“4. The Patent describes and claims a method of making acellular vaccine compositions against Bordetella pertussis, more commonly known as whooping cough. The specification discloses that a combination of two particular antigens known as pertactin (or the 69kDa protein) and filamentous haemagglutinin (or FHA) produces, surprisingly, a synergistic effect which is such that a third antigen called pertussis toxin (or LPF) is not required to produce an effective dose of vaccine. 5. This, explains the specification, was an important discovery. Prior to the invention there was a general understanding that pertussis toxin was an essential part of any acellular vaccine. But it was also believed that some of the adverse effects associated with pertussis vaccination were related to this antigen. Accordingly, the synergistic combination of pertactin and FHA meant that pertussis toxin need no longer be used, and consequently the risk of adverse reactions could be reduced. Additionally, a bivalent vaccine containing only pertactin and FHA would be cheaper to produce. 6. The relevant claims reflect the disclosure in the specification. Claim 1 is directed to a method of making the synergistic combination of the pertactin and FHA antigens and reads: “A method for the preparation of an acellular vaccine, which method comprises preparing the 69kDa antigen of Bordetellapertussis as an individual component, preparing the filamentous haemagglutinin antigen of Bordetellapertussis as an individual component, and mixing the 69kDa antigen and the filamentous haemagglutinin antigen in amounts that provide the 69kDa antigen and the filamentous haemagglutinin antigen in a weight ratio of between 1:10 and 1:1 so as to provide a synergistic effect in vaccine potency.” 7. And claim 2 is directed to a vaccine which does not contain pertussis toxin: “A method according to claim 1 wherein the vaccine is devoid of the B. pertussis toxin.” “A method for the preparation of an acellular vaccine, which method comprises preparing the 69kDa antigen of Bordetellapertussis as an individual component, preparing the filamentous haemagglutinin antigen of Bordetellapertussis as an individual component, and mixing the 69kDa antigen and the filamentous haemagglutinin antigen in amounts that provide the 69kDa antigen and the filamentous haemagglutinin antigen in a weight ratio of between 1:10 and 1:1 so as to provide a synergistic effect in vaccine potency.” “A method according to claim 1 wherein the vaccine is devoid of the B. pertussis toxin.”
“8. Despite the teaching in the specification, no vaccine containing only pertactin and FHA has ever been produced. The first commercial vaccine made in accordance with the invention contained pertactin, FHA and pertussis toxin. It was launched in 1996 as a combination with diphtheria toxoid and tetanus toxoid (DTPa) and was effective against the three diseases: pertussis, diphtheria and tetanus. 9. The desirability of combining vaccines against different diseases was something that had been appreciated for many years, so it was natural to develop even larger vaccine combinations from DTPa. But each time a new antigen is built into a combined vaccine there is a risk of an increase in the frequency of existing side effects or of a reduction in the immune response to certain antigens. So extensive clinical testing is required. 10. It was therefore not until 2000 that the first such larger combination (DTPaP-Hib) was approved. This included antigens against haemophilus influenzae type b, an agent which causes meningitis. It was followed in 2001 by the approval of a combination which included inactivated polio virus vaccine (DTPa-IPV) and then, in 2002, by the approval of the ultimate goal in the UK for childhood vaccines, namely DTPa-IPV/Hib, which provides a measure of protection against pertussis, diphtheria, tetanus, polio and meningitis. By 2004, DTPa-IPV/Hib was routinely recommended as the primary immunisation for babies.”
“...the Deputy Director concluded that the Patent did not protect the product the subject of applications 09/015, 09/016, 09/017 or 09/019 for the purposes of Article 3(a) of the SPC Regulation. Further, he concluded that marketing authorisation PL 06745/0120 for Pediacel was not, for the purposes of Article 3(b) of the SPC Regulation, a valid authorisation to place the product the subject of application 09/018 on the market as a medicinal product.”
“The term `product' is open to a number of possible interpretations, none of which can be excluded on purely textual grounds. The term `active ingredient ... of a medicinal product' is not defined in the SPC Regulation. On the one hand, it would be possible to construe the term `product' as being the particular form of a patented pharmaceutical, for example the particular salt of a free base which is the `active constituent' referred to in a marketing authorisation. An alternative approach is to interpret the term `product' as referring, broadly speaking, either exclusively to the parent compound or variants expressly referred to in the patent claims, or to the ensemble of the parent compound and its pharmaceutically acceptable derivatives for which patent protection can be secured in infringement proceedings.”
“I would construe an active ingredient as being the pharmacologically active free base or parent compound underlying a medicinal product which is subject to a marketing authorisation. Different salts and esters can normally be understood as being simply variants of the active ingredient and, thus, of the product, rather than as being either products in their own right or distinct elements of the product. As a result, and in view of the fact that the patent claims will normally be phrased, as in the present case, in terms of the free base, these can be taken as defining the product and, therefore, as dictating the terms in which a subsequent SPC is granted. In my view, therefore, the certificate should be granted in the same terms as the patent claims. This would have the advantage of establishing a uniform criterion for the grant of a certificate, which could not easily be arrived at on the basis of the scope of protection of the basic patent, and of permitting national competent authorities to grant certificates without having to engage in an inquiry into the likely additional scope of protection of the patent and of the certificate, which is alien to their normal function. Furthermore, it would preserve the normal division of functions between those authorities and the national courts, permitting the latter to decide the ultimate scope of protection of a certificate worded in terms of the patent claims on the basis of the same principles of national law as are applied to the patent itself (subject always to the caveat required by Article 4 that the certificate's scope be limited to authorised medicinal uses of the product). Thus, manufacturers of generic pharmaceutical products would enjoy no greater freedom than under the basic patent, and infringement proceedings could be conducted on broadly the same procedural lines as those in respect of a patent, with the same balance of advantage between the parties.”
“my recommended approach to the definition of the product would result in a negative answer to both parts of the first question regarding the definition of the active ingredient and, as should already be clear, in the second question being answered in favour of the use of the wording of the patent claims rather than the use of the scope of protection of the basic patent to define the product in question and, thus, to determine whether it is protected by a basic patent.”
“[23] By its second question, the Bundesgerichtshof is, in substance, asking what are the criteria, according to Regulation 1768/92 and in particular Article 3(a) thereof for determining whether or not a product is protected by a basic patent. [24] In that connection, it should be noted that one of the conditions for obtaining a certificate is that the product should be protected by a basic patent in force. [25] As indicated in the seventh recital in the preamble to Regulation 1768/92, the patent concerned may be either national or European. [26] As Community law now stands, the provisions concerning patents have not yet been made the subject of harmonisation at Community level or of an approximation of laws. [27] Accordingly, in the absence of Community harmonisation of patent law, the extent of patent protection can be determined only in the light of the non-Community rules which govern patents. [28] As is clear in particular from paragraph [21] of this judgment, the protection conferred by the certificate cannot exceed the scope of the protection conferred by the basic patent. [29] The answer to be given to the second question must therefore be that, in order to determine, in connection with the application of Regulation 1768/92 and, in particular, Article 3(a) thereof, whether a product is protected by a basic patent, reference must be made to the rules which govern that patent.”
“The so-called “combination” of lansoprazole and an antibiotic would only infringe because of the presence of the lansoprazole. In truth, the combination is not as such “protected by a basic patent in force”
“The licence, both in its original form and its varied form, is for lansoprazole as such. It is that chemical compound which has a marketing authorisation. The product or products to be used for indications are not what is licensed. Putting it another way, it is not this product licence which permits the marketing of the antibiotic component. That would have to have its own marketing authorisation.”
“24. There are, however, other matters which bear on this issue and which do not appear to have been explored in argument before the court in Takeda. The first is the decision of the European Court of Justice inCase C-392/97 Farmitalia Carlo Erba Srl's Supplementary Protection Certificate[2000] RPC 580 . This primarily concerned the question whether the Regulation requires an SPC to be restricted to the particular form of the active ingredient described in the medicinal authorisation. The Court held it does not and that an SPC is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent. As a secondary question the Court was asked, in substance, what are the criteria for determining whether or not a product is protected by a basic patent? The Court answered that, in the absence of Community harmonisation of patent law, the extent of patent protection can be determined only in the light of non-Community rules which govern patents. As both parties before me were disposed to accept, this ruling suggests I must determine whether the product is protected as a matter of English law. 25. Second,s.125 of the Patents Act 1977 defines the extent of protection of a patent as being that specified in a claim as interpreted in the light of the specification. For this purpose the Protocol on the Interpretation of Article 69 of the EPC applies and this too refers to the extent of protection conferred by a patent and how it is to be understood. These two provisions make it clear that a product is protected by a patent within the meaning of the Act if it falls within the scope of a claim. 26. Third, no other provision of domestic law addresses the issue of protection of a product by a patent. This suggests the Court of Justice in Farmitalia must have had the infringement test and, for Contracting States to the EPC, Article 69 in mind. Anything less would have required the Court to interpret the term "protected" in the context of the Regulation as having a particular and different meaning, and that was something it declined to do. Certainly that appears to be the understanding of a number of other Member States, including Germany, as illustrated by the decision of the Federal Supreme Court in Case X ZB 12/00 of March 12, 2002. 27. Fourth, it must be remembered that the monopoly conferred by an SPC for a product consisting of both tenofovir and emtricitabine would be narrower and comprised wholly within a monopoly for tenofovir alone. It would be, in effect, a monopoly for tenofovir only when used with emtricitabine. 28. Fifth, I can envisage circumstances where the application of the Takeda test may produce a harsh result. For example, the holder of a patent for a new pharmaceutical may have chosen to market it only in combination with another active ingredient and duly secured a marketing authorisation for the medicinal product containing those ingredients. In such a case the product would appear to be the combination of active ingredients (Article 1(b)) for which authorisation has been obtained (Article 3(b)). Yet, upon an application of the Takeda test, it would not be protected by the basic patent and hence the inventor would be deprived of an opportunity to secure any SPC at all. 29. A possible answer, canvassed briefly before me in argument, is to regard such a medicine as containing, effectively, three products, that is to say the two active ingredients separately and in combination. In such a case an SPC could then be granted for the ingredient claimed by the basic patent. This solution has its attractions and would permit the holder of the basic patent claiming only one of two active ingredients to secure an SPC for that particular ingredient, assuming, of course, it is not already the subject of a certificate (Article 3(c)) and the authorisation is the first authorisation to place that ingredient on the market in a medicinal product (Article 3(d)). However, it must depend upon the proper interpretation of, at least, Articles 1(b) and 4 and it is my initial impression that it is hard to reconcile with the words of Article 4 which specify that protection shall extend only to the product covered by the marketing authorisation. 30. These are difficult questions and they raise a serious issue as to whether the decision in Takeda is correct. I believe they merit further consideration by a higher court and perhaps even the Court of Justice. In that latter regard, it is my understanding the Court of Justice has not yet considered how the requirements of the Regulation are to be interpreted in the case of a medicinal product consisting of a combination of active ingredients where only one is claimed in the basic patent. It may require a development of the reasoning in Farmitalia. But in this case and in the light of my conclusion on the second submission advanced by Gilead, it is not necessary for me to express a final conclusion and, in the circumstances, I prefer not to do so.”
“34. I am not convinced that Takeda is wrong. To my mind, Jacob J's reasoning remains persuasive. Furthermore, I agree that there is a distinction between the scope of protection and the question of infringement. As to Farmitalia, it is not clear to me that the ECJ either endorsed or rejected the infringement test in that case. Nevertheless, I agree with Kitchin J that there are arguments in favour of the infringement test which do not appear to have been considered in Takeda and which merit consideration by a higher court and perhaps the ECJ. 35. I have considered whether it is appropriate to refer this question to the ECJ. If I were confident that the Court of Appeal would refer it, I would avoid delay by making a reference now. I am not confident that the Court of Appeal will refer it, however. I conclude that the decision whether to refer should be left to that Court.”
“...has two strands. The first is that a combination vaccine is a medicinal product which comprises a group of antigens directed at multiple diseases. They are, in effect, operating independently and in parallel. Accordingly, it is said, the product is indeed protected by the Patent within the meaning of Article 3(a). The second is that the implementation of the invention by Medeva in the form of combination vaccines directed at multiple diseases has been driven by national health policy and, unless vaccines are treated as a special case, Medeva will be deprived of any opportunity to secure an SPC in respect of any product covered by the Patent.”
“…that is precisely the argument rejected by Jacob J in Takeda. It would mean that the holder of a basic patent could first obtain an SPC for the active ingredient the subject of the patent, so giving him perhaps one or two years of protection beyond the life of the patent, and then, some years later, obtain another SPC for a combination of the same ingredient together with another active ingredient and so gain protection for a full five years beyond the life of the patent. That, it may be said, is contrary to the purpose of the Regulation which is to provide an effective period of protection for the invention the subject of the patent and so encourage research, and not to provide an extension of protection based upon the adoption of another, possibly quite different, ingredient. I believe this reasoning underpins the decision in Takeda and it plainly provides powerful support for the Comptroller's position.”
“….Thus I believe a test emerges from Takeda which is clear and can be applied without difficulty to a product comprising a combination of active ingredients. It is to identify the active ingredients of the product which are relevant to a consideration of whether the product falls within the scope of a claim of the basic patent. It is those ingredients, and only those ingredients, which can be said to be protected within the meaning of the Regulation. So, in the case of a product consisting of a combination of ingredients A and B and a basic patent which claims A, it is only A which brings the combination within the scope of the monopoly. Hence it is A which is protected and not the combination of A and B.”
“where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the certificate is capable of covering that product, as a medicinal product, in any of the forms enjoying the protection of the basic patent.”