"A Supplementary protection certificate search makes it possible to search through applications for supplementary protection certificate as well as granted SPC’s and extension of SPCs".
‘(1) Is the date, referred to in Article 19(2) of Regulation No 1768/92, upon which that regulation enters into force to be understood for [the Republic of] Lithuania as the date of its accession to the European Union?Today the Court ruled as follows:
(2) Should the answer to the first question be in the affirmative, what is the relationship between Article 19 and Article 7 of Regulation No 1768/92 when calculating the six-month period and which of those articles is it necessary to apply in a case?
(3) Did an authorisation to place a product on the market in the European Community enter into force unconditionally in the Republic of Lithuania from the date of its accession to the European Union?
(4) Should the answer to the third question be in the affirmative, can the entry into force of the authorisation to place the product on the market be equated to its grant for the purposes of Article 3(b) of Regulation No 1768/92?’
"Articles 7 and 19a(e) of Council Regulation ... 1768/92 ..., as amended by the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic ..., must be interpreted as not allowing the holder of a valid basic patent in respect of a product to apply to the competent Lithuanian authorities, within six months of the date upon which the Republic of Lithuania acceded to the European Union, for the grant of a supplementary protection certificate where an authorisation to place that product on the market as a medicinal product was obtained more than six months before accession under Council Regulation ... 2309/93 ... laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, but the product did not obtain a marketing authorisation in Lithuania".In its analysis of the legal position, the Court justified its position in the following terms:
"45 As regards the objective pursued by Regulation No 1768/92, it is admittedly true that the regulation establishes a uniform solution at European Union level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State and by providing, in particular, for a uniform duration of protection (see, by analogy, Case C-350/92 Spain v Council [1995] ECR I-1985, paragraph 34, and Hässle, paragraph 37). As is apparent from the sixth recital in its preamble, that regulation seeks thereby to prevent the heterogeneous development of national laws leading to disparities 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.
46 Nevertheless, certain Member States wished, in accordance with the 10th recital in the preamble to that regulation, to safeguard for a longer period the achievement of other legitimate objectives, concerning their public-health policies, and, in particular, ensure the financial stability of their health system by supporting the generic medicinal product manufacturing industry (see, to this effect, Hässle, paragraph 38).
47 In order to take account of those differences in assessment, Articles 19 and 19a of Regulation No 1768/92 contain different relevant dates as a transitional measure. The setting of those dates according to the Member State thus appears to be justified inasmuch as each of them shows the assessment made by each Member State in the light, in particular, of its health system, the organisation and financing of which vary from one Member State to the next (see, by analogy, Hässle, paragraphs 39 and 40).
48 It follows from the foregoing that the objective pursued by Regulation No 1768/92 of according uniform protection for a medicinal product throughout the European Union does not preclude transitional provisions, resulting from the accession negotiations, which may mean that it is not possible to apply for an SPC for certain medicinal products in certain Member States. This outcome, which may impede, even if only temporarily, that objective and the functioning of the internal market, is justified by the legitimate objectives concerning health policies, including, as the case may be, the financial stability of the health systems of the Member States (see, to this effect, Hässle, paragraph 46).
49 In the circumstances of the main proceedings, it would run counter to the outcome of the negotiations which led to the accession of the Republic of Lithuania to the European Union to accept that a holder of a Community marketing authorisation such as the holder in the main proceedings can rely on Article 7 of Regulation No 1768/92 to obtain an SPC in Lithuania. Article 19a(e) of that regulation provides for the possibility of applying to the competent Lithuanian authorities for grant of such an SPC only on the basis of a first marketing authorisation obtained in Lithuania before the accession of that State. As has been stated in paragraph 33 of the present judgment, that provision does not lay down any derogation concerning products which have been the subject of a Community marketing authorisation.
50 Furthermore, if the entry into force of a Community marketing authorisation in a new Member State could be equated to its grant there, every Community marketing authorisation would confer entitlement to the grant of an SPC if it were applied for within six months of the accession of such a Member State to the European Union, even if the date of grant of that marketing authorisation were prior to the dates for the obtaining of an authorisation that are referred to in the transitional provisions of Regulation No 1768/92. This would also run counter to the outcome of the accession negotiations.
51 To give an example concerning another Member State, it would be possible, if the grant of a marketing authorisation were equated to its entry into force, for the holder of a Community marketing authorisation obtained before 1 May 2004 to apply in the Czech Republic for an SPC until 30 November 2004, although Article 19a(a)(ii) of Regulation No 1768/92 provides for the lodging of such an application, so far as concerns that Member State, only within six months of the date on which the first marketing authorisation was obtained.
52 Consequently, the wording and the context of Articles 3(b), 7 and 19a(e) of Regulation No 1768/92 as well as the objective of the latter, and in particular the objective pursued by its transitional provisions, preclude the entry into force of the Community marketing authorisation from being equated to its grant within the meaning of Article 3(b)".
This coming Thursday, 2 September, sees the handing down by the Court of Justice of the European Union of its ruling in Case C-66/09 Kirin Amgen. This is a reference for a preliminary ruling from Lithuania, noted by The SPC Blog when the Advocate General's Opinion was published here. The underlying dispute relates to the effective date of the Lithuanian marketing authorisation for Aranesp.
On 25 June The SPC Blog reported on the questions that the Court of Appeal (England & Wales) has referred to the Court of Justice of the European Union for a preliminary ruling in Case C-322/10 Medeva v Comptroller General of Patents. For the record, this case deals with SPCs for multi-component vaccines against multiple diseases and seeks a determination as to whether the product is protected by the basic patent and therefore is subject of a valid marketing authorization"On Article 3(a)
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"?
On Article 3(b)
6. Does the SPC 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 SPC 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?".
"Listed on your Resources website is a pretty interesting Swedish case, AB Hässle, which is cited in the UK Takeda case and provides the same reasoning with regard to the question of whether a combination product is covered by a basic patent relating to only one of the components. The question of course is highly interesting in light of the Medeva ECJ referral.The SPC Blog thanks Niklas very much for his thoughtfulness and hopes that other readers, when the opportunity arises, will be able to promote knowledge and understanding in our field of interest in the same way.
In connection with some casework relating to the same issue some years ago, I had occasion to prepare an informal, translation of the Swedish decision into English. If you would like to post it to the Resources web site, you’re more than welcome to use it, in the interest of “promoting the dissemination of legal information".
Martin Paltnoi (MPA Research) has contacted me and has told me all about his company's newInteractive Online Report & Search Services. He adds "We would be happy to provide our services at a generous discount if contacted through the SPC Blog".These services include (i) European Drug Patent Status Review, which covers major product/preparation patent information plus allied supplementary protection certificates for all products on the market in 27 European territories, (ii) EU 1st Marketing Authorisation, (iii) MPA SPC Watch, which identifies SPCs for all 27 member states in the EU, with additional information available for up to 39 countries and (iv) UK/ROI Veterinary Drug Patent Status Review, which covers major product/preparation patent information plus allied SPCs for all veterinary medicines on the market in the UK and the Republic of Ireland.
In "Patent firm blazes trail with new drugs app for the iPad", a short article in The Belfast Telegraph by Anne Madden, it is reported that Patentnav, based at the Northern Ireland Science Park, has created AtoZGenerics, which is said to be one of the first patent information applications for iPads."The AtoZ Generics app contains a lot of valuable information that can be difficult to find, and all for only 59p. It provides expiry dates on US patent term extension and UK Supplementary Protection certificate expiry dates, as well as approximate global drug sales."
The Irish Patents Office has announced that Ireland's Department of Enterprise, Trade and Innovation is conducting a review of the fees charged for Supplementary Protection Certificates. This seeks to engage with interested parties to seek their views on the proposal to review the current application and renewal fees for Supplementary Protection Certificates. Responses should be received by close of business on Friday 30th July 2010. The rationale for changing fees is as follows:"Fees for Supplementary Protection Certificates fall somewhat outside the rationale for keeping fees for intellectual property protection low, as the circumstances for granting SPCs are very different to those for granting patents. As a Supplementary Protection Certificate will provide patent protection to a pharmaceutical company up to a maximum of 25 years, a balance must be struck between paying a premium for
continued market monopoly and allowing for entry into the market for generic medicines.
By comparing current fees charged for Supplementary Protection in all Member States of the European Union, Ireland is currently the fourth least expensive country. In cost per head of population (per million) Ireland ranks as the tenth least expensive country of the EU 27, in line with countries with a population of approximately 10 million, namely Belgium, Sweden, Portugal and the Czech Republic. The preliminary fees for consultation as set out would bring Ireland closer in line with countries with similar population size such as Denmark, Finland and Slovakia".The proposed new fees and European averages are indicated in tabulated form here.
Giving judgment yesterday in the Patents Court (England and Wales) in Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat), Mr Justice Lewison dismissed Yeda's appeal against the Dr Lawrence Cullen's decision to refuse its application for two SPCs.* What constitutes a "product" must be strictly construed, looking at what it is, rather than what it does, and taking into account only its active ingredients.* The Commission's authorisation decision clearly identified the medicinal product, 'Erbitux – cetuximab' as its subject-matter -- no other medicinal product was identified. It alluded to irinotecan only in order to explain how cetuximab was used. This could not constitute a marketing authorisation of a product consisting of both cetuximab and irinotecan.
* Given the restrictive interpretation of the term "product", to incorporate the notion of secondary infringement into the SPC regime would be illegitimate. While this was not acte clair, it was in any event a matter for national rather than European law, so no reference would be made for a preliminary ruling from the Court of Justice of the European Union.
Case T-321/05 AstraZeneca v Commission, a complex decision delivered by the General Court of the European Union at the beginning of this month, is not only about SPCs as such -- it concerns the rectitude or otherwise of the Commission's assessment that AstraZeneca, the UK's second-largest pharma company, misled patent officials and flouted antitrust rules in order to keep generic competition at bay with regard to its Omeprazole product."361 ... the Commission applied Article 82 EC correctly in taking the view that the submission to the patent offices of objectively misleading representations by an undertaking in a dominant position which are of such a nature as to lead those offices to grant it SPCs to which it is not entitled or to which it is entitled for a shorter period, thus resulting in a restriction or elimination of competition, constituted an abuse of that position. The question whether those representations were objectively misleading must be assessed in the light of the specific circumstances and context of each individual case. ...".The SPC Blog may return to this decision again, if time and resources permit.
"366 ... the Court rejects the applicants’ argument that the existence of specific remedies which make it possible to rectify, or even annul, patents and SPCs granted unlawfully justifies application of the competition rules only where an anticompetitive effect is demonstrated. Where behaviour falls within the scope of the competition rules, those rules apply irrespective of whether that behaviour may also be caught by other rules, of national origin or otherwise, which pursue separate objectives. Similarly, the existence of remedies specific to the patent system is not capable of altering the conditions of application of the prohibitions laid down in competition law and, in particular, of requiring, in cases of behaviour such as that at issue in the present case, proof of the anticompetitive effects produced by such behaviour".
