Medeva BV v The Comptroller General of Patents

This is an appeal by Medeva BV (“Medeva”) against the decision of Dr Cullen, the Deputy Director acting on behalf of the Comptroller, dated 16 November 2009, whereby he refused five applications for supplementary protection certificates (“SPCs”) relating to EP (UK) 1 666 057 B1 (“the Patent”).

The Deputy Director decided that the product the subject of four of the applications was not “protected” by the Patent within the meaning of Article 3(a) of Council Regulation (EC) No 469/2009 (“the SPC Regulation”). In the case of the fifth application he decided that the marketing authorisation relied upon was not a valid authorisation to place the product on the market as required by Article 3(b) of the SPC Regulation. It is against these findings that Medeva now appeals. I am also invited to decide a procedural point as to whether Medeva filed its appeal prematurely and before any decision of the Comptroller had been made. This is a point of some importance to the Comptroller for reasons I shall explain.

The Patent was filed on 20 April 1990, with a priority date of 8 May 1989, and it was granted on 18 February 2009, that is to say just over one year before it was due to expire.

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.

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.

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.

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.

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.

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.

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.

On 17 April 2009, Medeva filed the five applications for SPCs the subject of this appeal. They were accorded the numbers SPC/GB/09/015, 09/016, 09/017, 09/018 and 09/019. Three of them (09/015, 09/016 and 09/018) relate to DTPa-IPV/Hib. The other two (09/017 and 09/019) relate to the combination DTPa-IPV (that is to say, without Hib) which is the primary booster vaccine used in the UK. At the hearing of the appeal, counsel for the Comptroller helpfully produced a table setting out details of each application, including the relevant marketing authorisation (MA), trade name of the relevant medicinal product, the combination of active ingredients sought to be protected and the combination of active ingredients actually approved. I reproduce it with gratitude below:

As I have mentioned, 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. On this appeal Medeva contends that he fell into error in so doing. Before assessing the merits of that contention I must set out the relevant parts of the SPC Regulation.

The SPC Regulation came into effect on 6 July 2009 and codified various amendments made to Council Regulation (EEC) No 1768/92 of 18 June 1992. It recognises in its recitals that medicinal products will not continue to be developed in the Community unless they are covered by rules that provide for sufficient protection to encourage research. Further, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the product on the market makes the period of effective protection under the patent itself insufficient to cover the investment put into research. The scheme of the SPC Regulation is therefore to provide for an additional period of protection by means of an SPC. The duration of protection is a maximum of 15 years from the time the medicinal product first obtains marketing authorisation, as explained in Recital (9):

“The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.”

A certificate should not, however, be granted for a period exceeding five years and the protection conferred should be confined to the product in respect of which marketing authorisation has been obtained, as made clear by Recital (10):

“All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector must nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.”

The relevant Articles of the SPC Regulation read:

“Article 1

Definitions

For the purpose 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;

…..

Article 2

Scope

Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.

Article 3

Conditions for obtaining a certificate

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 authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate.

(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.

Article 4

Subject-matter of protection

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 authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.

…..

Article 13

Duration of the certificate

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 authorisation 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.

……”

On the hearing of the appeal, the parties first addressed the finding of the Deputy Director in relation to applications 09/015, 09/016, 09/017 and 09/019, and in this judgment I shall do the same.

The basis of the Deputy Director’s finding is readily apparent from a comparison of the claims of the Patent set forth in paragraphs [6] and [7] of this judgment with the list of active ingredients of the various products the subject of the applications set forth in the table reproduced in paragraph [11]. In each case the list of active ingredients is far more extensive than the particular antigens the subject of the claims, and that is so even in the case of applications 09/017 and 09/019 for SPCs in respect of the booster products which do not contain the Hib antigens. Accordingly, he held the products were not protected by the Patent within the meaning of the SPC Regulation.

The approach adopted by the Deputy Director was entirely consistent with a number of decisions of this court: Takeda Chemical Industries Ltd’s SPC Applications (No 3) [2004] RPC 1; Gilead Sciences Inc.’s SPC Application [2008] EWHC 1902 (Pat) and Astellas Pharma Inc.’s SPC Application [2009] EWHC (Pat). In each of these cases the court was concerned with a product which comprised a combination of active ingredients, not all of which were the subject of the relevant basic patent.

In Takeda the applicant had secured a patent for the antibiotic lansoprazole and sought an SPC for a combination product comprising lansoprazole and another active ingredient. On appeal, Jacob J (as he then was) considered that the combination of lansoprazole and the other active ingredient only infringed the basic patent because of the presence of lansoprazole and so the combination was not protected by the patent within the meaning of Article 3(a). Indeed he described the 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).”

Gilead concerned a patent which covered a class of new antiretroviral compounds useful in the treatment of HIV, including one called tenofovir. Subsequently Gilead obtained a marketing authorisation for a medicinal product comprising, as its active ingredients, tenofovir and another antiretroviral called emtricitabine and it filed an application for an SPC for that combination product. The Hearing Officer relied on Takeda as authority for the proposition that not everything that infringes can be said to be protected within the meaning of the SPC Regulation. More was required andthe specification should at least provide a “clear pointer” in the right direction. This was lacking and so he held the product was not protected by the patent.

The appeal in Gilead came before me. There were two grounds of appeal. First, it was submitted that the decision in Takeda was wrong, that I should decline to follow it and that I should apply a simple “infringement” test. I elaborated at paragraphs [24] to [28] of my judgment various arguments in favour of such an approach which do not appear to have been explored fully in argument before the court in Takeda. One finds an echo in this appeal:

“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.”

Conversely, however, to apply the infringement test would permit what was described in argument before me as “evergreening”, the vice identified by Jacob J in Takeda and described by me in Gilead in this way:

“23.

….. 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. ”

I formed the view these rival arguments merited consideration by a higher court. It was not, however, necessary for me to express a final conclusion upon them in the light of my finding on the second and narrower submission advanced by Gilead. In this connection it relied upon a subsidiary claim specifically directed to a medicinal product containing a combination of active ingredients. Hence it was able to argue that that the combination of tenofovir and emtricitabine was protected as such within the meaning of Articles 1(c) and 3(a). In accepting this argument I applied a test which I believe emerges from the decision in Takeda and is useful in cases involving a combination of active ingredients, as I explained at [33] to [34]:

“33.

….. 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.

34.

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.”

So the test involves identifying the active ingredients of the product the subject of the application which are relevant to a consideration of whether the product falls within the scope of a claim of the basic patent. It is only those ingredients which can be said to be protected within the meaning of the SPC Regulation.

In Astellas this court was again concerned with an application for an SPC containing two active ingredients, only one of which was disclosed and claimed in the basic patent. Applying the test in Gilead, Arnold J found the product was not protected by the basic patent. However, he too was also invited to apply the infringement test and find that Takeda was wrongly decided. He declined to do so. As he put it at [34]:

“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.”

Turning now to the particular applications 09/015, 09/016, 09/017 and 09/019, Medeva developed its case by reference to 09/015, accepting that my decision in relation to this application must apply equally to the other three. Its argument ran as follows:

Medeva recognised that its difficulty lay in step (iii) in the light of the various authorities to which I have referred. It did not go so far as to submit that I should now hold that the approach hitherto adopted by this court is wrong (although it reserved its position in the event of a further appeal) but instead sought to argue that vaccines are a special case in relation to which the infringement test should apply. The argument 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.

In my judgment the first strand of the argument is flawed both in law and in fact. Medeva has accepted that the Infanrix vaccine as a whole is the relevant medicinal product within the meaning of Article 1(a) and that the nine active ingredients together constitute the relevant product within the meaning of Article 1(b). No doubt it has done so because it wishes to secure an SPC for the whole combination of active ingredients and so secure protection which extends to the corresponding medicinal product - the DTPa-IPV/Hib combination vaccine - under Article 4. But having taken that line it seems to me that it is quite impermissible then to argue that the product comprises only the pertactin and FHA antigens for the purposes of the Article 3(a) qualification. It is plain that “product” must have the same meaning in Article 1(b) and Article 3(a). If the product of Article 1(b) is the whole combination of active ingredients then so it remains for the purposes of Article 3(a).

Turning to the facts, the evidence before me establishes quite clearly that combining vaccines involves much more than the simple mixing of antigens. A report published by the Viral Hepatitis Prevention Board in 2001 recognises that all major vaccine manufacturers are working towards more polyvalent vaccines. But experience has shown that possible incompatibilities or mutual interferences between the antigens themselves, or between excipients, preservatives, adjuvants, residual contaminants, stabilisers and suspending fluids makes it mandatory that each formulation is thoroughly tested for quality, stability, efficacy and safety through vaccine trials. I therefore do not accept that the antigens of a vaccine combination are necessarily operating independently, although I recognise that they may be directed at different agents responsible for diverse diseases.

As for the second strand of the argument, I accept that the approach hitherto adopted by this court may produce harsh results in some cases. I expressly acknowledged this in that part of my judgment in Gilead cited at paragraph [21] above. But it seems to me that this is not a problem which is peculiar to vaccines and that it applies with equal force to all combination products. It does not, therefore, justify applying a different test to vaccines or otherwise treating them as a special case. Moreover, I can see no basis in the SPC Regulation for applying different qualifying criteria to different classes of product. It would result in a lack of clarity and uncertainty for third parties. As I said in Gilead, the scheme of the SPC Regulation is to provide a simple and straightforward system for the grant of SPCs based only upon a consideration of the requirements it contains. In my judgment this scheme would be undermined were this court to adopt the approach contended for by Medeva.

This conclusion is reinforced by a consideration of the various applications in this case. They all concern the same invention yet, as is apparent from the table reproduced in paragraph [11] of this judgment, the SPCs would expire at very different times. In particular, the protection afforded by 09/019 would expire in 2011, yet that afforded by 09/016 would extend to 2015. Whilst I would not categorise this as deliberate evergreening so as to engineer an unwarranted extension of protection, I believe it does suggest the grant of the SPCs as sought would provide protection beyond that necessary to compensate for lost time in the exploitation of the patented invention, which is what, in my judgment, the SPC scheme is intended to do.

For all these reasons the appeal in relation to applications 09/015, 09/016, 09/017 and 09/019 must be dismissed.

I can deal with the appeal in relation to application 09/018 very shortly. Here, it will be recalled, the Deputy Director found that it failed to satisfy the requirement of Article 3(b). I believe he was right to do so. It is apparent from the table reproduced in paragraph [11] that no authorisation has ever been granted to place a product consisting of pertactin and FHA on the market as a medicinal product, and I did not understand Medeva seriously to suggest otherwise. It follows that the appeal in relation to application 09/018 must also be dismissed. The same point may be said to arise in relation to application 09/016, but this was accepted to be curable by amendment and I need say no more about it.

The Comptroller contends that the notice of appeal was filed by Medeva prior to any appealable decision having been made by the Intellectual Property Office (“IPO”). The relevant facts are these.

The SPC applications in issue were filed on 17 April 2009, some two months after the grant of the Patent. But it is also right to record that the applications were preceded by related SPC applications filed in 2005 which had generated a good deal of correspondence but no decision.

By letter dated 25 June 2009, the agents acting for Medeva wrote to IPO indicating that if they did not hear from it with a decision in relation to the applications by 31 July 2009 then Medeva would treat the failure to make a decision as a refusal of the applications.

By letters dated 31 July 2009, the examiner on behalf of the Comptroller responded in relation to each application. Each letter was headed “Examination as to formal and substantive requirements” and contained detailed reasons as to why the examiner considered the applications should be refused. The letters included this expression of opinion: “Consequently, it remains my opinion as the substantive examiner on behalf of the Comptroller that your application does not meet the requirements of Article 3(a) of the Regulation and that it should be refused under Article 10(2) of the Regulation”. The letters invited a reply by 3 December 2009.

On 24 August 2009, the agents for Medeva wrote again, referring to their letter of 25 June 2009 and reiterating that Medeva would treat the failure to make a decision as a refusal of the applications and that it would bring the matter before the Patents Court as an appeal. They emphasised Medeva’s concern to ensure that any dispute concerning the applications was resolved before the Patent expired. The letter concluded: “Please advise before 28 August 2009 if you do not accept our position that the refusal in your letters of 31 July 2009 is a final decision, failing which we will assume you agree”.

By letter dated 1 September 2009, the examiner replied making clear that IPO’s position was that the letters of 31 July 2009 contained the opinion of the substantive examiner acting for the Comptroller but did not constitute decisions actually to refuse the applications. Such decisions would have to be made by a hearing officer either after a hearing or, if Medeva so wished, on the basis of the papers on file.

In the meantime, on 29 August 2009, Medeva filed its notice of appeal. In its grounds of appeal, it stated that it regarded the letters of 31 July 2009 as a decision refusing the applications. This prompted an application by the Comptroller to strike the appeal out as having been made prematurely and on the basis there was no decision from which to appeal.

Subsequently the Deputy Director issued his decision and Medeva amended its notice of appeal to refer to it. Consequently it is accepted by all parties before me that the appeal can now be heard. Nevertheless the Comptroller requests that I decide whether the notice of appeal was properly filed on 28 August 2009 for the following reasons. First and most importantly, the Comptroller is concerned that unless this issue is resolved it will result in a series of premature and potentially speculative appeals. In that regard it seems that a number of third parties have inquired of IPO as to how Medeva’s appeal has been heard so quickly after the decision of the Deputy Director. Second, the parties have expended costs in dealing with the issue, not least as a result of the Comptroller’s decision to apply to strike out the appeal.

In my judgment the letters dated 31 July 2009 were not decisions against which appeals could properly be filed under s.97 of the Patents Act 1977. It is clear from the terms of the letters that they did not purport to be decisions. Rather they contained a statement of the opinion of the examiner and invited a response. Moreover, practitioners well know from the IPO Manual of Patent Practice that an examiner has no authority to make a decision on behalf of the Comptroller to refuse an SPC application.

Further, I do not accept the Comptroller was guilty of any actionable failure to make a decision or that any inaction by the Comptroller can properly be said to amount to a decision to refuse the applications or any other procedural impropriety. IPO did respond to the applications within the one month deadline set by the letter of 25 June 2009 and, moreover, did so in terms which were both clear and reasonable. Nothing further was heard from Medeva until their agents sent to IPO the letter dated 24 August 2009 with its four day deadline. The response from IPO by the letter dated 1 September 2009 was prompt, though just outside the deadline. Once again the terms of the letter were both clear and reasonable and provided no basis for treating the letters of 31 July 2009 as anything other than that which they purported to be, namely an expression of the opinion of the examiner. In the event, the Deputy Director, acting on behalf of the Comptroller, did issue his decision on 16 November 2009, some seven months after the filing of the applications.

For all these reasons I find that the appeal was indeed filed prematurely.

The appeal must be dismissed.