Laboratoires Prographarm v F.H.Faulding & Co Ltd

OFFICIAL NOTICE

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application: No. 666666 in the name of Laboratoires Prographarm

Title: Rapidly disintegratable multiparticulate tablet

Action: S.59 opposition by F.H. Faulding & Co. Ltd.

Decision: Issued .
Abstract:Opposition successful. Claims to a tablet per se not novel and lacked an inventive step in the light of the prior art (pp.15, 20)

Evidence insufficient to be considered for a whole-of-contents novelty objection. (p.9)
Claim 1 to a combination of known features, therefore not necessary that any one of the features be defined with absolute precision, as long as the combination is reasonably well defined. (p.7)
Experts' opinions considered to decide whether prior art tablets were "suitable for" disintegration rate claimed (p.12)
Methods of treatment of the human body: invention patentable and not considered to be "generally inconvenient" (p.22)

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 666666 by Laboratoires Prographarm and opposition under S.59 of the Patents Act 1990 by F.H. Faulding & Co. Ltd.

background

Application 666666 (AU 24171/92, WO 93/01805) for a patent for an invention entitled "rapidly disintegratable multiparticulate tablet" began as an international application filed on 21 July 1992, with priority claimed from an application filed in France on 22 July 1991. The application was advertised as accepted on 22 February 1996, a notice of opposition was filed on 20 May 1996 and the evidence stages were completed by 20 February 1998. Amendments were proposed to the specification on 3 December 1997, after the evidence-in-answer was served, and these were advertised as allowable on 18 June 1998.

The opposition was heard in Melbourne on 5 August 1998. The applicant was represented by Mr Barry Hess of Counsel and Ms Karen Sinclair, patent attorney, and the opponent was represented by Mr Glenn McGowan of Counsel and Mr Greg Bartlett, patent attorney. Ms Kathryn Harrison and Messrs Gustave Koch, Etienne Bruna and Edouard Gendrot were attending the hearing for the applicant and Ms Jennifer Potter and Mr David Hayes were attending for the opponent.

the specification

The specification indicates that the invention relates to a tablet which rapidly disintegrates in saliva in the mouth or "buccal cavity". The invention is defined by five claims, as proposed to be amended, claims 1-3 read as follows:

"1 Rapidly disintegratable non-effervescent multiparticulate tablet comprising an excipient and an active substance which are mixed with one another, the thus obtained mixture being then tabletted after addition of a lubricant, the said excipient which is selected from the group comprising one or several disintegrating agents and/or one or several swelling or soluble agents, being suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in the presence of saliva in less than sixty seconds, the said tablet being characterized by the fact that the active substance is present in the form of microcrystals or microgranules, said microcrystals or microgranules having an at least taste-masking coating.

2 Tablet according to claim 1, characterized by the fact that the mixture of excipients comprises one or several disintegrant agents of the carboxymethylcellulose or insoluble reticulated PVP type, one or several swelling agents of the starch, modified starch or microcrystalline cellulose type and possibly a direct compression sugar.
3 Tablet according to one of claims 1 or 2, characterized by the fact that it can be disintegrated in the mouth, in a glass of water or in liquid or semi-liquid food, as for example, in yoghourt, in connection with its use in the paediatric field, or in food for animals in connection with its use in the veterinary field".

Dependent claims 4 and 5 include details of active substances for which the invention is suitable.

The specification indicates that the applicant has found that it was possible, surprisingly, to introduce into a multiparticulate tablet with a high disintegration rate, the active substance in the form of coated microcrystals or microgranules. Such a tablet is not to be swallowed in its initial form but after disintegration in the buccal cavity; thus its size may be greater than that of a typical tablet. Other advantages of the invention are further described in the specification, eg. the tablets can be taken without water, say whilst walking.

grounds of opposition

The Statement of Grounds and Particulars alleges that the invention is not novel, is not a manner of new manufacture, does not involve an inventive step and does not comply with Section 40.

the evidence

The opponent's evidence-in-support is directed to the claims before amendment and is summarized as follows.

A declaration dated 17 February 1997 by Michael John Story and Exhibits MJS-1 to MJS-62.
Dr Story is an experienced consultant to the pharmaceutical industry. From 1973 to 1986 he was employed by F. H. Faulding, the opponent in this case, and from 1973 to 1991 he was mainly involved in tableting and pelleting technology. Dr Story alleges that the present specification is insufficient, and that the claims are not clear and not novel. In the part on "common general knowledge and obviousness" he discusses the common general knowledge in some depth but I note that he does not specifically allege that the invention as claimed lacks an inventive step.

In particular he declares:

That the clause "a disintegration rate such that the tablet disintegrates in the mouth in the presence of saliva in less than sixty seconds" is indefinite, because conditions in the mouth vary, depending on the amount of saliva, temperature, and whether the tablet is moved about in the mouth.
That disintegrating agents such as those referred to in the present specification are widely used in tableting technology.
That lubricants are widely used in tableting technology to prevent sticking in the die after compression, and that they have no positive affect on disintegratability.
That swelling agents are usually added to increase the viscosity of the aqueous media surrounding the tablet or disintegrated tablet particles.
That direct compression sugars, referred to in the present specification as swelling agents, are most often used in chewable tablets.
That standard procedures are exemplified in examples 1-5 in the present specification.
That typical ranges of compression forces are 5 to 30 kNewtons, which encompasses the range given in the examples in the present specification.
That the closest approximation of mouth conditions would be disintegration of the tablet in minimal liquid at 37°C.
That the effect of claim 3 on claim 1 is that the tablet may disintegrate under any condition providing it is capable of disintegration in the mouth in less than sixty seconds.

A declaration dated 19 February 1997 by William James Thiel and Exhibits WJT-1 to WJT-63.

Dr Thiel is a senior lecturer at the Victorian College of Pharmacy, Monash University. Pharmaceuticals and tablet formulation are amongst his principal areas of research. A considerable portion of his declaration is word-for-word identical to Dr Story's declaration. However, some parts are different; Dr Thiel gives more details relating to disintegration testing for example, but I note that Dr Thiel's declaration does not refer to the lists and summary table of citations in Dr Story's declaration.

In particular Dr Thiel declares:

That the use of the terms "disintegrating agent" and "swelling agent" in the present specification is confused.
That it is common knowledge that conventional oral tablets contain agents functioning as (1) diluent, (2) a binder or an adhesive, (3) disintegrant, and (4) a lubricant.
That "it would be more than mere trial and experimentation to hit on a composition providing the characteristics of rapid disintegration" of less than sixty seconds in the mouth.
That the pressure and hardness values given in the examples in the present specification fall within the ranges used to make ordinary tablets.
That disintegration rate is generally measured by a standard mesh-screen type disintegration apparatus such as that described in the British Pharmacopoeia 1980.

A declaration dated 14 February 1997 by Kerrie Setiawan and Exhibit KS-1.

Dr Setiawan is an experienced pharmacist and she currently works for the opponent in the area of tablet formulation. She declares that she attempted to manufacture tablets according to the present specification, but that she could not make a rapidly disintegratable tablet by following the instructions and examples in the specification.

A declaration dated 19 November 1996 by Debra Denise Yin-Foo.

This declaration relates to publication dates of some of the opponent's citations and other exhibits.

The applicant's evidence-in-answer is summarized as follows.

A declaration dated 18 November 1997 by Vivian Bruce Sunderland and Exhibits VBS-1 to VBS‑11.

Prof Sunderland is at the School of Pharmacy, Curtin University of Technology, WA. He is very experienced in the field of pharmacology and solid dosage forms. He declares that in his view the present invention is a novel product.

In particular, Prof Sunderland declares:

That the state of the prior art was that compression of microcapsules into tablets was believed to be impracticable, if not impossible, because compression leads to damage of the microcapsule wall. This also applied to taste-masking coatings and chewable tablets.
That compression of coated particles without significant breakdown of the coating material is one of the central features of the present invention, and this is why the advance made by the present invention can be considered inventive.
That Setiawan's compression apparatus would not exert even compression forces, that one of the active substances used in her tests was unsuitable, and that she did not indicate whether she used conventional sodium carboxymethylcellulose (NaCMC) or cross-linked (or low-substituted) NaCMC, the latter being a much more rapid disintegrant.
That in Setiawan's tests, great effort was taken to ensure that the tablets were undisturbed in the mouth, and that this may have contributed to the long disintegration times.

A declaration dated 19 November 1997 by Karen Joy Sinclair and Exhibits KJS-1 to KJS-8.

Ms Sinclair's declaration relates to prior art searches done by the applicant.

Declarations dated 27 May 1997 and 19 November 1997 by Etienne Bruna and Exhibits EB-1 and EB‑2.

Dr Bruna is one of the co-inventors of the present invention. He declares that prior to the invention, the only multiparticulate pharmaceutical oral dosage forms comprised:

hard gelatin capsules containing polymer coated particles of active substances,
freeze-dried oral dosage forms, ie. coated particles and excipients incorporated in a semi-liquid aqueous suspension, then freeze-dried in a blister pack ("Lyoc" types),
chewable multiparticulate tablets, and
swallowable multiparticulate tablets.

In each case the polymer coating permits a "modified action" of the active substance; modified actions including extended-release and delayed-release actions. He declares that delayed-release coatings are designed to prevent drug release in the upper part of the gastro-intestinal tract, and he distinguishes taste-masking coatings from gastro-resistant coatings by the latter being thicker coatings. He states:

"When the thickness of the coating films is just enough to mask the unpleasant taste of certain active ingredients while having a minimum effect upon the dissolution characteristics and thus upon the active ingredient, the effect is called ‘taste masking’"

Dr Bruna discusses the history and advantages of the invention in some depth, eg. he declares that the tablets made according to the invention no longer had the drawbacks of Lyoc or gelatin capsules, but maintained and even optimized the advantages of both.

Declarations dated 1 August 1997 and 12 November 1997 by Charles Chauveau.

Dr Chauveau is a director of a subsidiary company of the opponent, located in France. He has a long history of experience in the field of the invention.

Dr Chauveau sets out reasons why he considers Setiawan's experiments were unsatisfactory, he gives details of how he prepared tablets according to the present specification, and he discusses how tests were done with 23 healthy people to determine whether the tablets disintegrated in the mouth in less than sixty seconds. None of the test subjects reported a bitter taste in the mouth. The disintegration time was also measured using European standard conditions and apparatus, which included using water at 37°C.

A declaration dated 12 November 1997 by Eric Doelker and Exhibits ED-1 to ED-21.

Prof Doelker is with the University of Geneva, Switzerland. He has had considerable experience with pharmaceuticals and tableting technology. Doelker supports Chauveau's comments on Setiawan's tests and conclusions. He declares that the problem relates to the type of NaCMC used in the disintegrating agent. He declares that Setiawan most probably used a conventional NaCMC whereas Chauveau used a cross-linked NaCMC, and that a person skilled in the art would have used the cross-linked version.

A declaration dated 12 November 1997 by Edouard Gendrot and Exhibits EGS-1 to EG-7.

Mr Gendrot is a senior manager with the applicant, and one of the co-inventors of the present invention. He has had considerable on-the-job experience in the field of the invention. Mr Gendrot makes some point-by-point responses to the Story and Thiel declarations. He declares for example that conditions in the mouth do not vary as much as the opponent's experts suggest. He also supports many statements of the other declarants for the applicant.

The opponent's evidence-in-reply relates to the present form of the claims and is summarized as follows. The amendments proposed on 3 December 1997 introduced the features of a non-effervescent multiparticulate tablet, the tablet disintegrating in the mouth in the presence of saliva, and the coating on the microcrystals or microgranules being an at least taste-masking coating.

A declaration dated 16 February 1998 by Michael John Story and Exhibit MJS-66.

In this declaration Dr Story:

Further explains why he thinks it is impossible to place any meaningful and consistent interpretation on the clause "… such that the tablet disintegrates in the mouth in the presence of saliva in less than sixty seconds". He refers to parts in the Sunderland declaration which may support the view that the said clause is difficult to interpret.
Alleges that claim 1 is difficult to construe in the light of claim 3; eg. should the tablet also dissolve in a glass of water in less than sixty seconds?
Suggests that the specification and applicant's evidence is generally confusing in referring at times to disintegration on the tongue, but at other times to the buccal cavity, which is between the tongue and cheek.

He also declares:

That claim 1 does not exclude chewable tablets, that "disintegration" could include disintegration by mastication, and that some of the prior art defines chewing fairly broadly, eg. to include sucking.

That the problem of coating rupture during tableting had been addressed and overcome as early as the mid 1970's. He refers to a list of prior art documents which show that coating rupture was not a problem and most of which also discuss the use of excipients to hasten disintegration.
That taste-masking coatings in conjunction with tablet compression was well-known in Australia in July 1991, and that this aspect of the present invention was not inventive.
That the combination of features in claim 1 is disclosed in seven prior art patent documents, viz: exhibits MJS-8, MJS-9, MJS-28, MJS-32, MJS-33, MJS‑36 and MJS-37, and that the "result" feature of disintegrating in less than sixty seconds, is either implicitly or explicitly disclosed in these documents.
That the "result" feature of disintegrating in less than sixty seconds, is also disclosed in exhibits MJS‑7, MJS-9 and MJS-10.
That patent literature has always formed a large part of the relevant research literature in the pharmaceutical industry.

A declaration dated 13 February 1998 by William James Thiel and Exhibit WJT-67.

In this declaration Dr Thiel further discusses the present invention in the light of the prior art and the applicant's experts' declarations. His comments are generally similar to, if not word-for-word the same as, those made by Dr Story.

Dr Thiel declares that a skilled worker in the art in July 1991 would have readily understood that a polymer coating which encapsulates an active microparticle will be "an at least taste-masking" coating, and just because a prior art document does not say that about its coating, does not mean that the coating is not taste-masking. Dr Story makes a similar comment in his declaration.

A declaration dated 18 February 1998 by Kerrie Setiawan and Exhibit KS-2.

In this declaration Dr Setiawan comments on the applicant's evidence, particularly on Chauveau's declaration. She describes how she re-conducted her tests in the light of comments in the evidence-in-answer, this time using human assessors and ingredients similar to those used by Chauveau. She declares however that none of the tablets disintegrated in the mouth in less than 60 seconds.

Declarations by Gregory James Bartlett and Angela Joy Dawes, both with exhibits.

These declarations relate to availability, accession dates and other matters relating to the prior art exhibits in the opponent's evidence.

submissions

Both parties made comprehensive verbal submissions at the hearing, and provided me with written submissions; though Mr McGowan's written submissions were sent to me after the hearing. I will refer to the submissions where appropriate in the following paragraphs of my decision.

decision

S.40 AND CONSTRUCTION ISSUES

The opponents' evidence, and some of the applicants' evidence, suggests that the clause "suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in less than sixty seconds" relates to a feature of the invention which is relatively difficult to accurately define, because of possible variations in conditions in the mouth. The opponent has argued that the specification is insufficient and that claim 1 is not clear because of this rather subjective definition. The question of sufficiency is one of fact, and whether a specification is sufficient to disclose the method of carrying out the invention is a matter which can best be determined by receiving evidence from persons skilled in the art. See Universal Oil Products v Monsanto (1973) 46 ALJR 658.

There is a considerable amount of evidence from Setiawan and the opponent's other experts on this issue, but I find the applicant's experts' opinions to be reasonably convincing. For example, it seems likely that a person skilled in the art would try and select the cross-linked NaCMC, so this doesn't have to be spelled out in the specification. Several examples of tablet formulation have been set out in the specification, and, according to the applicant's experts, by applying a little common knowledge, these examples will produce tablets with the features of the invention. Also, Mr Hess suggested that the opponent's attack on sufficiency was concentrated on Example 1 in the description, whereas there are no problems with Examples 2-5. To me, the specification is sufficient in the light of the evidence provided by the applicant.

I will now consider whether the clause "suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in less than sixty seconds" is unclear. I agree that the scope of claim 1 is not as accurately defined as in some patent claims, since the said clause is somewhat indefinite in scope due to (i) the use of "suitable for" and (ii) the subjective nature of conditions in the mouth. However, in my view, it is not so inaccurate as to make the claim invalid, since the words and meaning per se are grammatically sound, and since the parties' experts seem to have been able to interpret the meaning of claim 1. Also, even though the tablet may be used in the veterinary field, it is clear from the specification in general and from the evidence that the "mouth" referred to in claim 1 is a human mouth. Thus I do not think the clause "suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in less than sixty seconds", as used in claim 1, is unclear.

The opponent submitted that the clause "suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in less than sixty seconds" is speculative, and that therefore claim 1 is not fairly based. I do not agree with this submission; although this clause is somewhat indefinite, I don't think it's too broad. It is a feature which is simply "claiming by result" which is a common method of drafting patent claims. Also, this feature does not seem to relate to a single improvement over the prior art; rather the specification indicates to me that the invention is a combination of known features. Thus it is not crucial for any one of these features to be defined with absolute precision, as long as the combination is reasonably well defined.

Another issue is whether there is any feature in claim 1 which imparts a monopoly on the use of the tablet, since the evidence and description of the invention suggest that some of the advantages of the invention lie in the manner of administration of the tablet, namely that it disintegrates in the mouth before swallowing.

It could be argued that one possible construction of claim 1, when read in the light of the description, may have an implied degree of monopoly of use inherent in the feature "suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in less than sixty seconds", the use being that the tablet disintegrates in the mouth. Another possible construction is that the claim is to a tablet per se with no element of use.

Any doubt in this matter can be resolved by reference to claim 3. Claim 3 specifies that the tablets of the invention can be disintegrated in a glass of water, or in some food. To me this indicates that the tablets do not have to be disintegrated in the mouth to be effective. Claim 3 is specifying the uses of the tablet of the present invention, and it is clear that the uses are not restricted to disintegrating in the mouth. Furthermore, the clause "can be disintegrated in the mouth" in claim 3 may not exclude chewing, which occurs in the mouth and which at least contributes to tablet disintegration. Thus the first possible construction of claim 1, discussed above, is negated by claim 3, and the proper construction of claim 1 is that it is directed only to the substance of the tablet, and that there is no fetter, either direct or implied, on the use of the tablet.

Another issue relating to claim 3 is whether it should be interpreted to mean that claim 1 should be broadened in scope to include tablets which disintegrate in a glass of water in less than sixty seconds, as suggested by the opponent. To me this is not a valid construction of the claims. I think the skilled addressee's interpretation would be that, notwithstanding the alternative methods of disintegrating the tablets in use set out in claim 3, the tablets per se still have to be able to disintegrate in the mouth in the presence of saliva in less than sixty seconds, according to claim 1.

In summary, I think the invention is fully described and the claims are clear.

Another matter to consider is whether the claims define the invention. I have indicated that the evidence and description of the invention suggest that some of the advantages of the invention lie in the manner of administration of the tablet, namely that it is retained in the mouth whilst disintegrating and before swallowing; eg. lines 34 and 35 on page 5 of the specification read: "said tablet is not to be swallowed under its initial form but after disintegration within the buccal cavity …". A tablet made according to the invention was demonstrated to me at the hearing; the demonstration included emphasis on retaining the tablet in the mouth until it dissolved. Thus it could be argued that there is a feature in the concept of the present invention which relates to its use.

If this feature is an essential feature it should be included in the claims. However, there is some doubt in the matter: claim 1 is directed to a tablet, not to a method of administration, and presumably that is the intention of the applicant. I am prepared to resolve this matter in the applicant's favour and decide that there is no objection under S.40. (However, if this use feature proves to be a feature which distinguishes the invention from the prior art then it may be appropriate for the applicant to re-define its invention).

NOVELTY

The Statement of Grounds and Particulars and the evidence includes references to a large number of alleged anticipations; I will discuss in some depth those referred to by Mr McGowan at the hearing.

Mr Hess submitted that a claim which includes a feature which "claims by result", can only be anticipated by prior use of that feature, ie. it is not relevant if paper anticipations such as patent specifications disclose the feature. However, this interpretation of the law seems to be contrary to conventional thought; see for example, paragraphs 5 and 6 on page 12,714 of Volume 1 of Lahore, Patents, Trade Marks and Related Rights; so I think it is appropriate to consider the prior art patent specifications in the evidence.

WO 91/16043, Eurand, (MJS-9, WJT-9)

This PCT application was filed on 9-4-1991, it has an earlier priority date of 17-4-1990, it was published on 31-10-1991, and Australia is indicated as being one of the designated states of the application. There was no dispute that the priority date of the present specification is 22-7-1991, so the citation is one which could be considered for a "whole of contents" novelty objection.

Mr McGowan's written submissions, provided after the hearing, had further reference to this citation, including the Australian 6-figure serial number and 5-figure application number (635,133; 76812/92), and accompanying the submissions was a copy of a translation of the basic priority document, filed in Italy on 17 April 1990.

To establish a whole of contents objection it needs to be established that the citation is part of the "prior art base" defined in Schedule 1 of the Patents Act 1990, viz:.

"‘prior art base’ means:

(a) …
(b)in relation to deciding whether an invention is or is not novel:
(i) …
(ii) information contained in a published specification filed in respect of a complete application where:
(A)if the information is, or were to be, the subject of a claim of the specification, the claim has, or would have, a priority date earlier than that of the claim under consideration; and
(B)the specification was published after the priority date of the claim under consideration; and
(C)the information was contained in the specification on its filing date and when it was published …."

The WO 91/16043 document cited is the document published at the publication date, but in my view it alone is insufficient to establish paragraphs (A) and (C) above. A copy of the basic document was filed after the hearing; this would be sufficient to establish (A), but there is an issue of whether this copy of the basic document constitutes properly adduced evidence.

However, the evidence does not include a copy of the specification as filed, and it seems to me that such a document is necessary to establish paragraph (C) above; especially since the published document has some substitute pages, suggesting that the filed version was different, and the basic document is also different to the published document.

The opponent submitted that the judgement in Alcatel NV v Commissioner (1996) 35 IPR 255 is authority for citing the Eurand document, but I note that there is no part of that judgement dealing with the issue of which documents are necessary evidence to establish a whole-of-contents novelty objection.

I note also that specification pages 8 and 9 of WO 91/16043 are missing in both copies supplied in the evidence, ie. MJS-9 and WJT-9.

Taking all these matters into account, I am not satisfied that the evidence is sufficient to establish that the Eurand citation is part of the prior art base, so I think it is appropriate that I do not further consider this citation.

US 4,710,384, Rotman, (WJT-8, MJS-8)

The abstract of this US patent reads:

"A tablet for oral administration of a sustained-release medication is formed by compressing microcapsules of the active principle. The microcapsules are of a size range between about 5 and 300 microns and comprise particles of active principle coated with a thin, flexible layer of sustained release material. The sustained-release material contains about 15-30% by weight thereof of plasticizer and is coated in an amount corresponding to 10-25% of the weight of the active material. Excipients causing disintegration of the tablet after administration can be uniformly mixed with the microcapsules prior to compression."

The US patent discloses that the microcapsules are coated crystals of the active medication, and are smaller than conventional microcapsules which generally have a size range of 600 - 1000 microns. In column 4 the patent specification reads:

"A particular advantage of the use of microcapsules below about 300 microns is that they may be administered in the form of a chewable tablet. Because of the very small size of the capsules, it has been discovered that very few capsules are actually broken during the act of mastication of the tablet. Thus for the first time it is possible to administer a sustained release medicine in the form of a chewable tablet."

Known excipients such as starch and microcrystalline cellulose are used, and in column 4 the specification reads:

"… it is preferred that excipients be avoided which prevent disintegration of the tablets, after administration, into their constituent coated particles. On the contrary, it may be preferred to use an excipient which causes prompt disintegration of the tablets …"

In "Example 1" discussed in the US patent, ethyl cellulose coated paracetamol microcrystals were used as the active medication, and in "Experiment 1" these tablets disintegrated within 5 to 10 seconds, in simulated intestinal fluid or simulated gastric fluid.

The prima facie differences between the disclosure in the US patent and present claim 1 are that the US patent does not directly state:
1. that the tablet is non-effervescent,
2. that the coating is taste-masking, or
3. that the tablets disintegrate in the mouth in less than 60 seconds.

Re the first difference, it seems likely that the tablets disclosed in the citation are in fact non-effervescent because of the composition of the tablets, and because they are meant to be ingested and chewed rather than administered in a glass of water. Also, this is not an issue in the evidence, so I conclude that a person skilled in the art would construe the citation as disclosing a non-efferescent tablet.

Taste-masking

Re the second difference, I note that taste-masking is only one of a number of effects resulting from coating the active particles in multiparticulate tablets. For example, paragraph 2 on page 6 of the present specification reads:

"… the tablet according to the invention has all the advantages of coated particles which permit to obtain especially a taste-masking, a gastroresistance, a delayed release …"

The evidence suggests that these coating effects are well-known in the pharmaceutical field. The citation discloses coated microcrystals which are coated to resist damage by chewing and to release the active medication in the digestive tract after swallowing, so I think a person skilled in the art would construe the citation to include taste-masking as an additional effect of the coatings disclosed therein.

Also, Gendrot has indicated that taste-masking coatings may be thinner than gastro-resistant coatings, so it follows that a gastro-resistant coating, if thicker, would be very likely to also be taste-masking.

Disintegration rate of less than 60 seconds- preliminary consideration

Re the third difference, I have to determine whether the excipients used in the tablets disclosed in the US patent would be suitable for imparting a disintegration rate of less than 60 seconds.

In Example 1 in the US patent, 100mg of starch excipient is used with 400mg of the coated particles, thus the excipient comprises 20% by weight of the total mixture. In the present specification five Examples of tablets made according to the invention are discussed. By my calculations from the amounts of ingredients given in the examples, the present invention has a range of 14% -55% of excipients by weight. The tablet disclosed in the citation thus seems to have a similar amount of excipient to that disclosed in the present invention.

In Example 1 in the US patent the mixture of coated particles and excipients is compressed to 1.5 tons to produce the tablets. In the five examples discussed in the present specification the compression forces are in the range of 15-21 kNewtons, which is equivalent to 1.7-2.2 tons

Thus the excipient in the tablet in the citation is in a similar proportion of the total mixture as the tablets made according to the present invention, and the compression force used to form the tablet in the citation is of a similar order but somewhat less than that used in the examples of the present invention, and I imagine that a tablet formed with less compression would be more likely to rapidly disintegrate. Considering these parameters prima facie suggests to me that the excipient material in the tablet discussed in the citation would be likely to have a similar effect to the excipient material in the tablet of the present invention.

The US patent indicates that tablets made according to Example 1 disintegrated within 5 to 10 seconds, in simulated intestinal fluid or simulated gastric fluid. I imagine that saliva in the mouth would be less chemically active than intestinal or gastric fluids, but whether this difference would mean that the tablet would take longer than 60 seconds to dissolve in the mouth is questionable. Certainly the matter deserves closer analysis. In order to properly determine whether the tablet in the citation would be "suitable for" dissolving in the mouth in less than 60 seconds, I think it is appropriate to refer to the experts in this case. See Gynelab v Packard [1997] APO 28.

In the evidence-in-support, Story and Thiel briefly refer to the Rotman patent under the heading of "prior publication and novelty" and Story lists Rotman as one of a list of citations which anticipate the present claims and which "additionally … describe the advantages of or need for having the tablet disintegrate in the mouth". However, neither expert discusses the citation in any depth.

Sunderland distinguishes the present invention from Rotman by suggesting that chewable tablets are not included in the present invention because chewing would break the coating and prevent taste-masking. Bruna declares that Rotman is not relevant since mastication of the tablets is not required in the present invention and since saliva should be present to effect disintegration.

In the evidence-in-reply Story and Thiel declare that the tablets in Rotman

would provide rapid disintegration in the mouth, which would certainly occur in less than 60 seconds,
can be either chewed or not chewed, the latter being implicit in references to "immediate disintegration" and "disintegratable tablet", and
will mask taste.

Chewable

On the issue of whether a tablet is "chewable", I think two meanings are possible, viz:

(i) meant to be chewed, and
(ii) capable of being chewed, but may also be sucked or disintegrated in other ways.

A tablet complying with the first meaning would also comply with the second meaning, but the reverse situation is not true. On the negative side, a tablet not meant to be chewed could still be capable of being chewed.

When the applicant's experts in this case are arguing that the present invention is not directed to a chewable tablet, they seem to be suggesting that it is not meant to be chewed. However, this use of the word may be at odds with how the word is used in the prior art. In my view, the prior art indicates that the second meaning is more likely to come to mind in the skilled addressee, unless the document makes it clear that the first meaning is intended.

Rotman discloses a tablet which is meant to be chewed; but it is not clear whether the disclosure also includes tablets which are not meant to be chewed. The preferred embodiment in the US patent is chewable tablets, but the claims are not directed to chewable tablets, and references such as "may be administered in the from of a chewable tablet", line 23, col. 4, and "even upon chewing", line 37, col. 4, hint that other forms of disintegration may be possible.

The applicant's evidence and submissions indicate that the tablets of the present invention are not meant to be chewed, but whether present claim 1 defines a tablet which is "chewable" in any sense of the word is another matter. I note the words "chewable" or "non-chewable" are not used in present claim 1.

The present specification does not indicate that the tablets of the present invention are not meant to be chewed, and "disintegration" has not been defined to exclude chewing, so, prima facie, I cannot see any reason why an addressee of the specification would think that the tablets would not be capable of being chewed, if desired, as part of the disintegration process.

The applicant submits that the Rotman disclosure is outside the scope of claim 1, and that present claim 1 inherently excludes chewable tablets, because the use of the word "disintegration" used in the claim implies non-chewing. I reject this argument because the Rotman specification also refers to "disintegration" of the tablets, and chewing seems to be part of the disintegration process disclosed. Also, Sunderland's suggestion that chewable tablets are not included in the present invention because chewing would break the coating and prevent taste-masking, is not very convincing in the light of the Rotman disclosure which indicates that if the active substance is in the form of microgranules there in fact is no significant breakage of the coating. Both inventions use microgranules.

Even if there was some hint of non-chewability in the description of the present invention, that would not necessarily restrict the scope of the claims. An unambiguous claim must stand on its own and not be over-restricted by the description. See EMI v Lissen (1939) 56 RPC 23. My considered view is that claim 1 does not exclude chewable tablets, in the sense of my second meaning of "chewable"; ie. claim 1 does not exclude tablets which are capable of being chewed. The tablets disclosed in Rotman are meant to be chewed and are capable of being chewed; these tablets are therefore within the scope of claim 1.

However, it is important to regard the issue of chewability as relating to the use of the tablet, not to the substance of the tablet. I have already decided that there is no feature relating to use in claim 1, ie. it is to a tablet per se not to a tablet in use. Therefore it is my considered view that the issue of chewability is not a central issue in determining the novelty of claim 1.

Disintegration rate of less than sixty seconds- final consideration

Significantly, what I have to really decide is whether the tablets disclosed in the citation would be "suitable for" disintegrating in the mouth in less than sixty seconds. I will now consider how the evidence deals with this particular issue.

Firstly I note that Story and Thiel are both "certain" that the tablets in Rotman would dissolve in the mouth in less than sixty seconds. Eg. in parag. 5.8.5 of his second declaration, Thiel declares:

"In Experiment 1, there is reference to the tablets obtained from Example 1 disintegrating in a small volume of simulated intestinal fluid and a small volume of simulated gastric fluid in the rapid time of 5 to 10 seconds. This tells me that disintegration in the mouth would also be rapid, and would certainly occur in less than 60 seconds (with or without chewing)." [His italics and underlining].

Paragraph 67.1 of Sunderland's declaration refers to US patent 4,832,956 to Gergely (MJS-30). Sunderland indicates that this patent is aimed at producing rapidly disintegrating tablets which incorporate soluble substances such as mannitol. He refers to the disclosure in column 4 of the US patent. The significant part is from line 53, viz:

"Such compressed materials can, if desired, be caused to disintegrate in a relatively small amount of water, a suspension of the tablet ingredients being formed in the course of 30 to 60 seconds; however, they can also be swallowed, chewed or sucked."
"The effect is also noteworthy because a tablet of this type exhibits very different behaviour in the mouth. Here, because of the small amount of moisture provided by the saliva, the tablet does not disintegrate but behaves like a normal chewable or sucking tablet which is pleasant to take."

Mr Hess suggested that this disclosure indicates that, generally, conditions for disintegration in the mouth are significantly different to conditions in water. I note though that this is the only time Sunderland refers to the "small amount of moisture provided by the saliva", he has not made it a general point in his discussion of the prior art.

In his second declaration, Thiel does not respond specifically to the comments in paragraph 67.1 of Sunderland, but he does indicate that, in his view, conditions in the mouth are not significantly different to the other disintegration conditions referred to in the prior art. For example, in paragraph 5.10 he declares:

"I believe that it is apparent from almost every document that the tablets described would disintegrate in the mouth, and I believe that this would have been plain to a skilled worker reading them in July 1991. It is also readily apparent that a large portion of the tablets described would disintegrate in the mouth in less than sixty seconds." [His underlining]
"… close parallels can be drawn between disintegration in a glass of water at 37°C and disintegration in the mouth."
"I believe that a tablet tested for disintegration in water at 37°C would disintegrate slightly more rapidly than it would in the mouth, but would disintegrate more slowly than in an agitated disintegration apparatus. For example, it is likely that a tablet which disintegrated in a disintegration apparatus in under 30 seconds, would disintegrate in a glass of water at 37°C in under 50 seconds, and would most likely disintegrate in the mouth in under 60 seconds. I note that this type of comparison is actually confirmed in Chauveau (1) where Chauveau's testwork showed the same tablets disintegrating in a disintegrating apparatus in 34 seconds but in the mouth in 55 seconds."

Thiel makes other references to prior art references to similar disintegration behaviour of saliva, gastric juice and water at 37°C in paragraph 6.11 of his second declaration.

I note also that in WO 91/04757 (WJT-7) on page 13 it is stated:

"Disintegration time in the mouth can be measured by observing the disintegration time of the tablet in water at about 37°C."

Generally, I think the applicant's evidence in regard to the Rotman citation is of less probative value than the opponent's. Sunderland's and Bruna's arguments are based mainly on the chewability aspect, which I have already discussed, and Bruna's other comment that saliva should be present to effect disintegration is not particularly convincing in the light of the specification and claim 3 which suggest that the invention will work without saliva. Sunderland's reference to a supposed significant difference between disintegration in the mouth and disintegration in water or body fluids is strongly disputed by Thiel and Story.

I have indicated that many parts of the declarations of Story and Thiel are word-for-word the same, and I agree with Mr Hess's submission that this generally reduces the combined probative value of their evidence, since there is an implication that it is not original for at least one of the declarants. However, there are also many parts of their declarations which are not the same. I have taken these issues into account in my deliberations on this issue, but, to me, the weight of evidence on this matter is still heavily in the opponent's favour. Story and Thiel are suitable addressees of the citation, they are reading the citation in the light of their common general knowledge of the art (see Acme Bedstead v Newlands 58 CLR 689 at 704) and they are both certain that the disintegrating agents disclosed would be suitable for imparting a disintegration rate such the tablet disintegrates in the mouth in the presence of saliva in less than sixty seconds.

Whilst noting the abovementioned disclosure in the Gergely patent, I have indicated above that the feature of "suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in the presence of saliva in less than sixty seconds" in present claim 1 is somewhat indefinite because of varying conditions in the mouth; so present claim 1 could be broad enough to include a condition in someone's mouth where there was plenty of saliva, produced by sucking for example. Rotman discloses that his tablets disintegrated within 5 to 10 seconds. Even though simulated intestinal fluid or simulated gastric fluid is specified in Rotman, I think "5 to 10 seconds" is significantly less than the 60 seconds required by present claim 1. At least for the condition when there is plenty of saliva in the mouth, it is likely that the tablets in Rotman would take somewhat longer than 5 to 10 seconds to dissolve in the mouth; but the disintegration time, in my view, would be less than 60 seconds. Thus, in summary, when taking account of:

the somewhat indefinite scope of claim 1,
the significantly shorter disintegration time disclosed in the citation,
the relative values of the parties' evidence,
my conclusion that claim 1 does not exclude tablets which are capable of being chewed,
the apparent similar relative proportions of disintegrating agents and similar compression forces, and
other matters already discussed

I am satisfied that the tablets disclosed in Rotman would be within the scope of claim 1. Therefore I find that claim 1 is not novel in the light of the Rotman patent.

The features in appended claims 2, 4 and 5 in the present specification appear to merely add matters of common general knowledge to the claims; the appended features do not seem to be essential to the invention so I conclude that claims 2, 4 and 5 are also not novel in the light of Rotman. Also, I have indicated that the clause "it can be disintegrated in the mouth" in claim 3 can be construed to include chewing, so claim 3 is not novel in the light of Rotman.

US 4,666,703, Ciba-Geigy, (WJT-29, MJS-28)

This patent discloses a quick-disintegrating tablet comprising coated microgranules, similar to the present invention. The emphasis is on the coating materials used and the use of talcum and colloidal silicon dioxide for storage stability. Column 3 refers to rapid disintegration "in the stomach" and many of the examples discussed have disintegration rates of "< 1 minute", in water at 37°C. No further details of the disintegration time are given.

Sunderland declares that disintegration in the mouth or taste-masking are not mentioned in the citation; Bruna also refers to disintegration in the stomach. Story and Thiel declare that the reference to the coated granules being "neutral in taste" in col. 1 of the citation is referring to a taste-masking coating; and, with regard to the disintegration feature, they declare:

"Also, disintegration in water is again stated to be in less than one minute. Again I would expect disintegration in the mouth to also be within one minute."

In my view, the opponent's experts' opinions are stated with less conviction than the statements made in regard to the Rotman citation, and there is some doubt whether "less than a minute in water at 37°C" would anticipate "less than a minute in the mouth in the presence of saliva"; therefore I am inclined to resolve this doubt in the applicant's favour. Also, this citation does not raise any issues not already dealt with in the discussion of Rotman; it is simply a weaker citation.

US 3,488,418, Sterling (1), (WJT-37, MJS-36)

This patent describes tabletted particles of asprin encapsulated in ethyl cellulose. The prepared tablets contain additional disintegrating and swelling agents and are stated to disintegrate in less than 45 seconds in distilled water at 37°C. Col.2 line 67 et al reads:

"When ingested, such tablets disintegrate rapidly, and the individual granules of encapsulated asprin are dispersed in the stomach. The gastric fluids slowly diffuse in through the thin micro-capsule walls…"

Col. 5 line 46 et al reads:

"The composition must provide a tablet that will withstand storage and shipping without chipping or breaking, but will disintegrate quickly and easily when wetted by saliva or gastric fluid, to give discreet particles of encapsulated asprin.

Sunderland's declaration, in a table on pages 39 and 45, refers to this patent as follows:

"Sustained orally administered asprin tablets. Possible disintegration in the saliva is mentioned but it is peripheral to the invention and not claimed. Taste masking or taste neutral is not mentioned."

Sunderland does not refer to this citation in his text discussion of the prior art, but he does discuss US patent 3,488,419 to the same assignee (Sterling (2)); and this latter patent is not listed in the table. I assume the disclosures are so similar that they have been treated as one. Sunderland declares that "no information was provided on disintegration times in the mouth" (his underlining). Bruna also declares that there is no disclosure in US 3,488,418, of disintegration in the mouth in less than 60 seconds.

In reply, Thiel refers to all the pertinent parts of the US patent, emphasises the reference to "saliva" and declares:

"This document suggests it would have been worthwhile using WJT-37 in July 1991 to solve Prographarm's problems, particularly in combination with the teaching of WJT-10 in relation to melt tablets."

Even though there is a reference to the tablets disintegrating in saliva in this patent, the stated disintegration time of less than 45 seconds relates to disintegration in water, not in saliva. To me this citation is in the same category as the Ciba-Geigy patent- there is some doubt whether "less than 45 seconds in water at 37°C" would anticipate "less than a minute in the mouth in the presence of saliva". Also, Thiel's reference to combining WJT-37 with WJT-10 places some doubt on whether the former can stand alone as an anticipation. Taking all these matters into account I conclude that present claim 1 is novel in the light of this citation.

EP 0 273 005, Zyma, (WJT-34, MJS-33)

This patent also discloses rapidly disintegratable tablets with most of the features of present claim 1. The large-dose tablets are meant to be dissolved in a glass of water. Dispersion and disintegration times of "approximately one minute" and "generally in less than one minute" are mentioned. My conclusions on the Ciba-Geigy citation are also applicable to this patent.

WO 91/04757 (AU 646,232, AU 66012/90), Cima Labs, (WJT-7, MJS-7)

This patent discloses effervescent tablets which are for direct oral administration, ie. for direct insertion into the mouth. The effervescent disintegration agents are saliva activated. Carbon dioxide generated with the effervescence acts as a taste-masking agent. The description on page 4 reads:

"The effervescent sensation is not only pleasant to the patient but also tends to stimulate saliva production, thereby providing additional water to aid in further effervescent action. Thus, once the tablet is placed in the patient's mouth, it will disintegrate rapidly and substantially completely without any voluntary action by the patient.…..
Even if the patient does not chew the tablet, disintegration will proceed rapidly."

Micro-encapsulated forms of active ingredients are described as one embodiment of the invention. The first paragraph on page 7 reads:

"The combination of the effervescent disintegration agent and the microcapsules provides a uniquely effective dosage form for systemically distributable pharmaceutical ingredients which have unpleasant flavours or which should not be released within the mouth for other reasons. Because the tablet will disintegrate without chewing, the problem of microcapsule rupture during chewing of the tablet is substantially eliminated."

The description on page 13 states that the preferred embodiment of the invention "should dissolve in the mouth in between about 30 seconds and about 5 minutes".

Present claim 1 however defines a non-efferevescent tablet. Mr McGowan suggested that this is not an important feature because this it was added to the claim by amendment. I agree that generally, it does not seem to be a particularly important feature of the invention, but it is significant that paragraph 2 on page 5 of the applicant's specification refers to the "drawbacks" of effervescent tablets. To me this disclosure gives the non-effervescent feature in claim 1 some substance, and therefore I conclude that it is an essential feature. The Cima Labs patent teaches effervescent tablets, so claim 1 is novel in the light of this citation.

AU 49161/85, Elan, (WJT-10, MJS-10)

This application refers in Example 20 on page 36 to a "melt" tablet, which is described thus:
"melt tablets are similar to chewable tablets except that they disintegrate rapidly in the mouth and do not need to be chewed." Story summarizes the relevant disclosure as follows:

"The tablet comprises particles having a form of a micromatrix of active and non-toxic polymer, known as pharmasomes. These pharmasomes are distinguished from microcapsules (page 14, line 30 to page 15 line 2): in microcapsules the active ingredient is encapsulated by a polymer coating, and in pharmasomes the active material is uniformly distributed throughout the polymeric material. Example 20 describes a tablet which disintegrates in less than 30 seconds the disintegrating agents being microcrystalline cellulose, cross-linked polyvinylpyrrolidone and carboxymethyl starch. Mannitol is included as a soluble agent, and magnesium sterate as lubricant. "

I note that Thiel's summary of this citation is somewhat different to Story's. Sunderland declares that "this patent makes claim to a very wide range of formulations and does not definitely prove disintegration in the mouth." Bruna declares, in paragraph 7.2 of his declaration, that "Elan is irrelevant due to the fact that the active ingredient in that formulation is present in the form of a micromatrix", and he suggests that this is different to the coated microcrystals or coated microgranules in the present invention.

I agree with Bruna's assessment of this citation. Story's summary even suggests that there is an important difference; and I note that this citation was not one of the seven citations which Story declares in paragraphs 30.4 and 30.6 of his second declaration as disclosing the combination of all the features of the present invention. I think the feature of the coated microcrystals and microgranules in present claim 1 is an essential feature, the citation does not disclose this essential feature, so claim 1 is novel in the light of this citation.

The other citations referred to in the opponent's Statement of Grounds and Particulars and evidence, have been given less emphasis in the evidence and/or were not referred to at the hearing, and prima facie appear to be less relevant than the citations I have referred to above; so I do not think it is necessary for me to devote an in-depth analysis to those other citations.

inventive step

The present specification does not discuss the problems of the prior art, so it is difficult to determine where the improvement of the invention lies. Also, the evidence from both parties is rather muddled and vague on the issue of inventive step. There are comments in the evidence about whether there is any inventive ingenuity in some of the substance features of the invention: Sunderland suggests for example that there is invention in compression of the microgranules without significant breakdown of the coating, but Story argues that the problem of coating rupture was solved long ago. Bruna suggests that because taste-masking coatings are thinner than gastro-resistant coatings, there are savings to be made with a reduced amount of coating polymer; but I note that the specification clearly states that the invention extends to gastro-resistance and other forms of "modified action".

Bruna discusses the problems of the prior art and the history of the invention. He suggests that the problems to be overcome are the various disadvantages associated with the known types of multi-particulate tablets and capsules, previously discussed. Bruna's declaration and the present specification suggest that these problems are overcome in the present invention by the particular combination of tablet components claimed.

I agree that the invention is in the combination of components; the last paragraph on page 1 starts as follows:

"The applicants have had the merit of having found that it was possible, unexpectedly and surprisingly, to introduce into a multiparticulate tablet with high disintegration rate such as hereabove defined, the active substance in the form of coated microcrystals or microgranules …"

Also, in my opinion, there is nothing special about any of the individual tablet components; for example Sunderland states in paragraph 3.5 of his declaration:

"Hence the input elements are materials and methodologies that are each individually part of the prior art. "

However, the evidence shows that the general concept of combining the ideas of rapid disintegration and coated microcrystals or microgranules is known, and in my opinion, there is sufficient evidence to prove that it was a matter of common general knowledge, at the priority date of the present claims. Thus there is no invention in this general concept of a combination, but I think it is appropriate for me to go one step further and try to determine whether there is any particular aspect of the claimed combination which may exhibit an inventive step. To determine inventive step the common general knowledge may be considered with relevant prior art documents, so I will now re-consider the opponent's citations.

Re Rotman

I have found that all the features of present claim 1 are disclosed in the Rotman (US 4,710,384) citation. It follows that, if a tablet made in accordance with the Rotman specification was retained in the mouth until dissolved, then all the advantages of the present invention would also be apparent with the tablet made in accordance with Rotman. In my view there is no inventive step in the present invention in the light of Rotman.

Re Ciba-Geigy, Sterling, Zyma

I have found that the difference between the Ciba-Geigy (US 4,666,703), Sterling (1) (US 3,488,418) and Zyma (EP 0273005) citations and the invention is that, in the former, tablets may take longer than sixty seconds to disintegrate in the mouth. These citations are relevant to the present invention because they address the same problems of the prior art. I will now consider whether there is any inventive step associated with this particular aspect of the present invention.

The applicant's specification suggests that the advantages of the invention are apparent when the tablet is administered in a particular manner, ie. when disintegrated in the mouth before swallowing and without chewing. The use or administration features of the invention were also emphasised by the applicant's representatives at the hearing; eg:

the feature of how a saliva "slurry" is formed in the mouth before swallowing, without the need for water, was discussed,

the feature of how the tablets may be presented in a larger than usual size was demonstrated, and
submissions were made on how the "invention involves both structure and function".

It seems to me that the advantages of the invention are associated with the rapid disintegration rate, and if there is any inventive step in the present invention, in the light of these citations, it should be inherent in that feature. There may be some advantages associated with a faster disintegration rate, but in the present circumstances I don't think that is sufficient in itself to conclude that there is an inventive step. To properly determine whether there is any invention in achieving a faster rate it is appropriate to consider how that faster rate is achieved, since there is no inventive step if the faster rate can be achieved by mere routine steps or workshop variations.

On this issue I note that neither the specification nor the applicant's evidence place any emphasis on how the rapid disintegration is achieved. In paragraph 3.2 of his declaration Bruna refers to "a particular mixture of excipients", but there is no further elaboration of this point. Examples are given in the specification, but the mixtures of excipients seem to be similar to conventional mixtures of excipients. Thus, in my opinion, no practical difficulties have been overcome in selecting the excipients, and the present invention lacks an inventive step in the light of these citations.

Re Cima Labs

The multiparticulate tablets disclosed in the Cima Labs patent are directed to the same objects as the present invention. Also, the two invention are used in a similar manner, ie. the tablets are meant to disintegrate in the mouth. However, there are some differences between the two inventions; viz:

the tablets in the citation are effervescent, and
the disintegration time for the Cima Labs tablets "should be …between about 30 seconds and about 5 minutes"

I will now consider whether there is any invention in the differences between the two inventions.

Sunderland alleges that in the citation the issue of the microcapsule possibly being ruptured during compression is not adequately addressed or overcome. He also discusses the substances used to produce the effervescent gas.

Thiel refers to a part of the citation, page 15 lines 3-10, which refers to non-effervescent disintegrants, and suggests that a skilled worker "would have simply removed Cima's effervescing disintegrant and replaced it with one of the very well known non-effervescing disintegrants …"

In my view, the citation is definitely teaching away from non-effervescent tablets; the part on page 15 is simply referring to additional components which may be used in the tablet; all the embodiments are to effervescent tablets and there is no suggestion that the non-effervescent disintegrants can be used instead of the effervescent disintegrants.

The present invention is a slightly different and slightly narrower version of the Cima Labs invention. It is slightly different because it is non-efferevescent, and according to the paragraph on page 5 of the specification, an unpleasant taste is a drawback of effervescent tablets. It is slightly narrower because the disintegration time is less than sixty seconds, which I think is significantly faster than the time given in the citation, even though there is some overlap. The disintegration time seems to be an unimportant factor in the citation; no times were given for the Examples set out in the specification, and the one reference to disintegration time on page 13 is worded in rather vague terms such as "desirably" and "should". Presumably a faster disintegration time would give a more effective tablet. In my view, the sum of these differences and advantages of the present invention indicates that there is sufficient improvement in the present invention for it to be considered inventive over the prior art.

Re Elan

Story and Thiel suggest that it would have been clear to a skilled worker in Australia in July 1991 to substitute the "pharmasome" particles disclosed in the citation with conventionally coated active microparticles.

In this matter I have considered that:

Story and Thiel merely make the assertion that a skilled worker would have made the substitution, without any elaboration of this assertion,
the opponent has not presented any arguments relating to applying the legal tests for lack of inventive step,
prima facie, the present specification and the Elan specification are directed to different objects and problems, and
the pharmasomes seem to be structurally quite different to the coated microparticles of the present invention, so I cannot be certain that these different means of presenting active pharmaceutical substances would be considered to be in the same field of activity, or certain that the Elan specification would have been regarded as relevant by the person skilled in the present field of activity.

Thus, in my view, there is insufficient evidence and submissions provided by the opponent for me to conclude that there is a lack of inventive step in the present invention in the light of the Elan disclosure.

manner of new manufacture

Mr McGowan submitted that the present invention should be treated as a method of treatment of the human body, that it is generally inconvenient, that the claims are not directed to a classical pharmaceutical compound, and that the invention is a mere discovery. He referred me to the recent judgement of the Federal Court in Bristol-Meyers v Faulding VG109 (22-7-98) and other related cases.

The Bristol-Meyers case concerned a method of administering an anti-cancer drug. The Federal Court decided that that invention was a method of treatment of the human body, generally inconvenient, and therefore not patentable. The Court took into account the earlier judgement in Anaesthetic Supplies v Rescare (1994) 50 FCR 1, which dealt with the issue of whether monopolies for life-threatening surgical methods and other forms of treatment by medical practicioners, were "generally inconvenient". Cosmetic methods of treating the human body have found to be patentable.

I have decided that the present claims are directed to a tablet per se and not to a method, so my basic conclusion on this matter is that the invention is directed to a manner of new manufacture and that the Bristol-Meyers v Faulding case is not relevant. However, the opponent has suggested that the present invention is really a method, and I have decided that the advantages of the present invention are associated with its use, so I think some further comment is appropriate.

Thus, insofar as the present invention may have some element of use, and comparing the invention with cases relating to methods of treatment of the human body, I am inclined to conclude that the present invention is not one which would be considered generally inconvenient, because:

even in the light of the Bristol-Meyers judgement, it is still likely that only some methods of treatment of the human body may be non-patentable, ie. some may also be patentable-
eg. the High Court referred to "certain methods of treatment of the human body as an inappropriate subject for grants" in Advanced Building Systems v Ramset Fasteners (1998) 152 ALR 604 at 614, and
the use aspect in the present case is not related to life-threatening or surgical methods, or methods performed by a medical practitioner, since the tablets can be self-administered, and it seems to be more "commercial" than some of the prior art inventions.

Finally, I do not think the present invention can be construed as a mere discovery, as suggested by the opponent, since the specification sufficiently sets out details and examples of how the invention may be put into practice.

Thus I conclude that the present invention is directed to a manner of new manufacture.

conclusion

The opposition is successful because I have found that the claims are not novel and the invention as claimed lacks an inventive step in the light of the prior art. However, in my view, there may be patentable subject matter in the applicant's specification, so I allow Laboratoires Prographarm sixty days from the date of this decision to propose amendments to overcome the objections to the specification.

Both parties sought their costs in this matter. The usual practice in oppositions is to award costs against the losing party; I see no reason to change that practice in this case so I award costs in accordance with Schedule 8 against Laboratoires Prographarm.

John Welsh
Delegate of the Commissioner of Patents

Patent attorneys for the applicant : Watermark, Melbourne
Patent attorneys for the opponent : Phillips Ormonde & Fitzpatrick, Melbourne

[1998] APO 63

19 November 1998