1. (a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim could this patent, whether or not such an amendment is made, be relied upon as a "basic patent in force" for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2006/EC ("the Regulation")?If you would like to comment on this case, and thus guide the UK government in its decisions as to whether and how to make representations to the CJEU, please email firstname.lastname@example.org by the agreeably generous date of 10 January 2014.
(b) Can a patent that has been amended after the grant of the patent and either (i) before and / or (ii) after grant of the SPC be relied upon as the "basic patent in force" for the purposes of fulfilling the condition set out in Article 3(a) of the Regulation?
(c) Where an applicant applies for an SPC for a product comprised of active ingredients A and B in circumstances where,
(i) after the date of application for the SPC but before the grant of the SPC, the basic patent in force, being a European Patent (UK) (the "Patent") is amended so as to include a claim which explicitly identifies A and B;2. For the purposes of determining whether the conditions in Article 3 are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B where (i) the basic patent in force includes a claim to a product comprising the combination of active ingredients A and B and (ii) there is already an SPC for a product comprising active ingredient A ("Product X") is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone?
(ii) the amendment is deemed, as a matter of national law, always to have had effect from the grant of the Patent; is the applicant for the SPC entitled to rely upon the Patent in its amended form for the purposes of fulfilling the Art 3(a) condition?
3. Where the basic patent in force "protects" pursuant to Article 3(a):
(a) A product comprising active ingredient A ("Product X"); andand where
(b) A product comprising a combination of active ingredient A and active ingredient B ("Product Y")
(c) An authorisation to place Product X on the market as a medicinal product has been granted;does the Regulation, in particular Articles 3(c), 3(d) and/or 13(1) of the Regulation preclude the proprietor of the patent being issued with an SPC in respect of Product Y? Alternatively, if an SPC can be granted in respect of Product Y, should its duration be assessed by reference to the grant of the authorisation for Product X or the authorisation for Product Y?
(d) An SPC has been granted in respect of Product X; and
(e) A separate authorisation to place Product Y on the market as a medicinal product has subsequently been granted,
4. If the answer to question 1(a) is in the negative and the answer to question 1(b)(i) is positive and the answer to question 1(b)(ii) is negative, then in circumstances where:
(i) in accordance with Art 7(1) Regulation, an application for an SPC for a product is lodged within six months of the date on which a valid authorisation to place that product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 200l/82/EC;does the SPC Regulation prevent the competent industrial property office from applying national procedural provisions to enable (a) suspension of the application for the SPC in order to allow the SPC applicant to apply to amend the basic patent, and (b) recommencement of said application at a later date once the amendment has been granted, the said date of recommencement being
(ii) following the lodging of the application for the SPC, the competent industrial property office raises a potential objection to the grant of the SPC under Article 3(a) of the Regulation;
(iii) following and in order to meet the aforesaid potential objection by the competent industrial property office, an application to amend the basic patent in force relied upon by the SPC applicant is made and granted;
(iv) upon amendment of the basic patent in force, said amended patent complies with Article 3(a),
- after six months from the date on which a valid authorisation to place that product on the market as a medicinal product was granted but
- within six months of the date on which the application to amend the basic pate?
A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Thursday, 26 December 2013
Monday, 23 December 2013
Specifically, the applicants intended to obtain one SPC for each particle contained in Gardasil® (virus-like particles of the human papillomavirus types 6, 11, 16, and 18) and each particle contained in Cervarix® (virus-like particles of human papillomavirus types 16 and 18), as well as two additional SPCs for the combination of particles contained in each medicine, thus resulting in the following eight SPC applications:
1. Virus-like particles (VLPs) of human papillomavirus (HPV) type 6 in Gardasil.In order to fulfill the requirements provided by art. 3 of the SPC Regulation 1768/92 (SPCR), which was in force on the date of filing, the applicants referred in the applications to basic patents in force and also a valid marketing authorizations for the products. Thus, the basic patents quoted (art. 3.a) were EP 595 935 (for SPCs 1, 2 and 7), EP 1 298 211 (for SPCs 3 and 5) and EP 1 359 156 (for SPCs 4, 6 and 8). The marketing authorizations included (art. 3.b) were Gardasil® [Human Papillomavirus (Types 6, 11, 16, and 18) Vaccine, Recombinant] and Cervarix® [Human Papillomavirus (Types 16 and 18) Vaccine, Recombinant].
2. VLPs of HPV 11 in Gardasil.
3. VLPs of HPV 16 in Gardasil.
4. VLPs of HPV 18 in Gardasil.
5. VLPs of HPV 16 in Cervarix.
6. VLPs of HPV 18 in Cervarix.
7. The combination of VLPs of HPV types 6, 11, 16 and 18 in Gardasil.
8. The combination of VLPs of HPV types 16 and 18 in Cervarix.
In December 2009, the SPTO rejected the granting of all the SPC applications, arguing that the owner of various patents referred to the same product cannot obtain various SPCs over the same product, and also that the authorized product was not covered by a basic patent in force. In order to support this latter argument, the Office quoted a decision issued by the Supreme Court on 4 July 2007 (Asociación Española de Fabricantes de Sustancias y Especialidades Farmacéuticas Genéricas v SPTO/E.R. Squibb & Sons, Inc.) whereby the Supreme Court had refused to grant a SPC for a process to prepare products derived from proline.
The applicants filed administrative appeals against these decisions, based on the following arguments: (a) there are different active principles or products in the vaccines Gardasil® and Cervarix® which are the specific VLPs of HPV individually considered, as each particle is conceived to address a specific serotype; (b) each basic patent included in the application covers a different VLP; (c) the reasons given by the SPTO to reject the applications are inspired by a strict interpretation of the SPCR that is contrary to its underlying principles and also contrary to the interpretation given by the European Court of Justice (CJEU) - e.g., in Case C-392/97 Farmitalia - which stated that where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the supplementary protection certificate is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent; and (c) other national patent offices had already granted the SPCs.
Despite the above arguments, the appeals were dismissed by the Board of Appeals on the same basis that had already served to reject the granting of the SPCs.
Dissatisfied with these decisions, the patent owners filed 8 appeals before the Tribunal Superior de Justicia de Madrid (the regional High Court of Justice for administrative matters), one for each application.
In parallel, the applicants had faced the same trouble in the UK, where the UKPTO had dismissed the SPCs and also the appeals filed against the refusal decisions, so they brought the case to the High Court of Justice (CH/2010/APP0620), where Justice Arnold decided, on December 2010, to request the CJEU to give a preliminary ruling on the interpretation of arts. 3.a and 3.b of the SPCR (case C-630/10). The questions referred were aligned with those referred in other cases (C-322/10 Medeva, C-422/10 Georgetown University, C-518/10 Yeda Research & Development, or C-6/11 Daiichi Sankyo Company Ltd.). Among others, Mr Justice Arnold asked the CJEU to give response to these key questions: 1) For the purposes of art. 3.a, is a multi-disease vaccine comprising multiple antigens protected by a basic patent if one antigen of the vaccines is protected by the basic patent in force?; 2) Does art. 3.b permit the grant of a SPC for a single active ingredient where (i) a basic patent in force protects the single active ingredient within the meaning of art. 3.a of the SPCR, and (ii) a medicinal product containing the single active ingredient together with one or more other active ingredients is the subject of a valid marketing authorization?
In Spain, the applicants asked the Court to stay the proceedings until these questions were answered by the CJEU, but this petition was dismissed on two occasions. As a result of this, the applicants were obliged to submit their arguments without knowing the outcome of Case C-630/10. The arguments referred to the strict and incorrect interpretation of the SPCR made by the SPTO, in contrast to the interpretation made by the CJEU in previous rulings, taking into special consideration the rationale of the Regulation (e.g. in the Recitals 3, 7 and 8), which had been quoted by the Court in previous cases (C-392/97 and C-482/07). The claim also challenged the citation by the SPTO of the judgment of the Supreme Court dated 4 July 2007, stating that it was a different case: there the basic patent did not mention one of the two active principles which were included in the marketing authorization, whereas in case of the SPCs filed by the University of Queensland and CSL Limited, all the VLP of HPV types were expressly mentioned in both the basic patent and the marketing authorization of Gardasil® and Cervarix®.
Interestingly, despite of the dismissal to stay, the Spanish Court waited for the CJEU’s decision of in Case C-630/10 on 25 November 2011 prior to issue the judgments on 6 pending appeals, which were rendered between July and September 2013.
In line with the response given by the CJEU to the preliminary ruling request, the Spanish Court stated that art. 3.a of the SPCR does not allow the granting of SPCs for active ingredients that are not identified in the wording of the claim of the basic patent, and that art. 3.b allows the granting of a SPC for an active ingredient specified in the wording of the claims of the basic patent where the medicinal product of the marketing authorization included in the SPC application contains not only that active ingredient but also other active ingredients.
Before the Tribunal Superior de Justicia rendered the judgments, and in view of the interpretation given by the CJEU to art. 3.a SPCR in C-630/10, the applicants had withdrawn the appeals involving the combination of VLPs of HPV in Gardasil and Cervarix (i.e., applications 7 and 8 listed above), as the wording of the basic patents quoted in the application, individually considered, did not specify all the VLPs for which the SPC had been applied for.
In contrast, the remaining six appeals concerning SPCs of single active ingredients were upheld by the Tribunal Superior de Justicia, following the reasoning given by the CJEU. The State Attorney, defending the SPTO, has filed appeals to the Supreme Court against three of these judgments (SPCs 2, 4 and 5 of the list), but he missed the deadline for the other 3, so these decisions became non-appealable. The SPTO accordingly granted the applications in December 2013.
Thursday, 12 December 2013
Georgetown's patent claimed a vaccine for the prevention of papillomavirus infection, comprising at least that protein, or fragment thereof, of, among others, HPV‑16, HPV‑18 or HPV‑16 and HPV‑18 together. The patent, granted on 12 December 2007, expired on 23 June 2013.
Two SPC applications were granted but, on 19 May 2010 the SPC application based on the MA granted for Gardasil, which referred to the recombinant L1 protein of the human papillomavirus (HPV) type 16 as the ‘product’ within the meaning of Regulation No 469/2009, was rejected. Said the OCN, the MA which Georgetown relied on related to a medicinal product containing other active ingredients in addition to the recombinant protein of HPV-16. Georgetown appealed against the OCN’s decision to the Rechtbank’s-Gravenhage. That court observed that a rule to the effect that only one SPC may be granted per basic patent could be easily circumvented by the holders of patents protecting several products: it would be sufficient for such holders to separate their patents in such a way that each basic patent protected only one product, thus enabling them to obtain an SPC for each individual product. Said Georgetown, it would be prepared to surrender the two SPCs already granted and to withdraw its other pending SPC applications if that enabled it to obtain, in accordance with the Court’s interpretation of Regulation 469/2009, an SPC in respect of HPV‑16. The Rechtbank’s-Gravenhage was however uncertain whether the surrender of the two SPCs already granted might have retroactive effect. In any event, that court decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:
‘(1) Does Regulation No 469/2009 …, more particularly Article 3(c) thereof, preclude, in a situation where there is a basic patent in force which protects several products, the holder of the basic patent from being granted a certificate for each of the protected products?This morning the CJEU ruled as follows:
(2) If the first question must be answered in the affirmative, how should Article 3(c) of Regulation No 469/2009 be interpreted in the situation where there is one basic patent in force which protects several products and where, at the date of the application for a certificate in respect of one of the products (A) protected by the basic patent, no certificates had yet been granted in respect of other products (B, C) protected by the same basic patent, but where certificates were nevertheless granted in respect of the products (B, C) before a decision was made with regard to the application for a certificate in respect of the first-mentioned product (A)?
(3) Is it significant for the answer to the previous question whether the application in respect of one of the products (A) protected by the basic patent was submitted on the same date as the applications in respect of other products (B, C) protected by the same patent?
(4) If the first question must be answered in the affirmative, may a certificate be granted for a product protected by a basic patent which is in force if a certificate has already been granted for another product protected by the same basic patent, but where the applicant surrenders the latter certificate with a view to obtaining a new certificate on the basis of the same basic patent?
(5) If the issue of whether the surrender has retroactive effect is relevant for the purpose of answering the previous question, is the question of whether surrender has retroactive effect governed by Article 14(b) of Regulation No 469/2009 or by national law? If the question of whether surrender has retroactive effect is governed Article 14(b) of Regulation No 469/2009, should that provision be interpreted to mean that surrender does have retroactive effect?’
"In circumstances such as those in the main proceedings, where, on the basis of a basic patent and a marketing authorisation for a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained a supplementary protection certificate for that combination of active ingredients, protected by that patent within the meaning of Article 3(a).. , Article 3(c) of that regulation must be interpreted as not precluding the proprietor from also obtaining a supplementary protection certificate for one of those active ingredients which, individually, is also protected as such by that patent".At  to  the CJEU observed:
"29 ... the main proceedings concern a ... situation ... in which the same basic patent may be regarded as protecting a number of products within the meaning of Article 3(a) ..., thus raising a different question, namely whether such a patent may permit its holder to obtain several SPCs.
30 In that regard, it is possible, in principle, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, inter alia, that each of those products is ‘protected’ as such by that ‘basic patent’ within the meaning of Article 3(a) ..., and is contained in a medicinal product with an MA.
31 Indeed, the wording of Article 1(b) and Article 3(c) ... does not preclude such an interpretation. That interpretation is also borne out by the objective pursued by that regulation, which, as is apparent from paragraph 11 of the Explanatory Memorandum to the Proposal for a Council Regulation (EEC) of 11 April 1990 concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final), is to encourage research in the pharmaceutical sector by granting one SPC per product, a product being understood to mean an active substance in the strict sense. Any other interpretation might, moreover, give rise to circumvention tactics, entailing additional costs which may discourage innovation, in the sense that those concerned would be minded to apply for a separate basic patent for each of their ‘products’".
13 Claims 13, 14 and 18 of this patent read as follows:Eli Lilly wanted to market a pharmaceutical composition for use in the treatment of autoimmune diseases, containing as its active ingredient an antibody, LY2127399 (Tabalumab), that binds specifically to Neutrokine-α, which Eli Lilly refers to as (now also known as ). However, it it marketed that composition before the expiry of HGS’s patent, LY2127399 would infringe claim 13 on the basis that LY2127399 was an antibody as defined in claim 13, being an isolated antibody or portion thereof which binds specifically to Neutrokine-α polypeptide. Any pharmaceutical composition containing LY2127399 was thus a pharmaceutical composition as defined in claim 18 of that patent.
‘13. An isolated antibody or portion thereof that binds specifically to:
(a) the full length Neutrokine-α polypeptide (amino acid sequence of residues 1 to 285 of SEQ ID No: 2); or14. The antibody or portion thereof of claim 13 which is selected from the group consisting of:
(b) the extracellular domain of the Neutrokine-α polypeptide (amino acid sequence of residues 73 to 285 of SEQ ID No: 2).
(a) a monoclonal antibody; ...18. A pharmaceutical composition comprising … the antibody or portion thereof of any one of claims 13 to 17 and, optionally, a pharmaceutically acceptable carrier.’
Case C-322/10 Medeva test. Said Eli Lilly, for an SPC to be granted on the basis of HGS’s patent, the patent would have had to contain a structural definition of the active ingredients and the claims would have had to be significantly more specific.
Claim 13 of HGS’s patent was broadly worded, covering a large number of antibodies: the antibody was defined functionally, but not structurally, the definition thus covering an unknown number of otherwise unspecified antibodies, this being the broadest way of claiming an antibody. The patent specification contained no example of an antibody having been made or tested; nor did it contain any structural description of antibodies that might function as therapeutic antibodies. HGS disagreed, pointing out that its form of claim was a standard one that was routinely granted by the European Patent Office (EPO) and that its patent had been held valid in proceedings both before the EPO and in the UK.
The Patents Court decided to stay proceedings and refer the following questions to the Court for a preliminary ruling:
‘(1) What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation [No 469/2009]? [the first question posed, but found unnecessary to answer, in Case C-443/12 Actavis v Sanofi, here]This morning the CJEU ruled as follows:
(2) Are the criteria different where the product is not a combination product, and if so, what are the criteria?
(3) In the case of a claim to an antibody or a class of antibodies, is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?’
"Article 3(a) ... must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) ... does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court".At  and  the CJEU observed:
"42 As stated in recital 4 in the preamble to Regulation No 469/2009, the purpose of that additional period of exclusivity is to encourage research and, to that end, it is designed to ensure that the investments put into such research are covered.
43 In the light of the objective of Regulation No 469/2009, the refusal of an SPC application for an active ingredient which is not specifically referred to by a patent issued by the EPO relied on in support of such an application may be justified – in circumstances such as those in the main proceedings and as observed by Eli Lilly – where the holder of the patent in question has failed to take any steps to carry out more in-depth research and identify his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients. In such a situation, if an SPC were granted to the patent holder, even though – since he was not the holder of the MA granted for the medicinal product developed from the specifications of the source patent – that patent holder had not made any investment in research relating to that aspect of his original invention, that would undermine the objective of Regulation No 469/2009, as referred to in recital 4 in the preamble thereto".
The ruling in Case C‑443/12, Actavis Group PTC EHF, Actavis UK Ltd v Sanofi, Sanofi Pharma Bristol-Myers Squibb SNC intervening, a reference for a preliminary ruling from the Court of Justice of the European Union (CJEU), was handed down this morning.
On the basis of that basic patent and marketing authorisations (MAs) granted on 27 August 1997 for the medicinal product Aprovel, which had irbesartan as its single active ingredient and was used principally to treat primary hypertension, Sanofi obtained its first SPC for that active ingredient on 8 February 1999. That certificate expired on 14 August 2012. Also, on the basis of its basic patent but with MAs granted on 15 October 1998 for the medicinal product CoAprovel, comprising a combination of irbesartan and a diuretic (hydrochlorothyiazide, used to treat primary hypertension), Sanofi obtained a second SPC relating to the irbesartan–hydrochlorothiazide combination: this was granted on 21 December 1999 and expired on 14 October 2013.
Actavis wanted to market generic versions of Aprovel and CoAprovel. However, as a generic medicinal product corresponding to CoAprovel would infringe Sanofi's second SPC, for the irbesartan-hydrochlorothiazide combination, Actavis brought proceedings before the Patents Court, England and Wales, challenging its validity. Said Actavis, Sanofi's second SPC for the combination of irbesartan and hydrochlorothiazide was invalid: that combination was not protected by the basic patent within the meaning of Article 3(a) of Regulation 469/2009 since that combination of active ingredients was not expressly specified or identified in the wording of any of the claims of that patent. No, said Sanofi, that combination was specified or identified in claim 20, which stated that the patent related to a combination of irbesartan and a diuretic -- after all, hydrochlorothiazide was nothing other than a diuretic. Actavis also relied on Article 3(c) of the same Regulation since that the ‘product’ within the meaning of that provision had already been the subject of an initial SPC. No, said Sanofi: the first SPC and the MAs granted for Aprovel were obtained for the single active ingredient irbesartan, while the second SPC and the MAs for CoAprovel were obtained for a different product --the combination of irbesartan and hydrochlorothiazide.
The Patents Court noted the growing number CJEU rulings on SPCs but considered that it was impossible to resolve the dispute in the main proceedings on the basis of those ruling alone. This being so, the Court decided to stay proceedings and refer two questions to the Court for a preliminary ruling:
‘(1) What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of … Regulation No 469/2009?The CJEU ruled as follows:
(2) In a situation in which multiple products are protected by a basic patent in force, does Regulation [No 469/2009], and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?’
"In circumstances such as those in the main proceedings, where, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) ... must be interpreted as precluding that patent holder from obtaining – on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second supplementary protection certificate relating to that combination of active ingredients".On this basis, said that CJEU at 
"In view of the answer given to Question 2, to the effect that a second SPC, such as that at issue in the main proceedings, may not be granted to Sanofi for the irbesartan-hydrochlorothiazide combination, irrespective of whether that combination was protected as such by the basic patent within the meaning of Article 3(a) ..., there is no need to answer Question 1".In its review of Question 2 the CJEU said, at  to 934]:
"31 The SPC is designed simply to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of his patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted ...
32 In the main proceedings, Sanofi’s patent, which protects the active ingredient irbesartan as such within the meaning of Article 3(a) ..., has already enabled its holder to obtain an SPC relating to that active ingredient. Moreover, it is common ground that hydrochlorothiazide, an active ingredient that is a member of a class of diuretics, is not protected as such by that patent or indeed by any other patent.
33 In accordance with Article 5 ..., an SPC granted in connection with a product confers, upon the expiry of the basic patent, the same rights as were conferred by that patent in relation to the product, within the limits of the protection conferred by the basic patent, as provided for in Article 4 ... Accordingly, if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, the use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of that certificate ...
34 Thus, in the main proceedings, since it is common ground that, during the period in which the first SPC was valid, Sanofi was entitled to oppose, on the basis of its basic patent, the use or certain uses of irbesartan in the form of a medicinal product consisting of such a product or containing it, the SPC (now expired) granted for that product also conferred on Sanofi the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of that certificate".