Pharmacia Aktiebolag v Ueno Fine Chemicals Industry, Ltd
[1995] APO 59
•10 October 1995
official notice
decision of a delegate of the commissioner of patents
Application : No. 625096 in the name of PHARMACIA AKTIEBOLAG
Title: Prostaglandin derivatives for the treatment of glaucoma or ocular hypertension
Action: Opposition under section 59 of the Patents Act by UENO FINE CHEMICALS INDUSTRY, LTD
Decision: Issued
Abstract: i) Claims found to be entitled only to partial priority from basic documents.
ii) Claims found to be not novel in the light of a generic disclosure.
iii) Prior claiming not established as claims of citation could not be notionally rewritten.
iv) Term "or such like" found not to be unclear.
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent Application No. 625096 by Pharmacia Aktiebolag and opposition thereto under section 59 of the Patents Act 1952 by Ueno Fine Chemicals Industry, Ltd
background
Australian patent application number 41898/89 was lodged as a PCT application (number PCT/SE89/00475) on 6 September 1989 by Pharmacia AB. The application claimed priority from Swedish applications numbered 8803110 and 8803855, which were filed on 6 September 1988 and 28 October 1988 respectively. During the prosecution of the application the applicant was changed to Kabi Pharmacia AB, and then to Pharmacia Aktiebolag (hereafter referred to as "PHARMACIA").
The application was advertised accepted on 2 July 1992, and assigned the number 625096. A notice of opposition was lodged by Ueno Fine Chemicals Industry, Ltd (hereafter referred to as "UENO") on 2 October 1992. A statement of grounds and particulars was filed on 2 November 1992, and amended three times without opposition. The process of serving evidence was completed on 1 March 1994.
The matter was heard in Melbourne on 9 and 10 May 1995. PHARMACIA was represented by Dr J.McL Emmerson of counsel, assisted by Mr B.Wellington of E.F.Wellington & Co., Melbourne. UENO was represented by Mr B.Caine of counsel, assisted by Ms D.Beadle of Davies Collison Cave, Melbourne.
statement of grounds and particulars
The statement of grounds and particulars identifies the following grounds of opposition:
.the invention as claimed in any claim is prior claimed;
.the invention as claimed in any claim is prior published;
.the invention as claimed in any claim is not a manner of manufacture as it involves a mere admixture of known ingredients;
.the invention as claimed in any claim is obvious and does not involve an inventive step;
.the invention as claimed in any claim is not novel; and
.the specification does not fully describe the invention, and the claims do not clearly define the invention and are not fairly based.
evidence
UENO's evidence in support consists of declarations by Julian L Rait (dated 2 February 1993), Ivan Goldberg (dated 3 May 1993), Terence G. Corbett (two declarations dated 2 February 1993 and 29 March 1993), Ngaire Ann Petit-Young (three declarations dated 23 February 1993, 29 March 1993, and 2 April 1993), Elizabeth G. Dolby (dated 22 February 1993) and Kary Ratz (dated 3 May 1993).
PHARMACIA's evidence in answer consists of declarations by Johan W. Stjernschantz (dated 26 August 1993), Ian Favilla (dated 30 August 1993), Mark Edward Loane (dated 2 September 1993) and Ivan Goldberg (dated 31 August 1993).
UENO's evidence in reply consists of declarations by Julian L Rait (dated 31 December 1993), Ivan Goldberg (dated 2 February 1994), Tomio Oda (dated 22 February 1994), Ngaire Ann Petit-Young (dated 26 January 1994) and Fiona Margaret Bathgate (two declarations dated 11 January 1994).
It was accepted by the parties that the Rait declarations are the principle declarations for UENO, and the Goldberg and Oda declarations are largely corroborative. It was also accepted that the Stjernschantz declaration is the principle declaration for PHARMACIA, and the Favilla and Loane declarations are largely corroborative.
Details of the evidence will be given where appropriate in my decision. I will not refer to the Goldberg, Oda, Favilla or Loane declarations where they are merely corroborative of the principle declaration.
submissions at the hearing
UENO stated that it was limiting its case to the grounds of prior claiming, prior publication, novelty and lack of clarity.
UENO made submissions on the following matters:
.claims 1 to 10, 12, 13, 15, 17 to 31, 33, 34, 36, 38 to 41 are prior claimed by AU 600168;
.claims 1 to 6, 9, 10, 12, 13, 15, 18 to 27, 30, 31, 33, 34, 36, 39 to 41 are prior published and not novel in the light of AU 600168;
.claims 1 to 17, 21, 22 to 38 are prior published and not novel in the light of US 4131738;
.claims 42 and 43 are prior published and not novel in the light of CA 986926 and an article by Granström;
.claims 1 and 22 are not clear due to the use of the term "or such like"; and
.award of costs.
PHARMACIA made submissions on all of these matters.
Details of the submissions will be given where relevant in my decision.
decision
The relevant law
Patent application 625096 was lodged on 6 September 1989, advertised accepted on 2 July 1992 and a notice of opposition was lodged on 2 October 1992. By virtue of subsections 234(2) and 234(3) the present opposition is governed by the Patents Act 1990, except that Part V of the Patents Act 1952 replaces Chapter 5 of the Patents Act 1990.
Matters to be decided
The matters that have to be decided in this opposition are threefold:
.novelty (including prior publication);
.prior claiming; and
.section 40 matters.
The decision on novelty and prior claiming depends in large part on the determination of the priority date(s) of the claims, and on the disclosure afforded by an anticipation couched in generic terms.
Before considering these matters I will discuss the specification.
The specification
The specification relates to the treatment of glaucoma or ocular hypertension.
The specification admits that prostaglandin compounds are known to reduce intraocular pressure, but they possess the side effect of causing superficial irritation and vasodilation in the conjunctiva, and have an irritant effect on the sensory nerves of the cornea (page 3). The solution provided by the invention lies in the use of a specific class of prostaglandin derivatives:
"We have found that a solution to the problems discussed above is the use of certain derivatives of prostaglandins A, B, E and F, 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.
The prostaglandin derivatives have the general structure
wherein A represents the alicyclic ring C8-C12 and the bonds between the ring and the side chains represent the various isomers. In PGA, PGB, PGE and PGF, A has the formula
The invention is based on the use of derivatives characterized by their omega chain and various modifications of the alpha chain is therefore possible still using the inventive concept. ...
The omega chain is defined by the following formula:
(13) (14) (15-24)
C B C - D - R2
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, preferably 2-8, and especially 2-5, and particularly 3 carbon atoms, optionally interrupted by preferably not more than two hetero atoms (O,S, or N), the substituent on each carbon atom being H, alkyl groups, preferably lower alkyl groups within 1-5 carbon atoms, a carbonyl group, or a hydroxyl group, whereby the substituent on C15 preferably being a carbonyl group, or (R)-OH or (S)-OH; each chain D containing preferably not more than three hydroxyl groups or not more than three carbonyl groups,
R2 is a ring structure such as a phenyl group which is unsubstituted or has at least one substituent selected from C1-C5 alkyl groups, C1-C4 alkoxy groups, trifluoromethyl groups, C1-C3 aliphatic acylamino groups, nitro groups, halogen atoms, and phenyl group; or an aromatic heterocyclic group having 5-6 ring atoms, like thiazol (sic), imidazole, pyrrolidine, thiophene and oxazole; or a cycloalkane or a cycloalkene with 3-7 carbon atoms in the ring, optionally substituted with lower alkyl groups with 1-5 carbon atoms."[pages 4 to 5]
The specification ends with 44 claims, including 4 independent claims. The claims are directed to a method of treatment of glaucoma or ocular hypertension (claims 1 to 21), an ophthalmological composition (claims 22 to 41), and to some compounds per se (claims 42 to 44).
Claim 1 reads:
"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 hetero atoms 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."
This claim is directed to a method of treatment involving the administration of a prostaglandin derivative having the specified structural formula. The prostaglandins are qualified by the limitation that they must be "therapeutically active and physiologically acceptable". PHARMACIA stated that this term must be understood as excluding those prostaglandins that the person skilled in the art would not consider to be both therapeutically active and physiologically acceptable, and does not require further explanation. I accept this interpretation.
Claim 22 reads:
"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 hetero atoms 0, 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 group 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."
This claim is directed to a composition characterised by the presence of a prostaglandin derivative of the specified structural formula. I interpret the term "therapeutically active and physiologically acceptable" in the same way as in claim 1.
A composition of known materials is defined by the components that make up the composition and the amounts in which they are present. The composition of claim 22 is characterised by the fact that it contains a carrier and "an effective intraocular pressure reducing amount" of the prostaglandin. PHARMACIA stated that this terminology defines the proportion of prostaglandin in the total composition as the ratio of "an effective intraocular pressure reducing amount" of the prostaglandin to the amount of total composition that would be used for a normal administration. If this is so, then the claim implicitly limits the quantity of carrier. I cannot see that this is necessarily true. The composition of claim 22 is characterised by the amount of the prostaglandin only (the amount being defined by result). In the present opposition nothing turns on this point.
Claims 42 to 44 read:
"42. 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2a.
43. 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2a -alkylester, in which the alkyl group has 1-10 carbon atoms.
44. A compound of claim 43 wherein the alkyl group is isopropyl."
These claims are directed to compounds per se.
Onus of proof/standard of proof
Before proceeding to examine the issues, I will deal with the onus of proof and the standard of proof that applies in this matter.
PHARMACIA submitted that the opposition should only succeed if it is quite clear that a patent would be invalid. In support of this position, PHARMACIA referred to the judgements of the High Court in McGlashan v Rabett (1909) 9 CLR 223, Stamp v W.J.Powell Pty Ltd (1918) 24 CLR 339 and Henry Berry & Co. Pty Ltd v Potter (1924) 35 CLR 132. The tenor of these submissions can be summarised by quoting from the judgement of Isaacs ACJ and Gavan Duffy J in Henry Berry v Potter, supra, at page 138:
"The opposition under sec. 56 is a proceeding intended only to intercept a patent which would be clearly invalid on one of the grounds specified in the section (McGlashan v Rabett (1) and Stamp v W.J.Powell Pty Ltd (2)). It has some resemblance in principle to the summary proceedings under Order XIV of the Supreme Court Rules. The issue for the Court - as for the Commissioner - is whether for the reasons specified the matter is so plain that the application ought to be at once ended and not left to the fuller consideration of more deliberate examination."
(1) (1909) 9 CLR 223
(2) (1918) 24 CLR 339
[Note: Section 56 of the Patents Act 1903 corresponds to section 59 of the Patents Act 1952]
I accept that UENO carries the onus of substantiating the opposition, and that the standard of proof required is that it can only succeed if it is clear that a valid patent cannot be granted.
Priority dates of the claims
The application claims priority from the Swedish basic documents SE 8803110 (dated 6 September 1988) and SE 8803855 (dated 28 October 1988). There was disagreement as to the priority dates that apply to the claims of the opposed application. These dates are critical to the determination of whether the claims are anticipated.
a) The relevant law on priority dates
Priority dates are determined by section 43 and regulation 3.12. In the present case:
.the application is a PCT application (as defined in regulation 3.12(2));
.the Swedish applications were made not more than 12 months before the international filing date; and thus
.the application can claim priority from the Swedish applications to the extent that the claims are fairly based on the matter disclosed in the basic documents.
I was referred to the following cases for guidance on how to apply the concept of fair basis to determining priority dates: F.Hoffman-La Roche & Co Aktiengesellschaft v Commissioner of Patents (1971) 123 CLR 529 at 538-539, AMP Incorporated v Utilux Pty Ltd (1971) 45 ALJR 123 at 131, Interact Machine Tools (NSW) Pty Ltd v Yamazaki Mazak Corporation (1993) 27 IPR 83 at 91, CCOM Pty Ltd v Jiejing Pty Ltd (1994) 28 IPR 481 at 496-501.
From these cases I discern that it is not necessary to identify a correspondence of essential features between the basic document and the application. However, the basic document must contain a real and reasonably clear disclosure of the invention. This requirement is satisfied if the matter claimed in the application is foreshadowed by the disclosure in the basic document.
At the hearing there was some discussion of the following passage from Stauffer Chemical Co.'s Application [1977] RPC 33 (quoted in CCOM at page 501):
"If a new feature were a development along the same line of thought which constitutes or underlies the invention described in the earlier document, it might be that that development could properly be regarded as fairly based on the matter disclosed in the earlier document, and that the new process described in the later document which incorporates that development could as a whole be regarded as fairly based upon the matter disclosed in the earlier document. If, on the other hand, the additional feature involves a new inventive step or brings something new into the combination which represents a departure from the idea of the invention described in the earlier document, it could not, I think, be properly described as fairly based upon the earlier document."
This passage suggests to me that if the basic document gives fair notice of a general proposition, a further development of that proposition "along the same line of thought" is fairly based on the earlier document.
PHARMACIA also referred to the passage from Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd (1986) 67 ALR 390 at 436 (quoted in CCOM at page 501):
"Where the holder of the provisional specification proceeds with a complete specification with a view to the grant of a patent, it is recognised that greater definition, as a result of further experimentation or otherwise, may be achieved before the later step is taken and the result expressed therein. Some generality of expression in the provisional specification is accepted."
Although the present case does not involve a provisional specification under the Australian Patents Act, the Swedish documents can be viewed as analogous to provisional specifications. I believe that the principle in the Coopers case is equally relevant to the present case, and consequently it may be acceptable if the basic document is couched in general terms, and the application is more specific.
I will now consider the disclosures of the basic documents.
b) Disclosure of SE 8803110 and SE 8803855
The Swedish basic documents are written in Swedish. In what follows I will refer to the verified translations of these documents, which form part of the official file of the opposed application.
The specification of SE 8803110 states:
"The invention is conserned (sic) with the use of derivatives of prostaglandin F2alpha, viz. 17-phenyl-18,19,20-trinor PGF2alpha, for the treatment of glaucoma or ocular hypertension. The invention furthermore relates to ophthalmic compositions containing an active amount of these prostaglandin derivatives. ...
With respect to the practical usefulness of some of the previously described prostaglandins and derivatives, as suitable as drugs for treating glaucoma or ocular hypertension, a limiting factor is their property of causing superficial irritation and vasodilatation in the conjunctica (sic). ...
We have now found, surprisingly, that 17-phenyl-18,19,20-trinor PGF2alpha-derivatives, for instance 17-phenyl-18,19,20-trinor PGF2alpha-1-isopropyl ester, will lower the intraocular pressure without causing any substantial irritation. ... This compound has been described for instance by Miller et al, 1975, but its very strong and durable eye pressure lowering effect without local irritation has not earlier been described.
The present invention thus relates to 1-alkyl or 1-alkylaryl esters of 17-phenyl-18,19,20-trinor PGF2alpha to be used for treating glaucoma or ocular hypertension. The alkyl chain of the 1-alkyl esters comprises 1-10, preferably 1-7, and especially 1-5 carbon atoms. The 1-alkylaryl esters have an aryl group monosubstituted by a lower alkyl chain. This lower alkyl chain has 1-5 carbon atoms. In an embodiment currently preferred, the 17-phenyl-18,19,20-trinor PGF2alpha - isopropyl ester is used."
[pages 1 to 4]
The only compounds exemplified are 17-phenyl-18,19,20-trinor-
PGF2a and its isopropyl ester.
The specification of SE 8803855 states:
"The invention is conserned (sic) with the use of derivatives of prostaglandin F2alpha, viz. 15-dehydro-17-phenyl-18,19,20-trinor PGF2alpha, for the treatment of glaucoma or ocular hypertension. The invention furthermore relates to ophthalmic compositions containing an active amount of these prostaglandin derivatives. ...
With respect to the practical usefulness of some of the previously described prostaglandins and derivatives, as suitable as drugs for treating glaucoma or ocular hypertension, a limiting factor is their property of causing superficial irritation and vasodilatation in the conjunctica (sic). ...
We have now found, surprisingly, that 15-dehydro-17-phenyl-18,19,20-trinor PGF2alpha-derivatives, for instance 15-dehydro-17-phenyl-18,19,20-trinor PGF2alpha-1-isopropyl ester, will lower the intraocular pressure without causing any irritation or conjunctival hyperemia. ... The present patent application is related to the use of 15-dehydro-17-phenyl-18,19,20-trinor PGF2alpha and its esters for treatment of glaucoma or ocular hypertension. We have found that this form of 17-phenyl-18,19,20-trinor PGF2alpha lacks substantially all irritating and vasodilatory effect in conjunctiva.
The present invention thus relates to 1-alkyl or 1-alkylaryl esters of 15-dehydro-17-phenyl-18,19,20-trinor PGF2alpha to be used for treating glaucoma or ocular hypertension. The alkyl chain of the 1-alkyl esters comprises 1-10, preferably 1-7, and especially 1-5 carbon atoms. The 1-alkylaryl esters have an aryl group monosubstituted by a lower alkyl chain. This lower alkyl chain has 1-5 carbon atoms. In an embodiment currently preferred, the 15-dehydro-17-phenyl-18,19,20-trinor PGF2alpha - isopropyl ester is used."
[pages 1 to 4]
The only compounds exemplified are 15-dehydro-17-phenyl-18,19,20-trinor-PGF2a and its isopropyl ester.
PHARMACIA contended that SE 8803110 discloses a prostaglandin wherein the omega chain has been modified by the inclusion of a ring, and SE 8803855 discloses further elaboration of this general proposition.
Paragraph 18 of the Stjernschantz declaration states:
"18. The Kabi Invention: Kabi Acceptance Serial No. 625096 ("Exhibit JLR-2" of the Rait declaration) claims priority of two basic applications filed September 6, 1988 and October 28, 1988, copies of verified English-language translations of those two basic applications being appended to this affidavit and marked "Exhibit JWS-12" and "Exhibit JWS-13", respectively. In the first of these basic applications, the use of 17-phenyl-18,19,20-trinor-PGF2a esters is described and claimed, and in the second of these basic applications, the use of 15-dehydro (that is, 15-keto)-17-phenyl-18,19,20-trinor-PGF2a esters is described and claimed. In my view, any person skilled in the art of prostaglandin chemistry and biology as at September 6, 1988, would have appreciated from a reading of the specifications of those two basic applications: firstly, that in general, prostaglandin analogues having a ring structure on the omega chain are especially suitable for the treatment of glaucoma; and secondly, that in particular, the 13,14-dihydro-15-keto-17-phenyl-18,19,20-trinor-PGF2a-isopropyl ester analogue, would also be suitable for the treatment of glaucoma. In short, it is my view that it would have been most unreasonable for such persons skilled in the art as of September 6, 1988, not to have regarded the two basic applications of Kabi Acceptance Serial No. 625096 as encompassing the use of prostaglandin analogues having a ring structure on the omega chain, such as the 13,14-dihydro-15-keto-17-phenyl-18,19,20-trinor-PGF2a-isopropyl ester analogue, in the treatment of glaucoma."
Paragraph 20 of the Stjernschantz declaration further states:
"20. In the two basic applications of Kabi Acceptance Serial No. 625096, the phenyl ring at position 17 of the omega chain is clearly used as an example of ring or aromatic structures in general. A person skilled in the art as of September 6, 1988, would readily understand from the specifications of those basic applications that the introduction of a ring structure into the omega chain fundamentally changes the properties of the omega chain, and that the phenyl ring had been used to exemplify in general the importance of a ring structure on the omega chain for improving the therapeutic index of prostaglandins in the eye. In short, the specifications of those basic applications clearly disclose that omega chain ring-substituted prostaglandin analogues exhibit markedly improved therapeutic index in a topical treatment for glaucoma compared with naturally occurring prostaglandins or their esters."
UENO contended that SE 8803110 only discloses 17-phenyl-18,19,20-trinor-PGF2a and its esters, and SE 8803855 only discloses the 15-dehydro derivative. Paragraph 9 of the second Rait declaration states:
"In paragraphs 18 and 20, Dr Stjernschantz states that "any person skilled in the art of prostaglandin chemistry and biology as at 6 September, 1988, would have appreciated from a reading of the specifications in the two basic applications (Exhibits JWS-12 and JWS-13): firstly, that in general, prostaglandin analogues having a ring structure on the omega ring are especially suitable for the treatment of glaucoma; and secondly, that in particular, the 13,14-dihydro-15-keto-17-phenyl-18,19,20-trinor-PGF2a-isopropyl ester analogue, would also be suitable for the treatment of glaucoma." I do not agree with this statement. Exhibit JWS-12 only discloses 1-alkyl or 1-alkylaryl esters of 17-phenyl-18,19,20-trinor PGF2a and in particular, isopropyl esters thereof. In view of this disclosure, I believe that only Claims 17 and 38 and portions of Claims 1 to 8, 12, 21 to 29 and 33 are entitled to the earliest priority date of 6 September, 1988. In particular, I point out that Exhibit JWS-12 does not describe any 13,14-dihydro compounds, and does not describe any 15-keto compounds. In fact, 13,14-dihydro-15-keto compounds, including those containing a ring as part of the omega chain were first described by the Opponent as disclosed in Exhibits JLR-ll and JLR-14. ...
Similarly, Exhibit JWS-13 only discloses 1-alkyl or 1-alkylaryl esters of 15-dehydro-17-phenyl-18,19,20-trinor PGF2a and in particular, isopropyl esters thereof. Especially, contrary to Dr. Stjernschantz's statement, there is no disclosure or statement of any type in Exhibit JWS-13 even remotely suggesting that 13,14-dihydro analogues might be useful, let alone the particular 13,14-dihydro-15-keto analogue mentioned by Dr. Stjernschantz. It is clear to me that there was no thought by the Applicant of including 13,14-dihydro-15-keto-17-phenyl-18,19,20-trinor PGF2a isopropyl ester in a patent application prior to the filing of the opposed patent application on September 6, 1989. I again point out that the significance of the 13,14-dihydro-15-keto structure in such prostaglandin compounds (including those including a phenyl ring as part of the omega chain) was understood by Opponent well before Applicant as evidenced by Opponent's Exhibits JLR-11 and JLR-14. In view of this disclosure, I believe that only Claims 14 and 35 and portions of Claims 1 to 7, 9, 11, 12, 21 to 28, 30, 32 and 33 are entitled to the priority date of 28 October, 1988."
PHARMACIA submitted that there is a disagreement between the experts on the matter of the disclosure of the basic documents, so the matter should be resolved in favour of the applicant since it could not be said that the opponent had discharged the onus of proof. UENO submitted that I could prefer one body of evidence over another and make my own decision.
I note that in F.Hoffman-La Roche v Commissioner, supra, Gibbs J examined the basic document to determine what he considered was disclosed. I believe that I am entitled to examine the basic documents and the declarations in evidence to arrive at my own opinion as to the priority date(s) of the claims of the present application.
SE 8803110 clearly discloses PGF2a esters in which the omega chain has been converted to the 17-phenyl-18,19,20-trinor form. Dr Stjernschantz considers that the document goes further, and teaches the use of compounds having a ring on the omega chain (paragraph 18 of the Stjernschantz declaration).
PHARMACIA argued that the application under opposition is a fair working out of the material broadly described in the basic documents, and should be seen as the development of the line of thought in the basic documents. I cannot agree with this submission. The idea described as the invention in the basic documents is very limited and not phrased in general terms. SE 8803110 only refers to esters (and the corresponding acid) of the type
SE 8803855 only refers to esters (and the corresponding acid) of the type
Neither basic document suggests alternative substitutions on the omega chain. Further, neither basic document suggests series of prostaglandins other than PGF2a. Dr Stjernschantz's opinion of the disclosure of the basic documents is in marked contrast to what they state on their face. Such an opinion requires some explanation before it is accepted.
Dr Stjernschantz does not state in simple terms how he arrived at his conclusion. It seems likely that it is based on his review of the use of prostaglandins for reducing ocular hypertension (at paragraphs 6 to 17 of his declaration). This history can be summarised by saying that it was known that prostaglandins were capable of lowering intraocular pressure, but their side effects made them unsuitable for practical use. There was a large body of research into the development of derivatives in order to identify a compound with improved therapeutic index. None of the compounds tried before 1989 had a ring structure on the omega chain. It appears to be against this background that, Dr Stjernschantz identifies the significant feature of the basic documents as a disclosure of the advantages of compounds containing a ring on the omega chain.
I have difficulty understanding why a reader would have considered that it was the presence of a ring on the omega chain (as against any other structural feature or features) that had produced the improvement in therapeutic index reported in the basic documents. There are three reasons for this:
Dr Stjernschantz's view of the teaching of the basic documents was either unknown to PHARMACIA at the time of writing the basic documents, or was not considered worthy of noting. Either situation does not militate in favour of Dr Stjernschantz's interpretation;
There is no explanation of the mechanism by which the compounds operate to achieve their effects. At the hearing PHARMACIA asserted that the improved activity is not the result of increased lipophilicity (paragraphs 24 to 28 of the Stjernschantz declaration supports this assertion). However, this does not illuminate what the mechanism is, so there is no basis for rationalising the activity in terms of the structure; and
The presence of a ring on the omega chain does not necessarily produce the desired result. The specification clearly states at page 7:
"Among these derivatives defined above it has been found that some are irritating or otherwise not optimal, and in certain cases not even useful due to adverse effects and these are excluded in that the group of prostaglandin derivatives defined above is limited to therapeutically effective and physiologically acceptable derivatives.".
In this situation, I concur with the reasoning of Mr Rait rather than that of Dr Stjernschantz. Consequently, I do not regard the basic documents as giving fair notice of a general proposition relating to the presence of a ring on the omega chain.
c) Priority date(s) of the application
I consider that the alternative structural formulae of the prostaglandins are different forms of the invention, so different priority dates can attach to the forms of the invention
Mr Rait stated that he believed that a priority date based on SE 8803110 could only be afforded to claims directed to the use of, and compositions containing, the following compounds (only the omega chain is shown in detail):
At the hearing, UENO contended that priority from SE 8803110 could only be afforded to claims directed to the use of, and compositions containing, the following compounds (only the omega chain is shown in detail):
As I can see nothing in the basic document that suggests prostaglandins other than PGF2a, I consider that claims to the use of, and compositions containing, the latter compounds only are entitled to priority from SE 8803110 (i.e. 6 September 1988).
With regard to priority from SE 8803855, analogous assertions were made by Mr Rait and UENO. Similarly, I agree that priority from SE 8803855 (i.e. 28 October 1988) is only appropriate for claims to the use of, and compositions containing, the following compounds (only the omega chain is shown in detail):
Claims to the use of, and compositions containing, the other compounds therefore take the date of filing as their priority date (i.e. 6 September 1989).
Claim 42 is directed to a single compound that is disclosed in SE 8803110, so takes 6 September 1988 as its priority date.
Claim 43 is directed to esters of the compound of claim 42. These esters are generally described in SE 8803110, so claim 43 also takes 6 September 1988 as its priority date.
Claim 44 is directed to the isopropyl ester, which is exemplified in SE 8803110, so claim 44 also takes 6 September 1988 as its priority date.
Novelty
a) The relevant law
The test for anticipation is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228, at page 235: "The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement". This requires the alleged anticipation to disclose all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 16 IPR 545 at page 549).
The degree of disclosure of the essential features by the alleged anticipation was described by Parker J in Flour Oxidizing Company Ld v Carr & Co Ld (1908) 25 RPC 428 at page 457:
"But where the question is solely a question of prior publication, it is not, in my opinion, enough to prove that an apparatus described in an earlier Specification could have been used to produce this or that result. It must also be shown that the Specification contains clear and unmistakable directions so to use it."
A more recent formulation of this test was given by the Court of Appeal in The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at pages 485 to 486:
"If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee's claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. ... if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated. ... To anticipate the patentee's claim the prior publication must contain clear and unmistakeable (sic) directions to do what the patentee claims to have invented"
In Application by American Home Products Corporation, Patent Office decision, 28 September 1994, patent application number 16397/92, unreported, I reviewed the reported cases on the application of these principles to disclosures of a generic nature. I concluded (at page 12):
"When a citation contains a generic formula that encompasses the formula of compounds claimed in a later application, I conclude that the reverse infringement approach to novelty should be as follows:
-was the citation published before the priority date of the application under examination;
-what are the essential features of the invention as claimed;
-what is disclosed by the citation
.what is clearly and unmistakably disclosed
.does the disclosure enable the preparation of the compounds; and
-is the application a selection?"
The significance of a selection was discussed as follows:
"A selection patent will only be anticipated by a specific disclosure of a compound. A non-selection patent can be anticipated by a disclosure which is both clear and unmistakable, and enabling. A higher degree of disclosure is needed to anticipate a selection patent."
[page 12]
The higher degree of disclosure needed to anticipate a selection was described as:
"Where selection is established, there is only a lack of novelty if the selected compounds have previously been made. The clearest evidence that a compound has been made before is provided if the compound is one of the worked examples of the invention."
[page 14]
I will apply this approach in the present case.
b) The disclosure afforded by a generic anticipation
In Application by American Home Products Corporation, supra, I interpreted "clearly and unmistakably disclosed" in the context of a generic disclosure in the following terms (at page 12):
"A generic structural formula represents all the specific structural formulae encompassed by the generic formula. This can be described as the intellectual content of the structural formula. (In F. Hoffman-La Roche & Co. AG v Commissioner of Patents (1970) 123 CLR 529 Gibbs J seems to have reached this conclusion at pages 541 to 542 of the report) The question of what compounds are clearly and unmistakably disclosed is equivalent to what technical information would the citation make public to the instructed reader (though not necessarily revealed in every detail)."
When considering whether the disclosure of the citation would enable the production of the compound, I suggested the following approach (at page 13 to 14):
"I conclude that an enabling disclosure is provided if a generic preparative method is given in a citation or is self-evident, and this method would have been considered to be technically credible by a person skilled in the art at the date of publication of the citation."
I will apply this approach in the present case.
When these principles are applied to compositions, the determination of what is disclosed involves asking what compositions have been made public to the instructed reader, though not necessarily revealed in every detail. In the case of the use of compounds, the determination of what is disclosed involves asking which compounds have had their use made public to the instructed reader, though not necessarily revealed in every detail, and what use has been made public.
c) AU 600168
Australian patent number 600168 in the name of R-Tech Ueno Ltd was published in its A level form on 23 March 1989, and in its B level form on 2 August 1990. Consequently, it is only the A level form that is relevant, and it is only relevant in relation to the claims to the form of the invention that take the date of filing as their priority date.
The A level form of the citation was not included in the evidence - only the B level and C level forms of the citation were in evidence. Hence, technically, there is no evidence relevant to this matter. This point was not raised at the hearing, and arguments on novelty were directed to the B level document.
Errors in the preparation of evidence are serious defects. However, I note that the descriptive part of the specification was not amended during examination, and is the same in the A and B level forms of the citation. Consequently submissions directed to the description in the B level form of the citation are also applicable to the description in the A level form of the citation. As both parties made submissions on the basis of the B level form of the citation, I do not believe that it would be a denial of natural justice to have regard to these submissions. I will consider the disclosure of the B level form, and take the disclosure of the A level form to be the same.
UENO asserted that claims 1 to 6, 9, 10, 12, 13, 15, 18 to 27, 30, 31, 33, 34, 36, 39 to 41 are prior published and not novel in the light of AU 600168. They argued that the citation teaches compounds that are effective against glaucoma, and that those compounds are of a generic class that includes compounds of the opposed specification. PHARMACIA argued that in the citation there are no examples of compounds containing a ring on the omega chain, and the compounds involved in the overlap were a theoretical possibility, and could not be said to have been known or used.
The disclosure of the citation can be summarised as follows:
"The present invention provides ocular hypotensive agents containing 13,14-dihydro-15-keto-PGs as active ingredients.
In the present invention, 13,14-dihydro-15-keto-PGs means PGs wherein carbons at the 13-14 positions are saturated and carbon at the 15 position forms a carbonyl group. ...
In the present invention, the intraocular hypotensive effect of 13,14-dihydro-15-keto-PGs may be especially remarkable in prostaglandins of the general formula:
[wherein, A is
(in which R is hydroxyl, hydroxyalkyl or alkyl);
Y is a saturated or unsaturated C2-6 hydrocarbon chain (some of the carbon atoms constituting the hydrocarbon chain may form a carbonyl group, and the hydrocarbon chain may be substituted with one or more atoms or groups);
Z is a C1-10 saturated or unsaturated hydrocarbon forming a straight-chain, branched-chain or ring (the hydrocarbon may be substituted with atoms or groups)] or physiologically acceptable salts derived from the general formula [I] or those having an esterified carboxyl group."
[pages 5 and 8]
The citation illustrates the use of esters of 98 prostaglandins, none of which have a ring on the omega chain.
The intellectual content of the disclosure of the citation clearly includes the use of compounds falling within claim 1, and compositions falling within claim 22 of the opposed application. The critical question is whether those uses and compositions have been made public to the instructed reader.
I believe that the instructed reader would have appreciated that the use of some 13,14-dihydro-15-keto-prostaglandins to reduce intraocular pressure had been made public. The use of such prostaglandins having a ring on the omega chain is not clearly made public. I conclude that it has not been established that AU 600168 anticipates the use claims (or the composition claims).
PHARMACIA also made submissions that the opposed application could be regarded as a selection from the citation, but given my conclusion above I do not need to consider this submission.
d) US 4131738
United States patent number 4131738 was laid open to public inspection in Australia on 12 February 1979 (Exhibit TGC-21 of the Corbett declaration of 2 February 1993).
UENO asserted that claims 1 to 17, 21, 22 to 38 are prior published and not novel in the light of US 4131738. The citation was published before the priority date of the claims to all forms of the invention.
UENO referred to the generic formula of the compounds of the citation, and pointed out that there was overlap with the compounds in the opposed application. In particular, the key substituent R7 can incorporate a ring. PHARMACIA pointed out that the citation relates only to 6-hydroxy PGE1 compounds rather than PGF2a compounds, and any overlap was accidental. PHARMACIA indicated that they would be prepared to disclaim any overlapping 6-hydroxy PGE1 compounds.
The disclosure of the citation in general terms is given in the portion of the specification headed "SUMMARY OF THE INVENTION", which states in part:
"The present invention particularly comprises: a prostaglandin analog of the formula
wherein Z1 is
(1) -(CH2)g-CH2-CH2-,
(2) -(CH2)g-CH2-CF2-, or
(3) trans-(CH2)g-CH=CH-,
wherein g is the integer one, 2, or 3;
wherein R8 is hydrogen, hydroxy, or hydroxymethyl;
wherein Y1 is(1) trans-CH=CH-,
(2) cis-CH=CH-,
(3) -CH2CH2-,
(4) trans-CH-C(Hal)-, or
(5) -CºC-
wherein Hal is chloro or bromo; wherein M1 iswherein R5 is hydrogen or ...
wherein L1 is
wherein R3 and R4 are hydrogen, methyl, or fluoro ...
wherein X1 is(1) -COOR1 wherein R1 is hydrogen; alkyl or one to 12 carbon atoms, ...
and wherein R7 is
wherein m is the integer one to 5, inclusive; h is the integer zero to 3, inclusive; s is the integer zero, one, 2, or 3; T is chloro, fluoro, trifluoromethyl, alkyl of one to 3 carbon atoms, inclusive; ..."
There follows 5 columns of examples of the variables. Next, twelve uses for the compounds are described. At column 11 the citation states:
"The novel prostaglandin analogs disclosed herein produce a multiplicity of prostacyclin-like biological responses, rendering these compounds useful for a variety of pharmacological purposes. In particular, the biological responses include platelet aggregation inhibition, smooth muscle stimulation, blood pressure lowering, gastric secretion reduction, NOSAC (nonsteroidal antiinflamatory compound)-induced lesion inhibition, bronchodilation, nasal decongestion, peripheral vascular circulatory improvement, renal blood flow alteration, dermatosis reversal, inflammation reduction, and intraocular pressure reduction."
The last use is expanded upon at column 16:
"(l) Reduction of Intraocular Pressure.
The novel prostaglandin analogs herein are finally useful in man for the reduction of intraocular pressure in those disease states where abnormally elevated pressure in the eye is a threat to the sight of the patient (i.e., glaucoma). While many routes of administration are successfully employed for this purpose, direct application of a sterile ophthalmic solution (e.g., in the form of drops) is the preferred route for convenience and minimization of systemic effects. While ultimate dosage is readily determined by patient response in the exhibition of significantly lower intraocular pressure and the absence of localized side effects, such as irritation of eye tissues, initial dosage levels of about 0.05 mg to 50 mg per several drops of sterile ophthalmic solution, repeated 2 to 4 times per day, are employed. For optimizing the absorption of drug when administered in the form of drops, the 2-decarboxy-2-aminomethyl-PGE1 analogs herein are employed."
Two worked examples are given. The first is the preparation of 6-hydroxy-PGE1, and the second is the preparation of 6-hydroxy-13,14-didehydro-PGE1. At columns 33 to 40 the names of other prostaglandins that can be prepared by the method of the worked examples are given. The list includes the following compounds:
"(6S)-6-hydroxy-PGE1-type compounds;
(6R)-6-hydroxy-PGE1-type compounds; or
(6RS)-6-hydroxy-PGE1-type compounds in free acid, amide, or ester form which exhibit the following side chain substituents: ...17-Phenyl-18,19,20-trinor-;
17-(m-trifluoromethylphenyl)-18,19,20-trinor-;
17-(m-chlorophenyl)-18,19,20-trinor-;
17-(p-fluorophenyl)-18,19,20-trinor-;
15-Methyl-17-phenyl-18,19,20-trinor-;
16-Methyl-17-phenyl-18,19,20-trinor-;
16,16-dimethyl-17-phenyl-18,19,20-trinor-;
16-Fluoro-17-phenyl-18,19,20-trinor-;
16,16-Difluoro-17-phenyl-18,19,20-trinor-; ..."
[Note: PGE1 has the structure
]
In addition, the 13,14-didehydro, 13,14-dihydro, 13-cis, 2,2-difluoro and trans-2,3-didehydro derivatives of the above compounds are also named.
It is stated that all of the named compounds can be prepared following the procedure in the worked examples, using the appropriate starting materials. The preparative information is technically credible.
The intellectual content of the disclosure of the citation clearly includes the use of compounds falling within claim 1, and compositions falling within claim 22. The critical question is whether those uses and compositions have been made public to the instructed reader.
I believe that the instructed reader would have appreciated that certain 6-hydroxy-PGE1 compounds are made public by the citation. Compounds having an omega chain with a 15-hydroxy and 17-phenyl group are clearly named, and I believe that the instructed reader would have been entitled to consider that they were made public by the document. However, what use have they been disclosed for? The citation refers to the compounds as prostacyclin analogues, and one of the prostacyclin uses is to reduce intraocular pressure (column 11 of the citation). To my mind this would not be enough to make public their use for reducing intraocular pressure.
However, the citation gives details of dosages for the use of the compounds in the reduction of intraocular pressure (column 16). To my mind, the instructed reader would have been entitled to consider that intraocular pressure reduction was made public as an actual use of the compounds, not merely as something that they might do.
I consider that the compounds specifically named in columns 33 to 40 of the citation are made public, and they are made public for use in the reduction of intraocular pressure. Compositions of these compounds are also disclosed, and these compositions involve the use of an intraocular pressure reducing amount of compound (see column 16 of the citation).
I have no reason to doubt that the preparation of the compounds, preparation of compositions, and use of the compositions could be carried out from the information contained in the citation.
Thus I conclude that there is a lack of novelty for those claims which involve the use of, or compositions involving, the PGE1 compounds that are named at columns 33 to 40 of the citation. Those claims are numbers 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 21, 22, 23, 24, 25, 26, 27, 28, 29, 31, 33.
e) CA 986926
Canadian patent number 986926 in the name of Imperial Chemical Industries Limited, U.K. became open to public inspection in Australia on 23 April 1976 (Exhibit TGC-23 of the Corbett declaration of 29 March 1993).
UENO asserted that CA 986926 prior publishes claims 42 and 43. The citation was published before the priority date of the claims in question.
UENO referred specifically to example 3 in the citation, which they stated includes the compound of claim 42. PHARMACIA pointed out that the citation is concerned with a class of compounds different to those of the opposed specification. They conceded that example 3 includes a compound outside the scope of the invention of the citation, and anticipates claim 42 only.
The citation does not claim compounds within the scope of claim 42 or 43. However, Example 3 (at pages 20 to 22) discloses a compound apparently outside the scope of the invention, but falling within the scope of claim 42 of the opposed application:
"Example 3
The process described in Example 1 is repeated, using the appropriate bis(tetrahydropyranyl) derivatives, to give the compounds shown below. The products were identified by n.m.r. spectroscopy ..."
The example identifies the compounds by means of a generic formula, and a table (the relevant part of which is reproduced):
| No. | R4 | X | A |
| 1 | phenyl | -CH2.CH2- | -CH2.CH2- |
It is clear that the compound 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2a is disclosed. Although this is not a compound asserted as the invention in CA 986926, it is disclosed as actually made, and that is enough to prior publish claim 42 and render it not novel.
CA 986926 does not refer to esters of 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2a. Consequently, claim 43 is novel and not prior published in the light of this citation.
f) The Granström article
The Granström article is the journal article "Metabolism of 17-phenyl-18,19,20-trinor-prostaglandin F2a in the cynomolgus monkey and the human female" by E.Granström, published in Prostaglandins, 1975, volume 9, pages 19 to 45. There is no direct evidence as to the date of publication of this article. The Petit-Young declaration of 23 February 1993 gives the date of availability in the library of the University of New South Wales of various journal articles, including the following:
"Prostaglandins vol 9 no.1 1975 containing, at pp. 9-18, an article entitled 'Biological activities of 17-phenyl-18,19,20-trinorprostaglandins' W.L.Miller, ... et al. (5/3/1975)"
From this I conclude that the relevant part of volume 9 of Prostaglandins was available on or shortly after 5 March 1975, and that this is also the publication date for the Granström article.
UENO asserted that Granström prior publishes claims 42 and 43. The citation was published before the priority date of the claims in question.
UENO stated that Granström reveals compounds that are metabolites of a known PGF2a derivative. They pointed out that metabolite B3 is the compound of claim 42, and that the methyl ester of B3 is also prepared. PHARMACIA agreed that claim 42 is anticipated, and claim 43 is anticipated in so far as it claims the methyl ester.
I agree the the Granström article discloses the existence of 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2a (the B3 metabolite) and its methyl ester, and a method of preparation which is synthetically unattractive, but technically credible. I agree that claim 42 (which is directed only to 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2a) is prior published and not novel in the light of Granström. Claim 43 (which is directed to an alkyl ester of 13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2a) is prior published and not novel in the light of Granström in that it includes the methyl ester.
Prior claiming
a) The relevant law
The ground of opposition of prior claiming by a patent is found in section 59(1)(d):
"Opposition to the grant of a standard patent
59. (1) The Minister or a person interested may ... oppose the grant of the patent on one or more of the following grounds, but on no other ground: ...
(d)that the invention, so far as claimed in any claim, is the subject of a claim of earlier priority date contained in the complete specification of petty patent specification of a patent;"
In the case of claims involving generic formulae the key question is which compounds covered by a generic formula are "the subject of a claim"? UENO referred to the following cases on prior claiming:
Merck & Company (Macek's) Patent [1967] RPC 157 at 160 to 163
Union Carbide Corporation's Patent [1971] FSR 21 at 27, 30 to 33
Daikin Kogyo Company Limited (Shingu's) Application [1974] RPC 559 at 575, 580 to 581
The application of the principles in these cases to the situation of prior claiming by a citation involving a generic disclosure was explicitly considered in Allen & Hanburys Limited (Hayes') Application [1977] RPC 113. It is clear from this decision that a claim involving a compound that is generically described cannot be regarded as prior claiming all of the compounds within the intellectual content of the formula:
"The question therefore as to whether or not in any particular case, a general formula ought to be regarded as a convenient way of specifying a number of alternatives which would occur to the reader on seeing the formula must be a matter of degree. If the conclusion is that any particular compound would as a matter of course occur to the reader as being included within and disclosed by the formula, then it seems to me it would be proper following the principles of the authorities and in particular the Merck case notionally "to rewrite the claim" so as to include specifically within its scope such a compound."
[pages 117 to 118]
Graham J decided that a claim to a generic structural formula may be notionally rewritten as a claim to a specific compound if the compound would, as a matter of course, occur to the reader as being included within and disclosed by the generic structural formula (this is similar to asking what compounds within the scope of the claim are made public). Mere overlap between the claims of the citation and those of the application under consideration is not sufficient. I believe that this approach can be applied to the present situation in that a claim incorporating a generic structural formula can be notionally rewritten to a claim incorporating a specific group of compounds if that group of compounds would, as a matter of course, occur to a reader. It is not sufficient to find that the particular values of the various substituents would occur to a reader; the specific combination of values as a compound must occur to a reader.
b) AU 600168
Australian patent number 600168 in the name of R-Tech Ueno Ltd claims priority from two Japanese basic documents. At the hearing, UENO disclaimed priority from these basic documents (for the purposes of the present opposition). Consequently, the earliest priority date for the claims of AU 600168 is its date of filing: 16 September 1988.
PHARMACIA also contended that the relevant claims of AU 600168 are not entitled to this priority date as the claims had been amended after acceptance. PHARMACIA asserted that the amended claims claim new matter, so their priority date should be the date of filing the amended claims (as a consequence of section 114 and regulation 3.14).
The date of filing the amended claims numbered 1 to 31 is 2 November 1992. On 8 January 1993 it was proposed to delete claims 22 to 31, and in this form the amendment was allowed. As the date of filing the amended claims is after the priority date of all forms of the claims of the opposed application, there cannot be prior claiming by claims taking this as their priority date.
I do not need to decide the appropriate priority date(s) for the claims of the citation because I consider that the claims of the citation cannot be notionally rewritten as required. I will explain my reasons for this conclusion.
The citation as amended has 21 claims. UENO asserted that the claims of the opposed application are prior claimed as follows:
| Claim number | Prior claimed |
| of 625096 | by claim no. |
| 1 | 2,4,5,6,10 |
| 2 | 2,4,5,6,10 |
| 3 | 2,4,5,6,10 |
| 4 | 2,4,5,6,10 |
| 5 | 2,4,5,6,10 |
| 6 | 2,4,5,6,10 |
| 7 | 2,4,6,10 |
| 8 | 2,4,6,10 |
| 9 | 2,4,6,10 |
| 10 | 2,4,6,10 |
| 11 | |
| 12 | 7,8,10 |
| 13 | 8,10 |
| 14 | |
| 15 | 8,10 |
| 16 | |
| 17 | 8,10 |
| 18 | 2,4,6,10 |
| 19 | 7,8,10 |
| 20 | 8,10 |
UENO stated that there was overlap between the relevant claims, and that this was sufficient for remonopolisation. PHARMACIA stated that the invention in the opposed application is the presence of a ring on the omega chain, and this feature is not mentioned in the claims of the citation as accepted. Thus they argued that the citation is not directed to the same invention as the opposed application. The claims that refer to rings had been inserted after seeing the opposed specification, but there was no corresponding amendment to the description.
The relevant claims are as follows:
"1. A method of ocular hypotensive treatment comprising the systemic or topical administration of a pharmaceutically effective amount of at least one 13,14-dihydro-15-keto-prostaglandin of the A, B, C, D, E or F series to a subject in need thereof.
2. A method according to claim 1 in which the 13,14-dihydro-15-keto-prostaglandin of the A, B, C, D, E or F series is of the general formula:
[wherein, A is
(in which R is hydroxyl, hydroxyalkyl or alkyl);
Y is a saturated or unsaturated C2-6 hydrocarbon chain (some of the carbon atoms constituting the hydrocarbon chain may form a carbonyl group, and the hydrocarbon chain may be substituted with one or more atoms or groups);
Z is a C1-10 saturated or unsaturated hydrocarbon forming a straight-chain, branched-chain or ring (the hydrocarbon may be substituted with atoms or groups)] or physiologically acceptable salts derived from the general formula [I] or those having an esterified carboxyl group....
4. A method according to claim 2 in which Z is a saturated or unsaturated C1-10 hydrocarbon forming a ring.
5. A method according to claim 4 in which Z is selected from a cyclopentyl and cyclohexyl group wherein the carbon atoms at positions 16 or 17 in the w-chain may be a constituent of the ring.
6. A method according to any one of Claims 3 to 5 in which Z is substituted with one or more atoms or groups selected from a halogen atom, an alkyl group, an alkoxy group, a phenyl group and a phenoxy group.
7. A method according to any one of the preceding claims in which the carboxyl group at the end of the a-chain in the prostaglandin is in the form of a lower alkyl ester.
8. A method according to claim 7 in which the lower alkyl ester is isopropyl ester.
...
10. A method according to any one of the preceding claims wherein glaucoma is being treated."
It is clear that there is overlap between the claims of the citation and the claims of the opposed application. As noted above, this is not enough to establish prior claiming. In order to prior claim the claims of the opposed application it is necessary to select from the claims of the citation a rewritten claim incorporating the following combination of values of the substituents A and Z:
A is
and Z is a ring or a ring substituted hydrocarbon (having 1 to 9 carbon atoms) where the ring is aromatic, a limited number of heteroaromatics, or a 3-7 carbon cycloalkane or cycloalkene.
None of the claims of the citation fall entirely within the scope of any claim of the opposed application. I do not consider that the necessary combination of values of the substituents are suggested as a matter of course in any of the claims. The description does not make public any compounds of the opposed application (see the discussion under the heading of novelty), so there is no basis for notional rewriting based on the disclosure of the description. Consequently, it has not been established that any of the claims are prior claimed by the citation.
Clarity
a) The relevant law
In order to determine whether a claim is clear I have to consider whether a third party could ascertain whether an act would fall within the scope of a claim, and would thus infringe the claim (for example, see Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59). However, I also note that I should "give little weight to puzzles which may arise 'at the edge of the claim' if those puzzles would not, as a practical matter, cause difficulty for the skilled addressee or manufacturer wishing to satisfy himself that what he proposes to do will not infringe the patent" (Glaverbel SA v British Coal Corp [1994] RPC 443 at 495).
b) Application to the facts
The expression in the claims that was alleged to make the claims unclear is "or such like". UENO asserted that this term is unclear and indeterminent. PHARMACIA stated that the term should be read in the context of an aromatic heterocylic group having 5-6 ring atoms. In this context, they asserted, the term was clear.
The context of this expression in claim 1 is as follows (the term in question is shown underlined, but was not underlined in the original):
"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 ...
R2 is selected from thiazole, imidazole, pyrrolidine, thiophene, oxazole or such like aromatic heterocyclic groups having 5-6 ring atoms; ..."
The five specific heterocycles contain oxygen, sulfur and nitrogen as heteroatoms, and have either 1 or 2 heteroatoms in the ring. The term "or such like" is further limited to 5 or 6 membered rings.
I believe that the "like" heterocycles would be understood as 5 or 6 membered heterocycles containing 1 or 2 heteroatoms selected from oxygen, nitrogen and sulfur. Consequently, I do not consider that the term, or the claim, is unclear.
The term "or such like" is used in the same context in claim 22. For the same reasons, claim 22 is not unclear.
CONCLUSION
I have found that the opposition succeeds on the ground that claims 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 21, 22, 23, 24, 25, 26, 27, 28, 29, 31, 33, 42 and 43 are not novel. The opposition was not successful on the grounds of prior claiming and section 40.
I allow PHARMACIA sixty (60) days from the date of this decision to propose amendments to the specification.
COSTS
The power of the Commissioner to award costs is based on section 210 and regulation 22.8. The power to award costs is discretionary, so I must take into account all relevant considerations (see American National Can Co. v W.R. Grace & Co.-Conn (1994) AIPC 91-063, 29 IPR 292).
UENO has succeeded on the substantive ground of lack of novelty. In this situation, I consider it appropriate that costs should follow the event.
I award costs against the applicant, PHARMACIA.
S.D.BARKER
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : E F Wellington & Co, Melbourne
Patent attorneys for the opponent : Davies Collison Cave, Melbourne
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