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:

And claim 2 is directed to a vaccine which does not contain 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):

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):

The relevant Articles of the SPC Regulation read:

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”:

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:

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:

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]:

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]:

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:

The whole Infanrix product comprising nine active ingredients is the relevant medicinal product within the meaning of Article 1(a).

Those nine active ingredients together constitute the relevant product within the meaning of Article 1(b).

The Patent protects that product within the meaning of Article 3(a).

A valid authorisation to place that product on the market has been granted, so satisfying Article 3(b).

The product has not already been the subject of an SPC and the marketing authorisation is the first authorisation to place that product on the market in the UK because although there have been other earlier authorisations which included the same pertussis components in a similar context, those authorisations were not for the same SPC product consisting of the particular combination of antigens the subject of this application. Hence Article 3(c) and (d) are satisfied.

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.