Re Council Regulation (EEC) No 1768/92

This is an appeal by Gilead Sciences, Inc (“Gilead”) against the decision of Mr A C Howard, the Hearing Officer acting for the Comptroller, dated 10 January 2008. It raises an important question as to the proper interpretation of Council Regulation (EEC) No.1768/92 (“the Regulation”) and its application to pharmaceutical compositions containing more than one active ingredient.

By his decision, the Hearing Officer rejected Gilead’s application for a supplementary protection certificate (“SPC”) in relation to European Patent (UK) No. 0915894 (“the Patent”) on the basis that the product the subject of the application was not “protected” by the Patent within the meaning of the Article 3(a) of the Regulation. It is against that finding that Gilead appeals.

The application for the Patent was filed by Gilead on 25 July 1997 and it was granted on 14 May 2003. It discloses new antiretroviral compounds useful in the treatment of HIV and other diseases. Claim 1 covers a class of these compounds including tenofovir disoproxil (tenofovir) and claim 25 is directed to tenofovir itself.

Paragraph [0047] of the specification explains that the formulations of the invention comprise at least one active ingredient and potentially other active ingredients. It says this:

“While it is possible for the active ingredients to be administered as pure compounds it is preferable to present them as pharmaceutical formulations. The formulations of the present invention comprise at least one active ingredient, as above defined, together with one or more acceptable carriers and optionally other therapeutic ingredients. The carrier(s) must be “acceptable” in the sense of being compatible with the other ingredients of the formulation and not deleterious of the patient.”

As the Hearing Officer accepted, this was consistent with the common general knowledge that different antiretroviral compounds could be used in combination.

Claim 27 reflects the teaching of the specification and is specifically directed to a combination of active ingredients:

“A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.”

On 21 February 2005, Gilead obtained a marketing authorisation for a medicinal product comprising, as its active ingredients, tenofovir and another antiretroviral called emtricitabine.

On 1 August 2005, and within the prescribed period of six months, Gilead filed an application for an SPC in respect of the combination of tenofovir and emtricitabine. As amended, the product description reads:

“Composition containing both Tenofovir disoproxil optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate thereof, together with Emtricitabine.”

The examiner objected that the product was not protected by a basic patent as required by Article 3(a) of the Regulation and, as I have indicated, his objection was upheld by the Hearing Officer.

The Regulation was adopted by the Council with the intention of improving the protection of innovation in the pharmaceutical sector. It was recognised that it takes many years to secure a marketing authorisation to place a new medicine on the market and this makes the period of protection under a patent insufficient to cover the investment put into research. Accordingly, the scheme of the Regulation is to provide an additional period of protection. It is conferred by the grant of an SPC for a period not exceeding five years beyond the life of the patent and it is strictly confined to the particular product which has been authorised to be placed on the market as a medicine.

The conditions for obtaining an SPC are of particular importance and are set out in Article 3 which reads, so far as relevant:

“A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

(a)

the product is protected by a basic patent in force;

(b)

a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate…;

(c)

the product has not already been the subject of a certificate;

(d)

the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product.”

These expressions are defined in Article 1:

“For the purposes of this Regulation:

(a)

'medicinal product' means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

(b)

'product' means the active ingredient or combination of active ingredients of a medicinal product;

(c)

'basic patent' means a patent which protects a product as defined in (b) as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;

(d)

'certificate' means the supplementary protection certificate.”

The subject matter of protection is defined in Article 4 as extending onlyto the product the subject of the marketing authorisation to place the corresponding medicinal product on the market, always within the limits of protection of the basic patent:

“Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorization to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate.”

Article 5 deals with the effects of the SPC and provides that, subject to Article 4, it shall confer the same rights as are conferred by the basic patent.

The period or protection is addressed by Article 13:

“1.

The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community reduced by a period of five years.

2.

Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.”

So the maximum five year period will only be obtained if the marketing authorisation was obtained ten or more years after the filing of the basic patent application.

In this case Gilead has applied for an SPC in respect of the combination of tenofovir and emtricitabine. These together form a product within the meaning of Article 1(b) and comprise the active ingredients of a medicinal product within the meaning of Article 1(a), for which a marketing authorisation has been obtained. That product has not already been the subject of an SPC and the authorisation was the first authorisation to place the product, that is to say the combination of tenofovir and emtricitabine, on the market as a medicine. Hence it is accepted the requirements of Article 3(b)-(d) are met. The dispute lies over (a) and whether the product is protected by a basic patent. In short, it is whether the Patent protects the combination of tenofovir and emtricitabine as such within the meaning of Articles 1(c) and 3(a).

In reaching his decision, the Hearing Officer relied heavily on the decision of Jacob J (as he then was) in Takeda Chemical Industries Ltd’s SPC Applications (No.3) [2004] RPC 1. Takeda had secured a patent for the antibiotic lansoprazole and conducted clinical trials which led to the grant of a marketing authorisation, some nine years after the date of filing of the patent. Based upon that authorisation, Takeda applied for and was granted an SPC. Further research by Takeda also showed lansoprazole was effective in eliminating a particular bacterium when used in combination with two of three other antibiotics, and it applied for a further product licence for this new indication. In the event, the MCA amended Takeda’s existing product licence so as to include the new indication and thereupon Takeda applied for another SPC for the combination. The Hearing Officer was unsympathetic. He considered that only one element of the combination, the lansoprazole, was identifiable with the invention of the patent, and the specification neither disclosed nor suggested that the products of the invention could be used with any other active ingredient. Accordingly, the combination was not protected.

Jacob J dismissed the appeal. He reasoned that the combination of lansoprazole and another active ingredient only infringed because of the presence of the lansoprazole and so the combination was not as such protected by the patent, describing Takeda’s contention that the combination was protected as a “sleight of hand”:

“10

……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”. What is protected is only the lansoprazole element of that combination. It is sleight-of-hand to say that the combination is protected by the patent. The sleight-of-hand is exposed when one realises that any patent in Mr Alexander's sense protects the product of the patent with anything else in the world. But the patent is not of course for any such “combination”.

11.

I think the position is absolutely clear. I am not surprised to find that the Swedish courts think so too. A/B Hassle sought an SPC for a combination of two active ingredients. Only one of these was covered by a patent. The Swedish Patent Office, the Patent Appeal Court and the Supreme Administrative Court unanimously concluded that there was no compliance with Art.3(a). (Case number 3248-1996).

12.

The Swedish courts thought the point was acte claire and refused to make a reference to the Court of Justice. I think so too. The SPC system is to provide supplementary protection to that provided by the patent—to extend the relevant part of the patent monopoly. It is not a system for providing protection for different monopolies. Here, Takeda's monopoly is in lansoprazole. The monopoly which they seek is a combination of lansoprazole and an antibiotic. The fact that that combination might infringe the monopoly given by the patent simply because one component infringes is irrelevant. Accordingly, I uphold Mr Walker's decision in relation to Art.3(a).”

The Hearing Officer relied upon Takeda as authority for the proposition that not everything that infringes can be said to be protected as such within the meaning of the Regulation. More is required. This does not need to amount to the level of support necessary to allow a claim to the particular combination the subject of the SPC application but the specification should at least provide “a clear pointer” in the right direction. That was lacking and so the application had to be refused.

Gilead advances two submissions. The first is that Takeda is wrong and I should decline to follow it. If a product infringes a patent claim then it is protected by the patent. Here there is no dispute that the combination infringes claim 27 and hence Article 3(a) is satisfied. Secondly, and in the alternative, it says the facts of this case are distinguishable from those of Takeda, primarily because the patent does expressly disclose and claim the use of combinations of the described compounds and other therapeutic ingredients. Accordingly, the application should have been accepted.

The Comptroller submits the decision of the Hearing Officer was right for the reasons he gave and that that there is no material difference between this case and Takeda. I should therefore apply the “clear pointer” test and dismiss the appeal.

I would begin by noting that if Gilead’s first submission is correct then the product is protected not just by claim 27 but also by claims 1 and 25, and 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.

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 in Case 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.

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.

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.

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.

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.

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.

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.

I come then to the narrower ground of appeal. Gilead says that this is not a case where the basic patent only discloses and claims the use of one of the active ingredients of the product. Here claim 27 is specifically directed to a medicinal product containing a combination of active ingredients and hence there can be no doubt that the combination of tenofovir and emtricitabine is protected as such within the meaning of Articles 1(c) and 3(a). So, it says, the facts of this case are materially different from those in Takeda and, indeed, the reasoning in that case should have led the Hearing Officer to accept this application.

In considering this submission I think it helpful at the outset to identify the various tests that have been applied. In Takeda,the Hearing Officer asked himself whether the product the subject of the application for the SPC was “identifiable with the invention” of the basic patent. In the present case the Hearing Officer asked himself whether there was “a clear pointer” to the specific combination authorised for use in a medicine.

I have difficulty with both of these formulations because they are neither precise nor find any foundation in the Regulation or the Act. But I think the reasoning in both decisions reveals an attempt to identify the features of the product which, were it to be unauthorised, would have a bearing on the question of infringement. As Jacob J explained in Takeda at paragraph [10], what was protected was only the lansoprazole element of the combination. 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.

Application of the test in the context of this appeal produces a ready answer. The product comprises two active ingredients, tenofovir and emtricitabine. It falls within the scope of claims 1 and 25 of the basic patent, but only because of the presence of tenofovir. Hence, on the Takeda test, claims 1 and 25 do not protect the product within the meaning of the Regulation. However, claim 27 is directed to a composition comprising tenofovir (amongst other compounds) together with a carrier and optionally other active ingredients. The product falls within this claim too and it does so, in so far as the claim is directed to a combination, as result of the presence of both tenofovir and emtricitabine.

The product comprising the combination of tenofovir and emtricitabine is therefore protected by claim 27 within the meaning of Articles 1(c) and 3(a) of the Regulation, and that is so whether the infringement test or the Takeda test is adopted. I feel some support for this conclusion because I understand that an equivalent SPC has been granted in France, although I recognise from investigations kindly carried out at my request by the Comptroller and supplied to me after the hearing that practice is not consistent across all Member States.

The Comptroller resists this conclusion for a number of reasons. First he submits that the particular active ingredients must be disclosed, at least in substance, in the specification. This I take to be the same as the need for “a clear pointer” to the combination.

As I have said, I am unable to accept this submission because I think the suggested test is too vague and, more importantly, has no basis in the Regulation. Moreover, it is quite clear and, indeed, accepted by the Comptroller that there is no requirement that a particular ingredient must be specifically disclosed, nor does an ingredient require explicit support in the body of the specification.

Second, the Comptroller contends the skilled person would have attached no particular significance to claim 27, would not have considered it inventive and would not have thought it was the result of any significant research effort.

I feel bound to reject this contention too. It can be no part of a determination as whether a product is protected by a basic patent to embark upon an analysis of whether the patent or the claim in issue is obvious or invalid for any other reason. Nor can it be right to investigate the extent of research that lies behind it. The scheme of the Regulation is to provide a simple and straightforward system for the grant of SPCs based only upon a consideration of the requirements laid down in the Regulation. Such is also apparent from the Commission Proposal COM (90) 101 of 11 April 1990 which says in terms at paragraph [16] that the proposal provides a simple transparent system which can easily be applied by the parties concerned and does not lead to excessive bureaucracy. I would add that any person may apply to have an SPC declared invalid if the basic patent is revoked or limited to the extent that the product for which the SPC was granted would no longer be protected by the patent claims (Article 15(1)(c)).

I conclude Gilead is entitled to an SPC in respect to the combination of tenofovir and emtricitabine. That combination is protected by claim 27 of a basic patent. The protection conferred by the SPC will be for a period of between two and three years and will be limited to the combination of tenofovir and emtricitabine. It will not extend to the use of tenofovir on its own or in any other way. The appeal must be allowed.