Minnesota Mining and Manufacturing Company v Adhesives Research, Inc
[2002] APO 6
•1 February 2002
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 702593 in the name of MINNESOTA MINING AND MANUFACTURING COMPANY
Title: Matrix for Transdermal Drug Delivery
Action: Opposition by ADHESIVES RESEARCH, INC. under Section 59 of the Patents Act 1990
Decision: Issued .
Abstract
The opponent raised the grounds of non-compliance with Section 40, lack of fair basis and lack of novelty in its opposition. Under Section 40/Fair Basis the opponent identified the use of the terms "compliance value" and "softener. Regarding use of the term "compliance value":
· The description in the opposed specification was found not to be lacking in sufficiency in respect of the measurement of compliance values.
· The claims were determined to have clearly set out the forbidden ground in respect of the term "compliance value".
· Claims found not to lack fair basis in failing to define an advantage of the invention.
Regarding use of the term "softener":
· The specification found to have an adequate disclosure of the meaning and scope of the term softener to enable the skilled addressee to work the invention.
· The definition of "softener' provided in the description cannot be read in a manner to exclude claims 19-20 from application of that definition.
The opponent was unsuccessful on the grounds of section 40/Fair basis.
In the matter of lack of novelty the opponent had stated that claims 19 and 20 were not novel in light of a mosaic of US 4732808 and EP 554106. They also submitted that claims 19 and 20 lacked novelty in light of the individual disclosure of EP 554106. Found that the disclosures of EP 554106 and US 4732808 cannot be considered as a single source of information when challenging the novelty of claims 19-20 in the opposed specification. Also determined that the disclosure of EP 554106 failed to disclose all the essential features of claims 19-20, in particular the feature of the compliance value had not been disclosed. Hence the opponent was also unsuccessful on the ground of lack of novelty.
Costs awarded against the opponent, Adhesives Research, Inc. and in favour of the applicant, Minnesota Mining and Manufacturing Company.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 702593 by MINNESOTA MINING AND MANUFACTURING COMPANY and an opposition under section 59 of the Patents Act 1990 by ADHESIVES RESEARCH, INC.
BACKGROUND
Patent Application No. 702593 was filed on 12 September 1995 under the provisions of the PCT by Minnesota Mining and Manufacturing Company (hereinafter referred to as 3M), claiming priority from a US basic application (US 305,833) filed 14 September 1994. The Australian application was advertised accepted on 25 February 1999.
Adhesives Research, Inc. (hereinafter referred to as ARI) filed a notice of opposition on 18 May 1999. The statement of grounds and particulars was filed on 17 August 1999. The service of evidence in support, evidence in answer and evidence in reply was completed on 10 October 2000.
The hearing was held in Canberra on 16 November 2001. Mr. David Catterns of Counsel instructed by Mr Gary Nock, patent attorney of Freehills Carter Smith Beadle represented the applicant. Mr Bruce Caine of Counsel instructed by Dr. Bruce Wellington, patent attorney of E.F. Wellington & Co. represented the opponent.
EVIDENCE
Evidence in support consists of declarations made by:
Bruce Stephen Wellington, patent attorney, EF Wellington & Co., dated 4 November 1999 and exhibits BSW-1 to 14.
Jane E Workinger, dated 12 November 1999 and exhibit JEW-1. She states that she possesses an Associate Chemistry degree and is currently the Analytical Department Manager at Adhesives Research, Inc., United States of America.
Michael J. Zajaczkowski, dated 12 November 1999 and exhibit MJZ-1. He states that he possesses a B.S. degree with a major in Polymer Science and is currently a Group Leader on a research project at Adhesives Research, Inc., United States of America.
Evidence in answer consists of a declaration made by Robert Paul Burford, dated 13 July 2000. He states that he possesses a PhD from the University of Adelaide and is currently serving as a Professor in Polymer Science at the University of New South Wales.
Evidence in reply consists of declarations made by:
Jane E Workinger, dated 6 October 2000.
Michael J. Zajaczkowski, dated 6 October 2000 and exhibit MJZ-2.
THE SPECIFICATION
The specification under consideration is the specification as advertised accepted on 25 February 1999. It commences by stating that the invention relates to drug containing matrices for use in transdermal drug delivery devices. It further states that the invention relates to pressure sensitive skin adhesives and also to pharmaceutical formulations involving a pressure sensitive skin adhesive layer.
The invention seeks to provide a device that achieves and maintains intimate skin contact between the skin and the drug-containing matrix. A further requirement is that the polymers used in the matrices must be able to comply to the surface of the skin and still release cleanly from the skin. The specification proceeds with a description of related prior art and sets out requirements for pressure sensitive adhesives ("PSA") used in transdermal drug delivery devices. In particular it indicates that PSAs require a balance of viscous and elastic properties which result in a four-fold balance of adhesion, cohesion, stretchiness, and elasticity. It further states that PSA products have sufficient cohesiveness and elasticity so that, despite their tackiness, they can be handled with the fingers and removed from the skin without leaving substantial residue.
The consistory statement repeats claims 1 and 19. In essence the invention consists of a copolymer comprised of two/three comonomers, a softener and a drug. The copolymer and softener also constitute the pressure sensitive adhesive of the invention. The description indicates that in order to achieve skin contact, clean release, preferred levels of adhesion, and resistance to cold flow the amount and structure of the comonomers in the copolymer, the inherent viscosity of the copolymer, and the amount and structure of the softener are selected such that the matrix has a compliance value (measured according to a test method set out later on in the description) in the range 2x10-6cm2/dyne to about 4x10-3cm2/dyne.
The specification proceeds to provide a detailed description of the invention including embodiments of the copolymers and macromonomer. This is followed by description of a Compliance Test Method to determine the compliance value referred to in the description and claims. The description then provides examples illustrating the invention. The specification concludes with 21 claims. I have set out below the main claims (1, 19 and 20) that were under attack by the opponent:
1. A transdermal drug delivery device, comprising:
(1) a backing;
(2) a matrix adhered to one side of the backing and comprising
(a) a copolymer comprising:
(i) one or more A monomers selected from the group consisting of alkyl acrylates containing 4 to 10 carbon atoms in the alkyl group and alkyl methacrylates containing 4 to 10 carbon atoms in the alkyl group; and
(ii) optionally one or more ethylenically unsaturated B monomers copolymerizable with the A monomer; and
(iii) a macromonomer, copolymerizable with the A and B monomers defined above and having a molecular weight in the range 500-500,000;
(b) a softener dissolved in the copolymer; and,
(c) if the softener is not therapeutically effective, a therapeutically effective amount of a drug,
wherein the structure and amount of the comonomers in the copolymer, the inherent viscosity of the copolymer, and the amount and structure of the drug and the softener are such as to provide the matrix with a compliance value in the range 2x10-11cm2/N to about 4x10-8cm2/N.
19. A pressure sensitive skin adhesive comprising:
(1) a copolymer comprising:
(a) one or more A monomers selected from the group consisting of alkyl acrylates containing 4 to 10 carbon atoms in the alkyl group and alkyl methacrylates containing 4 to 10 carbon atoms in the alkyl group; and
(b) optionally one or more ethylenically unsaturated B monomers copolymerizable with the A monomer; and
(c) a macromonomer copolymerizable with the A and B monomers defined above and having a molecular weight in the range 500-500,000; and
(2) a softener dissolved in the copolymer,
wherein the structure and amount of the comonomers in the copolymer, the inherent viscosity of the copolymer, and the amount and structure of the softener are such as to provide the pressure sensitive skin adhesive with a compliance value in the range 2x10-11cm2/N to about 4x10-8cm2/N.
20. A pressure sensitive skin adhesive according to Claim 19, wherein the B monomer or monomers comprise a functional group selected from the group consisting of carboxylic acid, carboxylic acid ester, hydroxy, sulfonamide, urea, carbamate, carboxamide, amine, oxy, oxo, and cyano.
STATEMENT OF GROUNDS AND PARTICULARS
ARI filed a statement of grounds and particulars on 17 August 1999. They contended that the invention lacked novelty, was obvious and did not constitute a manner of manufacture. They also submitted that the specification did not comply with the requirements of section 40.
At the Hearing ARI said that they would pursue only, the grounds of non-compliance with section 40 and lack of novelty.
SUBMISSIONS
I shall refer to the submissions from the opponent and applicant wherever necessary in my decision.
DECISION
Section 40/Fair Basis
The opponent raised two issues in this regard. The first issue related to the term "Compliance Value" and the second issue related to use of the term "Softener".
Compliance Value
The opponent raised three issues regarding the term compliance value. I shall call the issues CV-1, CV-2 and CV-3. The issues 1 & 2 raised by the opponent were:
An addressee of the 3M specification is unable to:
1. carry out the alleged invention purported to be defined in the claims of that application (CV-1), or to
2. determine whether those claims have been infringed (CV-2);
because of the requirement that:
(i) the claimed matrix (claim 1); and
(ii) the pressure sensitive adhesive (claims 19 and 20) must possess the requisite "compliance value".
This value is indefinite and does not therefore permit the public (e.g. a competitor) to ascertain the scope of the alleged invention.
Issue CV-1
This issue relates to sufficiency of description of the invention. This concept was discussed in Universal Oil Products v Monsanto, (1973) 46 ALJR 658, Gibbs J. stating:
"The specification is sufficient if the patentee makes the nature of his invention, and how to perform it, clear and intelligible to persons having a reasonably competent knowledge of what was known before on the subject to which the patent relates, and having reasonably competent skill in the practical mode of doing what was then known."
There is no dispute regarding the nature of the invention and hence the issue relates to the performance of the invention. In support of their contention that the skilled addressee was unable to perform the invention the opponent made a number of submissions, which were addressed by the applicant's declarant, Professor Burford, in evidence in answer. In evidence in reply the opponent's declarant Ms Workinger still maintained some of her previous submissions. I shall consider the submissions of both parties (directed to the same matter) on an individual basis to resolve the matter relating to lack of sufficiency.
Opponent's submission 1 stated:
1. The test method by which "compliance value" is determined is not one which is standard in the industry.
The applicant did not contest this statement.
The opponent's second submission stated:
2. The testing apparatus required to conduct such tests is neither commercially available nor can it be purchased (both confirmed by 3M's US attorneys).
The applicant did not contest this statement.
The opponent's third submission had three parts (3(a)-(c)) and I shall deal with each part individually. The first part was:
3. The testing apparatus required to conduct such tests is not able to be prepared on the basis of the disclosures contained in the 3M specification. In particular:
(a) Even if the addressee of the opposed specification attempted to construct such a test apparatus with the information provided by the specification, given the variables involved it would not be possible to determine with any degree of statistical confidence whether an adhesive exhibits "compliance values" within the range of "compliance values" in the accepted claims of the opposed specification. Such a comparison could only be made, if at all, by use of the identical test apparatus and procedure used to calculate the compliance values in the above claims. Clearly, it is only when the tests are conducted under the same test conditions that the compliance value data obtained from the test will have any validity. By way of comparison, the "oscillatory" compliance value tests that the addressee of the opposed specification may conduct require, among other standards, standard diameters of parallel plates and adhesive sample thicknesses. Without such "standardization" of the test procedures, the results of the test would be suspect and incapable of comparison with other test results.
The applicant's declarant, Professor Burford provided a detailed response to the above issue. He responded to item 3(a) as follows:
1. At page 15, the 3M Patent sets out a compliance test method by which a compliance number can be obtained using an equation provided there. The units in that equation are defined at the end of page 15 and beginning of page 16. The term "J" is the compliance value described in claim 1 of the 3M patent. On the right hand side of the equation are provided "A", which is the area of one face of the test sample and "X", which is the displacement of the sample being measured during the test. While AX is not outlined in the prescriptive fashion, it becomes evident that this will fall within a range controlled by J, H and F. H is the thickness of the adhesive and guidance to its value is provided in column 8 of the US Patent 4,737,559 (Kellen), as disclosed on page 15 of the 3M patent. The value F is typically, but not necessarily, 500 grams so that we now have boundaries within which the product of A and X would fall.
It is evident that with a wide range of J values, the reader is given a degree of latitude as to the optimal value of A. Therefore in my opinion, the reader would understand that the displacement, X would have to be sufficient to be able one to obtain a reading but not so great that the centre plate runs out of travel. The Kellen patent column 8 line 67 provides some guidance as to the extent of X by stating as follows:
"A suitable weight (one sufficient to measurably deform the sample a distance no greater than its thickness)."
In my opinion, X is the measured variable obtained during the experiment for which one ultimately obtains the value of compliance. The experiment would be performed so that X falls within a range which is neither too low to render the measurement inaccurate, nor too large as this would reflect excessive displacement of the non-stationary plate. It is evident from this equation that X could be controlled either by selection of A: the area of one face of the test sample, or (more conveniently), the selection of F: the force applied to the sample during the test.
2. Any minor experimental error could be established by the use of secondary laboratory standards, as is commonly practiced in inter-laboratory comparisons by allied polymer industries. A standard polymeric material, for which known viscoelastic properties are provided, can be employed to reduce any uncertainties in values obtained with different items of equipment. Such methods are routinely conducted between individual laboratories.
3. The description provided in this patent, together with the supplementary information provided by the Kellen Patent, provides sufficient information for me to obtain a working value of the compliance J. I am aware that compliance values are dependent upon temperature and time. In this patent the time is prescribed precisely and the compliance value obtained would ordinarily be associated with a nominated test temperature.
4. The adhesive material of the drug delivery device of the 3M Patent would show long relaxation times. On this basis transient methods such as creep compliance methods or stress relaxation techniques are appropriate and in the present case the 3M Patent describes such a method. Oscillatory methods such as the dynamic mechanical analysis technique preferred by Jane Workinger may also be suitable particularly if low frequencies are used. However the method provides no fundamental advantage over that used by 3M and further, in my opinion, simulates less the mode by which the adhesive would behave in the transdermal patch application.
The opponent's evidence in reply accepted the technical submissions of the Professor but still raised issues of a standard testing apparatus and standard testing materials. I shall consider the disclosures of the opposed specification and the Kellen Patent (which is incorporated by reference into the opposed specification) in regard to the compliance test. The apparatus described for the test is fairly simple and I am satisfied that the skilled addressee would have no difficulty in constructing such an apparatus. Professor Burford has given a detailed explanation of the values of the various variables and their impact on each other. In the matter of standardisation, he has also indicated how standardisation of equipment is carried out by the use of standard polymeric materials. I do not consider that a skilled addressee would be unable to construct and operate such an apparatus from the details given.
The opponent's submission 3(b) stated:
(b) The 3M claims fail to define the time period over which the compliance should be measured (i.e. how long the weight is permitted to hang from the adhesive sample during the test procedure). Without knowledge of the time period over which the compliance value of a prior art adhesive composition is intended to be obtained, a valid comparison with a stated range in the claims is not possible.
The professor responded as follows:
"I am aware that compliance values are dependent upon temperature and time. In this patent the time is prescribed precisely and the compliance value obtained would ordinarily be associated with a nominated test temperature."
As the term "compliance value" has no plain meaning in the claims one may refer to the specification to determine its meaning. In this regard, see the teaching of the Courts below:
"The words of a specification should generally be given their ordinary English meaning (Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 at 478). The exception to this is that where a word or expression has a special meaning in the relevant art, then the specialised meaning should be adopted (Electric & Musical Industries Ltd v Lissen Ltd (1939) 56 RPC 23 at 41). Another exception to the plain meaning rule is that the specification may indicate that a special meaning is to apply. This is known as the dictionary principle (British Thomson-Houston Company Ltd. v Corona Lamp Works Ltd., (1922) 39 RPC 49 at page 67)."
The description has provided a definition which is consistent with the "Dictionary Principle". The description at page 10, lines 24-25 states:
"…a compliance value (measured according to the test method set forth in detail below)…"
And at page 15, line 2 onwards:
"The compliance values given in the examples below were obtained using a modified version of the Creep Compliance Procedure described in U.S. Pat. No. 4,737,559 (Kellen), the disclosure of which is incorporated herein by reference."
The Compliance Test Method set out at page 15 of the opposed specification clearly discloses a time period of exactly 3 minutes (see lines 23-24). I do not see a need for the claims to include this feature as the description has set out the manner in which the compliance value is to be measured. Thus I consider that a valid comparison of the measured compliance value with a stated range in the claims is possible.
The opponent's submission 3 (c) stated:
(c) The amount of "compressive" force which is applied to the adhesive during the test procedure (i.e. while determining the compliance value) is not provided.
The professor responded as follows:
"It is not critical to the results of the compliance test that the force applied to compress the interposed layers of the skin adhesive be exactly quantified. Due to the tolerances involved, it is my belief that a satisfactory result for an adhesive's compliance value can be determined by compressing the adhesive layers by 10%. The way in which the layers of adhesive are prepared by compression within the equipment are not ambiguously outlined or described. Compression of the layers of a magnitude of 10%, can be readily measured with commonly available workshop tools."
The 3M specification does not directly provide the value of the compressive force but the Kellen patent (incorporated by reference) in the test method does indicate that the test sample of adhesive is compressed 10%. I do not think any inventive effort would be required to work out the compressive force to achieve a compression of 10% of an adhesive test sample.
Overall I do not see any deficiencies in the specification which lead to a lack of sufficiency. I am satisfied that the skilled addressee would be able to construct and operate an apparatus to measure creep compliance values.
Issue CV-2
The second issue raised by the opponent related to the claims setting out the forbidden ground. In particular two aspects relating to this were raised as follows:
· The public is not capable of independently determining whether a pressure sensitive skin adhesive possesses compliance values which fall within the scope of those claims.
· The compliance value limitation in claims 1 and 19 is so indefinite that the public is not capable of determining the scope of those claims.
Both aspects relate to the scope of the claims and in particular the range of compliance values defined therein and what values would be encompassed by those ranges. In the matter of claims defining the monopoly I shall refer to the teaching of the courts. Thus in AMP v Utilux, (1971) 45 ALJR 123 at page 128, McTiernan J. states:
"The description of the invention is not the definition of it. A claim is a portion of the specification which fulfils a separate and distinct function. It, and it alone, defines the monopoly; and the patentee is under a statutory obligation to state in the claims clearly and distinctly what is the invention which he desires to protect."
Further, the full bench of the High Court indicated on appeal (see AMP v Utilux, (1974) 48 ALJR 17) that:
"…the definition of any invention must be found in the claims read with the specification as a whole."
The teaching in Electrical and Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23 at 39 indicates that the purpose of a claim is to:
"…define clearly and with precision the monopoly claimed so that others may know the exact boundaries of the area within which they will be trespassers. Their primary object is to limit and not extend the monopoly."
The issue thus lies in what is encompassed by the term "compliance value" in the claims. I shall consider the opposed specification to determine if the term "compliance value" and its scope are clearly defined in the claims and description.
The independent claims 1 and 19 define "a compliance value in the range 2x10-11cm2/N to about 4x10-8cm2/N." Thus a range of values with definite end points is clearly specified. None of the declarants have identified any difficulties in understanding the range specified for compliance values. Thus the scope of the invention with regard to an actual compliance value range has been clearly defined in the claims. The opponent is not concerned about the exact values specified but is worried about the variations arising when the skilled addressee proceeds to practise the invention using non-standard equipment and materials which could generate values lying outside the ranges specified yet practise the invention. The description provides some guidance in this matter at page 10, line 28 onwards:
"Compliance values outside the broad range recited above sometimes are obtained from materials that are suitable matrices, and even for some that are suitable for use as pressure sensitive skin adhesives. However, those matrices having substantially lower compliance values will generally be relatively stiff and have less than optimal skin contact and adhesion to the skin. Those having substantially higher compliance values will generally have less than optimal cold flow and might leave substantial residue when removed from the skin. Also, a matrix of the invention that is intended for use as a pressure sensitive skin adhesive preferably has a glass transition temperature of -10oC or lower."
I shall now proceed to resolve the matter regarding issues arising out of the use of nonstandard equipment and materials. Professor Burford has provided detailed submissions relating to construction of the apparatus, standardization of the apparatus and how the variables relating to the compliance value can be controlled/altered to obtain the compliance values. The opponent has accepted the submissions of Professor Burford regarding the manner in which standardisation may be carried out but is still of the view that as long as:
· the exact same apparatus is not available
· and no standard material has been specified
then the compliance values cannot be accurately measured and the ranges within which the forbidden ground lies cannot be determined.
I have considered the arguments from both sides. I note that the creep compliance procedure is disclosed in detail in the Kellen patent. Further the Kellen patent has provided reference to various texts and documents which discuss the fundamentals of creep compliance. Professor Burford has provided detailed reasoning of how the skilled addressee would go about using the apparatus including how it may be standardised. The 3M specification has provided information
on how varying the content of the various components of the matrix would cause the compliance value of the product to either fall within or outside the specified range. The specification also indicates how such matrices would behave (see page 10, line 28 onwards). I have also considered the disclosure relating to construction of the apparatus and do not find it particularly complex. I note that the opponent is not saying that it cannot construct the apparatus but rather that if they did it would need to be standardised. The opponent says that they are not aware of any particular standard testing material suitable to determine creep compliance and that the applicant has not disclosed an example of such a material. The opponent accepted Professor Burford's basic premise of the use of secondary laboratory standards using a standard polymeric material with known visco-elastic properties. I note that the applicant's declarant, Ms Workinger is not a skilled addressee in the relevant art in Australia. Professor Burford is highly experienced in the polymer arts and is a skilled addressee in the art in Australia. Accordingly I shall place greater weight on his submissions. In the circumstances I accept that Professor Burford's declaration:
"The description provided in this patent, together with the supplementary information provided by the Kellen Patent, provides sufficient information for me to obtain a working value of the compliance J."
is true for the person skilled in the art in Australia at the relevant date.
In regard to the issue of terms in the claim not clearly setting out the forbidden ground, the court in Glaverbel SA v British Coal Corp, [1994] RPC 443 at 495 taught:
"The court will give little weight to puzzles which may arise 'at the edge of the claim' if those puzzles would not, as a practical matter, cause difficulty for the skilled addressee or manufacturer wishing to satisfy himself that what he proposes to do will not infringe that patent."
Professor Burford has shown that that the puzzle regarding compliance values which lie in the forbidden territory can be dealt with by the skilled addressee using non-inventive techniques to determine the forbidden ground. In these matters the onus is on the opponent to provide evidence supporting their case. The opponent has not provided evidence to show that they attempted to work the invention to show that the compliance values were indefinite but were unable to do so and the reasons if any as to why they were unsuccessful. The standard of proof required is the civil standard, that is, the balance of probabilities (see the teaching of the Court of Appeal in Dunlop Holdings Ltd's Application (1979) RPC 523). The Commissioner is functioning as a tribunal and any benefit of doubt in the validity of the patent is accorded to the applicant/patentee. Ms Workinger has raised a couple of issues but has not provided supporting evidence to show that the claims have not defined the monopoly sought. Professor Burford's technical submissions have been accepted as valid (but with provisos mentioned above) by Ms Workinger. Accordingly, in light of all the evidence discussed above, I consider that the claims in the opposed specification have set out the monopoly in respect of compliance values. This finding resolves the issues raised in item 2 of the opponents submissions regarding the compliance value.
Issue CV-3
In regard to the third issue the opponent submitted that:
The "compliance value" which has a range of 2000 (i.e. 2 x 10-11 to 4 x 10-8) is dependent upon:
(i) the structure and amount of co-monomers in the co-polymer;
(ii) the inherent viscosity of the co-polymer; and
(iii) the amount and structure of the:
(a) softener (claim 19);
(b) softener and drug (claim 1)
The only variable amongst the five variables described above that relates to the quantity of softener is the amount described in (iii) above. This will not necessarily result in a "heavy loading with oily excipients". Yet if the product of the 3M invention is not so limited the claims are not fairly based. Items (i) and/or (ii) and/or the structure of (iii) could be arranged so that there is a low level of softener yet meet the compliance value as claimed.
The opponent has referred to a disclosure at page 10, lines 21-28 and compared it with a disclosure at page 3, lines 11-15 of the opposed specification. I shall look at the specification to resolve this issue. The disclosure at page 3 of the opposed specification states:
"The invention provides a transdermal drug delivery device that allows dissolution of drug and relatively heavy loading with oily excipients, maintains contact with the skin, and can be removed cleanly from the skin. The pressure sensitive skin adhesives of the invention provide these advantages (my emphasis) and in addition adhere to the skin."
Thus the " relatively heavy loading with oily excipients" has been clearly identified as an advantage but not been specified as being essential to the working of the invention. The description and claims indicate that the invention lies in a combination of the various components producing a matrix with a compliance value within a specified range. In particular the description (see page 10, lines 20-26) indicates that in order to achieve skin contact, clean release, preferred levels of adhesion, and resistance to cold flow the amount and structure of the comonomers in the copolymer, the inherent viscosity of the copolymer, and the amount and structure of the softener are selected such that the matrix has a compliance value (measured according to a test method set out later on in the description) in the range 2x10-6cm2/dyne to about 4x10-3cm2/dyne. The relatively heavy loading with oily excipients (the softener of the inventive composition) is not disclosed as being the only advance of the invention over the prior art. It is one of several advantages, but needs to satisfy the requirement of compliance values as clearly set out in the description and claims. Hence, the claims do not travel beyond the disclosure of the invention as set out in the description and supported in the examples. I do not consider that the claims are lacking in fair basis.
I shall now consider the second issue relating to Section 40/Fair Basis regarding use of the term "Softener".
Softener
The opponent raised two issues. The first issue related to the meaning and scope of the term softener. The following submissions were made regarding the first issue:
1. An addressee of the 3M specification is unable to work the alleged invention purported to be defined in the claims of that application or to determine whether those claims have been infringed, having regard to the word "softener" in those claims. The 3M specification defines "softener" in the paragraph on page 8 at lines 29-32 reading:
"A matrix of the invention further comprises a softener. The softener is dissolved in the matrix. As used herein the term "softener" refers to a generally oily material that raises the compliance value or lowers the glass transition temperature (Tg) of the matrix compared to the copolymer."
2. According to this definition, the "softener" of claim 1 is:
"a generally oily material that raises the compliance value or lowers the glass transition temperature (Tg) of the matrix"
referred to in item (2) [actually item (2)(b)] of the claim, "as compared to the copolymer" referred to in item (a) [actually item (2)(a)] of the claim. However, the range of materials embraced by the term "softeners" in claim 1 is indefinite having regard to the uncertainty of the scope of the expression "compliance value" which forms part of the final integer of claim 1. The obscurity is compounded by the use of the open ended words "generally", "oily material", "raises" and "lowers" in that purported definition.
3. The 3M specification fails to shed any useful light on the precise nature or scope of compounds embraced by the term "softener" in claims 1-15 and 19, 20. The following passages in the 3M specification refer to "softness" in such broad terms as to be wholly unhelpful:
(a) page 8, lines 33-34, reading:
"Suitable softeners include certain materials that have been used as skin penetration enhancers or solubilizes (sic) in transdermal drug delivery systems.",
having regard to the use of the words "include certain" in that sentence, aside from the presence of the word "suitable";
(b) page 9, lines 1-16, reading:
"Exemplary materials include……are also suitable, as are solubilizes (sic) such as……Likewise certain drug substances function as softeners, including……",
having regard to the use of the words "include", "such as" and "certain" in that passage, aside from the presence of the word "exemplary" and "suitable";
(c) pages 9-10 reading:
"While many of the softeners enumerated above are known to effect skin penetration rate, certain softeners affect aspects of performance other than and in addition to skin penetration rate. For example, they are useful in softening or increasing the compliance value and/or lowering the glass transition temperature of otherwise non-compliant (and therefore non-pressure sensitive adhesive) copolymers, rendering them suitable for use as pressure sensitive skin adhesives. However, the softeners enumerated above are generally oily substances that function as plasticizers when incorporated in a copolymer. Such materials can affect adversely the performance of a transdermal matrix, for example by softening it to the point of cohesive failure (where substantial copolymer residue is left on the skin upon removal of the device from the skin), or by separating from the continuous phase and forming an oily layer that reduces adhesion of an otherwise adhesive matrix. Also, certain softeners (e.g. glyceryl monolaurate, N,N-dimethyldodecylamine-N-oxide) can crystallize in the copolymer, resulting in unstable properties (e.g. unstable drug delivery rates in a transdermal drug delivery device).",
having regard to use of the words "certain" and "For example" in that passage.
The applicant indicated that this matter had not been raised in the statement of grounds and particulars, but they were prepared to deal with the issue. They made the following submissions:
1. No evidence had been provided by the opponent showing that they were unable to work the invention in view of the difficulties they had outlined with regard to their understanding of the term "softener" and its scope.
2. The High Court teaching in Kimberly-Clark (supra) stated:
"The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?"
The Court thus referred to an enabling disclosure. The specification has named a number of suitable softeners and provided practical examples. The specification has thus provided an enabling disclosure.
I shall refer to a relevant rule of construction which in essence states that the body of the description is construed as a technical document. In particular the teaching from Décor Corp v Dart Industries 13 IPR 385 at 400 states:
"The body, apart from the preamble, is there to instruct those skilled in the art concerned in the carrying out of the invention; provided it is comprehensible to, and does not mislead, a skilled reader, the language used is seldom of importance."
The descriptive part of the specification is more particularly a technical disclosure, and is construed with particular regard to the person skilled in the art. In particular the teaching of Bennet J in Unifloc Reagents Ltd v Newstead Colliery Ltd 60 RPC 165 states:
"But the body of the specification is a document giving working instructions to working men - highly skilled working men with high technical qualifications, no doubt, in the case of many modern fields of industry. It is to such persons and not to grammarians or lawyers or even expert witnesses that specifications are considered to be addressed, and they ought not, I think, to be construed as if they were acts of Parliament or conveyances or wills or instruments of that description. The working man in whose hands the specification is assumed to have been placed must also, I think, be assumed to be a man who is going to try to achieve success and not one who is looking for difficulties or seeking failure."
None of the expert witnesses have indicated any difficulty with the scope and meaning of the term "softener" in the opposed specification. As the applicant has stated, the description has provided several specific examples of the softener (see page 9, lines 9-19) as well as examples illustrating the invention where the softener is one of many components. The opponent has not provided any evidence that "an addressee of the 3M specification is unable to, either work the alleged invention purported to be defined in the claims of that application or to determine whether those claims have been infringed, having regard to the word "softener" in those claims." I consider that the specification has provided an adequate disclosure of the meaning and scope of the term softener to enable the skilled addressee to work the invention.
I shall now consider the second issue raised relating to the use of the term softener. The opponent submitted that:
"The definition for "softener" in the specification of the opposed application as set out above (i.e., opponent's item 1 above) is not seen to be relevant to claims 19-20 as those claims do not refer to a matrix, in contrast to claim 1."
The applicant submitted:
"The skilled reader knows what is a matrix and what is a softener."
I note that none of the declarants have expressed any difficulty in this regard. A proper reading of the description discloses the composition of the matrix and its relationship to the softener. In particular the description at page 3, lines 26-28 states:
"The matrix is preferably a pressure sensitive skin adhesive. In addition, the matrix (whether adhesive or not) can be removed cleanly from the skin."
The specification as a whole indicates that the matrix could be a pressure sensitive skin adhesive comprising the copolymer and softener OR an adhesive comprising the copolymer and softener plus drug (see page 14, lines 5-10). Claims 19-20 do not refer to a matrix, but the description has made clear what the term matrix encompasses and the term matrix must be read accordingly when used in the definition of softener. Claims 19-20 have defined the components of the matrix individually, that is the copolymer and softener. I do not consider that the definition of "softener' provided in the description can be read in a manner to exclude claims 19-20 from application of that definition.
Novelty
The opponent confined their attack to claims 19 and 20. They contended that these claims lacked novelty when compared with the combined disclosures of US4732808 and EP 554106. They contended that EP 554106 could be read together with US 4732808 as per section 7(1)(b) of the Patents Act 1990. They also contended that claims 19-20 lacked novelty when compared with the individual disclosure of EP 554106.
The reverse infringement test from Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1976) 137 CLR 228 at 235 sets out the basic test for anticipation or want of novelty:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement."
It follows from the reverse infringement test that if a citation discloses all the features of the claim, the claim will lack novelty. If the citation does not disclose all the features of the claim, the claim will still lack novelty provided the citation discloses all the essential features of the claim; but if the essential features are not disclosed in the citation, the claim is novel (Nicaro Holdings v Martin Engineering 16 IPR 545 and Catnic Components Ltd v Hill and Smith Ltd (1982) RPC 183).
I shall begin by assuming that all features of the independent claims are essential (Catnic Components Ltd v Hill and Smith Ltd (1982) RPC 183). Claim 19 has the following features:
1. A pressure sensitive skin adhesive comprising:
2. A copolymer comprising:
3. One or more A monomers selected from the group consisting of alkyl acrylates containing 4 to 10 carbon atoms in the alkyl group and alkyl methacrylates containing 4 to 10 carbon atoms in the alkyl group; and
4. Optionally one or more ethylenically unsaturated B monomers copolymerizable with the A monomer; and
5. A macromonomer copolymerizable with the A and B monomers defined above and having a molecular weight in the range 500-500,000; and
6. A softener dissolved in the copolymer,
7. Wherein the structure and amount of the comonomers in the copolymer, the inherent viscosity of the copolymer, and the amount and structure of the softener are such as to provide the pressure sensitive skin adhesive with a compliance value in the range 2x10-11cm2/N to about 4x10-8cm2/N.
I shall consider the novelty of claims 19 and 20 of the opposed specification based on:
· A mosaic of EP 554106 and US 4732808 (providing the relevant criteria for a permissible mosaic are satisfied), and
· EP 554106 on its own
EP 554106 & US4732808
First I shall determine if a mosaic of the two documents is permissible in the circumstances. The opponent referred to the relevant parts of Section 7, which states:
"(1) For the purposes of this Act, an invention is taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a)…
(b) prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information;…"
The opponent then referred to the teaching of Gummow J in Nicaro Holdings Pty Ltd v Martin Engineering Co, 16 IPR 545 at 570:
"Plainly, the degree of connection which is stated to exist in the documents themselves will be important. It is difficult to see how mere identification of prior patents as related or prior art would bring them sufficiently closely together for the purpose under consideration here. Again even where there is a further description of the prior publication, it may nevertheless be that the purpose of the reference is to direct the reader away from it, as disclosing something outmoded or defective."
The opponent stated that EP 554106 (the '106 patent) in the name of Adhesives Research Inc., (the opponent in this matter) was published one year before the opposed specification. US 4732808 (the '808 patent) in the name of 3M (also the applicant in this matter) was published six years before the opposed specification. The opponent then drew attention to the evidence in support of their contention as follows:
1. At page 2, line 35 the '106 patent refers to the '808 patent and a further 13 US patents in referring to known polymeric compositions comprised of backbone polymers having grafted thereto pendant polymeric moieties, and then states:
"Typical of the type of polymeric compositions disclosed in the above patents are compositions comprised of a backbone polymer such as an acrylic or methacrylic backbone polymer having attached thereto a graft polymer comprised of a polymerizable macromolecular monomer such as styrene or alpha-methylstyrene."
2. In discussing the '808 patent in particular as well as discussing four of the above US patents, the '106 patent states at page 2, line 58:
"US 4732808 is directed to a macronomer(sic)-reinforced pressure sensitive skin adhesive comprised of a macromer reinforced acrylate copolymer."
3. The European inventors then state that those cited US patents suffer from the disadvantage that adhesive failure may occur after only a short time. Further, none of the cited patents disclose water-inactivatable, pressure-sensitive adhesives.
4. However, against that backdrop the European inventors go on to suggest that a solution to such problems is described in a further US patent ('637) directed to use of a water-soluble tackifying agent in admixture with a hydrophilic based polymer.
5. The European inventors then state that the solution provided by the US '637 patent is enhanced or improved by using a water-soluble tackifying agent in admixture with a backbone polymer having a polymeric moiety grafted thereto, rather than the polymer of '637.
6. The European '106 patent teaches the use of the backbone polymer with a graft co-polymer in accordance with the teaching of US '808 patent together with a tackifyer (sic) (which include "softness" (sic) in 3M specifications).
7. Far from the European inventors teaching away from the use of the disclosure in US '808 patent, a person seeking to carry out the European invention would be directed to the US '808 patent as a basic source of information on co-polymers employed in the European invention.
8. The connection between the European '106 patent and the US '808 patent is evident from cross-referencing in the European patent to three US patents that are also cited in the body of the specification of the US '808 patent. The European patent also refers to an additional two US patents listed as references cited during the prosecution of the US '808 patent.
9. Indeed, the opposed 3M application acknowledges '808 as a basic source of information on macromonomers of the co-polymers of 3M at page 8, line 17 and page 24 line 25. It is also a basic source of information as to the preparation of the co-polymers in the 3M specification (see 3M specification, page 14 line 3), with those co-polymers being the same as those disclosed in the European patent.
I shall consider the matters raised above to determine if "the relationship between the documents is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information." I shall consider the disclosures of EP 554106 to determine its relationship with US 4732808. US 4732808 was published five years before the '106 patent and hence makes no mention of it. Thus I will have to determine from the '106 patent if it establishes a relationship with the '808 patent such that a person skilled in the relevant art in the patent area would treat them as a single source of that information.
The '106 patent makes reference to the '808 patent and similar patents as disclosing "compositions comprised of a backbone polymer such as an acrylic or methacrylic backbone polymer having attached thereto a graft polymer comprised of a polymerizable macromolecular monomer such as styrene or alpha-methylstyrene." It then gives details of adhesives of five patents including the '808 and then (page 3, lines 2 to 6) states that:
"Said adhesives have been found to suffer from the disadvantage that their adhesive properties are not sufficiently compatible for use with skin (due to inadequate long term tack), with the result that adhesive failure may occur after a short time due to movement of the skin.
Further, none of the above patents disclose water-inactivatable, pressure sensitive adhesives which may be readily inactivated once applied to the skin and which exhibit highly desirable tack when applied to the skin."
The '106 patent then suggests that US 5032637 provides a solution to the above problem but that while it enables many advantages to be achieved, it is still desirable to provide such a composition wherein the adhesive exhibits enhanced stability under conditions of use.
Declarant Zajaczkowski has asserted that:
"…the information in the specifications of EP 554106 and US 4732808 can properly be regarded as "a single source of that information" within the terms of Section 7(1)(b) of the Patents Act 1990. Thus, the relationship between the documents is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information."
In support of this contention reference is made to certain passages in the'106 patent as raised by the attorney. However in view of the disclosures I have reviewed I do not find any teaching in the '106 patent which would direct the skilled reader to use either all or part of the '808 disclosures in combination with the disclosures of the '106 patent. In fact the passages I have quoted from page 3 of the '106 patent clearly teach away from usage of the disclosures of the '808 patent. Thus the opponent has not established a relationship between the documents which would lead the skilled addressee to treat them as a single source of information. Accordingly, I will treat the prior specifications relied upon as independent documents. Consequently the disclosures of EP 554106 and US 4732808 cannot be considered as a single source of information when challenging the novelty of claims 19-20 in the opposed specification. As US 4732808 has not been raised as an individual citation for claims 19 and 20, I shall proceed to consider EP 554106.
EP 554106
I shall review the document to determine if it has disclosed the essential features of claim 19. I shall assess the disclosure of the features of claim 19 as set out below.
1. A pressure sensitive skin adhesive comprising:
The description and claims of the '106 patent reveal a pressure sensitive adhesive suitable for use on human skin.
2. A copolymer comprising:
3. One or more A monomers selected from the group consisting of alkyl acrylates containing 4 to 10 carbon atoms in the alkyl group and alkyl methacrylates containing 4 to 10 carbon atoms in the alkyl group; and
4. Optionally one or more ethylenically unsaturated B monomers copolymerizable with the A monomer; and
5. A macromonomer copolymerizable with the A and B monomers defined above and having a molecular weight in the range 500-500,000; and
The copolymer of feature 2 is comprised of three kinds of monomers specified as features 3, 4 and 5 with feature 4 being optional. Considering feature 3, '106 discloses:
· Page 3, lines 28-29, "…wherein monomer A is a monomeric acrylic or methacrylic acid ester of a non-tertiary alcohol having from 1 to 14, preferably, on average, 4 to 12, carbon atoms…"
· Page 4, lines 2-6, "Exemplary A monomers include, but are not limited to, esters of acrylic acid or methacrylic acid with 1-butanol, 1-pentanol,…"
· Page 7 onwards, examples, "Isooctyl acrylate (A monomer)…"
The opposed specification discloses at page 4, line 6 onwards: "…suitable alkyl acrylates and methacrylates are n-butyl, n-pentyl,…acrylates and methacrylates. Preferred alkyl acrylates include isooctyl acrylate,…" Thus monomer A is disclosed.
Looking at feature 4, '106 discloses:
· Page 4, lines 7-9, "Exemplary B monomers include, but are not limited to, one or more of acrylic acid, methacrylic acid,…acrylamide, methacrylamide,…diacetone acrylamide,…"
· Page 7 onwards, examples, "Vinyl Acetate (B monomer)…"
The opposed specification discloses at page 4, line 23 onwards: "Preferred B monomers include but are not limited to acrylic acid, methacrylic acid,…acrylamide, methacrylamide, diacetone acrylamide,…and vinyl acetate." Thus monomer B is disclosed.
Looking at feature 5, '106 discloses:
· Page 4, line 29 onwards discloses that the macromonomer is copolymerizable with the A and B monomers.
· Page 5, lines 37-38 discloses, "…the molecular weight of the graft polymeric moiety will be within the range of from 2,000 to 60,000…"
· Page 7 onwards, examples, "Polystyrene Methacrylate Macromer, Poly Alpha-Methyl Styrene Macromer."
· Page 7 onwards, the examples disclose Graft molecular weights ranging from 13,000 to 54,000.
The description of the opposed specification discloses:
·Page 5 line 15 onwards, "…a macromonomer…copolymerizable with the A and B monomers defined above and having a molecular weight in the range 500-500,000…"
·Page 6, line 16 onwards: "Suitable macromonomers include polymethylmethacrylate, styrene/acrylonitrile, and polystyrene macromonomers."
Thus the citation has disclosed polystyrene macromonomers (within the molecular weight range specified) which are an embodiment of feature 5. Thus feature 5 is disclosed.
6. A softener dissolved in the copolymer,
Regarding the softener, the opponent submitted that the tackifier referred to in the '106 patent was equivalent to the softener referred to in the 3M application. The applicant did not challenge this submission and the opponent showed that some of the tackifiers listed in the '106 patent were in fact the same substances as the softeners identified in the 3M specification.
The 3M specification disclosed softeners (see page 9) such as "polyethylene glycol, propylene glycol, diethylene glycol, glycerol, N-methyl pyrrolidone, isopropyl alcohol.
The '106 patent discloses at page 15, "polysorbitol, glycerol, polypropylene glycol, polyethylene glycol (including dipropylene and diethylene glycols).
Thus some softeners have been disclosed and consequently feature 6 has been disclosed.
7. Wherein the structure and amount of the comonomers in the copolymer, the inherent viscosity of the copolymer, and the amount and structure of the softener are such as to provide the pressure sensitive skin adhesive with a compliance value in the range 2x10-11cm2/N to about 4x10-8cm2/N.
The opponent had indicated that even though the feature of the compliance value had not been explicitly disclosed in the '106 patent, it was linked to the '808 patent which disclosed this feature. However I had considered the issue of reading of the '106 and '808 patents as a single disclosure and I had concluded that a person skilled in the art would not treat them as a single source of information. The opponent further submitted that:
· The '106 patent disclosed all the ingredients of the composition within the amounts claimed and hence the final product would inevitably arrive at the extremely broad compliance value claimed.
· Hence the '106 patent on its own renders claims 19 and 20 not novel.
I have considered the evidence regarding the various weight percentages of the ingredients within the composition and I am satisfied that the citation has disclosed ranges falling within those set out in the 3M specification. The applicant did not seriously challenge submissions relating to the disclosed ranges but did raise the issue of non-disclosure of the compliance value in the citation. I have considered the submissions of the declarants regarding the feature of the compliance value and the opponent's declarants did not identify any disclosure of the compliance value in the '106 patent. Neither did the declarants indicate that in their opinion:
"If the adhesive of the citation was prepared as directed then inevitably a product would be obtained that had a compliance value falling within the ranges claimed in the 3M specification."
I note that no such an assertion was made and more importantly, that; the opponent did not provide any concrete evidence (e.g. experimental results/laboratory tests) supporting such an assertion. The description of the opposed specification itself has made clear that not all compositions with ingredients having weights within the ranges specified will possess compliance values within the defined ranges. The embodiments in the description disclose several examples of compositions with ingredients within specified weight ranges wherein a defined compliance value is not attained. The opposed description at page 25 refers to results of examples 2-33 being shown in Table 1 wherein it states that "When the compliance was "not run", the formulation was too soft to be tested." Examples 19, 28 and 33 indicate that compliance was "not run". In particular the description at page 10 states:
"In order to achieve skin contact, clean release, preferred levels of adhesion, and resistance to cold flow the amount and structure of the comonomers in the copolymer, the inherent viscosity of the copolymer, and the amount and structure of the softener are selected such that the matrix has a compliance value (measured according to the test method set forth in detail below) in the range 2x10-6cm2/dyne to about 4x10-3cm2/dyne,"
Thus factors other than mere weight of each component need to be considered to obtain the requisite compliance value.
Thus EP '106 fails to disclose the feature of the compliance value and the opponent has not established that it would be an inherent feature. I conclude that claims 19 and 20 do not lack novelty in light of EP 554106.
SUMMARY
The opponent had raised the grounds of non-compliance with section 40 and lack of novelty against the opposed specification. The opponent has been unsuccessful on both grounds.
COSTS
Section 210 and regulation 22.8 gives the Commissioner power to award costs against a party to proceedings before the Commissioner.
Both parties submitted that costs should follow the event. I have found that the opponent has not established that
1. The opposed specification is defective on the basis of Section 40/Fair Basis
2. Claims 19 and 20 are lacking in novelty.
As the opponent has been unsuccessful in the matter I award costs against the opponent Adhesives Research, Inc. and in favour of the applicant Minnesota Mining and Manufacturing Company.
Jacob Elijah
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Freehills Carter Smith Beadle, Sydney
Patent attorneys for the opponent : E.F. Wellington & Co., Melbourne
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