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You are here: BAILII >> Databases >> High Court of Ireland Decisions >> Novartis AG -v- The Controller of Patents, Designs and Trademarks [2007] IEHC 442 (20 December 2007) URL: http://www.bailii.org/ie/cases/IEHC/2007/H442.html Cite as: [2007] IEHC 442 |
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Judgment Title: Novartis AG -v- The Controller of Patents, Designs and Trademarks Composition of Court: McGovern J. Judgment by: McGovern J. Status of Judgment: Approved |
Neutral Citation Number: [2007] IEHC 442 THE HIGH COURT [2006 No. 363 SP] IN THE MATTER OF AN APPEAL AGAINST A DECISION OF THE CONTROLLER OF PATENTS, DESIGNS AND TRADE MARKS UNDER COUNCIL REGULATION (EEC) 1768/92 AND THE PATENTS ACT 1992 BETWEEN NOVARTIS AG PLAINTIFF AND THE CONTROLLER OF PATENTS, DESIGNS AND TRADEMARKS DEFENDANT JUDGMENT of Mr. Justice McGovern delivered on the 20th day of December, 2007 1. This is an appeal from a decision of the defendant (“the Controller”) made on the 10th March 2005, rejecting the plaintiff’s application for a grant of a Supplementary Protection Certificate (“SPC”) pursuant to Council Regulation (EEC) 1768/92, for the pharmaceutical product “Valsartan or a pharmaceutically acceptable salt or ester thereof in combination with hydrochlorothiazide” which is branded under the trade mark Co-Diovan”. (In the course of this judgment hydrochlorothiazide may be referred to from time to time as “HCTZ”). The appeal is brought to the Court pursuant to section 96 of the Patents Act 1992. Background 2. Regulation 1768/92/EEC (“the Regulation”) created Supplementary Protection Certificates which applied to medicinal products for human or animal use. The Regulation was brought into force to address a problem which is expressed as follows in the Preamble to the Regulation:-
5. An SPC takes effect when the patent expires and has a term equal to the period which elapsed between the date on which the application for the patent was lodged and the date of the first authorisation to place the product on the market in the community, reduced by five years. The maximum duration of an SPC is five years. 6. In the course of these proceedings a motion was brought by the plaintiff to extend the time for bringing the appeal against the Controller's decision of 10th March 2005 and by order made on the 12th day of March 2007 the time for appeal was extended up to and including the 4th day of August 2006. 7. On the 26th February 1999 the applicant filed a request for the grant of an SPC for
combination with hydrochlorothiazide” and with the name “Co-Diovan”. 9. On the 31st July 2003 the Controller notified the applicant/plaintiff of an outstanding requirement relating to the request for the SPC. In particular the Controller notified the applicant/plaintiff of the following matters:-
(iii) An SPC (SPC1997/012) had already been granted for the medicinal product Diovan containing the active ingredient Valsartan.” (Decision of defendant 16th March 2005 - page 2). 10. On the 28th November 2003 the applicant/plaintiff responded with the following arguments:-
(ii) A medicinal product at issue, Co-Diovan, a combination of Valsartan and Hydrochlorothiazide, fell within the scope of composition claimed 35 and 36. (iii) The limitation of the protection of the certificate to the medicinal product as authorised should not be confused with the meaning of the term “product” as “protected by the basic patent”. 12. On the 30th June 2005 the plaintiff formally requested a hearing on the matter pursuant to rule 68(1) of the Patent Rules and a hearing was conducted on the 26th October 2005 before the defendant's hearing officer, Dr. Michael Leydon, in the presence of two examiners. Dr. Leydon is “a person skilled in the art”, as that expression is understood in patent law. 13. At the hearing the plaintiff was represented by Ms. Assumpta Duffy of F.R. Kelly & Co. who are the Irish patent agents of the plaintiff. Ms. Duffy can be regarded as a person “skilled in the art”. At the hearing before Dr. Leydon it was agreed that the fundamental issue in question was whether or not the product, i.e., the combination of the active ingredients, Valsartan and HCTZ, was protected by the basic patent 71155 as required by article 3(8) of Regulation 1768/92. Ms. Duffy argued that the combination was protected by the basic patent by virtue of independent claim 35 and its dependant claim 36 and in particular she argued that the term “comprising” in claim 35 had a well-established meaning in patent law to the effect of “including the following elements but not excluding others”. In the application for the patent and the claims made in respect of the product, claims 35 and 36 are as follows:-
36. An antihypertensive pharmaceutical preparation according to claim 35, wherein an antihypertensive active ingredient is selected.” 14. Ms. Duffy asserts while the combination of Valsartan and HCTZ was not specifically disclosed in the basic patent, it was not excluded from the scope of the claims in view of the presence of the term “comprising” in claim 35. She argued that the expression “as active compound” in claim 35 was not restricted to a sole active compound and that the term “comprising” in the claim did not exclude the possibility that one or more additional active compounds may be present in the composition. Having heard the arguments made by Ms. Duffy and the examples and case law furnished by her to illustrate her arguments, the hearing officer rejected the application for an SPC
Regulation 18. On the 18th June 1992 Council Regulation 1768/92/EEC was adopted for the purpose of creating a Supplementary Protection Certificate (“SPC”) for medicinal products for human or animal use. The Regulation was given effect on the 5th May 1993 by the European Communities (Supplementary Protection Certificate) Regulations 1993 and deemed to have come into operation on the 2nd January 1993. Under the Regulations an SPC can only be granted for a medicinal product for human or animal use. “Product” means the active ingredient or combination of active ingredients in a medicinal product. Article 2 provides that
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC ...; (c) the product has not already been the subject of a certificate; (d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product.” 21. The certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations - article 5. The application for a certificate must be lodged within six months of the date on which the authorisation to place the product on the market as a medicinal product was granted or within six months of the date of grant of the patent, whichever is the later - article 7. 22. It seems to me that the regulations set out above and at the beginning of this judgment are the relevant regulations for the purposes of the matters in issue before the Court and set out the relevant requirements to be complied with before an SPC can be granted. The law 23. In Ranbaxy Laboratories Limited v. Warner Lambert Co. [2006] 1 IR 193 the Supreme Court held that the interpretation of a patent was a question of law. The Court said that the statutory interpretation as expressed in section 45 of the act and the second schedule thereof confirmed the approach taken by Diplock LJ in Catnic Components Ltd. v. Hill & Smith Ltd. [1982] R.P.C. 183 where he stated at p. 243:- “A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked”. In the Ranbaxy case, McCracken J., in referring to the above passage, said at page 197 “The relevance of this passage to the present case is the emphasis on the understanding of persons with practical knowledge and experience rather than being on the actual intention of the patentee. Frequently, as in the present case, claims in a patent are of a very technical nature and the nuances of such claims would not be understood by the ordinary man in the street. The test therefore is not what the claim would mean to the man in the street but rather what it would mean to an expert in the field to which it relates, or what has been expressed in a number of cases as a person skilled in the art. A patent is addressed to and intended to be read and understood by such persons. It may well be that the understanding of such persons may not be a meaning which was actually intended by the patentee or the inventor, but as the purpose of a claim in a patent is to provide certainty as to the extent of the monopoly granted, the relevant test is the understanding of the persons to whom it was addressed rather than the understanding of the patentee or inventor.” 25. Section 96 of the Act states that an appeal to the Court shall lie from any decision or order of the Controller other than the decision under section 22 (2) or section 28 (5). “The Court” in this context means the High Court. The case of Carrickdale Hotel Ltd. v. Controller of Patent [2004] 3 IR 410 suggests that in a matter of this kind the test to be applied in determining whether the decision of the Controller should be confirmed, annulled or varied is whether the plaintiff has established as a matter of probability that, taking the adjudicative process as a whole, the decision reached was vitiated by a serious and significant error or a series of such errors. In applying the test regard must be had to the degree of expertise and specialist knowledge which the adjudicator has. See remarks of Laffoy J. at p. 423. In the Carrickdale Hotel Ltd case Laffoy J reviewed a substantial number of decisions dealing with the Court’s role in hearing appeals from decisions of expert tribunals. In considering recent authorities on the subject, she said at p. 417: “I take as the starting point the decision of the Supreme Court in Henry Denny and Sons (Ireland) Limited –v. The Minister for Social Welfare [1998] 1 IR 34. In that case, Hamilton C.J. made what was subsequently described as “a very strong statement in favour of deference” (per Barron J. in Orange Ltd. v. Director of Telecoms (No. 2) [2000] I.R. 159). In the following passage at pp. 37 to 38 he said:-
27. The plaintiff points to the fact that in a significant number of other European jurisdictions it has been granted an SPC in respect of the product Co-Diovan. It submits that insofar as the Controller sought to support his decision on the judgment of Jacob J in Takeda Chemical Industries v. Comptroller General of the Patent Office [2003] EWHC 649 (Pat). He was in error. In that case the unsuccessful applicant for an SPC failed to either disclose or suggest in the basic patent that Lamsoprazole, the active ingredient protected by that patent, could be combined with any other active ingredient, and in particular, specific antibiotics. 28. The respondent contends that his decision was in line with the judgment of Jacob J. in the Takeda case and also with a decision of the Supreme Administrative Court in Stockholm in AB Hassle (case No. 3 428-1996). In that case the application for an SPC related to a combination of two active compounds namely Felodipin and Metroprolol. The basic patent in that case protected only one of the mentioned active compounds name Felodipin. At no point in the patent claim or in the general part of the description was it mentioned or suggested that any additional active compound would be contained in the pharmaceutical preparation. The Swedish court therefore held that the requirements of article 1(c) and article 3(8) of Regulation 1768/92 were not complied with and an SPC should not be granted. 29. Counsel for the defendant says that the decision of the Controller was consistent with earlier decisions made by his office with regard to the grant of SPC numbers 9/93 and 10/93 where the second active ingredient, HCTZ, had been expressly disclosed in the basic patent. The decision to refuse an SPC in respect of Co-Diovan was consistent with these decisions insofar as the failure of the plaintiff to disclose HCTZ in the context of the basic patent for Valsartan effectively precluded the grant of an SPC in respect of Co-Diovan to the plaintiff. It appears that the plaintiff has not yet made an application for an SPC in the United Kingdom, France, Germany or Sweden. Counsel for the defendant invites the Court to take this in to account. 30. It seems to me that I should approach the matter, not on the basis of a requirement for uniformity among Member States of the European Union, but on the basis of the principles which I have set out above. The recitals to the Regulation contain the following clauses: -
33. The decision of the respondent’s hearing officer was given on the 16th March 2005. The decision and the grounds thereof are set out in a document which sets out in detail the consideration of the case made by the plaintiff. In particular the hearing officer considered the claim made by the patent agent on behalf of plaintiff to the effect that a skilled person would appreciate that one or more of the compounds claimed in claim 1 could be combined with a diuretic, especially HCTZ as such a combination was common in the art at the priority date of the patent. The examples offered to the hearing officer included Fosnopril and HCTZ and Captopril and HCTZ. The hearing officer reviewed the cases offered by way of example and noted that the combinations of the particular active compound with a diuretic such as HCTZ were explicitly disclosed in both the description and the claims of these patents. The hearing officer weighed up the various arguments made on behalf of the plaintiff and considered the regulation and the legislation in addition to the basic patent 71155 and the claims made for same. He also considered the material furnished in respect of claims for an SPC in other jurisdictions. 34. He took into account that the combination of Valsartan and HCTZ was not specifically disclosed in the basic patent and this was accepted by the plaintiff’s agent in making arguments before him although it was urged on him that the presence of the term “comprising” in claim 35 meant that HCTZ was not excluded from the scope of the claims. In the legal submissions made to the court counsel for the plaintiff also conceded that the combination of Valsartan and HCTZ is not specifically claimed in the basic patent but argued that it was not excluded from the scope of the claim in view of the wording of claim 35. 35. The hearing officer rejected the request for the grant of an SPC on the grounds that the product, namely the combination of Valsartan and HCTZ, is not protected by a basic patent in force as required by article 3(a) of Regulation 1768/92. It seems to me that applying the test laid down in Carrickdale Hotel Ltd. v. Controller of Patents that there is nothing unreasonable about the decision and I cannot find any serious or significant error in the adjudicative process. In saying this I have regard to the degree of expertise and specialist knowledge which the hearing officer had when determining the matter. The decision which he reached appears to be one which combines a fair protection for the patentee with a reasonable degree of certainty for third parties thus satisfying the direction set out in the second schedule to the act. In interpreting section 45 of the act the court is obliged to have the regard to these directions and I do so. 36. In the circumstances I dismiss the appeal and refuse the relief sought. |