Alza Corporation
[2012] APO 70
•21 June 2012
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Alza Corporation [2012] APO 70
Patent:774594
Title:Transparent transdermal nicotine delivery devices
Patentee: Alza Corporation
Delegate: Dr S.D.Barker
Decision Date: 21 June 2012
Hearing Date: 29 March 2012 in Canberra
Catchwords: PATENTS – re-examination of patent on the ground of lack of novelty – inherency – features of opacity index, stability of nicotine and visibility of skin colour considered – certain claims found to lack novelty – patent revoked in relation to certain claims
Representation: Patentee: Shelston IP
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent:774594
Title:Transparent transdermal nicotine delivery devices
Patentee: Alza Corporation
Date of Decision: 21 June 2012
DECISION
Claims 1, 6 and 7 lack novelty in the light of the WO 1991/09592.
I revoke patent 774594 so far as it relates to claims 1, 6 and 7.
REASONS FOR DECISION
Alza Corporation is the patentee in respect of Australian patent 774594. The patent has an earliest priority date of 18 December 1998. A request for re-examination was filed by LTS Lohman Therapie-Systeme AG. The request identifies two documents that are asserted to be relevant to novelty and inventive step. The Commissioner issued three adverse re-examination reports. The last report indicated that in view of the fact that the issues had not been overcome, the Commissioner considered that the best way to progress the re-examination was by way of a hearing. The matter was heard in Canberra on 29 March 2012. The patentee appeared by telephone.
The law on re-examination
Section 97(2) of the Patents Act 1990 empowers the Commissioner to carry out re-examination:
(2) Subject to this section and the regulations, where a patent has been granted, the Commissioner may, and must if asked to do so by the patentee or any other person, re-examine the complete specification."
The manner in which re-examination occurs is governed by section 98:
"(1) On re-examining a complete specification, the Commissioner must ascertain and report whether, to the best of his or her knowledge, the invention, so far as claimed in any claim and when compared with the prior art base as it existed before the priority date of that claim:
(a) is not novel; and
(b) does not involve an inventive step.(2) For the purposes of subsection (1), the prior art base is to be taken not to include information made publicly available only through the doing of an act (whether in or out of the patent area)."
The way in which re-examination is carried out was considered by the Full Court of the Federal Court in Commissioner of Patents v Emperor Sports Pty Ltd [2006] FCAFC 26 at [24], (2006) 67 IPR 488 at 493:
“The Commissioner is an administrative decision-maker equipped with technical expertise. Subject to the rules of natural justice both common law and statutory (see e.g. s 101(2)), he or she is entitled to make use of that expertise, and draw inferences that may be rationally drawn from technical knowledge, including how skilled persons of various descriptions may act in their respective occupations: R v Milk Board; Ex parte Tomkins [1944] VLR 187 at 197, Kalil v Bray [1977] 1 NSWLR 256 at 261, R v Industrial Appeals Court; ex parte Maher [1978] VR 126 at 142, Rodriguez v Telstra Corporation Ltd [2002] FCA 30; (2002) 66 ALD 579 at 585, Tisdall v Health Insurance Commission [2002] FCA 97 at [103].”
At this point I note that Lohman supplied copies of citations, as required by regulation 9.2, and also a declaration by Mohammad Sameti. Alza submitted that Lohman are not entitled to provide any material other than documents that it asserts show a lack of novelty or inventive step (and by extension, I am not entitled to consider this declaration). This submission was based on Capral Aluminium Ltd v G&J Koutsoukos Holdings Pty Ltd [2004] FCA 1199, (2004) 63 IPR 254. In that case the Federal Court decided to direct the Commissioner to carry out re-examination. The relevant issue for the present case was whether the Court should direct that the Commissioner consider material from the file wrapper of a US application. The Court decided at [9] it would not give such an order:
“the Commissioner should consider issues of validity by reference to primary material and not additional material which might indicate the views others took in broadly analogous circumstances”
There is a significant difference between a copy of a file wrapper of a US application and a declaration setting out the results of tests undertaken. The file wrapper shows what another Patent Office did in similar circumstances, and represents an opinion and not primary evidence. The declaration in the present case is clearly evidence. It is consistent with the decision in Capral for me to have regard to the declaration, and give it consideration according to its relevance.
The standard of proof that applies in re-examination was considered by Lindgren J in Emperor Sports Pty Ltd v Commissioner of Patents [2005] FCA 996 at [107], (2005) 66 IPR 46:
“I see no reason why the approach taken in pre-grant examination and in opposition proceedings should not be taken in relation to post-grant re-examination, that is, that it must be clear that a patent would be (or is) invalid before the Commissioner should refuse to grant (or should revoke) it; cf F Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283; (2000) 99 FCR 56 at [67] (opposition proceeding); Commissioner of Patents v Microcell Ltd [1958] HCA 58; (1959) 102 CLR 232 at 245 (examination stage).”
This conclusion was not upset by the Full Court on appeal. It appears that I should not revoke the patent unless it is clear that the patent would be invalid. Lindgren J based this conclusion on an analogy with the standard applying in normal examination. I note that the standard of proof required for a novelty objection to apply during examination has been altered to the balance of probabilities as a consequence of the Patents Amendment Act 2001, which would suggest that the same standard should apply to re-examination. In the present case nothing turns on which standard of proof should be applied, and I will apply the standard most favourable to the patentee - the clearly invalid test.
The patent and the objection
The patent relates to a device for transdermal delivery of nicotine. Such devices are commonly known as a nicotine patch. The key feature of the present patent is that the device is transparent. Consequently the patient’s skin colour is visible through the device. In effect, the device is skin coloured regardless of the colour of the patient’s skin.
The relevant claims are as follows:
1. A device for the transdermal administration of nicotine comprising a backing layer, a drug reservoir layer containing nicotine carried by said backing layer, and means for maintaining the device in nicotine transmitting relationship with the skin, wherein the device has an opacity index of less than 48.6% so as to transmit the natural colour of the subject to whom the device is applied to be visible through said device, while substantially preventing degradation of nicotine on exposure of the device to light.
6. A device according to any preceding claim wherein the device has an Opacity Index of less than 35.11%.
7. A device according to claim 6 wherein the device has an Opacity Index of less than 20%.
Claim 1 defines a device in which six features are apparent.
(i)The device has a backing layer
(ii) The device has a drug reservoir layer containing nicotine
(iii)The device has an adhesive layer (i.e. means to maintain the device in contact with the skin)
(iv)The device has an opacity index of less than 48.6%
(v) The natural colour of the skin is transmitted through the device
(vi) Nicotine in the device is not degraded by exposure to light
The definition of opacity index is provided on page 7 of the specification:
“the Opacity Index, which is the percentage of incidental light which is absorbed by passage through the device”
It is unclear whether the measurement in question measures the absorbance of light at all wavelengths of the electromagnetic spectrum, or merely absorbance of visible light.
The sole outstanding objection is that claims 1, 6 and 7 lack novelty in the light of WO 1991/09592.
The citation
Patent application WO 1991/09592 is an international application filed by Pharmacia AB. The citation is titled “Transdermal system”. The inventive concept disclosed in the citation is stated on page 4 as follows:
“According to the present invention the release rate of an active substance, e.g. a drug, from a transdermal system, is controlled by the dissociation of an inclusion complex of the substance in a drug depot. Specifically the active substance in the depot or reservoir is at least partly in the form of an inclusion complex. It is preferred that the cyclo compound according to the invention is a cyclisized (sic) polysaccharide. The best known of these compounds and the most preferred ones are the cyclo-dextrins. Derivatives and polymers of cyclodextrins are also of special interest.”
It is clear that the citation relates to transdermal devices in which the active compound is presented as an inclusion complex. Despite this, the citation exemplifies transdermal devices that do not involve an inclusion complex. The Examiner referred specifically to System 10, which is described at pages 30 – 31. As this is the key part of the citation, I will quote it in full.
System 10
2,4 g nicotine was added to 91,6 g polyisobutylene-type gel composed of 2,0 g Oppanol 10, 1,5 g Oppanol 50, 1,0 g Oppanol 120 dissolved in 30 ml hexane whereafter 2,0 g liquid paraffin was added to give the drug gel. The drug gel was solvent cast onto a polyester sheet 75 mm thick by means of the coating machine in a 0,8 mm layer. After drying at room temperature adhesive preparation 1 (example 4) was laminated onto the gel coated sheet. The lamination was accomplished by solvent casting adhesive preparation 1 onto a siliconized polyethylene foil in a 100 mm layer, drying at room temperature and pressing the layer onto the dry drug gel layer by means of a steel roller (5,5 kg) after which the polyethylene foil was removed. The adhesive layer was covered by a release liner (PerlasticTM-L36, PETP-Folie) and the sheets were kept in heat-sealed pouches (BarexTM,polyacrylnitrit/aluminiumlaminate) at 8°C until use.
The resulting sheet with backing layer, reservoir layer and adhesive layer was 293 mm thick. The concentration of nicotine was determined to 0,8 mg cm-2 according to the following method. Patches of 0,63 cm2 was (sic) punched out and extracted with 5,00 ml heptane. The heptance phase was extracted with 10,00 ml 0,01 N HCl and after separation of the phases the amount of active substance in the aqueous phase was determined according to example 8.
In vitro release studies according to USP paddle method (USP XXII p. 1581, apparatus 3, paddle over disc) were carried out on the systems 9 and 10 described above. The results of those studies are reported graphically in fig. 6. From system 9 with comprises b-cyclodextrin inclusion complex of nicotine in the reservoir layer nicotine is released with a slower rate than from system 10 which comprises neat nicotine without b-cyclodextrin in the reservoir layer. As shown, the release profile for system 9 are (sic) approximately linear corresponding to a zero order release.
In vitro permeation of nicotine from transdermal system 9 and 10 across human epidermis was investigated with Franz diffusion cells.
Epidermis was heat separated from full thickness human skin and mounted in glass diffusion cells with an available diffusion area of 1,8 cm2. Patches of 1,54 cm2 of system 9 and 10 were punched out and applied on the skin surface and the dermal side of the skin was exposed to 12,1 ml recipient phase, 0,01 M acetate buffer solution of pH 4.
Permeation of nicotine was followed by removing samples periodically and measuring the concentration by a HPLC method according to example 11. The cumulative amount of nicotine appearing in the recipient phase versus time are shown in fig. 7. As it appears, system 9 revealed zero order permeation kinetics with a permeation rate of 6,7 mg cm-2 h-1. For comparison purposes permeation studies were carried out on system 10 which comprises neat nicotine without b-cyclodextrin in the reservoir layer. System 10
System 7 was also mentioned in an earlier report, and I will also quote it in full.
1000 ml nicotine and 400 ml propylene glycol were added to 12.6 g polyvidon 90 gel (example 3) to give the drug gel. The drug gel was solvent cast onto a polyester sheet 75 mm thick by means of the coating machine in a thin layer (70 mm) After drying at room temperature adhesive preparation II (example 4) was solvent cast onto the gel coated sheet and subsequent drying at room temperature.
The adhesive layer was covered by the release liner, and the sheets were kept at 8°C until use.
The resulting sheet with backing layer, reservoir layer and adhesive layer was 109 mm thick. The concentration of nicotine was determined according to example 8 to 0.2 mg nicotine per cm-2.
In vitro release studies according to example 9 were carried out on the systems 6 and 7 described above. The results of those studies are reported graphically in fig. 4. From system 6 which comprises b-cyclodextrin inclusion complex of nicotine in the reservoir layer nicotine is released with a slower rate than from system 7 which comprises neat nicotine without b-cyclodextrin in the reservoir layer. As shown, the release rate of nicotine from system 6 declined slightly over the period but more closely approximated zero order release than first order release.
Novelty of the claimed invention
Section 7 of the Act states that an invention is taken to be novel unless it is not novel in the light of the prior art. A document is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim. The citation has an international publication date of 11 July 1991, which is well before the earliest priority date of the patent. Consequently the citation is part of the prior art base.
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19, (1977) 137 CLR 228 at 235:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
The citation discloses devices having a backing layer, a reservoir layer containing nicotine, and an adhesive. The issue of novelty depends on whether the device has the following features:
(i)an opacity index of less than 48.6%;
(ii)the natural skin colour of the patient is visible through the device; and
(ii) the nicotine is not substantially degraded on exposure to light.
The claimed invention lacks novelty if the devices of the citation possess these features. In the absence of an explicit statement in the citation, I must decide whether I can infer these features are present. Alza approached this question as a matter of “inherent disclosure” and referred to Danisco A/S v Novozymers A/S (No 2) [2011] FCA 282, (2011) 91 IPR 209. Bennett J discussed that issue as follows at [248]:
“A claimed invention is deprived of novelty if it has been given to the public prior to the priority date. One way of this occurring is if a product or a process has been prior used. Another is if information that equates to the claimed invention has been published. To constitute an anticipation, a prior publication must, before the priority date of the claims of the patent, disclose all of the integers of the claimed invention. There are, however, circumstances in which a prior publication does not expressly make that complete disclosure but still deprives the subsequently claimed invention of novelty: see generally Lundbeck at [180]-[182] per Bennett J, Middleton J agreeing. One example is where the skilled reader understands the disclosures of the prior publication to include a missing integer. Another is where the prior publication contains a direction to use a process that inevitably or inexorably results in something within a claim: General Tire; Lundbeck at [181]-[182].”
It is also worth noting what Jessup J said in Abbot GMBH & Co KG v Apotex Pty Ltd (No 2) [2010] FCA 940, (2010) 87 IPR 561 at [58]:
“If the document is reasonably open to two or more interpretations, only one of which will lead to the compound of interest, it will, in my view, be impossible to conclude that following the instructions in the document would inevitably lead to that compound.”
In the Danisco case, Bennett J was considering a claim to a process for preparing a foodstuff by the use of an appropriate enzyme. Her Honour found that the citation disclosed a similar process that could involve the use of an appropriate enzyme, but equally could involve a different enzyme. Consequently, there was no inherent disclosure of an anticipating process. However, Her Honour went on at [257] to consider what would have followed if the citation had disclosed an appropriate enzyme. While this is clearly obiter, I consider that I am bound by this approach:
“Even if the enzyme was the polypeptide of SEQ ID No 2 and had the requisite activity and would in fact have yielded two functional ingredients by generating them from the two constituents, there is no provision, disclosure or recognition of the reaction or of the fact that the products of the reaction had functionality in the foodstuff. This is not the case of an inevitably produced product of a disclosed process, as in General Tire, but of an alleged inevitable carrying out of a process with identified results.”
The reason why the use of the specific enzyme of SEQ ID No 2 would not have been a citation is then explained.
“There is no sufficient evidence here that the performance of example 20 would necessarily infringe the claims of the Patent. In view of the limited information about any lipase activity of the phospholipase of the Novo patent, it cannot be said that the disclosure enables the skilled addressee to perceive, understand or apply that disclosure necessarily to obtain the claimed invention.”
While this statement is open to different interpretations, the following statements seem very clear. At paragraph [255] it is stated:
“It is not sufficient for the purposes of Novozyme’s claim of anticipation by reason of the inherent activity of the enzyme only to provide information that enables the use of an enzyme in baking that will ‘inherently’ result in the claimed process where, at the end of that use, the public will be none the wiser as to the integers of the claims.”
and then at paragraph [259]:
“Even if, in the dosages used, the enzyme inherently generated those products, there is no evidence that this would have been ascertained or understood by the skilled addressee at the priority date.”
It seems clear that in order to find lack of novelty based on inherency the citation must disclose something that would infringe the claim, and it is also necessary that the citation contain information that would enable a person to understand that they would infringe the claim. Thus, when considering a claim to a process involving specific transformations, it must be apparent from the citation that those transformations have taken place. Her Honour gives a good example in her discussion of the feature of inactiviation at [244]:
“The information in the Novo patent is that, if desired, the enzyme may be inactivated, under heating conditions less stringent than those of example 20. I accept that the baking conditions would have caused inactivation and that the skilled reader would, taking the whole of the disclosure of the Novo patent into account, have understood that the enzyme would have no phospholipase activity after the baking process. I am of the view that the directions and data of the Novo patent disclose inactivation, at least to the practical standard that no significant or material amount of active enzyme remains in the foodstuff. The specification provides information that is, in my view, sufficient disclosure to the skilled addressee of that integer.”
Consequently, in order to establish lack of novelty I need to find that the devices of the citation would possess the properties specified in the claim, and that it would have been apparent, to a practical standard, that they would possess those properties. A matter can be disclosed to a practical standard without being explicitly stated if it would have been apparent to a skilled reader, without difficulty, had they turned their mind to the issue.
Alza pointed out that the citation describes several devices, but only two were referred to during re-examination (i.e. System 7 and System 10). It was submitted that it was not inevitable that a person skilled in the art would decide to construct either System 7 or System 10, and consequently that the citation does not inherently anticipate the claimed invention. This is a misunderstanding of the test to be applied. The question is not whether System 7 or System 10 would be constructed by a person. Those Systems have already been constructed by the inventors of the citation. The only question is whether the devices of System 7 and System 10 possess the features in question, and whether the citation contains appropriate information. Alza stated that there was not a disclosure of these features sufficient to meet the inherency requirement. I will discuss the citation in detail with particular reference to these examples.
(i) Opacity index of the device in the citation
The preparation of System 7 has already been quoted above. The key features are:
“1000 ml nicotine and 400 ml propylene glycol were added to 12.6 g polyvidon 90 gel (example 3) to give the drug gel. The drug gel was solvent cast onto a polymer sheet 75 mm thick by means of the coating machine in a thin layer (70 mm). After drying at room temperature adhesive preparation II (example 4) was solvent cast onto the gel coated sheet and subsequent drying at room temperature. .. The resulting sheet with backing layer, reservoir layer and adhesive layer was 109 mm thick. The concentration of nicotine was determined according to example 8 to 0.2 mg nicotine per cm2.”
In vitro release studies of System 7 are presented in Figure 4 of the specification. System 7 delivers approximately 70% of the nicotine after 250 minutes.
The request for re-examination included a declaration by Mohammad Sameti. Dr Sameti prepared a device according to System 7. Alza submitted that Dr Sameti relies on experience that he gained after the priority date of the present patent, and thus his evidence is not relevant. I do not agree. Dr Sameti is attempting to reproduce the device of the citation and determine its properties. This is clearly highly relevant evidence.
Dr Sameti determined the opacity index of the devices that he prepared as 0%.
“I undertook experimental studies to replicate, to the best of my abilities, the example described as System 7 in the Pharmacia document, to determine the opacity index of a TTS [transdermal therapeutic delivery device] made substantially in accordance with that described in System 7, and as described in Exhibit MS-1 and MS-. … I have concluded on the basis of my studies, as set out in MS-1, that a transdermal drug delivery system constructed in accordance with System 7 of the Pharmacia document, would have an Opacity Index of less than 1 based on light transmission studies.”
Exhibit MS-1 is a description of Dr Sameti’s reproduction of System 7. Dr Sameti states:
“To prepare the respective layers and drug gels the following preparations were made substantially in accord with those described in System 7. In some instances certain of the specific components required substitution with equivalent components currently available, and as described in the following sections.”
Alza referred to three differences between the device prepared by Dr Sameti and that in System 7 – the backing layer, the thickness of the backing layer, and the adhesive layer – with the implication that his results are not relevant. I will deal with the differences in turn.
a) The backing layer: Dr Sameti used a 23 mm polyester film (manufactured by Hueck) which he said was “equivalent to Mylar D made by DuPont”. Alza submitted:
“In relation to the backing layer, the Product Information sheet submitted by LTS, relating to Mylar Type D polyester film does not state that the film is entirely transparent. Indeed, although describing the film as ‘clear’, it is apparent the film has a transmission index of 90%, not 100%.”
I note that the transmission index reported for Mylar D is 90% according to ASTM D1003. This measurement technique is used to determine the haze of a transparent plastic, which can be thought of as the amount of spreading of a beam of light travelling through the material. Clearly this is entirely different to the opacity index, which measures the amount of incident light absorbed by a material. The point made by Alza is not a valid criticism.
b) Thickness of the layers: System 7 uses a backing layer of 75 mm, and the total system had a thickness of 109 mm. Dr Sameti produced devices with a backing layer of 23 mm and a total thickness of either 91 mm , 112 mm or 120 mm. While the total thickness is comparable, the backing layer used by Dr Sameti is much thinner. Dr Sameti also measured the opacity of different thicknesses of the backing layer on its own. His results showed that there was a 0% opacity regardless of whether the backing layer was 23 mm, 46 mm or 69 mm. It is seems an inevitable inference that the thickness of the backing layer used by Dr Sameti does not alter the opacity index.
Dr Sameti tested the opacity of a 23 mm layer of polyester, as well as two sheets laid on top of each other (i.e. 46 mm thickness) and three sheets laid on top of each other (i.e. 69 mm thickness). In each case, the opacity was 0%. It is clearly reasonable to infer that the difference in thickness of the backing layer would have no significant impact on the overall opacity of the device.
c) The adhesive layer: The citation refers to Acronal V 205. Dr Sameti used BASF Acronal DS 3618, which he says is the “successor product to Acronal V 205”. Unless there is some evidence that Acronal DS 3618 is substantially different to Acronal V 205, it is reasonable to proceed on the assumption that it is a similar product having a similar opacity index.
It is clear that the results obtained by Dr Sameti are highly relevant. The results provide a sound basis to conclude that the device of System 7 device has an opacity index of 0%.
Turning now to the device of System 10, its preparation can be summarised as follows:
“2.4 g nicotine was added to 91.6 g polyisobutylene-type gel composed of 2.0 g Oppanol 10, 1.5 g Oppanol 50, 1.0 g Oppanol 120 dissolved in 30 ml hexane whereafter 2.0 g liquid paraffin was added to give the drug gel. The drug gel was solvent cast onto a polymer sheet 75 mm thick by means of the coating machine in a 0.8 mm layer. After drying at room temperature adhesive preparation 1 (example 4) was laminated onto the gel coated sheet. The lamination was accomplished by solvent casting adhesive preparation 1 onto a siliconised polyethylene foil in a 100 mm layer, drying at room temperature … The resulting sheet with backing layer, reservoir layer and adhesive layer was 293 mm thick. The concentration of nicotine was determined to 0.8 mg cm-2”
Dr Sameti did not attempt to prepare a device according to System 10. Consequently, any conclusions as to the opacity index of the device are an inference. Oppanol is a product that is described as transparent (in product sheets provided in the request for re-examination). The polymer sheet used in the citation is Mylar type D, which is also described as transparent (in product information sheets provided in the request for re-examination). The product assembled is very similar to that in System 10, which has an opacity index of 0%. Without preparing a product it is not possible to know with certainty what its opacity index would be. However, the use of transparent integers to produce a device of similar construction to that of System 7 leads to a very strong inference that the System 10 device would have an opacity index of close to 0%. In the face of a strong inference, the patentee needs to present a credible doubt, for instance by either repeating the work or performing a sound theoretical analysis. In the absence of technically based doubt, it is very unlikely that System 10 would have an opacity index of greater than 48.6%. I am satisfied that it is clear that System 10 would have an opacity index of close to 0%.
It is now necessary to consider whether the citation contains information about the transparency of the systems. I have been unable to find any reference in the citation to this aspect of the device. The device is constructed of materials that are in fact transparent, even though this is not stated as such. A person reading the citation would be capable of repeating the examples, and I expect they would have appreciated that System 7 and System 10 are composed of transparent materials. This is a property that is apparent to the naked eye, and does not require any sophisticated analysis. I consider that transparency of the components of the Systems is a property this is apparent to a “practical standard” to a reader of the citation.
(ii) Stability of nicotine in the device in the citation
Figure 7 of the citation shows the permeation of nicotine across the epidermis for System 10. The specification at page 31 explains the results as:
“System 10 revealed a curve-linear profile and the active substance permeated very fast as about 80% of the dose is released in about 30 hours”
The patentee submitted that an 80% release indicates that there is up to a 20% degradation, and that this cannot be regarded as “substantially preventing degradation”. The specification provides no definition of substantial degradation, and gives no examples of the degradation level in the examples. In the absence of any guidance in the specification, this term must be construed according a common sense interpretation. Clearly, it is not necessary that there be no degradation of nicotine. In my view, the intention of the claim is to exclude devices where the degree of degradation makes the device unsuitable for use. Where no more than 20% is degraded, it seems to me that this is a substantial prevention of degradation. I consider that the device in the citation possesses this feature.
Figure 4 of the citation shows the in vitro release of nicotine for System 7. It is apparent that approximately 70% of the nicotine was released in a period of 4 hours. At most there is a 30% degradation of nicotine (although if the measurement in the Figure were extended to longer time periods, it may that an even smaller level of degradation is revealed). From a technical point of view, the loss of 30% of the active substance would be less efficient, but I cannot see how this would not be suitable for use. The majority of the nicotine is delivered in a controlled manner. I consider that even if a maximum of 30% of the nicotine was degraded, this would still be a substantial prevention of degradation.
The citation does not state that the nicotine is stable, but equally does not say that the nicotine is degraded. In my experience, a document dealing with a medical device should be approached on the basis that the stability of the active agent is assumed unless there is a good reason to think otherwise. I conclude that it is apparent from the citation that the nicotine is stable, to the extent of at least 70 or 80%.
(iii) Is skin colour visible
The opacity index that is used in the claims of the patent seems to have been selected by studying certain known devices. A device with an opacity index of 48.6% (i.e. the Minitran® system) was “clearly visible from a distance of about 5 feet”, whereas an opacity index of 20.21% (i.e. the Alora® system) was “extremely inconspicuous”. The patent asserts, quite reasonably, that a low opacity index leads to the device being less noticeable, which I understand to mean that the skin colour of the wearer is visible through the device. It seems likely that this feature is really just a restatement of the low opacity index feature, and is not an additional feature in its own right.
However, on the assumption that this is an additional feature, I consider it is clear from the specification that a low opacity index (less than 20%) would produce a device that is not clearly visible and the skin colour of the wearer is visible. The devices in System 7 and System 10 have a very low opacity index, close to 0%. I have no doubt that it is a sound technical inference that the skin colour of the wearer would be visible through these devices. While the citation makes no reference to skin colour being visible, I have already noted that transparency is apparent in the citation to a practical standard. I cannot see how it could be correct that the citation makes it apparent that the devices are transparent, but does not make apparent the obvious consequence of transparency.
Conclusion
It is clear that the devices exemplified in Systems 7 and 10 of the citation possess all of the features of the invention claimed in claim 1, and those features are apparent in the citation. Consequently claim 1 lacks novelty. Claim 6 has the extra feature that the opacity index is less than 35.11%, and claim 7 has the feature that the opacity index is less than 20%. Based on my conclusions above, it is clear that these claims also lack novelty. According to section 101(1), the Commissioner may, by notice in writing, revoke a patent either wholly or so far as it relates to a particular claim(s). However, this is qualified by subsection (2) – I must not revoke unless the patentee has been given a reasonable opportunity to amend. In the present case the examiner issued three re-examination reports, and the patentee has had several opportunities to amend. Accordingly there is no barrier under section 101(2) to revocation, and this decision represents written notice that I revoke the patent so far as it relates to claims 1, 6 and 7.
Pursuant to section 101(4), the patent can appeal this decision to the Federal Court.
Dr S.D.Barker
Delegate of the Commissioner of Patents
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