BEECHAM GROUP LIMITED

[1984] APO 6

In the Matter of the Patents Act 1952

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In the Matter of Patent Application No. 52638/79 for Letters Patent in the Name of BEECHAM GROUP LIMITED

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In the Matter of Examiner's Objections thereto.

DECISION OF A SUPERVISING EXAMINER OF PATENTS:
         This matter concerns an application for a patent entitled "MEDICAMENT CONTAINER" lodged on 8 November, 1979.  Examination in accordance with section 52C was first requested but following an adverse examiner's report, the request for modified examination was withdrawn and examination under section 48 requested and undertaken.  Despite proposed amendments having been lodged, the examiner in the most recent report dated 25 November, 1983 has maintained objections raised in earlier reports, namely that the application is not in respect of a manner of new manufacture and that the invention claimed is not novel.  The applicant requested a hearing which took place in Melbourne on 15 February, 1984 with Mr. J. Slattery, patent attorney, of Davies & Collison appearing on behalf of the applicant.
         The proposed amended specification commences by stating that the "invention relates to a blister pack holding dosage units for the relief of symptoms common to respiratory tract disorders", disorders including coughs, colds, etc.  The specification continues:

"Existing methods of treatment of these symptoms generally use a single type of phramaceutical formulation which provides 24‑hour relief.  When, as is often the case, a sedative action is desired at night, such a single formulation regime contain‑

ing a sedative entails obvious disadvantages during the day.

It is an object of this invention to overcome these dis‑

advantages in a simple and cheap manner."

Then follows a consistory statement in terms identical to claim 1.
         There are six claims included in the proposed amended specification and they read as follows:

"1.A blister pack which contains two dosage units which are symptomatic treatments for respiratory tract disorders, said pack comprising two labelled sets of blisters, one set of blisters containing non‑sedative dosage units labelled for day‑time administration and the other set of blisters containing sedative dosage units labelled for night‑time administration, the day‑time dosage units being visually distinct from the night‑time units.

2.A blister pack according to claim 1, wherein the dosage units are soft gelatin capsules.

3.A method of treating a patient suffering from respiratory tract infections, which comprises administering to the patient during the day‑time at least one dosage unit of a non‑sedative composition for symptomatic treatment of respiratory tract disorders in combination with administering during the night‑

time at least one dosage unit of a sedative composition for symptomatic treatment of respiratory tract disorders, said non‑sedative composition being administered only during the day‑time and said sedative composition being administered only during the night‑time.

4.The method according to claim 3, wherein said non‑sedative composition comprises an antitussive and a decongestant.

5.The method according to claim 3, wherein said sedative composition comprises an antitussive, a decongestant and an antihistamine.

6.A blister pack according to claim 1, substantially as hereinbefore described with reference to, and as illustrated in, the accompanying drawings."

The specification mentions that a sedative action according to the invention may be the desired sedative action of a sedative drug contained in the night‑time dosage unit, or may be the sedative side‑effect of a drug.
         One embodiment of the invention is described with reference to drawings.  Figure 1 illustrates a blister pack comprising an array of blister elements, each containing a dosage unit, on a rectangular base card.  The specification indicates that the blisters and pack construction are of conventional blister pack type.  The card shown in Figure 1 has an arrangement of 5 groups of 4 blisters, with the 5 groups being headed with the titles "DAY 1" up to "DAY 5", and with 3 blisters within each group being additionally labelled "DAY" and the other "NIGHT".  The description calls this labelling of the groups and blisters a "time chart".  An area on the card outside the time chart is identified as available for "printed administration instructions".  Contained within the blisters labelled "DAY" and "NIGHT" are dosage units of non‑sedative and sedative compositions respectively.
         The description mentions alternative arrangements for the blister pack shown in the drawings.  For example the "administration instructions" may be "written or printed on a separate surface such as a sheet of paper, or on a label attached to the pack".  Additionally the array of blisters can be varied (both in geometric configuration and in blister number) to suit the particular treatment regime required.  The specification also envisages the complete omission of the time chart from the pack but then the dosage units of the different types must have a "visible distinguishing feature".
         With regard to the dosage units, the description mentions that these can be in the form of tablets, pills, dragees, lozenges or capsules.  As regards to the active agents making up the compositions of the dosage units the description states as follows:

"A suitable non‑sedative composition for use in the dosage units comprises an antitussive and a decongestant.

A suitable sedative composition for use in the dosage units comprises an antitussive, a decongestant and an antihistamine. Preferably the antitussive and decongestant are the same as those in the non‑sedative dosage unit.

Suitably antitussives include codeine, pholcodine and their pharmaceutically acceptable salts, and the like.

Suitably decongestants include phenylpropanolamine and its pharmaceutically acceptable salts such as the hydrochloride.

Suitable antihistamines include promethazine and its pharmaceutically acceptable salts such as the hydrochloride."

The specification makes no suggestion that the compositions specifically mentioned are novel compositions in treating respiratory tract disorders.  In fact reference to authoritative publications in the pharmaceutical field, such as 'MARTINDALE, The Extra Pharmacopoeia' (The Pharmaceutical Press, London; 27th Ed.) reveals that the antitussive and decongestant compounds mentioned are acknowledged as suitable compounds for the treatment of various respiratory tract disorders and that antihistamines such as those mentioned are known to produce a sedative effect.  Consequently I am satisfied that sedative and non‑sedative formulations for the symptomatic treatment of respiratory tract disorders were well known prior to the priority date of the present application.
         In relation to the present application and complete specification as proposed to be amended, the Examiner has maintained objections that the application is not in respect of a manner of new manufacture, and that the claims lack novelty having regard to the disclosures in Australian Patent Specifications Nos. 416690, 455879 and 27795/71.
         Referring firstly to claim 1, this claim is directed to a blister pack comprising two differently labelled sets of blisters, with the sets of blisters containing different dosage units, the different dosage units being visually distinct.  The only characterisation of the pack by construction is that it is provided with two sets of blisters.  The other characterisations of the pack involve its contents and labelling.  It is noted for instance that the claim includes no characterisation of the relative positioning or layout of the sets of blisters or any other characterisation relevant to the pack construction or assembly.
         Blister packs for the packaging of various items particularly pharmaceutical tablets or pills, have been known for some considerable time prior to the present invention as reference to widely circulated publications such as the "Modern Packaging" journals reveal (present publishers of "Modern Packaging" : Morgan‑Grampian Publishing Co.).  In fact the Australian Patent Specifications cited by the Examiner disclose packaging items, now commonly identified as blister packs, as early as 1966.  In my view, in the absence of any novel constructional feature being possessed by the pack, the mere containing of different treatment dosage units in respective blisters of such a pack cannot provide novelty to what is otherwise a known blister pack.  Nor can the mere labelling of the sets of blisters identifying the contents of those blisters import any novelty to the pack claimed.
         At the hearing, Mr. Slattery submitted that the totality of what is claimed, as distinct from individual features, needed to be taken into account when considering its novelty and patentability.  He further submitted that when thus considered, an interaction between the pack, its specific contents and the labelling was present which interaction contributed both to the novelty and patentability of the invention claimed.  I cannot agree that there is any such interaction as suggested by Mr. Slattery.
         The blister pack defined simply contains two known types of dosage formulations, albeit in two labelled sets.  The labelling in the present case merely distinguishes one set of blisters and its contents from the other set and its contents by indicating different time of day administration of the dosage units contained in these blisters.  Such labelling therefore simply provides some directions to a potential patient wishing to administer dosage units from the pack.  I am unable to agree that this constitutes an inter‑
action with the pack and its contents so as to provide novelty to the claim (see Wellcome Foundation Ltd. v. Commissioner of Patents 30 ALR 510). Without that interaction, novelty of the blister pack defined containing two known different types of treatment units has to be assessed against the background of the known existence of blister packs prior to the present invention, and the commonplace packaging of different types of treatment units in separate boxes, packages or blister packs. In my view the inclusion of two or more different and visually distinct tablets (treatment or dosage units) in the one blister pack makes no substantial contribution to the working of the thing as a blister pack and hence, in the patent sense, is not a novelty conferring factor relevant to that pack.
         In summary, I consider the blister pack of claim 1 to lack novelty.  Additionally, following similar considerations to those discussed in respect of novelty, I also consider that the invention of claim 1 is not in respect of a manner of new manufacture.
         Turning now to claim 3.  This claim is directed to a "method of treating a patient suffering from respiratory tract infections" and, briefly stated, comprises:

(a)administering to the patient at least one dosage unit of a non‑sedative composition only during the day‑time, together with

(b)administering to the patient at least one dosage unit of a sedative composition only during the night‑time.

(The respective compositions are for symptomatic treatment of respiratory tract disorders).  As both sedative and non‑sedative compositions for the treatment of respiratory tract disorders are known, the method defined is no more than a prescription in respect of taking dosage units of such known compositions.  It is necessary to consider whether a method containing the steps as indicated is novel and can come under patent protection.
         In my opinion the method of claim 3 lacks novelty.  Many treatment compositions (sedative and non‑sedative types) have been available to persons wishing to provide treatment of respiratory tract disorders, and it is not uncommon for persons to be administered or to administer to themselves more than one type of treatment composition per day.  Also it is usual for sedative‑type compositions to be administered to a patient to correspond with that patient's sleep period, which for most of the public is at night.  Viewed against such knowledge and known practices, I fail to see that a method of treatment as here defined, which involves a combination treatment of non‑
sedative and sedative compositions administered only at day and at night respectively, involves any inventive step so as to confer novelty to that method.
         Apart from the question of novelty, I consider that the method claimed is not entitled to receive patent protection.  A patent which would seek to prevent people from eating or swallowing something known, be it cold or cough tablets or vitamin tablets, would clearly be "generally inconvenient" to the public and outside the scope of section six of the Statute of Monopolies.  This aspect is one which was briefly considered by Barwick C.J. in the decision in Bernhardt Joos' Application (1972) 42 AOJP 3431, and by the Hearing Officer in the decision in N.V. Organon's Application (1974) 44 AOJP 4503 when discussing some aspects of patentability of medical treatment.  The present method claim seeks a patent monopoly for a method of administering dosage units of known compositions in a certain sequence.  Accordingly, if a patent were granted, the public would be prevented from administering such known compositions in a certain manner even though previously they had been free to administer these compositions as was sought fit.  In my view, such a patent monopoly would therefore be "generally inconvenient" to the public.  Consequently, I consider the method claim is not patentable subject matter.
         I have come to the conclusion that there are lawful grounds of objection to the application and complete specification, and that no further amendments to the specification are possible to overcome those grounds of objection.  Accordingly under the provisions of section 52, I refuse to accept the application and complete specification.

(T.R. BRUHN)