Novartis Pharmaceuticals UK Ltd v Medimmune Ltd & Anor

The First Defendant (“MedImmune”) and the Second Defendant (“the MRC”) (collectively, “the Patentees”) are joint proprietors of European Patent (UK) No. 2 055 777 (“the Patent”). The Patentees are the holders of Supplementary Protection Certificate No. SPC/GB09/053 (“the SPC”) granted in respect of the Patent. The Claimant (“Novartis”) seeks a declaration that the SPC is invalid. MedImmune is the exclusive licensee of the MRC’s interest in the Patent and the SPC. MedImmune counterclaims for infringement of the SPC by sales of a pharmaceutical product whose international non-proprietary name is ranibizumab and which is sold under the trade mark Lucentis. Lucentis is approved for the treatment of an eye condition known as wet age-related macular degeneration, which can lead to loss of vision. Ranibizumab was developed by Genentech, Inc., which is not a party to the proceedings.

In MedImmune Ltd v Novartis Pharmaceuticals UK Ltd [2011] EWHC 1669 (Pat) (“the first judgment”) I held that (i) the Patent was invalid and (ii) even if valid, it had not been infringed by Novartis because claim 1 on its true construction did not cover the process by which ranibizumab had been produced. It is common ground that, if either of these conclusions is correct, it follows that the SPC is invalid. I granted MedImmune permission to appeal, however, and the hearing of the appeal has been fixed for 9 July 2012. It is also common ground that I must approach the issues in the present proceedings on the hypothesis that the Court of Appeal will conclude that the Patent is valid and has been infringed.

In this judgment I will take the first judgment as read. The following sections of the first judgment are particularly relevant:

European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (“the Regulation”) enables the proprietor of a patent for a medicinal product to obtain a supplementary protection certificate which extends the duration of the patent with respect to that product so as to compensate the proprietor for the effective loss of patent term caused by the need to obtain a marketing authorisation before the product can be marketed.

The Regulation includes the following recitals:

“[3] Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.

[4] At the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.

[5] This situation leads to a lack of protection which penalises pharmaceutical research.

[6] There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.

[7] A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market.

[8] Therefore, the creation of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A Regulation is therefore the most appropriate legal instrument.”

Articles 1, 3, 4 and 5 of the Regulation provide:

“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;

…

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/EEC or Directive 2001/82/EEC, 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 5

Effects of the certificate

Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.”

I do not propose to repeat the description of the Patent given in the first judgment. In brief summary, however, the Patent is directed to a method of producing a molecule with specificity for a particular target comprising two key steps: (i) producing a population of phage particles displaying at their surface binding molecules having a range of binding properties wherein each particle contains nucleic acid encoding the binding molecule; and (ii) selecting particles displaying a binding molecule with a desired binding property by contacting the population of particles with a target epitope or antigen to which the binding molecule of interest binds. In essence, what the Patent discloses and claims is a technique for screening a library of binding molecules (or, more specifically, antibodies or antibody fragments or derivatives) to identify one of interest. Once the binding molecule has been isolated, it can be produced by conventional recombinant techniques.

The only claim of the Patent to which it is necessary to refer is claim 1, which is as follows:

“[1] A method for producing a molecule with binding specificity for a particular target, which method comprises:

[2] producing a population of filamentous bacteriophage particles displaying at their surface a population of binding molecules having a range of binding properties,

[3] wherein the binding molecules comprise antibody antigen binding domains for complementary specific binding pair members,

[4] wherein the binding molecules are displayed at the surface of the filamentous bacteriophage particles by fusion with a gene III protein of the filamentous bacteriophage particles,

[5] and wherein each filamentous bacteriophage particle contains nucleic acid encoding the binding molecule expressed from the nucleic acid and displayed by the particle at its surface;

[6] selecting for a filamentous bacteriophage particle displaying a binding molecule with a desired binding property by contacting the population of filamentous bacteriophage particles with a particular target

[7] so that individual binding molecules displayed on filamentous bacteriophage particles with the desired binding property bind to said target;

[8] separating bound filamentous bacteriophage particles from the target;

[9] recovering separated filamentous bacteriophage particles displaying a binding molecule with the desired binding property;

[10] isolating nucleic acid encoding the binding molecule from separated filamentous bacteriophage particles;

[11] inserting nucleic acid encoding the binding molecule, or a fragment or derivative thereof with binding specificity for the target, in a recombinant system; and

[12] producing in the recombinant system separate from filamentous bacteriophage particles a molecule with binding specificity for the target,

[13] wherein the molecule is said binding molecule or a fragment or derivative thereof with binding specificity for the target.”

Age-related macular degeneration is caused by abnormal blood vessels proliferating and damaging the retina. Human vascular endothelial growth factor (VEGF) promotes endothelial cell proliferation and neovascularisation, as well as vascular permeability. Ranibizumab is an anti-VEGF antibody which reverses or at least halts these processes. I do not propose to repeat the description of the development of ranibizumab given in the first judgment. In brief summary, however, Genentech’s starting point was a mouse monoclonal antibody specific to VEGF called MAb A4.6.1, which was generated in hybridoma cells using monoclonal techniques. It is common ground that this owed nothing to the invention of the Patent. MAb A4.6.1 was transformed into a humanised antibody ranibizumab in eleven steps. Three of these steps involved phage display. MedImmune contends that the method of claim 1 of the Patent was carried out in at least the third round of phage display (step 9). In the first judgment, I held that the process carried out by Genentech did not fall within claim 1 as I had construed it (see [520]-[527]), but that if the process fell within the claim ranibizumab was obtained directly by means of it within the meaning of section 60(1)(c) of the Patents Act 1977 (see [528]-[577]). As related above, however, for present purposes it must be assumed that the Court of Appeal will hold that the process did fall within the claim on its true construction.

The SPC was granted on 31 March 2011, came into force on 10 July 2011 when the Patent expired and is due to expire on 9 July 2016. It identifies the Patent as the basic patent, authorisation EU/1/06/374/011 as the marketing authorisation and ranibizumab as the product. Although the SPC does not say so, authorisation EU/1/06/374/011 was granted to Novartis Europharm Ltd, a member of the same group of companies as Novartis. Thus the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent.

Novartis contends that, even on the assumption that the Patent is valid and that ranibizumab is a product obtained directly by means of a process falling within claim 1 of the Patent, the SPC is invalid for two reasons. First, ranibizumab is not protected by the Patent within the meaning of Article 3(a) of the Regulation since it is not specified or identified in the wording of the claims of the Patent. Secondly, the Patent is not a basic patent within the meaning of Article 1(c) of the Regulation since it does not protect a process to obtain a product.

In support of the first of these contentions Novartis relies upon the judgments of the Court of Justice of the European Union in Case C-322 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 (“Medeva”) and Case C-422/10 Georgetown University v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 (“Georgetown”) and its reasoned orders in Case C-518/10 Yeda Research and Development Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 (“Yeda”), Case C-630/10 University of Queensland v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 (“Queensland”) and Case C-6/11 Daiichi Sankyo Co v Comptroller-General of Patents, Designs and Trade Marks [2011] ECR I-0000 (“Daiichi”).

MedImmune’s position in a nutshell is that the law remains unclear in the light of these decisions and a further reference to the Court of Justice is required to clarify it.

In order to explain the present situation it is necessary to begin by setting out the background to Medeva and the other four cases referred to above.

In Case C-392/97 Farmitalia Carlo Erba Srl [1999] ECR I-5553 Farmitalia had obtained a German patent for idarubicin. The claims specifically covered idarubicin hydrochloride. Farmitalia had also obtained a marketing authorization for idarubicin hydrochloride. Farmitalia applied for an SPC for “idarubicin and salts thereof including idarubicin hydrochloride”. The German Patent Office granted an SPC for idarubicin hydrochloride, but refused to grant one for “idarubicin and salts thereof including idarubicin hydrochloride”. Farmitalia appealed first to the Bundespatentsgericht and then the Bundesgerichtshof. The latter court referred two questions concerning the interpretation of Article 3(b) and (a) respectively of what was then Council Regulation 1768/92/EEC to the Court of Justice.

With regard to the second question, the Court held:

“23.

By its second question, the Bundesgerichtshof is, in substance, asking what are the criteria, according to Regulation No 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 No 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 No 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.”

In Takeda Chemical Industries Ltd’s SPC Applications (No 3) [2003] EWHC 649 (Pat), [2004] RPC 3 Takeda had obtained a patent, a marketing authorisation and an SPC for the anti-ulcer agent lansoprazole. Subsequently Takeda obtained a patent for the use of lansoprazole for the manufacture of a medicament for preventing or treating infectious diseases caused by Helicobacter pylori. It also obtained a variation to the marketing authorization adding the eradication of Helicobacter pylori as a new therapeutic indication for lansoprazole when used in combination with appropriate antibiotics. It filed six applications for SPCs for combinations of lansoprazole with two antibiotics selected from clarithromycin, amoxycillin and metronidazole. Three of the applications designated the first patent, and the other three the second patent. The hearing officer refused all the applications for non-compliance with Article 3(a) and (b) of the Regulation. Takeda appealed to the Patents Court.

Jacob J (as he then was) dismissed the appeal. In relation to Article 3(a) he held as follows:

“7.

Mr Alexander, for Takeda, submits that the combination of lansoprazole with an antibiotic, if sold, would infringe the patent (and for this purpose it matters not which). So, the combination is protected by a basic patent which is in force. So, Takeda comply with condition 3(a). Moreover, he submits, definition (b) specifically contemplates that ‘product’ may be a combination of active ingredients. So it is clear that condition 3(a) contemplates protection of a combination.

…

10.

Mr Birss, for the Comptroller, submits Mr Alexander's argument is flawed. I agree. 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 clair 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).”

In Gilead Sciences Inc’s SPC Application [2008] EWHC 1902 (Pat) Gilead had obtained a patent for a new class of antiretroviral compounds useful in the treatment of HIV and other diseases, including tenofovir. Claim 1 of the patent was directed to the class of compounds and claim 25 to tenofovir itself. Paragraph [0047] of the patent stated:

“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.”

Claim 27 of the patent was as follows:

“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.”

Gilead obtained a marketing authorisation for a product containing tenofovir and another antiretroviral called emtricitabine. It applied for an SPC in respect of the combination of tenofovir and emtricitabine. The application was refused by the United Kingdom Intellectual Property Office for non-compliance with Article 3(a) of the Regulation. Gilead appealed to the Patents Court on two grounds. The first was that Takeda was wrongly decided, and that the correct test was the infringement test which Jacob J had rejected. The second was that Takeda was distinguishable on the facts. Kitchin J (as he then was) allowed the appeal on the second ground. Accordingly, it was not necessary for him to come to a conclusion with regard to the first ground. He nevertheless set out a number of considerations which might be said to support the adoption of the infringement test, and suggested that the issue merited consideration by the Court of Appeal and possibly the CJEU.

Kitchin J’s reasoning for allowing the appeal on the second ground was as follows:

“31.

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.

…

33.

… 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.

34.

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.

35.

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.”

In Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat) Astellas was the proprietor of a patent which covered the anthelmintic emodepside. Astellas obtained a marketing authorization for a combination of emodepside and another anthelmintic called praziquantel. Astellas applied for an SPC in respect of the combination of emodepside and praziquantel. The patent did not disclose or claim praziquantel. Nor did it disclose or claim a combination of emodepside and praziquantel. Claim 19 of the patent was for:

“An anthelmintic agent which comprises a compound or a pharmaceutically acceptable salt thereof of any of claims 1 to 11 and 14 as an active ingredient.”

The UKIPO refused the application on the ground that it did not comply with Article 3(a) since the patent did not protect the combination. Astellas appealed to the Patents Court and advanced three arguments. Astellas’ first argument was that the patent protected the combination by virtue of Claim 19, relying on Gilead. Astellas’ second argument was that the patent protected the combination because the combination would infringe it, and Takeda was wrong. Astellas’ third argument was that paragraph 39 of the Commission’s Explanatory Memorandum when it proposed the Regulation showed that the Regulation should be interpreted as permitting the grant of an SPC for a combination of active ingredients even if the basic patent only covered one of those active ingredients.

I dismissed the appeal for the following reasons. First, I held that claim 19 covered the combination of emodepside with another compound with anthelmintic activity such as praziquantel, but did not disclose it. Applying the test in Gilead, emodepside was the only active ingredient which was relevant to deciding whether the product fell within the scope of the claim. Secondly, I was not persuaded that Takeda was wrong, but agreed with Kitchin J that the matter merited consideration by the CA and perhaps the CJEU. Thirdly, I held that paragraph 39 of the Explanatory Memorandum did not support the grant of SPC for A plus B where the basic patent protected A and the marketing authorization was for A plus B. Moreover, Astellas’ interpretation of the Regulation depended on the infringement test being correct.

In Medeva Medeva was the proprietor of a patent the specification of which disclosed that a combination of two antigens known as pertactin and filamentous haemagglutinin (or FHA) produced a synergistic effect such that a third antigen called pertussis toxin (or LPF) was not required to produce a vaccine against Bordella pertussis (which causes whooping cough). The claims covered the combination of pertactin and FHA. Medeva obtained four marketing authorisations in respect of vaccines each of which was for immunisation against a number of diseases in addition to pertussis and contained between 8 and 11 different antigens. Each of these included pertactin, FHA and pertussis toxin. Medeva filed five applications for SPCs in respect of the medicinal products the subject of the authorisations. The UKIPO refused four of the applications on the ground that they did not comply with Article 3(a) since the patent did not protect the combinations of antigens which were the subject of the authorisations and were specified in the applications. It also refused a fifth application on the ground that it did not comply with Article 3(b) since although the application specified the combination of antigens protected by the patent the authorisation was for a combination product which included additional antigens.

Medeva appealed to the Patents Court. In relation to Article 3(a), it argued that vaccines were a special case in relation to which the infringement test should apply for two reasons. First, a combination vaccine was a medicinal product which comprises a group of antigens directed at multiple diseases. They were, in effect, operating independently and in parallel. Accordingly, the product was indeed protected by the patent within the meaning of Article 3(a). Secondly, the implementation of the invention by Medeva in the form of combination vaccines directed at multiple diseases had been driven by national health policy and, unless vaccines were treated as a special case, Medeva would be deprived of any opportunity to secure an SPC in respect of any product covered by the patent.

Kitchin J dismissed the appeal ([2010] EWHC 68 (Pat), [2010] RPC 20). He held that the first argument was flawed both in law and in fact. In the case of the first four applications the product as a whole was the medicinal product within the meaning of Article 1(a) and the 9 active ingredients together constituted the relevant product within the meaning of Article 1(b). It was impermissible to argue that the product comprised only the pertactin and FHA antigens for the purposes of Article 3(a). It was plain that ‘product’ must have the same meaning in Article 1(b) and Article 3(a). If the product of Article 1(b) was the whole combination of active ingredients, then so it remained for the purposes of Article 3(a). Turning to the facts, the evidence showed that the antigens of a vaccine combination did not necessarily operate independently. As to the second argument, the problem caused by Takeda was not peculiar to vaccines and it applied with equal force to all combination products. There was no justification for treating vaccines as a special case. Moreover, there was no basis in the Regulation for applying different qualifying criteria to different classes of products. Finally, he held that the UKIPO had been right to refuse the fifth application for non-compliance with Article 3(b).

Medeva appealed to the Court of Appeal. In relation to Article 3(a), Medeva argued that Takeda was wrong, alternatively should be distinguished for the reasons it had advanced before Kitchin J. Medeva also argued that, if Takeda was right and applied, for the purposes of Article 3(b) the product could be limited to that part of a multi-disease vaccine which was protected by the basic patent in force. The Court of Appeal decided to refer the following questions to the CJEU ([2010] EWCA Civ 700, [2010] RPC 27):

“1.

Regulation 469/2009 (‘the Regulation’) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by ‘the product is protected by a basic patent in force’ and what are the criteria for deciding this?

2.

In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not ‘the product is protected by a basic patent’ according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?

3.

In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not ‘the product is protected by a basic patent’ according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?

4.

For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens ‘protected by a basic patent’ if one antigen of the vaccine is ‘protected by the basic patent in force’?

5.

For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens ‘protected by a basic patent’ if all antigens directed against one disease are “protected by the basic patent in force”?

6.

Does the Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate for a single active ingredient or combination of active ingredients where:

(a)

a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the Regulation; and

(b)

a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or 2001/82/EC which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market?”

In Georgetown Georgetown, Rochester and Loyola were the proprietors of three patents. Georgetown’s patent claimed a vaccine for the prevention of HPV infection comprising L1 protein, or a fragment thereof, of HPV type 16 or type 18 or type 16 and type 18 together. Rochester’s patent claimed a recombinant HPV-like particle comprising type 16 L1 protein and a multivalent vaccine comprising a virus-like particle from different HPV viruses. Loyola’s patent claimed recombinant HPV-like particles in which one or more sections of the L1 protein were deleted. GSK was licensed under all three patents and had a marketing authorisation for Cervarix vaccine which contained a combination of HPV type 16 and type 18 L1 proteins. Sanofi Pasteur had a marketing authorisation for Gardasil/Silgard which contained a combination of HPV type 6, 11, 16 and 18 LI proteins. Georgetown, Rochester and Loyola applied for SPCs relying on the authorisations for Cervarix or Gardasil/Silgard. In each application the product was defined as a single HPV L1 protein, variously of type 6, 11, 16 or 18. The UKIPO refused the applications on the ground that they did not comply with Article 3(b). Georgetown, Rochester and Loyola appealed to the Patents Court. Kitchin J referred a question to the CJEU which was the same as question 6 in Medeva.

In Yeda Yeda was the proprietor of a patent, claim 1 of which was as follows:

“A therapeutic composition comprising:

(a)

a monoclonal antibody which inhibits the growth of human tumour cells by said antibody binding to the extra-cellular domain of the human EGF receptors of said tumour cells in an antigen-antibody complex, said tumour cells being characterised by their expression of human EGF receptors and mitogenic stimulation by human EGF; and

(b)

an anti-neoplastic agent

wherein the antibody is not antibody 108 produced by hybridoma cell line ATCC HB 9764 or antibody 96 produced by hybridoma cell line ATCC HB 9763.”

Yeda obtained a marketing authorisation for cetuximab (a monoclonal antibody specific for the receptor of epidermal growth factor or EGF) authorising its use in combination with irinotecan (an anti-neoplastic agent). Yeda applied for an SPC for cetuximab. The UKIPO refused the application on the ground that it did not comply with Article 3(a). Yeda appealed to the Patents Court, arguing that cetuximab was protected by the basic patent because sales of cetuximab would infringe pursuant to section 60(2) of the Patents Act 1977. Lewison J (as he then was) dismissed the appeal, holding that it was not enough that there would be infringement under section 60(2) ([2010] EWHC 1733 (Pat), [2010] RPC 29). Yeda appealed to the Court of Appeal which referred the following question to the CJEU:

“If the criteria for deciding that a product is ‘protected by a basic patent in force’ under Article 3(a) of the Regulation include or consist of an assessment of whether the supply of the product would infringe the basic patent, does it make any difference to the analysis if infringement is by way of indirect or contributory infringement based on Article 26 of the Community Patent Convention, enacted as s60(2) of the Patents Act 1977 in the UK, and the corresponding provisions in the laws of other Member States of the Community?”

In Daiichi Daiichi was the proprietor of a patent, Claim 5 was for:

“A pharmaceutical composition for the treatment or prophylaxis of hypertension which comprises an anti-hypertensive agent in admixture with a pharmaceutically acceptable carrier or diluent, in which the anti-hypertensive agent is at least one compound of formula (I) or a pharmaceutically acceptable salt or ester thereof, as claimed in any one of claims 1 to 4.”

Daiichi had obtained a marketing authorisation for a combination of olmesartan medoxomil, an anti-hypertensive agent of formula I, and hydrochlorothiazide, a different type of anti-hypertensive agent. Daiichi applied for an SPC for a combination of olmesartan medoxomil and
hydrochlorothiazide. The UKIPO refused the application on the ground that it did not comply with Article 3(a). Daiichi appealed to the Patents Court, relying upon claim 5 and Gilead. Floyd J held that claim 5 only covered a combination of olmesartan medoxomil with another hypertensive agent where the other agent was also a compound of formula I ([2010] EWHC 2897 (Pat)). He nevertheless referred the following questions to the CJEU:

“1.

Regulation 469/2009 (the Regulation) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by ‘the product is protected by a basic patent in force’ and what are the criteria for deciding this?

2.

In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not ‘the product is protected by a basic patent’ according to Art 3(a) of the Regulation and, if so, what are those further or different criteria?

3.

In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, is the condition that the product be ‘protected by a basic patent’ within the meaning of Articles 1 and 3 of the Regulation satisfied if the product infringes the basic patent under national law?

4.

In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, does satisfaction of the condition that the product be ‘protected by a basic patent’ within the meaning of Articles 1 and 3 of the Regulation depend upon whether the basic patent contains one (or more) claims which specifically mention a combination of (1) a class of compounds which includes one of the active ingredients in the said product and (2) a class of further active ingredients which may be unspecified but which includes the other active ingredient in the said product; or is it sufficient that the basic patent contains one (or more) claims which (1) claim a class of compounds which includes one of the active ingredients in the said product and (2) use specific language which as a matter of national law extends the scope of protection to include the presence of further other unspecified active ingredients including the other active ingredient in the said product?”

In Queensland Queensland was the proprietor of three patents, 935, 211 and 156. 211 and 156 were divisionals from 935. 935 covered vaccines made from HPV type 6 or 11 L1 protein, 211 covered vaccines made from HPV type 18 L1 protein and 156 covered vaccines made from HPV type 16 L1 protein. Claim 1 of 935 was a method claim. As noted above, GSK had obtained a marketing authorisation for Cervarix and Sanofi Pasteur for Gardasil/Silgard. Queensland applied for SPCs, filing applications both for the two combination products and for various products defined as single active ingredients. The UKIPO refused the combination applications on the ground that they did not comply with Article 3(a) and the single active ingredient applications on the ground that they did not comply with Article 3(b). Queensland appealed to the Patents Court. I referred the following questions to the CJEU:

“1.

Regulation 469/2009 (the Regulation) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by ‘the product is protected by a basic patent in force’ and what are the criteria for deciding this?

2.

In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not ‘the product is protected by a basic patent’ according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?

3.

Is one of these further or different criteria whether the active ingredients are admixed together rather than being delivered in separate formulations but at the same time?

4.

For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens ‘protected by a basic patent’ if one antigen of the vaccine is ‘protected by the basic patent in force’?

5.

In a case like the present one involving a medicinal product comprising more than one active ingredient, is it relevant to the assessment of whether or not ‘the product is protected by a basic patent’ according to Article 3(a) that the basic patent is one of a family of patents based on the same original patent application and comprising a parent patent and two divisional patents which between them protect all the active ingredients in the medicinal product?

6.

In a case like the present one involving a basic patent with claims to ‘a process to obtain a product’ in the sense of Article 1(c), does the ‘product’ of Article 3(a) have to be obtained directly by means of that process?

7.

Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate for a single active ingredient where:

(a)

a basic patent in force protects the single active ingredient within the meaning of Article 3(a) of the SPC Regulation; and

(b)

a medicinal product containing the single active ingredient together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or 2001/82/EC which is the first marketing authorization that places the single active ingredient on the market?

8.

Does the answer to Question 7 differ depending on whether the authorisation is for the single active ingredient admixed with the one or more other active ingredients rather than being delivered in separate formulations but at the same time?”

In Medeva the Court of Justice considered questions 1 to 5 together, beginning as follows:

“19.

By its first five questions, which it is appropriate to examine together, the Court of Appeal asks, in essence, whether Article 3(a) of Regulation No 469/2009 must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC where the active ingredients specified in the application include active ingredients not mentioned in the wording of the claims of the basic patent relied on in support of such an application.

20.

While the Latvian, Lithuanian and Portuguese Governments submit that only the wording of the claims is relevant for the purpose of determining whether a product is protected by a basic patent in force within the meaning of Article 3(a) of Regulation No 469/2009, Medeva and the United Kingdom Government maintain that the concept of a ‘product … protected by a basic patent in force’ within the meaning of that provision corresponds to any combination of substances of a medicinal product directly infringing the patent.”

The Court then repeated what it had said in Farmitalia at [26]-[27] and continued:

“24.

It should be noted that Regulation No 469/2009 establishes a uniform solution at European Union level by creating a SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State. It thus aims to prevent the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the European Union and thus directly affect the establishment and functioning of the internal market (see Case C-350/92 Spain v Council [1995] ECR I-1985, paragraphs 34 and 35; Case C-127/00 Hässle [2003] ECR I-14781, paragraph 37; and Case C-482/07 AHP Manufacturing [2009] ECR I-7295, paragraph 35).

25.

Moreover, it should be recalled that Article 5 of Regulation No 469/2009 provides that any SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations. It follows that Article 3(a) of the regulation precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent.

26.

Similarly, if a patent claims that a product is composed of two active ingredients but does not make any claim in relation to one of those active ingredients individually, a SPC cannot be granted on the basis of such a patent for the one active ingredient considered in isolation.

27.

That approach is also borne out by the second subparagraph of paragraph 20 of the explanatory memorandum to the proposal for Council Regulation (EEC) of 11 April 1990 concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final) (‘the explanatory memorandum’), which, in so far as concerns what is ‘protected by the basic patent’, refers expressly and solely to the wording of the claims of the basic patent. That interpretation also accords with that given in recital 14 in the preamble to Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ 1996 L 198, p. 30), which refers to the need for ‘products’ to be ‘the subject of patents specifically covering them’.

28.

The answer to the first five questions is, therefore, that Article 3(a) of Regulation No 469/2009 must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application.”

I am bound to say that I find this reasoning difficult to follow. The Court begins by repeating its statement in Farmitalia that “the extent of patent protection can be determined only in the light of the non-European Union rules governing patents”. Neither in Farmitalia nor in Medeva, however, does the Court clearly identify the rules to which it is referring.

In countries such as the United Kingdom, there are two sets of rules which might be relevant. The first consists of national laws which implement Article 69 of the European Patent Convention, which provides that:

“The extent of the protection conferred by a European patent … shall be determined by the claims. Nonetheless, the description and drawings shall be used to interpret the claims.”

Article 69 is supplemented by the Protocol on the Interpretation of Article 69. Both are quoted by the Court in Medeva at [9] and [10]. They are given effect to in the UK by section 125(1) and (3) of the Patents Act 1977, which the Court quoted in Medeva at [12]. The second set of rules consists of national laws that were intended to implement Articles 25 and 26 of the Community Patent Convention (as revised in 1989), which never came into force. In the UK, these are sections 60(1) and (2) of the 1977 Act, the first of which the Court quoted in part in Medeva at [11]. Since the Court refers to “the extent of patent protection”, it appears that at this stage of its analysis it is referring to the first set of rules.

The Court goes on to say at [24] that the Regulation establishes a uniform solution at EU level, but does not explain how this is to be achieved if the extent of protection is determined by non-EU rules. In this regard, it should be borne in mind that all EU Member States are party to the EPC, but not all EU Member States have implemented the CPC.

Next the Court notes in the first sentence of [25] that (subject to Article 4) Article 5 of the Regulation provides that an SPC “confers the same rights as conferred by the basic patent”. On its face, this means that an SPC is infringed by the same kinds of acts as would infringe the basic patent. In other words, the Court is now referring to the second set of rules mentioned above.

The Court then says that “It follows that Article 3(a) … precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent”. Leaving aside for now the question of what “specified in the wording of the claims” actually means, how does this follow? I cannot see that it does.

As a separate point, it will be noted that the Court did not actually answer question 1. I have to say that, as the national judge who made one of the references before the Court, I am disappointed by this. One of the reasons for the multiplicity of references was the need of the national courts for clear guidance as to the criteria to be applied in deciding whether a product is “protected by a basic patent” within the meaning of Article 3(a). As I shall discuss below, not only has the Court not answered the question referred, but also the guidance it has provided is not sufficiently clear to enable future disputes to be resolved.

As for question 6, the Court answered this as follows at [42]:

“In view of the foregoing, the answer to Question 6 is that Article 3(b) of Regulation No 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a SPC for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the MA is submitted in support of the SPC application contains not only that combination of the two active ingredients but also other active ingredients.”

In Georgetown the Court repeated this answer supported by the same reasoning.

In Yeda the Court of Justice began by saying at [30]-[32] that the question referred in this case was, for all essential purposes, similar to those referred in Medeva, and accordingly could be dealt with by way of reasoned order. It then stated at [33]:

“By its question, the Court of Appeal asks, in essence, whether Article 3(a) of Regulation No 469/2009 must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone.”

The Court went on at [34]-[38] to repeat its reasoning in Medeva at [22]-[26]. It concluded at [39]:

“ In view of the foregoing considerations, the answer to the question referred is that Article 3(a) of Regulation No 469/2009 must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone.”

In Daichii the Court of Justice again began by saying at [21]-[24] that the questions referred in this case were, for all essential purposes, similar to those referred in Medeva, and accordingly could be dealt with by way of reasoned order. It then repeated both its reasoning in Medeva and its ruling, except that its answer used the word “identified” rather than the word “specified”.

In Queensland the Court of Justice began by saying at [23]-[24] that the questions referred in this case were, for all essential purposes, similar to those referred in Medeva and Georgetown, and accordingly could be dealt with by way of reasoned order. It then repeated both its reasoning in Medeva and its answers to questions 1-5 and 6 in answer to questions 1-5 and 7-8, except that its answer to questions 1-5 used the word “identified” rather than the word “specified”. In relation to question 6, the Court said:

“37.

By Question 6, the referring court asks whether, in a case involving a basic patent relating to a process by which a product is obtained, it is necessary for the purpose of granting a SPC, in the light in particular of Article 1(c) of Regulation No 469/2009, for it to be possible for the ‘product’ to be obtained directly by means of that process.

38.

It is sufficient to point out that a patent protecting the process by which a ‘product’ within the meaning of Regulation No 469/2009 is obtained may, in accordance with Article 2 of the regulation, enable a SPC to be granted and, in that case, in accordance with Article 5 of the regulation, the SPC confers the same rights as conferred by the basic patent as regards the process by which the product is obtained (see Medeva, paragraph 32).

39.

If the law applicable to such a patent so provides, a SPC granted on the basis of that patent will also extend the protection of the process by which the product is obtained to the product thus obtained (see, to that effect, Medeva, paragraph 32).

40.

However, just as Article 3(a) of Regulation No 469/2009 precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent (Medeva, paragraph 25), where the basic patent relied on in support of a SPC application relates to the process by which a product is obtained, that provision also precludes a SPC being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from that process. The grant of a SPC is not conditional on whether it is possible to obtain a product directly as a result of the process by which the product is obtained, where that process has been the subject of a patent.

41.

The answer to Question 6 is therefore that, in the case of a basic patent relating to a process by which a product is obtained, Article 3(a) of Regulation No 469/2009 precludes a SPC being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it is possible to obtain the product directly as a result of that process is irrelevant in that regard.”

Again I find this reasoning hard to follow. At [38] the Court again refers to Article 5. It then says in [39] that, “if the applicable law so provides” an SPC “will also extend the protection of the process by which the product is obtained to the product thus obtained”. Under the applicable law, namely section 60(1)(c) implementing Article 25(c), however, this is only the case if the product is obtained directly by means of the process. Yet the Court goes on to say that this is “irrelevant”.

Novartis contends that ranibizumab is not protected by the Patent within the meaning of Article 3(a) of the Regulation since it is not specified in the wording of the claims of the Patent, nor is it identified in the wording of the claims of the Patent as the product deriving from the claimed process. In support of this contention counsel for Novartis argued in summary as follows:

MedImmune contends that ranibizumab is protected by the Patent, but accepts that in the present state of the law it is not clear that this is the case. Counsel for MedImmune argued in summary as follows:

I agree with counsel for MedImmune that Medeva and its progeny were all concerned with situations where either the patent claimed, or the product the subject of the application for an SPC consisted of, a combination of active ingredients, and therefore the present case is distinguishable since it is concerned with a single active ingredient and a claimed method by means of which it is alleged to have been produced.

In my view, counsel for MedImmune is also correct to say that the test laid down by the Court of Justice in Medeva and its progeny is unclear save in its rejection of the infringement test in combination cases. In particular, it is unclear precisely what is meant by “specified (or identified) in the wording of the claims”. Does this mean that it is sufficient for the product to fall within the scope of the claim on its true construction, or is something more required and if so what? For example, is it sufficient, say, for the claim to incorporate a Markush formula which covers a large number of compounds one of which is the product in respect of which an SPC is sought? Is it sufficient for the product to be defined in functional terms? Even in combination cases, it is not clear to me how the test enunciated by the Court should be applied in a case like Gilead. Regrettably, therefore, it is inevitable that there will have to be further references to the CJEU to obtain clarification of the test.

In my judgment, however, ranibizumab is not “identified in the wording of” claim 1 of the Patent “as the product deriving from the process in question” as required by the ruling in Queensland. My reasons are as follows.

First, it seems clear that the Court of Justice was intending in these cases to lay down a broad general rule. Thus the Court evidently did not consider it necessary to descend into the detail of a number of the questions which had been referred.

Secondly, the Court’s rulings do not merely require the product to be specified in the claims (compare section 125(1) of the 1977 Act), but specified or identified in the wording of the claims. It appears to me that this points to a test which is more demanding than merely requiring that the product be within the scope of the claim, although it is not clear how much more demanding.

Thirdly, even if Medeva can be interpreted as leaving open the possibility that it is sufficient for the product to be within the scope of the claim where the claim is a product claim, it seems to me that Queensland lays down a narrower rule in the case of process claims. The Court of Justice requires the product to be identified in the wording of the claim as the product deriving from the process in question. Furthermore, it says that it is irrelevant whether or not it was possible to obtain the product directly by means of that product, which points away from an infringement-type test. In the present case, claim 1 merely identifies the product of the method as “a molecule with binding specificity for a particular target”. This covers millions of different molecules of various kinds. It is not even limited to antibodies. Although ranibizumab falls within this extremely broad class of products, there is nothing at all in the wording of the claim, or even the lengthy specification of the Patent, to identify ranibizumab as the product of the process in question.

Fourthly, I am not persuaded to the contrary by Yeda. Although it is fair to say that the Court of Justice appears to have proceeded on the basis that cetuximab was “identified in the wording of” integer (a) of claim 1 of the patent in question, despite not being specifically referred to, the degree of specificity required was simply not in issue in that case. The question referred to the Court was solely about the effect of section 60(2), and the Court’s answer was only directed to rejecting the infringement test. In any event, claim 1 of the patent in question was a product claim, not a process claim, and although integer (a) defined the agent in question in functional terms, it did so considerably more specifically than integer [1] of claim 1 of the Patent.

Fifthly, I consider that this conclusion is in accordance with the policy underlying the Regulation. The Patent is not in any sense a patent for ranibizumab. I do not see that an extension of the term of the Patent is justified by the long period of time which was required first to develop, and then to obtain a marketing authorisation for, ranibizumab. Indeed, there is no reason to think that the Patentees were delayed in reaping rewards from the Patent at all, since the patented technique was of immediate utility in their own research. It was also licensed to a third party for substantial royalties in 1993 (see Cambridge Antibody Technology Ltd v Abbott Biotechnology Ltd [2004] EWHC 2974 (Pat), [2005] FSR 27).

Although presented by Novartis as a separate argument, it seems to me that upon analysis the second issue is the same as the first. A basic patent is defined by Article 1(c) of the Regulation as meaning inter alia “a patent which protects … a process to obtain a product”. This depends on whether the patent protects the product obtained by the process within Article 3(a). I do not see that this gives rise to a different issue.

As noted above, in the present case the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent. It might be thought that it was not the purpose of the Regulation to enable a patent owner to obtain an SPC in such circumstances, since the owner has not been delayed in getting the product to market by the need to get a marketing authorisation, and therefore no extension to the term of the patent is needed to compensate him for that delay. Counsel for MedImmune accepted that it was not clear from the judgment of the Court of Justice in Case C-181/95 Biogen Inc v SmithKline Biologicals SA [1997] ECR I-386 that this was permissible. Nevertheless, counsel for Novartis made it clear that Novartis was not taking this point.

Counsel for MedImmune submitted that I should refer one or more questions to the CJEU to seek clarification of the law. Counsel for Novartis resisted this. As I have said, I consider it inevitable that there will have to be further references to the Court of Justice. It does not follow, however, that the present case is an appropriate case in which to refer questions, still less that I should make a reference now rather than leaving the decision to the Court of Appeal. Counsel for MedImmune submitted that it was preferable for me to refer questions, since it would mean that they were answered more quickly. As counsel for Novartis pointed out, however, if the Court of Appeal uphold either of my conclusions in the first judgment that the Patent is invalid and has not been infringed, the issue considered in this judgment will be academic. Counsel for MedImmune replied that in that event the reference could be withdrawn.

In my judgment I have to proceed on the basis of the current position. As matters stand, it is not necessary for me to seek the guidance of the Court of Justice since I have held that the Patent is invalid and has not been infringed. Even if it is assumed that the resolution of the issue of law discussed in this judgment is not acte clair, it will only become necessary to make a reference if both of those conclusions are overturned by the Court of Appeal. In that event the Court of Appeal will be able to consider whether or not to make a reference. In my view it would not be right to impose the burden of a reference on the parties, the Court of Justice and the Member States at this stage when the issue may well turn out to be academic. I am comforted in this conclusion by the information provided to me by counsel for MedImmune that the Bundespatentgericht in Germany will be considering the validity of the German counterpart to the SPC at a hearing scheduled for May 2012, and will be in a position to make a reference then if it considers it appropriate to do so.

For the reasons given above I conclude that the SPC is invalid.