Allergan Inc v Alcon Laboratories (Australia) P/L

[1995] APO 42

official notice

decision of a deputy commissioner of patents

Application        :    No. 588049 in the name of ALLERGAN, INC.

Title:    Method and Composition for the Simultaneous Cleaning and Disinfecting of Contact Lenses

Action:    Opposition by ALCON LABORATORIES (AUSTRALIA) PTY. LTD. to amendments made under section 104

Decision:    Issued            .

Abstract: Opposition succeeds. Amendments not allowable under section 102(1), 102(2)(a) and 102(2)(b). Section 59 opposition to proceed. Costs for counsel disallowed.

patents act 1990

decision of a deputy commissioner of patents

Re:Patent Application No. 588049 by ALLERGAN, INC., Opposition thereto under Section 59 of the Patents Act 1952 by ALCON LABORATORIES (AUSTRALIA) PTY. LTD., and Opposition to amendments made under Section 104.

background

Patent Application 588049 by Allergan, Inc. (Allergan) was lodged on 20 August 1986 for an invention relating to cleaning contact lenses. The application was advertised accepted on 7 September 1989. Notices of opposition under Section 59 of the Patents Act 1952 were lodged by Pilkington Visioncare Inc and by Alcon Laboratories (Australia) Pty. Ltd. (Alcon), but the opposition by Pilkington was subsequently withdrawn. This decision relates to the opposition by Alcon.

On 8 November 1992, during the course of the evidence stages of the substantive opposition, Allergan filed some proposed amendments to their application under Section 104 of the Patents Act 1990. Acceptance of these amendments was advertised on 10 June 1993. On 10 September 1993 Alcon filed a Notice of Opposition to the request to amend. This was followed, on 10 December 1993, by the serving of a statement of grounds and particulars. Evidence-in-Support was served on 10 March 1994, evidence-in-answer was served on 10 June 1994 and evidence-in-reply was served on 9 September 1994.

I heard the opposition to the Section 104 amendments in Canberra on 1 March 1995. At the hearing Allergan was represented by Dr Peter Stearne, patent attorney of Davies Collison Cave. Alcon was represented by Mr B J Hess of counsel assisted by Mr Michael Houlihan, patent attorney of Callinan Lawrie.

GROUNDS OF OPPOSITION

The statement of grounds and particulars indicates that the amendments are opposed on 3 grounds, which equate to lack of compliance with sections 102(1), 102(2)(a) and 102(2)(b).  A number of particulars are listed under each ground.  I shall refer to the matters raised in the particulars in my decision, but, from the submissions made at the hearing, and from the evidence, the main objections to the amendments appear to relate to:

.The replacement of the expression "disinfecting amount of peroxide" in claim 1 by the numerical range of 0.5% to 10% w/v of hydrogen peroxide.

.The reference in the amended claims to "hydrophilic" contact lenses whereas the original disclosure referred to contact lenses having a hydrophilic surface.

.The extensive changes to Example 7 and its effects on the omnibus claim.

.The proposed amendment to page 5 to change "is" to "may be" and its effect on the clarity of the specification.

proposed amendments

The specification as accepted indicates the invention relates to a method of simultaneously cleaning and disinfecting contact lenses using a solution containing a mixture of a peroxide and a peroxide-active proteolytic enzyme.  It ends with 16 claims, all directed to methods, and with only one independent claim which reads as follows:

"1.  A method for simultaneously cleaning and disinfecting contact lenses which method comprises contacting a lens with a solution comprising a disinfecting amount of peroxide and an effective amount of peroxide-active proteolytic enzyme for a time sufficient to remove substantially all protein accretions and to disinfect the lenses."

The statement of proposed amendments details 25 amendments making a number of changes to the description.  Proposed amendment item 25 requires the replacement of the claim pages with a new claim page.  The amended claims total 7, of which claim 1 is the only independent claim and claim 7 is an omnibus claim.  Claims 1 and 7 read as follows:

"1.  A method for simultaneously cleaning and disinfecting hydrophilic contact lenses, which method comprises contacting a hydrophilic contact lens with a solution comprising from 0.5% to 10% w/v of hydrogen peroxide and an effective amount of peroxide-active proteolytic enzyme for a time sufficient to remove substantially all protein accretions and to disinfect the lens."

"7.  A method for simultaneously cleaning and disinfecting contact lenses according to claim 1, substantially as hereinbefore described with reference to the Examples."

evidence

The evidence-in-support of the opposition comprises a statutory declaration by John P F Strachan, an optomotrist (hereinafter referred to as the first Strachan declaration).  The points made in this declaration are essentially the same as those raised in the statement of grounds and particulars.

The evidence-in-answer comprises a statutory declaration by Russell Lowe, a clinical optomotrist.  Mr Lowe rebuts the evidence of Mr Strachan and in particular makes the following points:

.The specification at page 10 indicates that 0.5% to 10% hydrogen peroxide is a disinfecting amount.

.The specification discloses hydrophilic contact lenses at page 2.

.Amended Example 7 simply includes further details of the Azocoll assay method, a standard assay for detecting enzyme activity.

.The invention as described at page 5 of the specification relates to the simultaneous cleaning and disinfecting of contact lenses.

The evidence-in-reply comprises a further statutory declaration by John P F Strachan (hereinafter referred to as the second Strachan declaration).  Mr Strachan makes a number of points including:

.The claims of the amended specification, in no longer referring to a disinfecting amount of peroxide, are broader than the claims of the filed or amended specifications.

.There is no disclosure in the filed or accepted specifications to support the change from "contact lenses" to "hydrophilic contact lenses".

I shall refer more specifically to these declarations in my decision.

submissions

At the start of the hearing Mr Hess indicated that the opponent had no objections to proposed amendments 2, 4, 6, 10, 12, 14-21, 23 and 24.  In relation to proposed amendment 9, he pointed out that the word "the" did not appear at page 6 line 27 as indicated in the amendments.  In relation to proposed amendment 11 he indicated that Alcon had no objection to the amendment but that it was probably made in error since a similar amendment had already been made prior to acceptance.

Mr Hess first referred to the large number of amendments which limit the peroxide to hydrogen peroxide.  He indicated this may be a matter of importance in the substantive opposition in determining whether a generic reference discloses a specific.  Alcon therefore reserved their position with respect to the limitation if amendment to hydrogen peroxide was allowed.  He pointed out there was a public interest requirement to look at amendments where "hydrogen" is inserted before "peroxide".

In relation to amendments 1, 3, 7 and 25 Mr Hess submitted that they changed to a significant extent the subject matter of the method of the invention.  In the description and claims as filed and accepted the contact lenses to be treated were described as hydrophilic at the surface or treated to be hydrophilic at the surface.  The proposed change makes the lenses to be treated hydrophilic per se.  In Mr Hess' view this limitation was not supported by the original disclosure and hence there was no disclosure in substance of hydrophilic lenses and the amendments contravened section 102 (1).  Furthermore there was an inconsistency between new claim 1, which specifies hydrophilic contact lenses, and new claim 7, which refers to "contact lenses".  Mr Hess submitted that amendment 25 creates a lack of clarity in the claims and hence this raises a section 40 issue.

Concerning amendment 5, Mr Hess submitted that the change from "is" to "maybe" at page 5 raised the question of what was the invention.  As originally described the invention concerned a synergistic effect achieved between using the combination of peroxide and enzyme.  If there was no synergistic effect, there was no longer a best method of performance and hence a lack of compliance with section 40.

In Mr Hess' view the problem of the amendment to page 5 was rendered more difficult by proposed amendments 8, 13 and 25 concerning the definition of a disinfecting amount of hydrogen peroxide as being 0.5 to 10% w/v.  He pointed out that, according to original page 10, 0.5% was described as a disinfecting amount "under most circumstances".  This meant that at 0.5% w/v hydrogen peroxide there would be some circumstances where a disinfecting amount was not achieved.  New claim 1 now provides that 0.5% w/v will be a disinfecting amount in all circumstances.  Therefore, in Mr Hess' submission, new claim 1 will now create an infringement in some circumstances when 0.5% w/v hydrogen peroxide is used where previously there was no infringement.  Following the decisions in The Distillers Co. Ld.'s Application, (1953) 70 RPC 221, and AMP Incorporated v Commissioner of Patents, (1974) AOJP 3224, new claim 1 is broader in scope than before amendment and hence does not comply with section 102 (2)(a).  Mr Hess also considered there were definitional problems which caused lack of compliance with section 40 and considered there could be difficulties under section 102 (1) because there was no disclosure of the change from "under most" to in all circumstances.

Mr Hess also referred to another section 40 problem with page 10 where, at lines 7-8, 10% was defined as the upper limit of the disinfecting amount, whereas at line 13 there was stated to be no upper limit on the amount of hydrogen peroxide.

Mr Hess raised some additional points in relation to the claims as amended by item 25.  He pointed out that in claims 3-5 the amount of enzyme was defined in "Anson units per ml" whereas the claims as accepted referred to "Anson units of activity per ml of solution".  Also in claim 4 the lower limit of 0.0001 for the specific enzymes is lower than the 0.0003 lower limit required by accepted claim 4.  Therefore amendment 4 had the potential to create an infringement where none existed before and hence it contravened section 102(2)(a).

Finally Mr Hess pointed to a problem with new omnibus claim 7 in addition to the clarity problem referred to above.  He did not know the precise effect the amendments to Example 7 had on this claim.  He was unsure whether Example 7 introduced new subject matter, and hence whether claim 7 offended against section 102(2)(a).  He considered it was encumbant on the applicant to show that the amendment to Example 7 was allowable.

In response Dr Stearne for Allergan first stressed that the specification must be given a purposive rather than a literal construction.  In relation to the obvious errors in amendments 9 and 11 and one error at page 10 he indicated he would file clarifying amendments soon after the hearing.

Concerning the limitation of the peroxide to hydrogen peroxide, Dr Stearne considered it was demonstrably clear from the specification as filed and as accepted that hydrogen peroxide was the preferred agent.  On the question of public interest Dr Stearne considered the key issue was whether, at the expiry of the monopoly, a person skilled in the art could carry out the invention.  In his view limiting the peroxide to hydrogen peroxide raised no public interest question.

With respect to the reference to "hydrophilic contact lenses" in the claims, Dr Stearne directed my attention to the description at page 1A which describes the evolution of contact lenses from glass to lenses based on hydrophilic polymeric materials.  He submitted the person skilled in the art reading this and the description at page 2 would be directed to the treatment of hydrophilic contact lenses.  Hence the amended claims do not describe matter not in substance disclosed in the specification as filed.

On the question of the synergistic effect of the combination of hydrogen peroxide and the enzyme Dr Stearne submitted that this was merely an effect of the invention and under certain circumstances there was a potentiating effect.  The statement of the invention and the claims made no reference to a potentiating effect.  The invention was the surprising finding that contact lenses could be cleaned and disinfected at the same time using an effective amount of a peroxide stable enzyme and disinfecting amount of peroxide.  Synergism was not an essential feature of the invention and the amendment to page 5 made this abundantly clear.

In relation to amendments pertaining to the disinfecting amount of peroxide, Dr Stearne considered the specification as accepted at page 10 lines 15-25 specifically defined a disinfecting amount of peroxide to range from 0.5% w/v through 10% or even more.  Claim 2 as accepted made reference to this amount (apart from an obvious mistake in referring to "0.05%").  In his submission the reference at page 10 to "most circumstances" was included to cover some identified and exceptional situation which, in the normal cleaning and disinfecting of contact lenses, would not arise.  Therefore claim 1 did not define an invention broader than that defined in the application as filed and accepted.
Concerning the upper limit to the amount of hydrogen peroxide, Dr Stearne indicated the applicant had chosen to limit the preferred range to that given as preferred at original page 10.

With respect to claims 3-5, Dr Stearne indicated Allergan would amend the claims to refer to "Anson units of activity per ml of solution" although he believed such amendments to be unnecessary if a purposive construction was applied to the claims.  He further submitted that the range of "0.0001 and 0.05 Anson units per ml" for the amount of specified proteolytic enzyme in proposed new claim 4 fell within the scope of the range 0.0001 to 0.5 Anson units for the amount of unspecified enzyme given in accepted claim 2.  Furthermore it and was based on the description at original page 9 lines 6-9 which state:

"...the working solution should preferably contain sufficient enzyme to provide between about 0.0001 to 0.5 Anson units of activity per ml of solution,..."

Finally, in response to Mr Hess' submissions concerning claim 7, Dr Stearne submitted that, applying a purposive construction to that claim meant that the contact lenses were hydrophilic since claim 7 is a method of claim 1.  In relation to Example 7, Dr Stearne submitted that the proposed amendments provide further illustration of the Azocoll method.  The Example shows the effect of the enzyme over varying concentration of hydrogen peroxide and does not describe a method for cleaning and disinfecting contact lenses.  Therefore, in Dr Stearne's view, when the specification is construed by a person skilled in the art, it is very clear that the amendments do not affect the scope of claim 7.

DECISION

At the hearing Dr Stearne indicated that Allergan would make further amendments to clarify the errors pointed out by Alcon. On 20 March 1995 Allergan filed further amendments under section 104 which not only appear to overcome the errors but also seem to address some of the other issues raised by Alcon at the hearing. As these amendments have not yet been finally dealt with, I can make no comment on them save to say it would seem unnecessary for me to discuss those issues in detail in this decision when Allergan does not now appear to wish to pursue them further.

However this case does seem to raise an issue of the advisability of an applicant filing amendments during the opposition process.  It seems that Allergan, in proposing amendments, may have been attempting to speed up the process by overcoming the grounds of opposition at an early stage.  However this strategy would appear to have delayed the substantive opposition since the opposition process for these amendments has taken nearly two years to complete and the further amendments now proposed by Allergan could also be opposed.  I also note that Alcon had not as yet served evidence-in-reply in the substantive opposition on the basis that there is uncertainty as to the final form of the claims of the specification.  Therefore, while it may be in the public interest for an applicant to file amendments to attempt to avoid a lengthy opposition process, the end result may be a substantial delay to that process.  I shall return to this point at the conclusion of my decision.

Turning now to the specific issues of this opposition, I shall first consider the limitation of the peroxide to hydrogen peroxide.  Mr Hess raised this as a public interest matter in terms of whether there was a basis in the original disclosure for this limitation.  He indicated the matter could be considered at the substantive opposition.  I note this issue has not been raised in the statement of grounds and particulars and hence does not form part of Alcon's case in the present opposition.  However, since the limitation is present in all the amended claims, and I have to decide whether those claims comply with section 102, I consider I should determine the issue at this stage.

There is no evidence on this point but Dr Stearne submitted it was clear from the specification that hydrogen peroxide was the preferred agent for disinfecting and cleaning contact lenses.  I note that page 9 as accepted gives hydrogen peroxide as an example of a suitable peroxide and page 10 refers specifically to suitable concentrations of hydrogen peroxide.  Page 12 as accepted refers to a possible formulation using hydrogen peroxide.  I also note all the Examples in the accepted specification use hydrogen peroxide as the peroxide.  Therefore it seems to me that the limitation to hydrogen peroxide in the amended claims is based on the preferred peroxide described in the specification

On the question of public interest, it seems to me that the opposition process provides an opportunity for an opponent to raise issues such as fair basis.  An opponent acts in the public interest in drawing attention to possible deficiencies in an application.  I cannot see a further public interest issue in the limitation to hydrogen peroxide at this stage of the process.

In relation to the limitation in the claims to "hydrophilic contact lenses", I am inclined to agree with Mr Hess that there was no disclosure in the original specification of such lenses.  The only reference to "hydrophilic" in the original disclosure is in relation to contact lenses having a hydrophilic surface.  The only evidence as to the meaning of the term "hydrophilic" occurs in the first Strachan declaration where, at paragraph 8, Mr Strachan states:

"...I consider "hydrophilic" has a broad meaning such that the lenses are formed from a homogeneously hydrophilic material."

This evidence is uncontraverted and there is no evidence to show the original disclosure included lenses made of homogeneously hydrophilic material.  Therefore I find that, insofar as the claims refer to "hydrophilic contact lenses", they claim matter not in substance disclosed in the specification as filed.

On the question of the change from "is" to "may be" at page 5, I believe this results in a lack of clarity in the description, but I am not convinced by Mr Hess' submission and the first Strachan declaration that the proposed amendment is altering the basis of the invention.  It seems, from paragraph 22 of the Lowe declaration where Mr Lowe refers to "the ongoing theme of the opponent" and then to certain paragraphs of his declaration served in relation to the substantive opposition, that the question of whether synergy is essential to the performance of the invention will form part of the substantive opposition.  Dr Stearne also referred to the Huth declaration served in the substantive opposition on this point.  I believe this question will be best resolved at the hearing for the substantive opposition when the Commissioner will have the benefit of considering all the evidence on this point.

On the clarity issue I referred to above, it seems to me that lines 20-23 of page 5 in referring to:

"...in one step, contact lenses can now be cleaned and sterilized more effectively than by independent use of the two components."

implies a synergistic effect between the peroxide and enzyme, as does the statement at page 9 line 4 referring to the "synergistic interaction".  The amendment at page 5 line 15 that there "may be" a synergistic effect appears to conflict with these passages and hence in my view results in a lack of clarity.  However at this stage I do not consider that the amendment is such as to result in the specification not fully describing the invention and hence I do not believe there is a section 40 problem with it.  I make no finding as to whether the invention resides in the simultaneous cleaning and disinfecting, as Dr Stearne submitted, or in the increased effect of the components in combination, as Mr Hess put to me.  The resolution of this issue at the substantive opposition will determine the nature of the amendments necessary to resolve the clarity problem.

In relation to the disinfecting amount of hydrogen peroxide, I find Dr Stearne's argument concerning the undue weight Alcon places on "under most circumstance" at page 10 unconvincing.  The statement at paragraph 6 of the Lowe declaration that:

"I suspect the words "under most circumstances" were originally included in the specification to cover some unidentified and exceptional situation."

does not clarify the situation.  On the plain meaning of the words I agree with Mr Hess that new claim 1 provides 0.5% w/v will be a disinfecting amount in all circumstances and that this is broader in scope than the "disinfecting amount" in claim 1 as accepted.  Therefore I find claim 1 does not comply with section 102(2)(a).  I also agree with Mr Hess that there is some conflict between lines 7-8 of page 10, referring to 0.5% to 10% as the disinfecting amount, and line 13 where it states there is no upper limit on the amount of hydrogen peroxide.

Dr Stearne agreed to propose amendments to overcome the clarity problems outlined by Mr Hess in relation to the term "Anson units per ml" in claims 3-5, and I note the proposed amendments of 20 March 1995 appear to do this.

With respect to the lower limit (0.0001 Anson units) of the range specified in claim 4, I agree with Dr Stearne that this was disclosed in original claim 2 and at original page 9.  Therefore I do not consider new claim 4 contravenes section 102(2)(a).

Finally in relation to omnibus claim 7, I believe there is some lack of clarity as to the limitation, if any, on the contact lenses to be treated by the method claimed.  In my view claim 7 is directed to the method of claim 1.  However claim 1 refers to "hydrophilic contact lenses" whereas claim 7 refers simply to "contact lenses".  Therefore it is possible that treatment of contact lenses other than hydrophilic contact lenses by the method of claim 1 could constitute an infringement of claim 7.  Consequently claim 7 does not define the invention as now limited by the remainder of the claims and hence I believe claim 7 does not comply with section 40 and contravenes section 102(2)(b).

Concerning the effect of amendments to Example 7 on claim 7, Mr Hess considered the applicant had to show these amendments were allowable.  Paragraph 17 of the Lowe declaration addresses this point in stating:

"...Amended Example 7 simply includes further details of the Azocoll assay method for determining enzyme activity.  This method is described in general terms at page 24 of the specification as filed.  The Azocoll assay method has nothing to do with disinfecting and cleaning contact lenses.  Rather, it is a standard assay for detecting enzyme activity."

The evidence-in-reply does not address this issue.  I consider the statement in the Lowe declaration sufficient to demonstrate that the amendments to Example 7 are limited to giving further details of an assay method and do not relate to the simultaneous cleaning and disinfecting method of claim 7.  Therefore I do not believe the amendments to Example 7 introduce new subject matter such that amended claim 7 would not satisfy section 102(2)(a).

CONCLUSION

I have found the opposition succeeds in that the amended claims in their reference to "hydrophilic contact lenses" claim matter not in substance disclosed in the specification as filed, that claim 1 in its reference to 0.5% w/v hydrogen peroxide does not comply with section 102(2)(a) and that claim 7 contravenes section 102(2)(b) since it is not limited to the treatment of hydrophilic contact lenses.  There are also some minor clarity matters resulting from the proposed amendments.  Therefore I refuse to allow the amendments.

I have referred previously to the considerable delay to the substantive opposition as a result of the proposed amendments and to the possible further delays resulting from the further amendments filed subsequent to the hearing. I believe the public interest will be best served by a speedy determination of the section 59 opposition so that there is certainty as to the scope of the monopoly claimed by Allergan. Consequently the Commissioner will proceed to determine the section 59 opposition based on the accepted specification, but, if the parties agree, the hearing may embrace proposed amendments agreed by the parties. Any such agreed amendments must be made the subject of a formal request to amend. Consequently evidence-in-reply is to be served within 3 months of the date of this decision and the Commissioner will set the matter down for hearing as soon as possible after service of this evidence. The Commissioner may have regard to the effect of the amendments proposed so far when considering an award of costs in the opposition.

COSTS

Both parties made submissions as to costs.  In Mr Hess' submission, regardless of the outcome of the opposition, Alcon are entitled to costs if the applicant made amendments that the Office deemed were necessary as a result of the opposition.  In Dr Stearne's submission Allergan are entitled to their costs because of the lack of merit in the opponent's case.  If the opposition succeeded on only minor points costs should be awarded against Alcon or be shared.  In addition he considered it was unnecessary for Alcon to be represented by both counsel and an instructing patent attorney.  In the event that costs were awarded against Allergan, he submitted that costs for two persons should not be allowed (per Piele v Nofel (Australasia) P/L [1966] VR 433).

I have found that the opposition succeeds on major points and therefore I award costs against Allergan.  However all of these major points were covered in the evidence.  Following the approach adopted in Piele v Nofel (supra), I believe a reasonable and prudent but not over-cautious party would consider that the submissions could have been adequately dealt with by a patent attorney without the need for counsel.  Therefore I disallow the award of costs with respect to counsel for Alcon.

Janet Werner
A/Deputy Commissioner of Patents

Patent attorneys for the applicant  :  Davies Collison Cave, Sydney

Patent attorneys for the opponent   :  Callinan Lawrie, Melbourne