable subject matter unless there was novelty in the container or the chemical composition (Wellcome Foundation Ltd v Commissioner of Patents 30 ALR 510). In any event I think the skilled person would realise that the separate dosage units may be used according to the novel method of inducing labour or an abortion which is described in the present specification or may be used in an entirely different manner.
         Claim 37 contains a limitation on the total amount of the combination of the components of the pharmaceutical preparation, however I think the skilled person would have no difficulty in applying the dosage units from the preparation to a different use because this person would understand that this use may require more or less than one dosage unit from the preparation.  For example more than one dosage unit of prostaglandin from the preparation may be required if the prostaglandin is being used by itself, in the amounts customary in the prior art for termination of pregnancy. The unit dosages from the preparation which comprises each component in a separate dosage unit may be used in any of the prior art methods in which the compounds have been used.  For example the present specification admits that prostaglandins can be used alone to induce labour or an abortion whilst glucocorticoids are known as immunosuppresive drugs.  Similarly the use of a pharmaceutical preparation which comprises any two of the components combined in a separate dosage unit with the remaining component in another separate dosage unit, is not confined to the present method.  For example a pharmaceutical preparation consisting of a prostaglandin and an antigestagen in one dosage unit may be used according to the method described in AU patent No. 572569, and the glucocorticoid in the separate dosage unit may be used as an immunosuppressive drug.   It seems to me a similar argument applies to each preparation in which two of the components are combined in a single dosage unit.  Consequently I am satisfied that the pharmaceutical preparation which is defined in claim 37 and appended claims is not restricted to the novel method of inducing labour or an abortion as described in the present specification.
               The third point of the attorney's submissions draws attention to the definition of "manner of new manufacture" given in the NRDC case before the High Court (supra) which states that patentability was related to an artificially created state of affairs providing economic utility.  In relation to this argument I note that the High Court in Gum v Stevens ((1924) 33 CLR 267 at 270), agreed with the view expressed in the earlier decision of Tatham v Dania ((1869) Griffin's Patent Cases 213) that for an invention it is not necessary to merely show newness in the sense of doing a thing which has not been done before but it is necessary to show newness in the shape of novelty by producing a thing which requires some exertion of mind that could properly be called invention.  The assembly of a number of known chemicals, each in a separate dosage unit may be convenient for the performance of the novel method of inducing labour or an abortion but, in my opinion, does not require an exertion of the mind that could properly be called invention.
         Thus I consider that the pharmaceutical preparation which is defined in claim 37 and appended claims is not limited to the present inventive concept.  Consequently the separate dosage units, which are defined in claim 37 and appended claims, do not in my view, possess a potential working interrelationship more than any other collection of separate dosage units.  Therefore I am satisfied that claim 37 and appended claims are not directed to patentable subject matter.
         In my view this is a reasonable conclusion because the High Court in the Wellcome Foundation case (supra at page 516) stated it is one thing to say that an inventor of a process is entitled to a monopoly in the product of that process but it is quite different to say that the inventor of a process is entitled to a monopoly in a substance which is used merely as an ingredient in that process.  In the latter case the invention claimed makes no contribution to the manufacture of the substance and merely takes advantage of properties in the substance hitherto unknown or unsuspected.
         Turning to the proposed versions of claim 37 suggested in the attorney's submissions I note that it should be apparent from my findings earlier in this decision that deletion of the words "at least" from the claim would not render the claimed subject matter patentable.
         The attorney also raised the possibility of amending claim 37 to read "A blister pack containing a pharmaceutical preparation ..." and it was his contention that, in view of the Organon case (Organon Laboratories Ltd's Application 1970 RPC 574) this claim should be allowed. I note that the Australian application which corresponds to that considered in the Organon case was refused because the pack lacked novelty ((1974) 44 AOJP 4503).  I note further that such an amendment may not be allowable under sub‑section 49(4) as there was no disclosure of a blister pack in the specification as lodged.  In any case I have stated earlier in this decision that known blister packs do not ensure that in normal use the separate dosage units are applied to the same patient.  Thus claim 37 in this form is not restricted to the present inventive concept and thus is not directed to patentable subject matter.
         I have found that claim 37 and appended claims are not directed to patentable subject matter consequently I am satisfied that there are still lawful grounds of objection to application No. 48275/85.  I afford the applicant an opportunity to lodge a statement of proposed amendments to my satisfaction within the time remaining for acceptance.

(M. KENDALL)