Novartis AG v Bausch & Lomb (Australia) Pty Ltd

[2004] FCA 835

FEDERAL COURT OF AUSTRALIA

Novartis AG v Bausch & Lomb (Australia) Pty Ltd [2004] FCA 835

PATENTS – claim for infringement and cross claim for revocation – application for deletion and validating amendments of patent – application opposed at the final hearing as contrary to the public interest to the extent that the amendments are validating amendments in that they seek to cure a lack of fair basis – after the final hearing the parties settled their dispute and requested consent orders dismissing the claim and cross-claim and granting all of the amendments sought – consideration of circumstances in which the Court will exercise its discretion to grant or refuse to grant an application for amendment of a patent – application granted in respect of some amendments and refused in respect of others

PRACTICE AND PROCEDURE – whether a non-party should be permitted to intervene on the amendment application on the ground that there is no longer a proper contradictor in respect of that application

Patents Act 1990 (Cth) ss 40, 102, 105 and 138
Federal Court Rules O 58 r 10

Datadot Technology Ltd v Alpha Microtech Pty Ltd (2003) 59 IPR 402 – cited
Oil Basins Limited v The Commonwealth of Australia (1993) 178 CLR 643 – cited
Arrow Pharmaceuticals Ltd v Merck and Co Inc [2004] FCA 138 – cited
Eli Lilly and Co v Pfizer Research and Development Co NV/SA (2003) 59 IPR 234 – considered
New England Biolabs Inc v Commissioner of Patents (2001) 110 FCR 357 – cited
Wimmera Industrial Minerals Pty Ltd v RGC Mineral Sands Ltd (No 3) (1997) AIPC ¶91-366 (39,772) – considered
RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd (1998) 89 FCR 458 – cited
Fina Research SA v Halliburton Energy Services Inc (2003) 127 FCR 561 – cited
ICI Chemicals & Polymers Ltd v Lubrizol Corp (1999) AIPC ¶91-521 (40,012) – considered
ICI Chemicals & Polymers Ltd v Lubrizol Corp (2000) 106 FCR 214 – applied
C. Van der Lely N.V. v Bamfords Limited [1964] RPC 54 – considered
Chiron Corporation v Organon Teknika Limited (No. 5) [1994] FSR 258 – cited
Kirin-Amgen Inc’s Patent [2002] RPC 43 – cited
Smith Kline & French Laboratories Limited v Evans Medical Limited [1989] 1 FSR 561 – applied
Rescare Limited v Anaesthetic Supplies Pty Ltd (unreported, Federal Court of Australia, Gummow J, 4 March 1993) – considered
Gambro Pty Ltd v Fresenius Medical Care South East Asia Pty Ltd (1999) 48 IPR 625 – considered
Hsiung’s Patent [1992] RPC 497 – cited
Neurizon Pty Ltd v Lth Consulting and Marketing Services (No 2) (2003) AIPC ¶91-882 (35,633) – cited
Kimberly-Clark Australia Pty Limited v Airco Trading International Pty Ltd (2001) 207 CLR 1 – applied
Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 – applied
F. Hoffman-La Roche & Co. Aktien-Gesellschaft v Commissioner of Patents (1971) 123 CLR 529 – cited
Rehm Pty Ltd v Websters SecuritySystems (International) Pty Ltd (1988) 81 ALR 79 – cited
Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126 – cited
CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 – cited
Lockwood Security Products Pty Ltd  v Doric Products Pty Ltd (2003) 56 IPR 479 – cited
Olin Corporation v Super Cartridge Co. Pty. Ltd. (1977) 180 CLR 236 – applied
Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29 – cited
Chevron Research Company’s Patent [1970] RPC 580 – cited
Bristol Myers Company v Manon Freres Limited [1973] RPC 836 – cited
Matbro Limited v Michigan (Great Britain) Limited [1973] RPC 823 – cited
Bentley Engineering Co. Ltd.’s Patent [1981] RPC 361 – cited
Raleigh Cycle Co. Ld. v H. Miller & Co. Ld.. [1951] AC 278 – cited
Minerals Separation Ltd v Potter’s Sulphide Ore Treatment Ltd (1909) 8 CLR 779 – cited
Mullard Radio Valve Co. Ltd. v British Belmont Radio Ltd. [1939] RPC 1 – cited
Great Lakes Carbon Corporation’s Patent [1971] RPC 117 – cited
Texas Instruments Ltd v Hyundai Electronics UK Ltd (unreported, UK Patents Court, Pumfrey J, 30 July 1999) – cited
Richardson-Vicks Inc.’s Patent [1995] RPC 568 – cited
Minister of Agriculture’s Patent [1990] RPC 61 – cited

NOVARTIS AG, COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION, AND CIBA VISION AUSTRALIA PTY LTD (ACN 057 946 540) v BAUSCH & LOMB (AUSTRALIA) PTY LTD (ACN 000 650 251)
V 81 OF 2000

MERKEL J
24 AUGUST 2004
MELBOURNE

IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY	V 81 OF 2000

BETWEEN:

NOVARTIS AG
FIRST APPLICANT

COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION
SECOND APPLICANT

CIBA VISION AUSTRALIA PTY LTD (ACN 057 946 540)
THIRD APPLICANT

AND:

BAUSCH & LOMB (AUSTRALIA) PTY LTD
(ACN 000 650 251)
RESPONDENT

AND BETWEEN:

BAUSCH & LOMB (AUSTRALIA) PTY LTD (ACN 000 650 251)
FIRST CROSS-CLAIMANT

BAUSCH & LOMB INCORPORATED
SECOND CROSS-CLAIMANT

AND

NOVARTIS AG
FIRST CROSS-RESPONDENT

COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION
SECOND CROSS-RESPONDENT

JUDGE:

MERKEL J

DATE OF ORDER:

24 AUGUST 2004

WHERE MADE:

MELBOURNE

THE COURT MAKES THE FOLLOWING ORDERS BY CONSENT:

1.The application and the cross claim be dismissed with no order as to costs.

AND THE COURT FURTHER ORDERS:

2.Compliance with the requirements of Order 58 rule 10 of the Federal Court Rules be dispensed with in respect of the amendments set out in paragraph  3(g) hereunder.

3.The complete specification of Australian Letters Patent No 704749 (“the patent”) be amended as follows:

(a)On page 4 at lines 11–12, delete the words “lens allows”.

(b)On page 4 at line 22, replace “mm²/sec” with “cm²/sec”.

(c)On page 22 at the 7^th last line, delete the word “material”.

(d)On page 22 at line 25, replace “permeability” with “transmissibility”, and replace “transmissibility” with “permeability”.

(e)On page 23 at the 11^th last line, replace “material” with “ lens”.

(f)On page 99 at line 1, replace “F-13” with “F-12”.

(g)On pages 102–113 delete claims 1–66 and replace with:

1. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:
(a)       at least one oxyperm polymerizable material and
(b)       at least one ionoperm polymerizable material,
wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,
wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,
wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,
wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and
wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,
wherein said polymeric material comprises a plurality of co-continuous phases, including at least one oxyperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens and at least one ionoperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens.

2. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:
(a)       at least one oxyperm polymerizable material and
(b)       at least one ionoperm polymerizable material,
wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,
wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,
wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,
wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and
wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,
wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

3. An ophthalmic lens of claim 2, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of siloxane-containing polymeric material.

4. An ophthalmic lens of claim 2, wherein said pathways have a domain size which is less than a size which undesirably distorts visible light in an amount which is visible to the eye of the wearer.”

4.Save for the orders set out in paragraph 3 above, the applicants’ motion dated 6 December 2002 for amendment of the patent be dismissed.

5.The applicants pay any costs of the Commissioner of Patents that were incurred after 2 July 2004 in respect of the applicants’ motion for amendment of the patent.

6.The motion of Johnson & Johnson Pacific Pty Limited dated 16 July 2004 be dismissed.

7.Johnson & Johnson Pacific Pty Limited pay the costs of the applicants of and incidental to the motion.

8.Reserve liberty to apply.

Note:    Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY	V 81 OF 2000

BETWEEN:

NOVARTIS AG
FIRST APPLICANT

COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION
SECOND APPLICANT

CIBA VISION AUSTRALIA PTY LTD (ACN 057 946 540)
THIRD APPLICANT

AND:

BAUSCH & LOMB (AUSTRALIA) PTY LTD
(ACN 000 650 251)
RESPONDENT

AND BETWEEN:

BAUSCH & LOMB (AUSTRALIA) PTY LTD (ACN 000 650 251)
FIRST CROSS-CLAIMANT

BAUSCH & LOMB INCORPORATED
SECOND CROSS-CLAIMANT

AND

NOVARTIS AG
FIRST CROSS-RESPONDENT

COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION
SECOND CROSS-RESPONDENT

JUDGE:

MERKEL J

DATE:

24 AUGUST 2004

PLACE:

MELBOURNE

REASONS FOR JUDGMENT

Introduction

1. The first and second applicants are the registered proprietors of Australian Letters Patent No 704749 (“the patent”) which relates to an invention entitled “Extended Wear Ophthalmic Lens”. The third applicant is a subsidiary of the first applicant and the exclusive licencee of the patent in Australia.

2. The applicants (“Novartis”) claimed that the respondent (“Bausch & Lomb”) was infringing the patent by the manufacture and sale of its “PureVision” contact lenses in Australia. Bausch & Lomb denied infringement and cross-claimed to have the patent declared invalid and revoked. Some time after the service of Bausch & Lomb’s cross-claim, Novartis applied by motion to amend the patent under s 105 of the Patents Act 1990 (Cth) (“the Act”). The amendment application, which was opposed by Bausch & Lomb in respect of certain amendments, was heard at the final hearing together with the other issues in the proceeding.

3. The matter was listed for judgment on 1 July 2004 but the parties requested that the handing down of judgment be deferred until 4.15 pm on 2 July 2004 to enable them to finalise international settlement negotiations in relation to the patent and its international counterparts. On 2 July 2004 the parties announced that the matter had been settled and that they would be seeking orders by consent dismissing the claim and cross claim and granting the amendments sought by Novartis. As a result, judgment was not handed down and the further hearing of the matter was adjourned to 12 July 2004 to enable the parties to formulate the orders they were seeking and also to enable the Commissioner of Patents (“the Commissioner”), whom I directed to appear pursuant to s 105(3), to consider her position in respect of the amendment application.

4. When the matter came before the Court on 12 July 2004 Novartis requested orders dismissing the claim and the cross-claim with no order as to costs; a certificate under s 19(1) of the Act that the validity of the patent was questioned; and a direction that the patent be amended in the manner proposed by Novartis. Directions were given for the parties and the Commissioner to file any submissions they wished to make in relation to the orders sought by Novartis. The Commissioner’s submissions stated that because the Commissioner considered that the proposed amendments comply with s 102 of the Act she has no objection to them. The Commissioner also stated that she could not express any view as to the merits, or otherwise, in relation to the proceeding as she has not had the benefit of examining any of the evidence filed by the parties. However, the Commissioner added that if the Court “is concerned with the validity of the patent in question, or some of the proposed amendments sought, it is appropriate for the Court to direct the Commissioner to re-examine the patent in accordance with section 97(3).” Section 97(3) empowers the Court to direct the Commissioner to re-examine a patent the validity of which is disputed in a proceeding in the Court. The Commissioner also expressed concerns regarding the appropriateness of a s 19(1) certificate being issued in circumstances where a judicial determination of the merits has not occurred: see Datadot Technology Ltd v Alpha Microtech Pty Ltd (2003) 59 IPR 402.

5. Novartis filed submissions claiming that, as there was no longer any opposition to the amendments it was seeking and as the “relevant public interests have been properly protected”, the amendments should be allowed. It submitted that, as the validity of the patent is no longer in dispute, s 97(3) is not applicable to the circumstances of the present case. Novartis did not press its application for a s 19(1) certificate.

   Johnson & Johnson’s application to intervene

6. On 19 July 2004, Johnson & Johnson Pacific Pty Limited (“Johnson & Johnson”) applied to be heard in opposition to Novartis’ amendment application or to be joined as a party for the purpose of opposing that application.  Johnson & Johnson claimed that it had not previously taken any steps to oppose the amendment application because it knew that the amendments were opposed by Bausch & Lomb, which was regarded by it as a suitable contradictor.  Johnson & Johnson claims that, as Bausch & Lomb now consents to the amendment application, it is appropriate for it to be joined as a party to the application, so there is a proper contradictor before the Court.

7. On 11 September 2003 Johnson & Johnson commenced its own proceeding against Novartis in the New South Wales Registry of the Court for the revocation of the patent.  As the grounds for revocation were substantially the same as those raised by Bausch & Lomb, Johnson & Johnson requested Novartis’ consent for its proceeding to be joined or heard together with the present proceeding, which was fixed for hearing in October 2003.  Novartis refused to consent to that request and Johnson & Johnson did not further pursue the issue, although its  representatives have been present during the hearing in Melbourne and it has received a copy of the transcript and has been granted access to the evidence before the Court. The separate proceeding between Johnson & Johnson and Novartis remains on foot in the New South Wales Registry of the Court, although on 23 March 2004 Wilcox J ordered that the proceeding be stayed pending the giving of judgment in this matter.

8. However, more relevantly for present purposes, although Johnson & Johnson claims that it was unaware of Novartis’ advertisement of the proposed amendments it is clear that after it became aware of those amendments it took no step to oppose them.  Johnson & Johnson has explained that its election not to intervene came about because it regarded Bausch & Lomb as a suitable contradictor.  However, in making that election it must be taken to have been aware of the possibility that the parties may, as they have in fact done, settle their dispute.

9. Johnson & Johnson submits that it is in the public interest for there to be a contradictor to Novartis’ amendment application and that as Bausch & Lomb no longer is fulfilling that role, it is appropriate that it do so.  It claims that, as it wishes to do no more than adopt Bausch & Lomb’s submissions in relation to the amendment application, its intervention will not delay, or add any additional expense to, the determination of the matter.

10. I have concluded that it is appropriate to refuse Johnson & Johnson’s application and shall briefly state my reasons for that conclusion.  Johnson & Johnson must be taken to have elected not to intervene in Novartis’ amendment application and the Court should not permit it to depart from its election absent compelling or persuasive reasons.  There are no compelling, or even persuasive, reasons for permitting Johnson & Johnson’s intervention. 

11. There is no public interest in Johnson & Johnson filling the role of contradictor in the present matter. Bausch & Lomb fulfilled the role of a contradictor at the hearing and in that role strongly opposed the amendment application.  Although Bausch & Lomb subsequently reversed its position and consented to that application, the submissions made by Bausch & Lomb, and the evidence in support of those submissions, remain before the Court.  Further, following Bausch & Lomb’s consent to the amendment application I directed the Commissioner of Patents to appear, which she has done.  Although the Commissioner did not oppose the amendments, that must be understood in the context of her not having considered or formed a view about the material in support of or against the amendment application.  Nonetheless, the Commissioner has filed submissions in respect of the application and in that role may perhaps have performed a role as a contradictor in a particular way: cf Oil Basins Limited v The Commonwealth of Australia (1993) 178 CLR 643 at 649. Thus, the present case is not one in which it can be truly said that there has been no contradictor.

12. Finally, Johnson & Johnson does not seek to do any more than adopt Bausch & Lomb’s submissions which remain before the Court. Thus, it is clear that the Court will not be assisted in any meaningful manner by an intervention by Johnson & Johnson.  Rather, the practical consequence of its application is that if Johnson & Johnson were permitted to intervene at this stage that would enable it to be an appellant or respondent in any appeal from the decision I make.  That, however, is a matter for the Full Court in the light of all the circumstances then existing if, and when, there is such an appeal. Those circumstances would include whether there is a proper contradictor before the Full Court.

1. For the above reasons Johnson & Johnson’s application to intervene is to be dismissed with costs.

   Dismissal of the claim and cross-claim
   The infringement and revocation proceedings are adversarial proceedings between Novartis and Bausch & Lomb and there is no reason why the Court should not give effect to the settlement that the parties have reached in relation to those proceedings. Accordingly, it is appropriate to order by consent that the claim for infringement and the cross-claim for revocation be dismissed with no order as to costs.

   Amendment

2. The application for amendment of the patent stands in a position different to that of the infringement and revocation proceedings. It is well established, and is not in dispute, that the Court has a general discretion under the Act to allow, or to refuse to allow, the amendment of a patent. In exercising the discretion, the Court will be guided by whether it is in the public interest that the amendments sought be allowed or refused. Thus, although the absence of any opposition to an amendment application is a matter that the Court may take into account, it does not relieve the Court of its duty to determine the application on its merits: see Arrow Pharmaceuticals Limited v Merck & Co Inc. [2004] FCA 138 at [7].

3. The Commissioner did not oppose the amendments, either initially or after the Court directed her to appear.  However, as explained earlier, the Commissioner’s non-opposition needs to be balanced against the fact that she has not had the benefit of examining any of the evidence filed by the parties. 

4. In regard to the merits of the application, although Bausch & Lomb now consents to the Court allowing the amendments, Bausch & Lomb’s consent cannot alter the evidence it led at trial in support of its now abandoned opposition to the substantive amendments. As a consequence, the evidence upon which the Court is to act in determining Novartis’ amendment application is the evidence adduced by Novartis and Bausch & Lomb in the course of the fully contested final hearing. Notwithstanding Bausch & Lomb’s present position it is appropriate to refer to the submissions it made at the hearing as that will enable a better understanding of the issues that require determination on Novartis’ amendment application.

5. Before turning to the issues arsing on the amendment application it is necessary to provide some background concerning the invention which is the subject of the patent.

   Extended wear contact lenses

6. The patented invention is an extended wear silicon hydrogel contact lens. Extended wear is generally regarded as involving continuous wear over a period of at least 24 hours.

7. The development of extended wear contact lenses had been a goal in the contact lens industry since at least the early 1980s. Initially, contact lenses were designed for daily wear with the lens being inserted each morning and removed each night. The lenses had to be stored overnight and cleaned before reinsertion because inadequate care of the lens between each day’s wear could result in eye infections and other complications. This problem, together with the inconvenience of the daily wear regime and the desirability of enabling lens wearers to wake up with corrected vision, led companies in the contact lens industry to work towards the development of a lens which could be worn 24 hours a day, for up to 30 days, without removal.

8. A basic requirement for an extended wear contact lens is that it be ophthalmically compatible, which means that the lens will not cause significant damage to the eye or user discomfort. In order for a lens to be ophthalmically compatible it must possess the following characteristics:

   (a)       High oxygen transmissibility

9. The oxygen transmissibility of a lens is the rate at which oxygen is able to pass through the lens to reach the cornea. Transmissibility depends, inter alia, on the oxygen permeability of the material used to construct the lens. Oxygen permeability, which is referred to by those skilled in the art as “Dk” and is usually measured in units of “barrers”, is the rate at which oxygen passes through that material. Oxygen transmissibility is referred to as “Dk/t”, with “t” representing the thickness of a lens, and is measured in “barrers/mm”.

10. High oxygen transmissibility is a pre-requisite for an ophthalmically compatible extended wear contact lens. This is because the cornea has no vascular system and therefore must obtain its oxygen supply directly by means of its contact with the atmosphere. If a lens with insufficient oxygen transmissibility is worn for an extended period the cornea begins to swell and to develop blood vessels, making the cornea susceptible to infections which can interfere with vision. Corneal swelling of about 4%, which usually occurs overnight during sleep when no lens is worn, is not harmful. But overnight use of conventional contact lenses can result in swelling of up to 12%. Thus, if lenses are to be worn for extended periods, including overnight, they must possess an oxygen transmissibility sufficient to ensure ophthalmic compatibility. At 8 December 1995, being the priority date, studies indicated that daily wear lenses must have an oxygen transmissibility of at least around 24 barrers/mm, whereas extended wear lenses required an oxygen transmissibility of at least 87 barrers/mm.

11. The above oxygen transmissibility values were measured by a technique referred to in the art as the polarographic method. Although there are at least two other methods of measurement of oxygen transmissibility the most commonly used are the polarographic and coulometric methods. The distinction between these two methods is significant, since a lens will show different transmissibility levels when tested coulometrically than it will when tested polarographically. Although there is no known mathematical relationship between coulometrically and polarographically measured transmissibility levels, generally polarographic measurements give higher values than coulometric measurements. The oxygen transmissibility values given in the patent were determined coulometrically. This is said to explain why they are lower than 87 barrers/mm, the polarographic measurement referred to above as the necessary oxygen transmissibility for extended wear lenses.

    (b)       On-eye movement

12. A lens must also move well on the eye. Good on-eye movement prevents adhesion of the lens to the eye, and is necessary to allow tear flow between the lens and the eye and the maintenance of a tear film. As at the priority date of the patent it was believed that the on-eye movement of a lens was related to its water content.

    (c)       Other characteristics

13. The lens must also avoid accumulation of deposits and must not cause any toxic or other acute ocular reactions or adverse symptoms.

14. Approval for some 30 day extended wear lenses was given by the United States Food and Drug Administration in 1981. However, the approval was later withdrawn when the lenses were found to cause damage to the eye, particularly ulcerative keratitis, a potentially sight-threatening inflammation of the cornea. Scientists theorised that the damage was caused by an inadequate flow of oxygen through the lens, causing the cornea to become oxygen deprived and therefore vulnerable to infections and other complications. Consequently, research began to focus on the development of lenses with higher oxygen transmissibility.

15. Soft hydrogel lenses, which had been predominantly used for daily wear, were hydrophilic and had good on eye movement, but low oxygen permeability. Soft siloxane lenses, which were also used for daily wear, had high oxygen permeability but were hydrophobic and, as a consequence, tended to adhere to the eye. Rigid gas permeable lenses, which were also used, provided high oxygen transmissibility and good on-eye movement, but caused mechanical trauma to the cornea due to their rigid properties.

16. Accordingly, the challenge facing those working in the field at the priority date was to develop a lens that was able to combine all of the requisite characteristics, with no adverse side effects. During the 1990s each of Novartis and Bausch & Lomb was seeking to meet that challenge by developing a contact lens which would be ophthalmically compatible for extended wear for up to 30 days.

17. The invention the subject of the patent is claimed to achieve ophthalmic compatibility for periods of extended wear. The invention was the outcome of the “SEE3” project, a collaboration between Ciba Vision in the United States, Ciba-Geigy’s Central Research Unit in Switzerland, and the Cooperative Research Centre for Eye Research and Technology (“CRCERT”) in Australia. CRCERT was itself a collaboration between various Australian research groups, including the second applicant and the Cornea and Contact Lens Research Unit (“the CCLRU”) at the University of New South Wales. The SEE3 project was headed by Paul Nicolson (“Nicolson”), who was called as a witness for Novartis. Other people who played significant roles in the SEE3 project and/or the patent’s drafting, and who were called as witnesses for Novartis, included the Ciba Vision patent attorneys for the United States and Europe respectively, Scott Meece (“Meece”) and Joerg Dietz (“Dietz”), and Lyn Winterton (“Winterton”) who developed the ionoton measurement for ion permeability.

    The Patent

18. Within the SEE3 project the patent was referred to as the Joint Umbrella Patent, or “JUMP”, since one intention behind it was the creation of a patent that “covered the field of extended wear contact lenses.” The two features of the invention claimed by Novartis to be significant breakthroughs were:

    (a)the discovery of a correlation between ion permeability (the rate at which sodium ions pass through a lens material) and on-eye movement, leading to the conclusion that extended wear lenses need a high ion permeability in order to avoid adhesion of the lens to the eye; and

    (b)the discovery that it was possible to achieve both good on-eye movement and sufficient oxygen transmissibility, and thereby ophthalmic compatibility, by the employment of a morphology characterised by separate and co-continuous phases. This means that within the material used to fabricate the lenses separate and continuous pathways exist, each leading from one surface of the lens to the other. One set of pathways (the “oxyperm phase”) is oxygen permeable and the other (the “ionoperm phase”) is ion permeable. The pathways enable sufficient oxygen and ion permeability for the lens to be ophthamically compatible for extended wear.

19. Novartis’ evidence was to the effect that the use of co-continuous and separate phases was counter-intuitive because the separation of phases had traditionally been avoided in contact lens technology. This was because the presence of separate phases larger than 100 nm in a lens was known to lead to opacity, which is inconsistent with the visual clarity required for a lens. Novartis avoided this problem by reducing the size of the separate phases in its lens materials by employing micro phase, rather than gross phrase, separation.

20. Similarly, the employment of ion permeability as an indicator of on-eye movement was said by Novartis to be novel because, although it was known previously that the water content of a lens had an impact on its ability to move on the eye, it was not previously known that the permeation of water and sodium ions through the lens was an important factor. In support of its case on novelty Novartis pointed to prior art suggesting that movement of water through the lens should be avoided.

21. The oxygen and ion permeability values required for ophthalmic compatibility are set out in the specification and in the claims. Those values provide the parameters required for the respective co-continuous oxyperm and ionoperm phases. The parameters taught in the patent were said to establish whether the co-continuous phases had been achieved. Thus Dietz, the attorney responsible for drafting the PCT patent for Novartis, stated that “the ionoton and ionoflux parameters are essential to the ionoperm continuous phase”.

22. The specification discusses ion permeability at page 14:

    “Unexpectedly, it has been determined that the ion permeability through the lens correlates well with on-eye movement. As discussed earlier, it is known that on-eye movement of the lens is required to ensure good tear exchange, and ultimately, to ensure good corneal health. While the invention is not bound by theory presented herein, it may be useful to discuss some theory for a better understanding of ways to practice the invention.

    It is theorized that water permeability is an exceptionally important feature for an extended wear lens which includes oxyperm polymers such as those disclosed herein. Siloxane-containing oxyperm materials tend to adhere strongly to the eye, thereby stopping on-eye movement. The ability to pass water through the lens is believed to allow a siloxane-containing polymeric lens to move on the eye, where the movement occurs via forces exerted by water being squeezed out of the lens. The water permeability of the lens is also believed important in replenishing lens water content once pressure is removed. Further, the permeability of ions is believed to be directly proportional to the permeability of water. Thus, ion permeability is a predictor of on-eye movement.

    However, regardless of whether the water permeability theory is a correct understanding of the actual on-eye movement phenomenon, it has been unexpectedly found that above a certain threshhold [sic] of ion permeability through a lens, from the inner surface of the lens to the outer, or vice versa, the lens will move on the eye, and below the threshhold [sic] the lens will adhere to the eye. Thus, the present innovative extended-wear contact lenses provide a balance between the relatively high oxygen permeability (and associated high binding capacity) of oxyperm materials with the low binding capacity (high on-eye movement) of ionoperm materials. It is believed that this is accomplished by providing a plurality of continuous ion transmission pathways for ion and water movement through the lens.”

23. The patent provides two methods for the measurement of ion permeability – the “ionoflux” and “ionoton” measurement techniques. A method, referred to in the patent as the “hydrodell water permeability technique” is also provided for the measurement of water permeability, which is said to be related to ion permeability. As explained above, although ion and water permeability are related they are qualitatively different.

24. The specification sets out in general terms the principles to be applied in the manufacture of extended wear contact lenses. It provides detailed information about certain specific materials, which were used in the “examples” described in the patent. There are also a number of tables in the body of the specification that record test data and which are relied upon as the source of the quantitative values claimed in the patent as necessary for an ophthalmically compatible contact lens. Three separate tables (Tables E, F and G) show, respectively, the ionoton, ionoflux and hydrodell values for the lenses referred to in the examples and state whether on-eye movement did or did not occur in each case.

25. Claim 1 is the primary claim. Sixty-five subsequent claims are based on claim  1 and on each other. The claims seek to protect not only the examples disclosed in the specification, but also the broader principles of the invention. It is unnecessary to consider all of the claims because Novartis has abandoned all claims other than claims 8, 11, 12 and 13. Because claims 8, 11, 12 and 13 are dependant upon claim 1 it is necessary to also consider the content of that claim. Claims 1, 8, 11, 12 and 13 are as follows:

    “1. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:
               (a)       at least one oxyperm polymerizable material and
               (b)       at least one ionoperm polymerizable material,
    wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids, wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material, wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids, wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and wherein said ophthalmic lens has an oxygen transmissibility of at least 10 weight percent upon full hydration, and wherein said ophthalmic lens has an oxygen transmissibility of at least 70 barrers/mm and an ion permeability characterised either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions.

    8. An ophthalmic lens of claim 1, wherein said polymeric material comprises a plurality of co-continuous phases, including at least one oxyperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens and at least one ionoperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens.

    11. An ophthalmic lens of claim 1, wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

    12. An ophthalmic lens of claim 11, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of siloxane-containing polymeric material.

    13. An ophthalmic lens of claim 11, wherein said pathways have a domain size which is less than a size which undesirably distorts visible light in an amount which is visible to the eye of the wearer.”

    Amendment of the Patent

26. It is convenient to provide a brief chronology of the events which led to the application for amendment. The patent is a Patent Cooperation Treaty (“PCT”) patent which was filed in Australia on 22 March 1996. The patent had previously been filed in the European Union (on 4 April 1995), Switzerland (on 19 May 1995), and the United States (on 8 December 1995). According to the evidence of Novartis the United States patent was drafted under the supervision of Meece and was then used as the basis for the PCT patent, the drafting of which was overseen by Dietz.

27. However, even after the filing of the PCT patent in the various jurisdictions, debate continued among the inventors as to the content of the patent. A series of emails, beginning in 1996 and continuing into 1997, raised questions about problems with the patent as drafted, including errors contained in it. By August 1996 the SEE3 team had begun to consider the filing of a second PCT patent, to be known as “JUMP II”, to ensure adequate protection for the invention and to correct any significant errors. However, notwithstanding the errors in the patent pointed out by some of the inventors, amendment of the patent was not pursued at that stage. The “JUMP II” patent did not proceed.

1. On 29 February 2000 the first and second applicants commenced the present proceeding against Bausch & Lomb for infringement of the patent. Bausch & Lomb denied infringement and cross claimed for the revocation of the patent. A number of grounds of invalidity were raised, none of which related to the ion permeability values in the patent that are sought to be changed by the amendment application. However by about October 2001, following discovery and the filing of some of Bausch & Lomb’s evidence, it became apparent to Novartis that Bausch & Lomb was proposing to rely upon the ion permeability values stated in the patent as an additional ground in support of its claim of invalidity.

2. Novartis was reluctant to amend the patent. But its counsel advised in September 2002 that unless the ionoton values in claim 1 were amended, it was likely the Court would find the patent invalid “not just for lack of fair basis but for ambiguity of definition”, including because “the ionoton value [in claim 1] might well be regarded by the Court as unduly avaricious because it exceeds the experimental data not by a small amount but by a factor of thousands.” Counsel also advised that the ionoflux value in claim 1 should be amended so as to make that value and the ionoton value “impervious to attack on fair basis grounds”. On 6 December 2002 Novartis filed a notice of motion seeking amendment of the patent. With the agreement of the parties the motion was adjourned for hearing together with all of the other issues arising in the proceeding.

   Proposed amendment to correct minor errors

3. At the final hearing Bausch & Lomb did not oppose amendments that corrected minor typographical or clerical errors. Those errors, and the amendments seeking to correct them, are as follows:

   (i)On page 4, at lines 11-12, the patent reads: “…wherein said lens allows oxyperm polymerizable material forms a phase or phases substantially separate from …”. The words “lens allows” appear to have been included accidentally. It is proposed that they be deleted.

   (ii)Also on page 4, at line 22, an ionoton ion permeability coefficient is given in units of mm²/sec. Everywhere else in the patent ionoton ion permeability coefficients are given in units of cm²/sec. This is clearly a typographical error. It is proposed to amend in order to make the units cm²/sec.

   (iii)On page 22, at the 7^th last line, the patent reads: “A preferred ophthalmic lens material will have an oxygen transmissibility, Dk/t, of at least…”. Novartis seeks amendment to remove the word “material” so that the sentence refers to the transmissibility of a lens, rather than of a material. This would reflect the fact that oxygen transmissibility is measured in relation to a particular lens, not a material, because it takes into account the lens thickness.

   (iv)On page 22, at lines 25-26, the patent reads: “The oxygen permeability of a lens and oxygen transmissibility of a lens material may be determined by the following technique.” Here the terms “permeability”, which should refer to a material, and “transmissibility”, which should refer to a lens, have been confused. Amendment is sought to correct this error.

   (v)On page 23, at the 11^th last line, the patent reads: “The oxygen transmissibility (D_k/t) of the material may be calculated…” Again, permeability and transmissibility have been confused in this sentence. Novartis seeks to replace the word “material” with “lens”.

   (vi)On page 99, at line 1, the patent reads: “Considering only Examples F-1 through F-13 of Table F…” However Table F contains only 12 examples (F-1 to F-12). The applicants seek amendment to replace “F-13” in that sentence with “F-12”.

4. Novartis advertised the amendments in sub-paras (i)-(vi) above in the Official Journal of Patents and no notices of opposition were received. These amendments do not affect the validity of the claims in the patent and seek only to clarify the specification by removing inadvertent errors. The amendments were not opposed by Bausch & Lomb at any stage and there is no reason why the amendments should not be allowed. In the circumstances it is appropriate to make orders directing that the proposed amendments be made.

   Proposed deletion and consolidation amendments

5. Novartis also seeks the deletion of all claims other than claims 8, 11, 12 and 13 (which also incorporate the content of claim 1). The claims now sought to be deleted were abandoned  by Novartis at the trial and that abandonment was not opposed by Bausch & Lomb. The deletion of a claim would not ordinarily be refused by the Court unless there were exceptional circumstances: see Eli Lilly and Co v Pfizer Research and Development Co NV/SA (2003) 59 IPR 234 (“Eli Lilly”) at 237 [20]. Further, the deletion of the claims, even if they were invalid, does not affect the validity of the patent in relation to the remaining claims: see s 22 of the Act. Although the deletion of the claims has not been advertised it is appropriate to dispense with the advertising required by O 58, r 10 of the Federal Court Rules.  The reason for that is that it is difficult to see what purpose would be served by advertising as there appears to be no special circumstances that could warrant disallowing the deletions sought.  I would add that none of the parties before the Court submitted that the deletions should be refused. Although, as I later explain, there are special circumstances in the present case, they are not such that the Court should refuse Novartis’ application to delete all claims other than claims 8, 11, 12 and 13. In the circumstances it is appropriate to make orders allowing the deletion of all claims other than claims 8, 11, 12 and 13 as presently formulated. 

6. Plainly, the deletion amendments will require claim 1 to remain to the extent necessary to allow the incorporation of that claim as part of claims 8, 11, 12 and 13.  In an endeavour to deal with that issue Novartis has applied to consolidate the remaining claims together with the substance of claim 1.  Putting to one side for the moment the ion permeability amendments that were opposed at trial by Bausch & Lomb, the proposed consolidated claims are as follows:

   “1.      An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:
   (a)      at least one oxyperm polymerizable material and
   (b)      at least one ionoperm polymerizable material,
   wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,
   wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,
   wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,
   wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and
   wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,
   wherein said polymeric material comprises a plurality of co-continuous phases, including at least one oxyperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens and at least one ionoperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens.

   2. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

   (a)      at least one oxyperm polymerizable material and
   (b)      at least one ionoperm polymerizable material,
   wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,
   wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,
   wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,
   wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and
   wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,
   wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

   3.        An ophthalmic lens of claim 2, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of siloxane-containing polymeric material.

   4.        An ophthalmic lens of claim 2, wherein said pathways have a domain size which is less than a size which undesirably distorts visible light in an amount which is visible to the eye of the wearer.”

7. The consolidation gives effect to Novartis’ abandonment of claim 1, other  than as a basis for claims 8, 11, 12 and 13 as presently formulated in the patent. The substantial issue remaining is whether the proposed amendments concerning the ion permeability values in the original claim 1 (and now in the consolidated claims 1 and 2) and the related amendments in the specification, should be allowed.  Accordingly, I propose to allow the consolidation and turn separately to consider the question of the proposed amendments concerning the ion permeability values.  In considering those amendments it is appropriate to treat the patent as having been amended as directed above.

   Proposed ion permeability amendments

8. As explained above, one of the significant breakthroughs Novartis claimed to have made as part of the patented invention was the discovery of a correlation between ion permeability and on-eye movement, which led to the conclusion that high ion permeability is necessary to achieve the on-eye movement required for an extended wear lens. Further, the minimum ion permeability values for on-eye movement are values that will indicate whether the required separate and continuous ionoperm phase has been established. Thus, those values relate to significant features of the invention.

9. Also, as explained above (at [35]), two sets of values for preferred ion permeability levels are given in the patent – one calculated by the ionoton measurement, and the other calculated by the ionoflux measurement. Novartis seeks to amend both sets of values, which provide alternative integers in claim 1 (and now in consolidated claims 1 and 2).

   (a)The ionoton ion permeability values

10. Data relating to ionoton ion permeability is contained in Table E in the patent. That table sets out the ionoton ion permeability coefficients of various materials that were tested and states whether those materials moved on the eye. Table E, which sets out the test results for examples E-1 to E-13, discloses that the lowest ionoton ion permeability coefficient for a lens which did move on the eye was 2.5 x 10^‑3 cm²/sec and that the highest coefficient for a lens which did not move on the eye was 0.008 x 10^‑3 cm²/sec. A value of “-0.063 [x 10^‑3 cm²/sec]” also appears in the table and, on the assumption that the negative sign is a typographical error, would be the highest value that did not show on-eye movement. However, presumably because of the negative sign, that measurement was ignored in the text under the table which states that the highest co-efficient of a lens that did not move on the eye was 0.008 x 10^-3 cm²/sec. That text states:

    “Considering Examples E-1 through E-13 of Table E, the lowest value of Ionoton Ion Permeability Coefficient for which a lens moves on the eye is 0.25 x 10^-3 cm²/sec. The highest value of Ionoton Ion Permeability Coefficient for a lens which bound on the eye is 0.008 x 10^-3 cm²/sec. Thus a contact lens preferably has an Ionoton Ion Permeability Coefficient greater than about 0.008 x 10^‑3 cm²/sec., more preferably greater than about 0.25 x 10^‑3 cm²/sec.”

11. Elsewhere in the specification a range of values is provided for ionoton ion permeability, which are ranked as the “preferred”, “more preferred”, and “most preferred” values. The values are “greater than about 0.2 x 10^-6 cm²/sec” (“preferred”), “greater than about 0.3 x 10^‑6 cm²/sec” (“more preferred”), and “greater than about 0.4 x 10^-6 cm²/sec” (“most preferred”). The “preferred” value is given in claim 1 of the patent, which includes the integer “an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec.” None of those preferred, more preferred or most preferred values correlates with any of the values in Table E.

12. Novartis seeks to amend the ionoton ion permeability values in the patent in two inter-related respects:

    (i)First, it wishes to change the exponent used in all ionoton values given outside Table E from -6 to -3. Novartis claims that the exponent of -6 is a typographical error which has been duplicated throughout the patent as a result of the “cutting and pasting” of erroneous sections of text. It contends that after amendment the text will reflect Table E in which all of the ionoton values have an exponent of -3.

    (ii)Secondly, it wishes to modify the lowest “preferred” ionoton value from “greater than about 0.2…” to “no less than about 0.25…”. The value of “no less than about 0.25 x 10^-3 cm²/sec” would reflect the data in Table E, which discloses that value as the lowest ionoton ion permeability coefficient that correlates with on-eye movement.

    (b)The ionoflux ion permeability values

13. Data relating to ionoflux ion permeability is contained in Table F in the patent. That table sets out the ionoflux ion permeability coefficients of twelve different lens materials, cited as Examples E1 to E12, that were tested and states whether those materials moved on the eye. Table F discloses that the lowest ionoflux ion permeability coefficient for a lens that did move on the eye was 2.6 x 10^-6 mm²/min and that the highest coefficient for a lens that did not move on the eye was 1.5 x 10^-6 mm²/min. The text under Tables F (after the amendments set out at [42] above are made) states:

    “Considering only Examples F-1 through F-12 of Table F, the lowest value of Ionoflux Ion Permeability Coefficient for which a lens moves on the eye is 2.6 x 10^-6 mm²/min. The highest value of Ionoflux Ion Permeability Coefficient for a lens which binds on the eye is 1.5 x 10^-6 mm²/min. Thus, a contact lens preferably has an Ionoflux Ion Permeability Coefficient greater than about 1.5 x 10^-6 mm²/min., more preferably greater than about 2.6 x 10^-6 mm²/min.”

14. The order of figures used in the body of specification (on page 16) is “greater than about 6.4 x 10^-6 mm²/min” for the “preferred” ionoflux permeability coefficient, “greater than about 2.6 x 10^-6 mm²/min” for the more preferable co-efficient and “greater than about 1.5 x 10^‑6 mm²/min” for the most preferable coefficient. Claim 1 of the patent includes as an integer “an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10 ^-6 mm²/min”.

15. Novartis seeks to amend the ionoflux values in the patent in two inter-related respects:

    (i)First, it wishes to reverse the order of the figures on page 16 of the specification. At trial Bausch & Lomb did not dispute that the order of the figures given for the preferable, more preferable and most preferable values should be stated in an increasing, rather than a decreasing, order; and that the decreasing order stated in the specification was the result of error and, in the usual course, should be corrected. Thus, it was common ground that the values intended to be given should reflect the fact that the preferable value was intended to be the lower ionoflux ion permeability coefficient and the “more” and “most” preferable values were intended to be the higher coefficients. If this amendment was permitted the specification would state that the preferable ionoflux permeability coefficient is “greater than about 1.5 x 10^-6 mm²/min” or “more preferably… greater than about 2.6 x 10^-6 mm²/min” or “most preferably… greater than about 6.4 x 10^-6 mm²/min”.

    (ii)Second, it wishes to change the lowest preferred value for the ionoflux ion permeability coefficient from “greater than about 1.5 x 10^-6 mm²/min” to “no less than about 2.6 x 10^-6 mm²/min”. The alteration is sought to be made in the specification and in claim 1. This alteration will also result in the deletion of “1.5 x 10^-6 mm²/min” as a preferred value in (i) above.

16. At the final hearing Bausch & Lomb opposed the substantive amendments. It argued that they do not comply with s 102 of the Act and are therefore impermissible under s 105(4). It also argued that, in any event, in the particular circumstances of the present case the Court should decline to exercise its discretion to direct that the proposed amendments be made.

    Amendments under the Act

17. Section 105 of the Act provides:

    “(1)In any relevant proceedings in relation to a patent, the court may, on the application of the patentee, by order direct the amendment of the patent, the patent request or the complete specification in the manner specified in the order.

    (2)An order may be made subject to such terms (if any) as to costs, advertisements or otherwise, as the court thinks fit.

    (3)The patentee must give notice of an application for an order to the Commissioner, who is entitled to appear and be heard, and must appear if the court directs.

    (4)A court is not to direct an amendment that is not allowable under section 102.

    (5)The patentee must file a copy of an order within the prescribed period.

    (6)On the filing of a copy of an order, the patent, patent request or complete specification is to be taken to have been amended in the manner specified in the order.”

    Section 102 provides:

    “(1)     An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.

    (2)An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:

    (a)a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or

    (b)the specification would not comply with subsection 40(2) or (3)

    (2A)     For the purposes of subsection (2), relevant time means:

    (a)in relation to an amendment proposed to a complete specification relating to a standard patent—after the specification has been accepted; or

    (b)in relation to an amendment proposed to a complete specification relating to an innovation patent—after the Commissioner has made decisions under paragraphs 101E(a) and (aa) in respect of the patent.

    (2B)An amendment to a patent request relating to an innovation patent application is not allowable if:

    (a)the patent application was provided for in section 79C; and

    (b)the effect of the proposed amendment would be to convert the application from an application for an innovation patent to an application for a standard patent.

    (2C)An amendment of a complete specification relating to a patent is not allowable if:

    (a)the patentee or the patentee’s predecessor in title failed to ensure the provision to the Commissioner of the information required by subsection 45(3) or section 101D in relation to the patent; and

    (b)the effect of the proposed amendment would be to remove a lawful ground of objection under paragraph 18(1)(b) or 18(1A)(b) to the specification arising from the existence of some or all of the information not provided.

    (3)This section does not apply to an amendment for the purpose of correcting a clerical error or an obvious mistake made in, or in relation to, a complete specification.”

1. Section 105 confers on the Court a wide discretionary power to direct the amendment of a patent (cf s 104: New England Biolabs Inc v Commissioner of Patents (2001) 110 FCR 357). The power, however, may not be exercised to direct an amendment that is not allowable under s 102: see s 105(4). Accordingly, before directing an amendment, the Court is required to consider whether the amendment is prohibited by s 102 and, if it is not, whether the discretion to direct the amendment should be exercised in favour of the patentee: see Wimmera Industrial Minerals Pty Ltd v RGC Mineral Sands Ltd (No 3) (1997) AIPC ¶91-366 (39,772) (“Wimmera”).

   Section 102

2. Section 102 sets out circumstances in which an amendment is not allowed. Bausch & Lomb relied in its submissions on subs 102(1). Under that subsection an amendment is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed. As was contended by Bausch & Lomb, the subsection does not only have the effect of prohibiting claim broadening: that function is performed by s 102(2). In Wimmera Sundberg J considered the scope of s 102(1) and observed (at 39,783) that:

   “A two stage process is involved. The first stage involves a comparison between the specification as it stands and how it would stand after amendment. Once the matter resulting from the amendment has been identified, that matter is compared with the specification as filed in order to determine whether the specification as amended would claim matter not in substance disclosed in the specification as filed.”

   On appeal (RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd (1998) 89 FCR 458) Carr and Goldberg JJ stated at 466:

   “[Subsection 102(1)] requires one first to identify precisely what is the amendment. In this case that is done by identifying the difference between the specification as accepted (and as it stood at the hearing of the motion at first instance) on the one hand and, on the other hand, as the specification would read if amended in the manner sought. Then one reads the specification as a whole (as so amended in the manner sought) to see whether as a result of the amendments sought (which must mean by reason of the amendment sought) the specification would claim matter not in substance disclosed in the specification as filed. The subsection focuses on the amendment proposed and it must be that amendment which has the result of pushing the claimed matter over the line defined by the expression ‘matter not in substance disclosed in the specification as filed’. The key point to keep in mind is, as counsel for the respondent contended (in our view correctly), that the words ‘as a result of the amendment’ are not to be confused with the expression ‘after the amendment’.”

   See also Fina Research SA v Halliburton Energy Services Inc (2003) 127 FCR 561 at 574 [37]; ICI Chemicals & Polymers v Lubrizol Corp (1999) AIPC ¶91-521 (40,012) (“ICI”) at 40,016 [15]; and on appeal in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc (2000) 106 FCR 214 at 252 [117].

3. The task required by s 102 is to consider whether, if the amendments now proposed were allowed the patent would, as a result of those amendments, claim matter not in substance disclosed by the specification as filed. Although changes were made to the specification (in particular to the consistory clause and claim 1) after it was filed but before it was granted, they were not such as to materially alter the disclosure contained in the specification in relation to ion permeability values. Accordingly, the disclosure relevantly made in the specification as filed is not materially different to that contained in the patent as it now stands.

4. The proposed amendments concern the changes to the ion permeability values set out above at [49] to [54]. The amendments would have the effect of amending the ion permeability values throughout the patent so that they are consistent with the results recorded in Tables E and F in the specification. After the amendments sought, the patent would both disclose and claim lenses with ionoton ion permeability of no less than 0.25 x 10^‑3 cm²/sec or an ionoflux ion permeability of no less than 2.6 x 10^‑6 mm²/min. Table E as filed shows that the lowest tested ionoton value which correlated with on-eye movement was 0.25 x 10^‑3 cm²/sec and  Table F as filed shows that the lowest tested ionoflux value which correlated with on-eye movement was 2.6 x 10^-6 mm²/min. Tables E and F purport to record the results of clinical tests in relation to ion permeability. Although, as I later explain, inconsistent ion permeability values disclosed elsewhere in the patent would cause a person skilled in the art some confusion, I consider that, notwithstanding that fact, the disclosure of the ion permeability values contained in Tables E and F is such that the proposed amendments do not claim matter not in substance disclosed in the specification as filed. 

5. Accordingly s 102(1) does not prohibit the proposed amendments.

   Section 105

6. The remaining issue is whether the discretion conferred under s 105 should be exercised. In relation to the discretion a distinction has been made between amendments that merely delete invalid claims (“deletion amendments”) and amendments that cure otherwise invalid claims (“validating amendments”): see Terrell on the Law of Patents (15th Ed, 2000) at pages 264–266. In the case of a validating amendment a court will consider the conduct of the patentee in order to determine whether it is in the public interest that the amendment be allowed. Terrell (at [9.38]) explains the approach in the United Kingdom:

   “Where the amendment was sought to validate claims, the court refused amendment if it considered that the patentee’s conduct had been such that as a matter of discretion it should refuse to allow amendment. In earlier cases, the court was comparatively strict and would refuse leave to amend if the patentee had shown any lack of diligence or had originally made unduly wide claims. From about the 1970s onwards, however, the courts became more liberal in the exercise of the discretion and, as a general rule, the discretion would not be adversely applied unless the patentee had deliberately elected to maintain invalid claims which he knew or should have known required amendment: ‘covetous claiming’. Attempts to assert or enforce such claims in the unamended form were regarded with particular distaste.”

7. In C. Van der Lely NV v Bamfords Limited [1964] RPC 54 (“Van der Lely”) at 76 Willmer LJ observed:

   “It cannot, I think, be too strongly emphasised that at the present stage of this litigation the question with which we are concerned is the plaintiffs’ right to relief in respect of claims which have been found to be valid. The plaintiffs do not seek, by the amendment for which they ask, to validate claims which have been found to be invalid, but merely, by deleting the invalid claims, to put themselves in a position the better to enforce such rights as they have in respect of their valid claims.

   It has been strenuously argued on behalf of the defendants that what the plaintiffs seek is none the less an amendment of the specification, and it has been said that there is no distinction in principle between an amendment of the specification designed to validate invalid claims and an amendment such as that for which the plaintiffs now ask.

   I find myself unable to accept that contention, which appears to me to be wrong in principle, contrary to the authority of decided cases and, furthermore, inconsistent with the plain terms of the statute. So far as the matter is one of principle, it seems to me that there is all the difference in the world between an amendment designed to assist in the enforcement of a valid claim and one designed to validate an invalid one. Where a claim has been found to be valid, the patentee has made good his claim to monopoly rights to that extent. But where a claim has been found to be invalid, the patentee has failed; and it may well be said that no good reason exists why he should be accorded a second chance.”

   See also Chiron Corporation v Organon Teknika Limited (No. 5) [1994] FSR 258 at 263-265 and 266; and Kirin-Amgen Inc’s Patent [2002] RPC 43.

8. Although the Australian legislative regime makes no specific provision for a distinction between validating and other amendments, and in that respect differs from the United Kingdom legislation, the distinction has been recognised in this Court.  In that regard in ICI Emmett J observed at 40,021 [39]:

   “A question of principle arises as to whether the conduct of a patentee in relation to invalid claims should in any way impinge upon its entitlement in relation to valid claims or claims that, with amendment, would be valid claims. It may be that persisting in a claim found to be invalid is enough to warrant refusal of relief, including leave to amend, in relation to such a claim. Such persistence by a patentee in invalid claims may be a good ground for refusing leave to amend such invalid claims – see Raleigh Cycle Co. Ltd v H. Miller & Co. Ltd (1948) 65 RPC 141. However, the position will be different where some claims are found to be valid. There is no reason why the fact that a patentee has failed on some claims should be held to deprive it of his prima facie right to put a specification in order so as to be able to enjoy the fruits of victory in relation to other claims. The position in such a case will be different from the position that would prevail where a patentee seeks to amend an invalid claim – Van der Lely NV v Bamfords Ltd [1964] RPC 54 at 78 per Willmer LJ.”

9. In Eli Lilly at 237 [20], (see also above at [44]) Heerey J considered that an amendment involving the deletion of a claim on the ground that it is invalid should be treated differently from other amendments:

   “One obvious reason for this approach is that there is a public interest in the validity of a patent, extending beyond the patentee and those currently seeking revocation. The existence of patent claims which are in truth invalid, and which the patentee does not seek to propound, may inhibit persons from engaging in lawful and productive economic activity, with resultant disadvantage to the public by loss of competition and innovation.”

   That situation is plainly to be distinguished from the situation where an amendment, rather than removing one of the claims that is invalid, cures the invalidity. 

10. Of course, the present case is not one in which a patentee’s claims have been found to be invalid and a second chance is being sought. Rather, it is one in which the opponent at trial contended that the patent is invalid, inter alia, for lack of fair basis and that the amendments sought are designed to cure any alleged invalidity. As explained above, the issue of whether the amendments are validating amendments can be relevant to the amendment application. The issue is not relevant because any higher standard of proof or higher standard of conduct is required to be established in respect of such amendments. Rather, the relevance relates to whether the more lenient approach that might be applied to deleting amendments, or amendments that merely seek to correct errors or mistakes or remove ambiguities might be applicable. The reason for the leniency was explained by Pearson  LJ in Van der Lely at 74–75 where his Lordship observed that a court is prima facie disposed to the deletion of invalid claims because if such claims were to remain in the patent they would constitute a potential “nuisance to industry”. A similar observation can be made in respect of the mere correction of errors or mistakes which are not sought to cure any actual or potential invalidity.

11. Putting to one side cases where the more lenient approach may be taken, well established principles have been applied by the courts in the United Kingdom and Australia in relation to the wide discretion to direct or to refuse to direct an amendment: see Smith Kline & French Laboratories Limited v Evans Medical Limited [1989] 1 FSR 561 (“Smith Kline & French”) at 569; Rescare Limited v Anaesthetic Supplies Pty Ltd (unreported, Federal Court of Australia, Gummow J, 4 March 1993) (“Rescare”) at 11; Wimmera at 39,789; Gambro Pty Ltd v Fresenius Medical Care South East Asia Pty Ltd (1999) 48 IPR 625 (“Gambro”) at 638-639 [69] and ICI at 40,020–40,021 [37]. The principles which guide the exercise of the discretion were helpfully summarised by Aldous J in Smith Kline & French, at 569:

    “The discretion as to whether or not to allow amendment is a wide one and the cases illustrate some principles which are applicable to the present case. First, the onus to establish that amendment should be allowed is upon the patentee and full disclosure must be made of all relevant matters. If there is a failure to disclose all the relevant matters, amendment will be refused. Secondly, amendment will be allowed provided the amendments are permitted under the Act and no circumstances arise which would lead the court to refuse the amendment. Thirdly, it is in the public interest that amendment is sought promptly. Thus, in cases where a patentee delays for an unreasonable period before seeking amendment, it will not be allowed unless the patentee shows reasonable grounds for his delay. Such includes cases where a patentee believed that amendment was not necessary and had reasonable grounds for that belief. Fourthly, a patentee who seeks to obtain an unfair advantage from a patent, which he knows or should have known should be amended, will not be allowed to amend. Such a case is where a patentee threatens an infringer with his unamended patent after he knows or should have known of the need to amend. Fifthly, the court is concerned with the conduct of the patentee and not with the merit of the invention.”

12. The above passage was cited with approval by the Court of Appeal in the United Kingdom in Hsiung’s Patent [1992] RPC 497 at 522-523; and in this Court by Gummow J in Rescare at 11; by Sundberg J in Wimmera at 39,789; and by Tamberlin J in Gambro at 638-639 [69]. One or more of the principles stated by Aldous J have also been applied in ICI at 40,021 [38], Neurizon Pty Ltd v Lth Consulting and Marketing Services (No 2) (2003) AIPC ¶91-882 (35,633) eg at 35,638 [17] and 35,639 [25] and Eli Lilly eg at 237 [21].

13. In Wimmera Sundberg J considered the manner in which the discretion should be exercised. He stated (at 39,790) that the discretion in s 105, like any other, is to be exercised in the light of all the circumstances of the case, and that the principles set out in the cases should be treated as guidelines and not as fixed or inflexible rules. As his Honour pointed out, there may be circumstances which mitigate, explain or excuse a matter that would otherwise call for the exercise of the discretion to be refused. His Honour also stated (at 39,790) that the Court should not approach the discretion in “a manner hostile or antipathetic to amendment.” See also Tamberlin J in Gambro at 641 [86].

14. Before turning to the application of the above principles it is appropriate to first consider whether the amendments in question in the present case are properly to be characterised as validating amendments or, rather, are amendments that merely seek to correct errors or mistakes or remove ambiguities. In particular, if the amendments fall into the latter category Novartis may be entitled to rely on that fact as a circumstance that might call for the application of a more lenient approach to be applied to its conduct. As explained above the determination of that question can be relevant to how the Court might consider the conduct of the patentee in relation to the amendments it is seeking.

    Are the ion permeability amendments validating amendments?

15. At trial Novartis claimed that the amendments, that were at that time opposed by Bausch & Lomb, would “put the matter [of validity] beyond doubt” and “make it perfectly plain what the appropriate values are”. However, it contended that the amendments were not essential for validity. If that is correct the amendments would not be validating amendments.

16. The relevant ground of invalidity relied upon by Bausch & Lomb at trial was a lack of fair basis. It claimed that the claims in question, being claims 8, 11, 12 and 13, (now the consolidated claims 1-4) do not comply with s 40(3) of the Act, which requires that “[t]he claim or claims must be clear and succinct and fairly based on the matter described in the specification”. The failure of a patent to comply with s 40(3) is a ground for revocation of the patent under s 138(3)(f) of the Act. If Bausch & Lomb’s contentions at trial were correct the amendments then sought by Novartis to claim 1 and thereby also to claims 8, 11, 12 and 13 (and now to the consolidated claims 1–4), and the related amendments in the specification, can be fairly described as validating amendments.

17. Determining whether there is a lack of fair basis involves a comparison between the disclosure provided in the body of the specification on the one hand, and the scope of the invention defined in the claims on the other: Kimberly-Clark Australia Pty Limited v Arico Trading International Pty Limited  (2001) 207 CLR 1 (“Kimberly-Clark”) at 12. The body of the specification must provide a “real and reasonably clear disclosure” of the matters that are claimed: in Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 per Fullager J at 11, followed in F. Hoffman-La Roche & Co. Aktien-Gesellschaft v Commissioner of Patents (1971) 123 CLR 529 at 359, Rehm Pty Ltd v Websters SecuritySystems (International) Pty Ltd (1988) 81 ALR 79 at 93, Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126 at 142, CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 281-282 and Lockwood Security Products Pty Ltd  v Doric Products Pty Ltd (2003) 56 IPR 479 (“Lockwood”) at 499 [92]. Correlatively, the claims must not travel beyond the matter described in the body of the specification: per Barwick CJ in Olin Corporation v Super Cartridge Co. Pty. Ltd. (1977) 180 CLR 236 (“Olin”) at 240 followed in Kimberly-Clark at 12, and Lockwood at 499 [91]. See also Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29 (“Atlantis”) at 50.

18. When s 40(3) requires that a patent’s claims must be fairly based on “the matter described in the specification”, it refers to the description required by s 40(2)(a): see eg Atlantis at 49-50. That subsection provides that a complete specification must “describe the invention fully, including the best method known to the applicant of performing the invention…”.

19. On the present application it is necessary to consider whether the ion permeability values in the original claim 1 (and now in consolidated claims 1 and 2) travel beyond the ion permeability values for the invention disclosed in the specification.

20. On Novartis’ submissions, a crucial aspect of the invention described in the specification is the role of ion permeability in achieving on-eye movement and, more specifically, the discovery described in the specification that “above a certain threshhold [sic] of ion permeability through a lens… the lens will move on the eye, and below the threshhold [sic] the lens will adhere to the eye.”  It is common ground that in order to be “ophthalmically compatible” an extended wear contact lens must move on the eye. Although Bausch & Lomb disputed the extent to which the threshold theory is valid, it is clear from the specification that a key aspect of the invention there disclosed is the discovery of minimum ion permeability values that are claimed to correlate with on-eye movement. Although the evidence establishes that the values may in fact be more accurately described as necessary but not sufficient requirements for on-eye movement rather than threshold values, the body of the specification discloses that the “threshold” values are significant features of the invention. The quantified level of ion permeability at which that threshold is disclosed to exist is therefore also an important part of the invention. Further, as explained elsewhere in these reasons, the body of the specification also reveals, albeit implicitly, that the minimum ion permeability values are also significant in determining whether the requirement of a separate and continuous ionoperm phase has been met.

1. Novartis pointed to the email sent by Dietz on 19 September 1996 to SEE3 project members in which he stated that he and Meece had concluded that:

   “…the deficiencies in JUMP with respect to units or numerical values, if they exist at all, are small and, in our view, not very significant. There is an enormous amount of disclosure in JUMP the correctness of which has not been questioned by any of the inventors, and we believe that we can successfully rely on said disclosure in order to delineate the claims from the prior art known to us.” [My emphasis]

2. However, Dietz’s email proffers no explanation as to why the deficiencies might not exist and, if they do, why they are “small” and “not very significant”. It does not explain the considerations that he and Meece took into account in reaching that view. In any event, the email was sent in the context of considering whether a new and additional patent (“JUMP II”) should be created, rather than whether the JUMP patent should be amended in any of the jurisdictions in which it was filed. That is, Dietz was explaining that he and Meece had decided that a JUMP II patent was not required, in part because “the deficiencies in JUMP… if they exist at all, are small and, in our view, not very significant”. There is no evidence of consideration having been given to whether there was a need for amendment of the existing patent.

3. Further, there is no reasonable basis for concluding that the errors alleged were “small and … not very significant”. In the case of the ionoflux figures, if the theory advanced by Court, and adopted by Bausch & Lomb, is correct, and the lowest ionoflux value which will not bind to the eye is in fact 6.4 x 10^-5 mm²/min, then the “preferred” value claimed in the patent (1.5 x 10^-6 mm²/min) would be more than 40 times too low. In respect of the ionoton values Novartis conceded that the ‘preferred’ value in the patent (0.2 x 10^‑6 cm²/sec) is more than a 1000 times too low (when compared to the value which resulted in on-eye movement, namely 0.25 x 10^-3 cm²/sec). Plainly, such errors are not capable of being reasonably characterised as small or insignificant. This is particularly so when it is considered that the errors pointed out were in both the body of the specification and in the claims.

4. Another explanation given by Dietz for the delay in seeking amendment was his unfamiliarity with Australian patent law. In that regard, he stated:

   ·    that he was not aware that a patentee wishing to amend should apply as early as possible, and that this is not the case in Europe; and

   ·    that he does not view it as a problem if some embodiments of an invention claimed by a patent do not work (“because what do you take away from the public if you claim something which doesn’t work?”).

5. As late as 21 August 2002, in an email to Novartis’ solicitors, Dietz continued to maintain that amendments to move the preferred values from “greater than” the highest value that did not work to “no less than” the lowest value which did work should not be made. In relation to the ionoflux values, he stated:

   “…example F8 does not work, while example F4 does. F8 has the 1.5 ionoflux value, F4 has the 2.6 ionoflux value. Thus we disclose: 2.6 is okay, 1.5 is too low. What the claim says (and corresponding portions of the specification) is: The value for ionoflux must be GREATER than (about) 1.5 – and I believe this is exactly what one is allowed to deduce from the F4/F8 comparison. In view thereof, I am strongly in favour not to replace the 1.5 ionoflux value by 2.6 as a lower limitation.”

   While it may be literally correct to state that the data in the patent shows that the ionoflux value must be greater than 1.5 to achieve on-eye movement, that data does not indicate that values above 1.5 but below 2.6 will achieve movement on the eye. Dietz’s evidence is consistent with the view that Novartis’ policy in respect of the patent was to maintain wide claims irrespective of whether the data justified such claims.

6. In his email of 21 August 2002 Dietz applied the same logic to the ionoton figures. His view was that substantial amendment was to be avoided “if ever possible”. At that time Elisabeth Opie, a lawyer for the CSIRO agreed with Dietz’s recommendation that in principle “amendments [should] be kept to a minimum”, although acknowledging that she did not feel qualified to comment on the particular amendments proposed.

7. Novartis’ conduct in relation to the question of amendment demonstrates little regard for the requirements of Australian patent law. Indeed, it appears that the first occasion on which those requirements were considered was in late 2001 and early 2002 when, in the context of Bausch & Lomb’s claim of invalidity, advice was sought on the issue of amendment from senior and junior counsel representing Novartis in the present proceeding. Although the patentees had employed an Australian patent attorney during the drafting of the patent there was no evidence that that attorney was consulted on the question of amending the patent.

8. For the foregoing reasons I am satisfied that no reasonable or satisfactory explanation has been provided for the long period of delay in making the application for amendment in respect of the ion permeability values. It was open to Novartis, at any time prior to the commencement of the current proceeding, to apply to the Commissioner for an amendment under s 104. After the proceeding had been commenced Novartis was able to apply to the Court under s 105 for amendment. It did not do so until December 2002. Further, the general lack of candour displayed by Novartis in relation to its amendment application, which I discussed above (at [130]), also taints the explanations proffered for its delay in seeking amendment. The result is that the patentees, without having reasonable grounds to do so, have maintained, for over six years, claims that are significantly broader than those to which they were entitled on the basis of the disclosures they made and the examples they provided in the patent.

9. I have also found earlier in these reasons (at [126] – [129]) that the ion permeability values claimed in the patent were chosen as part of a policy of claiming as broadly as possible. Where a claim is “covetous”, in that it is unjustifiably wide, the Court may refuse amendment of that claim: see Bristol Myers at 856 and Rescare at 13. This approach may also extend to the refusal of an amendment in cases where a claim is, perhaps for innocent reasons, drawn too broadly, and is unjustifiably persisted in. As was observed by Lord MacDermott in Raleigh at 295:

   “There are times when it may be to the commercial advantage of a patentee to leave a claim, wide or vague enough to be bad, unamended, and I see no reason why the court should not be free to prevent this in cases which do not call for the deletion of all but the valid claims.”

10. In the present case it is clear that Novartis remained reluctant to amend the patent until advised by counsel that at least one of the amendments now sought was essential to the patent’s validity. It is likely that Novartis, for commercial reasons, sought to maintain, as far as practical, a common form of the patent in the respective jurisdictions in which it was granted. Novartis’ persistence in maintaining the patent in its current wide form does not assist its case for amendment.

11. I turn next to Bausch & Lomb’s contention at trial that, if permitted, the amendments would result in an erroneous ionoflux value continuing to appear in the patent. Novartis claims that that contention is mere conjecture and has not been proved. I have referred earlier in these reasons (see [109] – [114]) to the evidence relied upon by Bausch & Lomb which raises serious questions about the accuracy of the ionoflux values in the patent, and which Novartis’ proposed amendments do not address. No evidence has been adduced by Novartis to demonstrate that the relevant ionoflux values are accurate. In the result I am left in some doubt as to whether the ionoflux values proposed by Novartis are in fact correct.

12. In Minerals Separation Ltd v Potter’s Sulphide Ore Treatment Ltd (1909) 8 CLR 779 at 800 O’Connor J stated:

    “In the exercise of the discretion it is clear that an amendment ought not to be allowed which would make a patent obviously bad – bad either by reason of insufficient description of the process or invention, or by reason of any failure in the duty of fully informing the public as to the manner in which the invention is to be carried out.”

    O’Connor J’s approach was later embodied in s 102 and its predecessor. It may well be that other matters that would render a patent “bad” may be considered as part of the Court’s discretion in amendment cases. Such a case may arise where a patentee seeks to amend a claim so as to include a value or values shown by empirical evidence external to the patent not to work, thereby raising a case of inutility. In the United Kingdom the Court may refuse amendments that fail to cure a claim that is invalid due to obviousness or lack of novelty: see Mullard Radio Valve Co. Ltd. v British Belmont Radio Ltd. [1939] RPC 1 eg at 18; Great Lakes Carbon Corporation’s Patent [1971] RPC 117 at 123 and 126; and more generally Texas Instruments Ltd v Hyundai Electronics UK Ltd (unreported, UK Patents Court, Pumfrey J, 30 July 1999) at [35]. On the other hand, there are grounds for contending that in such cases it may be appropriate to permit the amendment on the basis that the validity of the amended patent should be determined in revocation, rather than amendment, proceedings: see for example Richardson-Vicks Inc.’s Patent [1995] RPC 568 (where Jacob J allowed an amendment before revoking the amended patent for obviousness) and Minister of Agriculture’s Patent [1990] RPC 61 at 65.

13. In view of the other conclusions at which I have arrived I have not found it necessary to determine Bausch & Lomb’s contention that, if permitted, the proposed amendments would result in erroneous ionoflux values continuing to appear in the patent.

14. The factors that militate against the granting of Novartis’ application to amend can be summarised as follows:

    (i)the history of the patent’s drafting indicates that the ion permeability values contained in it were chosen not as a matter of scientific judgment but, rather, as part of a policy of claiming as broadly as possible, even if this meant overstating the patent’s claims without having reasonable grounds to do so;

    (ii)when problems with the ion permeability values were revealed, no steps were taken to correct those values by the amendment of the patent until more than six years after the patentees were aware or ought to have been aware of the problems, and no reasonable or satisfactory explanation for that delay has been provided;

    (iii)notwithstanding the problems concerning the ion permeability values, including the overstating of those values, there is no evidence that Novartis considered, or consulted its Australian legal advisers about, whether the patent should be amended until after the commencement of this proceeding and until after Bausch & Lomb had raised the issue of invalidity by reason of those ion permeability values;

    (iv)the patentees have not made a full and candid disclosure to the Court of all the circumstances relevant to the amendment application.

15. In summary, the present case is one in which the patentees knew or ought to have known that the substantive amendments they now seek to make should have been sought long ago, but have failed to provide a reasonable or satisfactory explanation for their delay, which can fairly be characterised as culpable delay. Further, the errors and other matters now sought to be corrected came about as part of a policy of overstating claims without having reasonable grounds for doing so.

16. Several factors, however, support the amendment application:

    (i)Some of the problems evident in the patent and its history might be referable to carelessness or a lack of diligence on the part of the patentees (whether in relation to proof reading the patent for errors, investigating alleged errors in the patent, familiarising themselves adequately with the legal requirements of various jurisdictions, or carelessness in other respects);

    (ii)the amendments now sought aim to give effect to the ionoton and ionoflux values disclosed in Tables E and F in the specification with respect to on-eye movement;

    (iii)no specific detriment has been shown to have been suffered by any particular person by reason of the claims in the patent being broader than was justifiable by reference to the disclosures made in the specification; however, this factor needs to be balanced against the public interest in a patentee not representing that it has valid claims when it knew, or ought to have known, that those claims cannot be supported in their present form;

    (iv)Bausch & Lomb now consent to the amendments with the consequence that they are no longer opposed amendments;

    (v)The Commissioner has not objected to the amendments; however, that needs to be balanced against the fact that the Commissioner is not in a position to consider the merits of the application as she has not examined the evidence of the parties in relation to that question.

    After taking into account all of the matters to which I have referred, I have concluded that the proposed substantive amendments should be refused because Novartis has failed to discharge the onus on it to satisfy the Court that those amendments should be granted. I have borne in mind the comment of Sundberg J in Wimmera (at 39,790) that “the Court does not approach the exercise of its discretion in a manner hostile or antipathetic to amendment.” However, the factors militating against amendment are powerful. In that regard I consider the extent of the delay, which I regard as “culpable delay”; the failure of Novartis to provide a satisfactory or reasonable explanation for its omission to act earlier to correct the ion permeability values and the other matters which it now seeks to address; and Novartis’ lack of candour in respect of those matters as weighing heavily against its application to amend. Further, the persistence by Novartis with claims drawn as broadly as possible, without having reasonable grounds for doing so, called for it to satisfy the Court that there were circumstances that mitigated, explained or excused the delay that has taken place. In my view that has not occurred.  Finally, I would add that the fact that the amendments are no longer opposed must be balanced against the opposition to the amendments at trial, the evidence adduced at trial in support of that opposition, and the Commissioner’s submission that if the Court is concerned about the validity of the patent it may be appropriate to direct the Commissioner to re-examine the patent.

17. I have considered whether the Court should permit Novartis to amend the ionoton exponent (from -6 to -3) and the descending order of the preferred ionoflux values on page 16 of the patent (to an ascending order) on the ground that (at least in Novartis’ submission) they are obvious errors that ought to be corrected. However, Court had pointed out both of those errors in 1996 and no step was taken to correct them.  In any event these errors do not stand alone. The ionoton exponent and the order of the ionoflux figures are both integral to the source of the values to which they relate. Further, those values were maintained pursuant to a policy of Novartis which I have found to have been persisted in by it in a manner antithetical to the public interest. Accordingly, I am not satisfied that it is appropriate to consider the ionoton exponent of -6 separately from the 0.2 to which it is applied and which I have not permitted Novartis to amend, or to consider the erroneous ascending order separately from the values contained in the order, particularly the 1.5 ionoflux value, in respect of which I have also refused amendment.

18. For the above reasons I have concluded that the validating and related amendments sought by Novartis, and which were opposed at trial by Bausch & Lomb, should be refused. Accordingly, it is appropriate to dismiss the application for those amendments. It is also appropriate that liberty to apply be reserved to enable any further application that may be appropriate, including any application the Commissioner may wish to make in the light of these reasons for judgment.

    Orders

19. The orders that are appropriate are:

    1.        The application and the cross claim be dismissed by consent with no order as to costs.

    2.Compliance with the requirements of Order 58 rule 10 of the Federal Court Rules be dispensed with in respect of the amendments set out in paragraph  3(g) hereunder.

    3.        Australian Letters Patent No 704749 (“the patent”) be amended as follows:

    (a)On page 4 at lines 11–12, delete the words “lens allows”.

    (b)On page 4 at line 22, replace “mm²/sec” with “cm²/sec”.

    (c)On page 22 at the 7^th last line, delete the word “material”.

    (d)On page 22 at line 25, replace “permeability” with “transmissibility”, and replace “transmissibility” with “permeability”.

    (e)On page 23 at the 11^th last line, replace “material” with “ lens”.

    (f)On page 99 at line 1, replace “F-13” with “F-12”.

    (g)On pages 102–113 delete claims 1–66 and replace with:

    1. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:
    (a)       at least one oxyperm polymerizable material and
    (b)       at least one ionoperm polymerizable material,
    wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,
    wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,
    wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,
    wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and
    wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,
    wherein said polymeric material comprises a plurality of co-continuous phases, including at least one oxyperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens and at least one ionoperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens.

    2. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:
    (a)       at least one oxyperm polymerizable material and
    (b)       at least one ionoperm polymerizable material,
    wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,
    wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,
    wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,
    wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and
    wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,
    wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

    3. An ophthalmic lens of claim 2, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of siloxane-containing polymeric material.

    4. An ophthalmic lens of claim 2, wherein said pathways have a domain size which is less than a size which undesirably distorts visible light in an amount which is visible to the eye of the wearer.”

    4.Save for the orders set out in paragraph 2 above, the applicants’ motion dated 6 December 2002 for amendment of the patent be dismissed.

    5.The applicants pay any costs of the Commissioner of Patents that were incurred after 2 July 2004 in respect of the applicants’ motion for amendment of the patent.

    6.The motion of Johnson & Johnson Pacific Pty Limited dated 16 July 2004 be dismissed.

    7.Johnson & Johnson Pacific Pty Limited is to pay the costs of the applicants of and incidental to the motion.

    8.        Reserve liberty to apply.

I certify that the preceding one hundred and sixty-six (166) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Merkel.

Associate:

Dated:             24 August 2004

Counsel for the Applicant:	Mr R Macaw QC with Mr G McGowan
Solicitor for the Applicant:	Davies Collison Cave Solicitors
Counsel for the Respondent:	Mr DK Catterns QC with Mr AJ Ryan
Solicitor for the Respondent:	Spruson & Ferguson Lawyers
Counsel for Johnson & Johnson	Mr D Yates SC
Solicitor for Johnson & Johnson	Freehills
Solicitor for the Commissioner of Patents	Australian Government Solicitor
Date of Hearing:	7, 8, 9, 10, 13, 14, 15, 16, 17, 20, 21, 22, 23, 24 October 2003, 9, 10, 11 December 2003 and 1, 2, 12 July 2004
Date of Judgment:	24 August 2004