FEDERAL COURT OF AUSTRALIA Alcon Laboratories (Australia) Pty Ltd v Trustees of Columbia University in the City of New York [2002] FCA 1314 ALCON LABORATORIES (AUSTRALIA) PTY LTD v THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK N676 OF 2002 EMMETT J 15 OCTOBER 2002 SYDNEY IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY N676 OF 2002 BETWEEN: ALCON LABORATORIES (AUSTRALIA) PTY LIMITED (ABN 88 000 740 830) FIRST APPLICANT ALCON LABORATORIES, INC SECOND APPLICANT AND: THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK FIRST RESPONDENT PHARMACIA AKTIEBOLAG SECOND RESPONDENT JUDGE: EMMETT J DATE OF ORDER: 15 OCTOBER 2002 WHERE MADE: SYDNEY THE COURT ORDERS THAT: 1. Australian Letters Patent No 625096 ("the Patent") be amended by: (a) deleting claims 1 to 43 of the Patent; (b) inserting claims 1 to 71 as set out in pages 1 to 11 of the Schedule to these orders ("the Schedule"); (c) cancelling page 5 of the Specification on file and substituting therefor page 12 of the Schedule; and (d) cancelling page 21 of the Specification on file and substituting therefor page 13 of the Schedule. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules. SCHEDULE TO THE ORDERS OF EMMETT J MADE 15 OCTOBER 2002 "1. A method for the treatment of glaucoma or ocular hypertension, comprising topical administration to a mammal of an effective intraocular pressure reducing amount of a therapeutically active and physiologically acceptable prostaglandin derivative of PGA, PGB, PGE or PGF in which the omega chain has the formula: (13) (14) (15-24) C B C - D - R2 or the pharmaceutically acceptable salts thereof, wherein C is a carbon atom (the number is indicated within parenthesis); B is a single bond, a double bond or a triple bond; D is a chain with 1-10 carbon atoms, optionally interrupted by one or more heteroatoms O, S, or N, the substituents on each carbon atom being selected from H, alkyl, carbonyl and hydroxyl groups; R2 is an aromatic ring structure which is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl groups; or R2 is selected from thiazole, imidazole, pyrrolidine, thiophene, oxazole or such like aromatic heterocyclic groups having 5-6 ring atoms; or R2 is a cycloalkane or a cycloalkene with 3-7 carbon atoms in the ring, optionally substituted with lower alkyl groups with 1-5 carbon atoms, with the proviso that, when the said prostaglandin derivative is a derivative of PGE1 in which R2 is substituted or unsubstituted phenyl, benzyl or phenoxy, then the carbon at position 6 of the alpha chain cannot be substituted by hydroxy. 2. [12] The [A] method according to claim 1 [any one of claims 1 to 11], wherein the prostaglandin derivative is an alkyl ester. New claim 3. The method according to claim 1 or 2, wherein the alpha chain of the prostaglandin derivative has the formula: wherein R1 is C1-C10 alkyl. New claim 4. The method according to claim 3 wherein R1 is isopropyl. New claim 5. The method according to any one of claims 1 to 4, wherein the alicyclic ring of said prostaglandin derivative has the formula I: New claim 6. The method according to any one of claims 1 to 4, wherein the alicyclic ring of said prostaglandin derivative has the formula II: New claim 7. The method according to any one of claims 1 to 4, wherein the alicyclic ring of said prostaglandin derivative has the formula III: New claim 8. The method according to any one of claims 1 to 4, wherein the alicyclic ring of said prostaglandin derivative has the formula IV: 9[6]. The [A] method according to any one of claims 1 to 8[5], wherein B is a single bond or a double bond and the substituent on C15 is [being] a carbonyl group or (R)-OH or (S)-OH. New claim 10. The method according to any one of claims 1 to 9, wherein B is a single bond or a double bond and the substituent on C15 is (R)-OH or (S)-OH. 11. [2] The [A] method according to any one of claims 1 to 10 [claim 1], wherein D is a chain with 1-10 carbon atoms optionally interrupted by one or more hetero atoms O, S, or N, the substituents on each carbon atom being selected from H, C1-C5 alkyl, carbonyl and hydroxyl [groups]. 12. [3] The [A] method according to any one of claims 1 to 11 [claim 1 or 2], wherein D is a chain with 2-8 carbon atoms. 13.[4] The [A] method according to any one of claims 1 to 12 [3] wherein D is a chain with 2-5 carbon atoms. New claim 14. The method according to any one of claims 1 to 13, wherein D is a chain with 2 or 3 carbon atoms. 15.[5] The [A] method according to any one of claims 1 to 14 [4], wherein D is a chain with 3 carbon atoms. New claim 16. The method of any one of claims 1 to 15, wherein D is a chain interrupted by one or more heteroatoms O, S or N. New claim 17. The method of any one of claims 1 to 16, wherein there is a single interruption in the D chain by a heteroatom O, S or N. New claim 18. The method according to any one of claims 1 to 17, wherein R2 is an aromatic ring structure which is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. 19. [7]. The [A] method according to any one of claims 1 to 18 [6], wherein R2 is [a] phenyl [group] which is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl [groups]. New claim 20. The method according to any one of claims 1 to 17, wherein R2 is selected from thiazole, imidazole, pyrrolidine, thiophene and oxazole. New claim 21. The method according to any one of claims 1 to 17, wherein R2 is a cycloalkane or a cycloalkene with 3-7 carbon atoms in the ring, optionally substituted with lower alkyl groups with 1-5 carbon atoms. 22. [8] The [A] method according to any one of claims 1 to 19 [1 to 7], wherein the prostaglandin derivative is a 17-phenyl-18, 19, 20-trinor analogue, and the phenyl substituent at position 17 of the omega chain is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. 23.[9] The [A] method according to any one of claims 1 to 19 or 22 [1 to 8], wherein the prostaglandin derivative is a 13,14-dihydro-17-phenyl- 18,19,20-trinor analogue or a 15-dehydro-17- phenyl-18,19,20-trinor analogue, and the phenyl substituent at position 17 of the omega chain is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. 24. [10]. The [A] method according to any one of claims 1 to 5, 7 to 19, 22 or 23 [1 to 9], wherein the prostaglandin derivative is a 13,14-dihydro-17- phenyl-18,19,20-trinor derivative of PGA, PGE or PGF, and the phenyl substituent at position 17 of the omega chain is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. 25. [11] The [A] method according to any one of claims 1 to 5, 7 to 9, 11 to 19 or 22 to 24 [1 to 9], wherein the prostaglandin is a 15-dehydro-17-phenyl-18,19,20-trinor derivative of PGA, PGE or PGF, and the phenyl substituent at position 17 of the omega chain is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. New claim 26. The method according to any one of claims 22 to 25, wherein the phenyl substituent at position 17 of the omega chain is unsubstituted. New claim 27. The method according to any one of claims 22 to 25, wherein the phenyl substituent at position 17 of the omega chain is substituted. 28. [19] The [A] method according to claim 1, wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α-alkylester, in which the alkyl group has 1-10 carbon atoms. [20. A method according to claim 19 wherein the alkyl group is isopropyl.] 29. [13]The [A] method according to claim 1, wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl- 18,19,20-trinor-PGF2α-isopropylester. 30.[14] The [A] method according to claim 1, wherein the prostaglandin derivative is 15-dehydro-17-phenyl-18,19,20- trinor-PGF2α-isopropylester. 31. [15] The [A] method according to claim 1, wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl- 18,19,20-trinor-PGA2-isopropylester. 32. [16] The [A] method according to claim 1, wherein the prostaglandin derivative is 15-(R)-17-phenyl-18,19, 20-trinor-PGF2α-isopropylester. 33.[17] The [A] method according to claim 1, wherein the prostaglandin derivative is 17-phenyl-18,19,20-trinor-PGF2α-isopropylester. 34. [18] The [A] method according to claim 1, wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl-18,19,20- trinor-PGF2α. 35. [21]The [A] method according to any one of claims 1 to 34 [20] wherein said prostaglandin derivative or pharmaceutically acceptable salt thereof is administered in admixture with an ophthalmologically compatible carrier. 36. [22]An ophthalmological composition for topical treatment of glaucoma or ocular hypertension which comprises an ophthalmologically compatible carrier and an effective intraocular pressure reducing amount of a therapeutically active and physiologically acceptable prostaglandin derivative of PGA, PGB, PGE or PGF in which the omega chain has the formula: (13) (14) (15-24) C B C - D - R2 or the pharmaceutically acceptable salts thereof, wherein C is a carbon atom (the number is indicated within parenthesis); B is a single bond, a double bond or a triple bond; D is a chain with 1-10 carbon atoms, optionally interrupted by one or more heteroatoms O, S, or N, the substituents on each carbon atom being selected from H, alkyl, carbonyl and hydroxyl groups; R2 is an aromatic ring structure which is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl groups; or R2 is selected from thiazole, imidazole, pyrrolidine, thiophene, oxazole or such like aromatic heterocyclic groups having 5-6 ring atoms; or R2 is a cycloalkane or a cycloalkene with 3-7 carbon atoms in the ring, optionally substituted with lower alkyl groups with 1-5 carbon atoms, with the proviso that, when the said prostaglandin derivative is a derivative of PGE1 in which R2 is substituted or unsubstituted phenyl, benzyl or phenoxy, then the carbon at position 6 of the alpha chain cannot be substituted by hydroxy. 37. [22] The [A] composition according to claim 36 [any one of claims 22 to 32], wherein the prostaglandin derivative is an alkyl ester. New claim 38. The composition according to claim 36 or 37, wherein the alpha chain of the prostaglandin derivative has the formula: wherein R1 is C1-C10 alkyl. New claim 39. The composition according to claim 38 wherein R1 is isopropyl. New claim 40. The composition according to any one of claims 36 to 39, wherein the alicyclic ring of said prostaglandin derivative has the formula I: New claim 41. The composition according to any one of claims 36 to 39, wherein the alicyclic ring of said prostaglandin derivative has the formula II: New claim 42. The composition according to any one of claims 36 to 39, wherein the alicyclic ring of said prostaglandin derivative has the formula III: New claim 43. The composition according to any one of claims 36 to 39, wherein the alicyclic ring of said prostaglandin derivative has the formula IV: 44. [27] The [A]composition according to any one of claims 36 to 43 [22 to 26], wherein B is a single bond or a double bond and the substituent on C15 is [being] a carbonyl group or (R)-OH or (S)-OH. New claim 45. The composition according to any one of claims 36 to 44, wherein B is a single bond or a double bond and the substituent on C15 is (R)-OH or (S)-OH. 46. [23] The[A] composition according to any one of claims 36 to 45 [22], wherein D is a chain with 1-10 carbon atoms optionally interrupted by one or more hetero atoms O, S, or N, the substituents on each carbon atom being selected from H, C1-C5 alkyl, carbonyl and hydroxyl [groups]. 47. [24] The [A] composition according to any one of claims 36 to 46 [claim 22 or 23], wherein D is a chain with 2-8 carbon atoms. 48. [25] The [A] composition according to any one of claims 36 to 47 [22 to 24] wherein D is a chain with 2-5 carbon atoms. New claim 49. The composition according to any one of claims 36 to 48, wherein D is a chain with 2 or 3 carbon atoms. 50. [26]The [A] composition according to any one of claims 36 to 49 [22 to 25], wherein D is a chain with 3 carbon atoms. New claim 51. The composition of any one of claims 36 to 50, wherein D is a chain interrupted by one or more heteroatoms O, S or N. New claim 52. The compositionof any one of claims 36 to 51, wherein there is a single interruption in the D chain by a heteroatom O, S or N. New claim 53. The composition according to any one of claims 36 to 52, wherein R2 is an aromatic ring structure which is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. 54. [28] The [A] composition according to any one of claims 36 to 53 [22 to 27], wherein R2 is [a] phenyl [group] which is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl [groups]. New claim 55. The composition according to any one of claims 36 to 52, wherein R2 is selected from thiazole, imidazole, pyrrolidine, thiophene and oxazole. New claim 56. The composition according to any one of claims 36 to 52, wherein R2 is a cycloalkane or a cycloalkene with 3-7 carbon atoms in the ring, optionally substituted with lower alkyl groups with 1-5 carbon atoms. 57. [29] The [A] composition according to any one of claims 36 to 54 [22 to 28], wherein the prostaglandin derivative is a 17-phenyl-18, 19, 20-trinor analogue, and the phenyl substituent at position 17 of the omega chain is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. 58. [30] The [A] composition according to any one of claims 36 to 54 or 57 [22 to 29], wherein the prostaglandin derivative is a 13,14-dihydro-17-phenyl- 18,19,20-trinor analogue or a 15-dehydro-17- phenyl-18,19,20-trinor analogue, and the phenyl substituent at position 17 of the omega chain is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. 59. [31] The [A] composition according to any one of claims 36 to 40, 42 to 54, 57 or 58 [22 to 30], wherein the prostaglandin derivative is a 13,14-dihydro-17- phenyl-18,19,20-trinor derivative of PGA, PGE or PGF, and the phenyl substituent at position 17 of the omega chain is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. 60. [32] The [A] composition according to any one of claims 36 to 40, 42 to 44, 46 to 54 or 57 to 59 [22 to 30], wherein the prostaglandin is a 15-dehydro-17-phenyl-18,19,20-trinor derivative of PGA, PGE or PGF, and the phenyl substituent at position 17 of the omega chain is unsubstituted or has at least one substituent selected from C1-C5 alkyl, C1-C4 alkoxy, trifluoromethyl, C1-C3 aliphatic acylamino, nitro, halogen and phenyl. New claim 61.The composition according to any one of claims 57 to 60, wherein the phenyl substituent at position 17 of the omega chain is unsubstituted. New claim 62.The composition according to any one of claims 57 to 60, wherein the phenyl substituent at position 17 of the omega chain is substituted. 63. [40]The [A] composition according to claim 36 [22], wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α-alkylester, in which the alkyl group has 1-10 carbon atoms. [41. A composition according to claim 40 wherein the alkyl group is isopropyl.] 64. [34] The [A] composition according to claim 36 [22], wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl- 18,19,20-trinor-PGF2α-isopropylester. 65. [35]The [A] composition according to claim 36 [22], wherein the prostaglandin derivative is 15-dehydro-17-phenyl-18,19,20- trinor-PGF2α-isopropylester. 66. [36]The [A] composition according to claim 36 [22], wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl- 18,19,20-trinor-PGA2-isopropylester. 67. [37]The [A] composition according to claim 36 [22], wherein the prostaglandin derivative is 15-(R)-17-phenyl-18,19, 20-trinor-PGF2α-isopropylester. 68. [38]The [A] composition according to claim 36 [22], wherein the prostaglandin derivative is 17-phenyl-18,19,20-trinor-PGF2α-isopropylester. 69. [39] The [A] composition according to claim 36 [22], wherein the prostaglandin derivative is 13,14-dihydro-17-phenyl-18,19,20- trinor-PGF2α. 70. [42] 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α-alkylester, in which the alkyl group has 3-10 carbon atoms. 71. [43] The [A] compound of claim 70 [42] wherein the alkyl group is isopropyl." IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY N676 OF 2002 BETWEEN: ALCON LABORATORIES (AUSTRALIA) PTY LIMITED (ABN 88 000 740 830) FIRST APPLICANT ALCON LABORATORIES, INC SECOND APPLICANT AND: THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK FIRST RESPONDENT PHARMACIA AKTIEBOLAG SECOND RESPONDENT JUDGE: EMMETT J DATE: 15 OCTOBER 2002 PLACE: SYDNEY REASONS FOR JUDGMENT 1 The second respondent in this proceeding, Pharmacia Aktiebolag ("Pharmacia") is the holder of Australian Letters Patent Number 625096 ("the Patent"). The Patent was granted on 26 March 1998. Section 105(1) of the Patents Act 1990 (Cth)("the Patents Act") provides that in any relevant proceedings in relation to a patent, the Court may, on the application of a patentee, by order direct the amendment of a patent in the manner specified in the order. By notice of motion filed on 30 August 2002, Pharmacia sought orders under s 105 for the amendment of the Patent. 2 I shall say something about the background to the application. On 4 January 2002 a gazettal notice reported that the Australian Drug Evaluation Committee ("ADEC") had resolved in December 2001 to advise the Parliamentary Secretary to the Minister for Health and Aged Care and the Secretary of the Department of Health and Aged Care that Travopost eye drops in aqueous solution ("the Alcon Product") should be approved for registration. The applicant for registration was the first applicant in the proceeding, Alcon Laboratories (Australia) Pty Limited ("Alcon Australia"). Having regard to that announcement, a decision was made on behalf of Pharmacia to review the Patent. 3 On 4 July 2002, E.F. Wellington & Co, patent attorneys, wrote to the Commissioner of Patents ("the Commissioner") lodging documents in support of a request for amendment of the Patent under s 104 of the Patents Act. Section 104(1) provides that a patentee of a patent may, subject to the Patents Act, ask the Commissioner for leave to amend the complete specification for such patent. Under s 104(5), however, the Commissioner must not allow an amendment that is not allowable under s 102. Further, under s 112, a complete specification relating to a patent must not be amended except under s 105 while relevant proceedings in relation to the patent are pending. Under s 3 and Schedule 1 to the Patents Act, "relevant proceedings" in relation to a patent includes court proceedings for revocation of the patent. 4 On 19 July 2002, E.F. Wellington & Co received a report from an examiner of the Commissioner in relation to the request to amend under s 104. The examiner requested confirmation that there were no relevant proceedings pending. This proceeding was, in fact, commenced on 10 July 2002. By the application in this proceeding, Alcon Australia and Alcon Laboratories Inc seek, inter alia, an order that the Patent be revoked. This proceeding is therefore relevant proceedings for the purpose of s 112 of the Patents Act. Accordingly, as from 10 July 2002, the Commissioner no longer had power to amend the Patent under s 104. Hence the application to this Court. 5 Under O 58 r 10 of the Federal Court Rules an application for an order under s 105(1) of the Patents Act may be made only after the applicant gives to the Commissioner a notice of intention to apply, accompanied by an advertisement that states certain matters as set out in O 58 r 10(1). Under O 58 r 10(2) the Commissioner must then publish the advertisement in the official journal once unless the Court otherwise orders. The application may be instituted by filing a notice of motion in the relevant proceedings before the end of 50 days after the date of publication of the advertisement. That period expired on 3 October 2002, this motion having been filed on 30 August 2002. I am satisfied that the requirements for advertising under O 58 r 10 have been complied with. 6 Section 105(4) of the Patents Act provides that the Court may not direct an amendment that is not allowable under s 102. Sections 102(1) and 102(2) relevantly provide as follows: "(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 an amendment; or (b) the specification would not comply with subsection 40, subsection 2 or subsection 3." 7 On 28 August 2002 the Commissioner informed the solicitors for Pharmacia that the proposed amendments had been reviewed and that the Commissioner is prima facie satisfied that the amendments are allowable under s 102 of the Patents Act. Under s 105(3) a patentee who makes an application under that section must give notice of the application to the Commissioner who is entitled to appear and be heard and must appear if the Court directs. The Commissioner has also informed Pharmacia's solicitors that she does not intend to appear on the hearing of this application. 8 I have not seen anything in the material before me that indicates that the Commissioner should be directed to appear. I am satisfied from the material before me that the Commissioner has been notified, as I have indicated, and that the Commissioner is satisfied that the proposed amendments would be allowable under s 102. That, of course, is not decisive of the matter, but it is a matter that would give comfort to the Court in dealing with an application of this nature. 9 On 10 October 2002 the applicants, the first respondent in this proceeding, the Trustees of Columbia University in the City of New York ("the Trustees"), and Pharmacia entered into a confidential settlement agreement. Under the terms of that agreement, the applicants and the Trustees relevantly agreed: · not to oppose the proposed amendments to the Patent, and · that within twenty-eight days after determination of the amendment application the proceeding would be dismissed by consent with no order as to costs. 10 No party has given notice of its intention to oppose the proposed amendments. Accordingly the application has proceeded before me unopposed. Nevertheless, it is incumbent upon the Court, having regard to the real nature of the proceeding, to be satisfied that the amendment is not contrary to the public interest. In addition, the Court must be satisfied that the amendment would not offend s 105(4). 11 It is desirable to say something about the Patent. The invention of the Patent is concerned with the use of prostaglandin derivatives. The complete specification of the Patent describes the general structure of the prostaglandin derivatives by reference to formulae and diagrams. The general structure of the prostaglandin derivatives includes "alicyclic rings" to which are attached what are described as "omega chains" and "alpha chains". The complete specification states that the invention is based on the use of derivatives characterised by their omega chain and that various modifications of the alpha chain are therefore possible still using the inventive concept. The complete specification states that the alpha chain could typically be the naturally occurring alpha chain, which is described in the specification. The omega chain is then defined by reference to a formula set out in the specification. 12 The invention is concerned with the treatment of glaucoma, or ocular hypertension. The invention also relates to ophthalmic compositions containing an active amount of the relevant prostaglandin derivatives and the manufacture of such compositions. Glaucoma is an eye disorder characterised by increased intra-ocular pressure, damage to the optic nerve head and gradual loss of the visual field. An abnormally high intra-ocular pressure is commonly known to be detrimental to the eye. Unless treated successfully, glaucoma will lead to blindness sooner or later. Its course towards that stage is typically slow with progressive loss of the vision. 13 The Patent states that glaucoma treatments can be given by means of drugs, laser or surgery. Prostaglandins have recently been the subject of increasing interest as an intra-ocular pressure-lowering substance. The Patent refers to the use of prostaglandins and their derivatives in materials published between 1983 and 1989. It also states that, with respect to the practical usefulness of some of the previously described prostaglandins and derivatives, the limiting factor is their property of causing superficial irritation and vasodilation in the conjunctiva. It is probable, moreover, that prostaglandins have an irritant effect on the sensory nerves of the cornea. Thus local side effects will arise in the eye even when the amounts of prostaglandin administered are quite small. 14 The Patent states that prostaglandins are very potent pharmacologically and affect both sensory nerves and smooth muscles of the blood vessels. The doses currently practicable in clinical tests are necessarily very low. The Patent claims to have found that a solution to the problems briefly described is the use of certain derivatives of specific prostaglandins in which the omega chain has been modified with the common feature of containing a ring structure for the treatment of glaucoma or ocular hypertension. 15 There are three independent claims in the specification of the Patent as granted, being claims 1, 22 and 42 of the 43 claims. All of the other claims are subsidiary to one or other of those three independent claims. Most of the existing subsidiary claims of the Patent are significantly narrower than the existing independent claims 1 and 22. In many cases, the existing subsidiary claims are directed to quite specific embodiments of the claimed invention. 16 The proposed amendments are designed to include additional subsidiary claims of scope intermediate between the existing independent claims and the existing subsidiary claims. They are also designed to include subsidiary claims for preferred or specific disclosures referred to in the body of the specification. There are also two amendments of obvious typographical errors. Apart from the two typographical errors, the only amendments are to the claims. The mechanism of the amendment is to delete all 43 claims and to insert 71 new claims. However, claims 1, 36 and 70 of the proposed new claims are identical to claims 1, 22 and 42 of the Patent as granted. In addition, a number of the proposed new claims reproduce existing claims. 17 Proposed new claims 3 to 8, 10, 14, 16 to 18, 20 to 21, 26 and 27 are new claims. Claims 37 to 69 are composition claims corresponding to the proposed new claims 2 to 34. Claims 20 and 41 of the existing claims are not reproduced. Proposed new claims 3 and 4 relate to the alpha chain to which I have already referred. Proposed claims 5 to 8 relate in respect of each of the alicyclic rings to which I have referred. Proposed claims 10, 14, 16 to 18, 20, 21, 26 and 27 relate to individual characteristics of the omega chain to which I have referred. 18 I have been taken to the proposed new claims by reference to the material contained in the body of the specification in the Patent as granted. I am satisfied that, as a result of the proposed amendments, the specification would not claim matter not in substance disclosed in the Patent as granted. 19 There has been amendment of the complete specification as originally filed. However, I am satisfied that it is not necessary for me to consider the terms of the complete specification as originally filed, having satisfied myself that the specification would not, as a result of the proposed amendments, claim matter not in substance disclosed in the specification as it stands. I am also satisfied that no claim of the specification as amended would not in substance fall within the scope of the claims of the specification before amendment. 20 In the proceeding, as it currently stands, there are claims of invalidity based on non-compliance with s 40(3) of the Patents Act. Whether or not those claims can be made out is not a matter for me to consider on the hearing of this application. The question is whether, as a result of the amendment, the specification would not comply with s 40(2) or s 40(3). I am satisfied that there is nothing in the amendments that would have the result that the specification would not comply with s 40. 21 In all the circumstances I am satisfied that amendment of the Patent should be directed as asked. I certify that the preceding twenty-one (21) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Emmett. Associate: Dated: 24 October 2002 Counsel for the Second Respondent: Dr J.McL. Emmerson QC & Mr R. Cobden Solicitor for the Second Respondentt: Allens Arthur Robinson Date of Hearing: 15 October 2002 Date of Judgment: 15 October 2002