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
Wednesday, 22 December 2010
This note has been published on the Advance Access service of the Journal of Intellectual Property Law & Practice (JIPLP), but has been made fully available to all on the jiplp weblog here.
Tuesday, 21 December 2010
|No time to cook the turkey and eat it if you're planning|
to comment to the UK IPO on Case C-518/10
The UK's Intellectual Property Office has just issued an email circular today, stating:
"If you would like to comment on this case please e-mail firstname.lastname@example.org before 6 January 2010 [presumably this should be 2011]".Given that the IPO must have known about this reference since October, and given that much of the UK is closed for business for most of the time between now and 6 January 2011, does anyone know why this invitation has been issued so late? If it's any consolation, the IPO routinely gives interested parties only a few days' notice of the deadline for commenting on references to the Court of Justice.
The deadline for the receipt of observations by the Court of Justice itself is believed to be 25 February 2011.
Monday, 6 December 2010
Under Article 3(a) of Regulation 469/2009
"A certificate shall be granted if, ...
(a) the product is protected by a basic patent in force".This was an application by Novartis, under the Civil Procedure Rules (CPR) r.19.2(2)(a), for an order that it be joined as a party to proceedings in which questions were to be referred to the Court of Justice of the Euroepan Union on the interpretation of Article 3(a) of Regulation 469/2009. Under r.19
""The court may order a person to be added as a new party if -What had happened here is that Daiichi had appealed against the Comptroller's decision to refuse to grant an SPC in relation to a combination of olmesartan medoxomil and hydrochlorothiazide (olmesartan medoxomil being one of a range of compounds disclosed in one of Daiichi's European patents, while the diuretic hydrochlorothiazide was used as an anti-hypertensive agent but was not one of the claimed agents). While Daiichi's SPC application was turned down as being non-compliant with Article 3(a), the court proposed to refer questions to the Court of Justice for a preliminary ruling on the interpretation of that article.
"(a) it is desirable to add the new party so that the court can resolve all the matters in dispute in the proceedings; or
"(b) there is an issue involving the new party and an existing party which is connected to the matters in dispute in the proceedings, and it is desirable to add the new party so that the court can resolve that issue".
What, then, was Novartis's interest? Teva was suing Novartis in Italy, Belgium and the Netherlands, alleging that Novarrtis's SPC for a combination of Valsartan and hydrochlorothiazide was invalid since the product in question was not protected by the basic patent -- thus also raising a question under Article 3(a). There were also proceedings in Belgium in which it was argued that a generic combination product could not infringe the SPC for Valsartan alone. According to Novartis, therefore, that any judgment on the reference which was to be made in Daiichi's case would be of direct relevance at least to some of the proceedings which it faced, and joining Novartis would bring "a new perspective" to these proceedings.
Mr Justice Floyd rejected the application, having concluded that it was not appropriate to join Novartis as a party since the requirements of CPR.19.2(2)(a) were not satisfied. It could not be said that, with the presence of the existing parties, the matters in dispute in the present proceedings could not be adequately and properly resolved and Novartis had failed to show that its involvement was needed in order to assist either the Patents Court or the Court of Justice to reach a conclusion.
The judge added that Novartis's interest was solely in the outcome of a question of law, on which submissions would be made both by Daiichi and by the Comptroller. Adding extra parties would not have any beneficial effect.
Monday, 29 November 2010
"Several provisions of the medicinal product SPC Regulation 1768/92 (codified as Regulation 469/2009) have been subject to interpretation and clarification by the ECJ. Because the initial administrative interpretation of a provision is undertaken by 27 national patent offices, it is not surprising that different national outcomes will result. Different outcomes may be confirmed at a national judicial level, unless a national court refers the issue to the ECJ.
Recital 14 of the plant protection product SPC Regulation 1610/96 has been subject to diverse national interpretation. This Recital also applies mutatis mutandis to the interpretation of several provisions of Regulation 469/2009. It concerns the issue of an SPC for a derivative of an active substance based on a second marketing authorisation issued for the derivative if an earlier authorisation exists for the active substance.
The article proposes the application of an existing regulatory approach to prevent disharmony within the EU. Notwithstanding the differences between EU and US law, recent US case law appears to support the appropriateness of the regulatory approach proposed in this article".
Wednesday, 24 November 2010
Tuesday, 23 November 2010
A qualified European Patent Attorney and Chartered UK Patent Attorney, James is a member of the Royal Society of Chemistry. His professional experience include drafting and prosecuting patent applications, managing and devising strategies for worldwide patent portfolios, due diligence exercises and obtaining non-patent IP protection for pharmaceutical products. He has also been involved in opposition and appeal work before the European Patent Office.
A member of the patent team at Olswang LLP, James is a graduate of the University of Glasgow and possesses a doctorate from Cambridge University. After obtaining post-doctoral experience at Columbia University, New York City, he worked as a medicinal chemist for a multi-national pharmaceutical company and is a named inventor on two patents derived from his research work.
We look forward to James's contributions to the blog.
Thursday, 11 November 2010
|Napoleonic Hussar: an early |
experiment in European unity?
Bayer owned a European patent covering, inter alia, a herbicide known as iodosulfuron. The application for this patent was filed on 12 February 1992; the patent issued on 11 November 1998 with an expiry date of 13 February 2012. On 13 December 1998, an application to have iodosulfuron included in Annex I to Directive 91/414 [concerning the placing of plant protection products on the market] was lodged with the German authorities by an undertaking the rights of which were subsequently acquired by Bayer. On 9 March 2000 the German authority issued a marketing authorisation to Bayer for a herbicide based on that substance, sold under the name ‘Husar’. This was a provisional MA, issued on the basis of a provision of national law designed to transpose Article 8(1) of Directive 91/414. In order to take account of Commission Decision 2003/370 [allowing Member States to extend provisional authorisations granted for the new active substances iodosulfuron-methyl-sodium, indoxacarb, S-metolachlor, Spodoptera exigua nuclear polyhedrosis virus, tepraloxydim and dimethenamid‑P], the expiry date of that provisional MA, initially fixed at 8 March 2003, was put back to 21 May 2005.
On 17 July 2003 the Bundespatentgericht granted Bayer an SPC for iodosulfuron and some of its salts and esters for the period between 13 February 2012, the expiry date of the European patent and 9 March 2015. In calculating the duration of the certificate, the Bundespatentgericht took the view that the provisional MA of 9 March 2000 was the first MA. On 25 September 2003 the Commission included iodosulfuron in Annex I to Directive 91/414 by means of Commission Directive 2003/84.
On 13 January 2005 the German authority issued a definitive MA to Bayer for Husar on the basis of the national provisions transposing Article 4 of Directive 91/414. Its expiry date was fixed at 31 December 2015.
|The word is spelled 'Husar' |
but an image search reveals
use of 'Hussar' only
Bayer challenged that interpretation of Article 3(1)(b), which it considered contrary to the general scheme of that regulation and to the practice of the competent national authorities. The Bundespatentgericht decided to stay proceedings and to refer the following question to the Court for a preliminary ruling:
‘For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must account be taken exclusively of [a MA] under Article 4 of Directive 91/414 … or can a certificate also be issued pursuant to [a MA] which has been granted on the basis of Article 8(1) of Directive 91/414 …?’Today the court ruled as follows:
"Article 3(1)(b) of Regulation ... 1610/96 ... must be interpreted as not precluding a supplementary protection certificate from being issued for a plant protection product in respect of which a valid marketing authorisation has been granted pursuant to Article 8(1) of Council Directive 91/414 ..., as amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005".Dutch speaking readers can note this decision on the excellent Boek9.nl blog here
Tuesday, 26 October 2010
Monday, 25 October 2010
By an order of 8 October 2010 (here) the Court of Appeal seeks further guidance relating to Article 3(a) of Regulation 469/2009. It seeks to ask, in particular:
"If the criteria for deciding whether a product is 'protected by a basic patent in force' under Article 3(a) ... 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 s.60(2) Patents Act 1077 in the UK, and the corresponding provisions in the laws of other Member States of the Community?"We've not yet had time to read the order in full (it runs to 17 pages) but will post further on this reference if it seems appropriate to do so.
Friday, 22 October 2010
"In the EU, the term of a national patent or a European patent for drug products is extended through the grant of a supplementary protection certificate. This is governed by Council Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.This piece features two useful figures, one being an example of a project lifecycle curve viewed from a cash flow perspective, the other being a graphic representation of the active ingredients/substances in the Medeva proceedings as they relate to the basic patent. marketing authorisations and SPC products.
Monday, 18 October 2010
|Let's all be pen-friends |
with the European Commission
The background is as follows: since the consolidated text of Regulation 469/2009 of 6 May 2009 concerning the creation of a supplementary protection certificate for medicinal products (codified version, replacing Council Regulation 1768/92 of 18 June 1992) still includes the now obsolete definition of "medicinal product" and requires amendment incorporating the new definition, Dr von Morzé wrote to the Commission as follows:
"The above-identified consolidated Regulation at least in the version available to me which was published in OJEU 16.6.2009 L152/1-L 152/10 requires revision of the definition of ‘medicinal product’ in Art. 1(a). The new definition of ‘medicinal product’ in Art. 1(2) of Directive 2001/83/EC as amended by Directive 2004/27/EC published 28.11.2004 in OJ L-311, pages 67-128 reads as follows:for the European Commission (DG Internal Market and Services), Oliver Vahhelyi has responded as follows:
‘2. Medicinal product:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’
As to the significance of the new definition please refer to Recital 7 of Directive 2004/27/EC.
Article 1(a) of Regulation (EC) No. 469/2004 still recites the previous, somewhat vague definition of ‘medicinal product’ which has been superseded by the new definition clarifying which actions exerted by the active substances of a medicinal product would be ‘restoring, correcting or modifying physiological functions’ (see the clause in bold above) .
The Hecht-Pharma GmbH judgment of the European Court of Justice C-140/07 of 15 January 2009 succinctly explains the significance of the expansion and the clarification achieved by the new definition:
‘33 As is apparent from recital 7 in the preamble thereto, the purpose of the amendments made by Directive 2004/27 to the definition of a medicinal product is to take account of the emergence of new therapies and of the growing number of so-called ‘borderline’ products. Also, in order to avoid doubts as to the applicable rules, the definition was made more precise and now specifies the type of action – pharmacological, immunological or metabolic – which a medicinal product must exert with a view to restoring, correcting or modifying human physiological functions.’
It must be assumed that the provisions of Regulation (EC) No. 469/2009/EC are set out to apply to all medicinal products within the ambit of the new definition. Regulatory concepts are not only key factors for administering and interpreting the Regulation but also must be incorporated in the codified Regulation in the version applicable as of the date of its codification to avoid uncertainty, improper limitations of its scope and unnecessary litigation.
I would be most grateful for your comments and would like to know which action would be taken to revise the definition".
"Regulation (EC) 469/2009 indeed still uses the definition of medicinal products of Directive (EC) 2001/83 prior to the amendments made in 2004 by Directive (EC) 2004/27 of 31 March 2004."When the most suitable opportunity arises" is anyone's guess. Readers' suggestions as to when we might see this amendment are welcomed.
We will consider introducing the definition of medicinal products of Directive (EC) 2001/83 as amended into Regulation (EC) 469/2009 when the most suitable opportunity arises to make such a technical adjustment.
I hope this information is useful to you".
Thursday, 14 October 2010
Wednesday, 13 October 2010
"... Despite the intent of Congress to compensate applicants for delays in prosecution in an industry-independent manner, applicants seeking reconsideration of a patent term adjustment in Federal District Court are highly-biased toward institutions seeking patents on pharmaceutical and related biotechnology inventions. Unlike patent term extensions, which are sought in a six-month period prior to regulatory approval and sale of a pharmaceutical product, and often long after a patent has issued claiming the product, court cases identifying patents needing longer PTAs provide early notice to the public, including investors and competitors, of technologies considered to have particular value to the applicant. ...".
Monday, 11 October 2010
Details of the conference programme will be available in due course.
Monday, 4 October 2010
You can read the current version of the SPC section here. A line in the left-hand margin highlights text which you won't find in the earlier January 2010 version.
Friday, 1 October 2010
Just in case you're not immune to issues around SPCs for HPV vaccines, here's the latest juicy case (BL O/335/10) that was decided before the UK Intellectual Property Office (IPO):
The University of Queensland and CSL Limited filed 8 SPC applications at the IPO: 6 different applications to single Human Papilloma Virus (HPV) L1 protein virus-like particles (VLPs) (2 applications for HPV 16, 2 applications for HPV 18, 1 application for HPV11 and 1 application for HPV6), 1 application for a product comprising HPV16 and HPV18 L1 protein LPV, and 1 application for a product comprising HPV6, HPV11, HPV16 and HPV18 L1 protein LPVs. The applications were based on basic patents EP 0595935, EP 1298211 and EP 1359156. The marketing authorisations for Cervarix and Gardasil/Silgard were used to support the applications.
The issues raised here are similar to those in the Medeva and Georgetown et al. cases and concern the interpretation of Articles 3(a) and 3(b) of the Regulation. The IPO therefore proposed to defer further consideration of the applications until the outcome of the references to the Court of Justice of the European Union (CJEU) in relation to the Medeva and Georgetown cases. The applicant however requested a decision to be issued based on the papers on file so that, if the IPO were to refuse the applications, the decision could be appealed and a further referral to the CJEU could be made and considered at the same time as the other HPV-related cases.
The hearing officer, Dr. L. Cullen, found that the 6 SPC applications directed to single HPV L1 protein VLPs did not meet the requirement of Article 3(b) of the Regulation because neither of the MAs cited was a valid authorisation to place any of the single HPV L1 protein VLP products on the market as a medicinal product. Each MA related to a combination of active ingredients rather than a single active ingredient.
Moreover, the HPV combination applications did not meet the requirement of Article 3(a) of the Regulation because the basic patents did not protect combination HPV L1 protein VLP products, but only related a method for preparing single HPV L1 protein VLPs, HPV L1 protein VLPs made by this method and vaccines prepared from HPV L1 protein VLPs made by this method. Nothing in the patents suggested that the single HPV products could be used in combination with each other.
The applications were rejected in accordance with Article 10(4) after the application was provided with an opportunity to correct the irregularities of the application.
The complete decision is available here.
Wednesday, 22 September 2010
The judge's decision has now been reported in full, together with a helpful headnote, in volume 127, issue 9, of the Reports of Patent, Design and Trade Mark Cases (RPC), published by Oxford University Press on behalf of the Intellectual Property Office.
Friday, 17 September 2010
The question referred is the same as question 6 in the Medeva vaccine reference (reported here) on Article 3(b).
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 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 authorisation that places the single active ingredient or combination of active ingredients on the market?
Thursday, 16 September 2010
"I want to know the I would like to know how to search the SPC details in Denmark and Switzerland. I have been trying for a long time but couldn't reach the right URL. Can you please help me in this regard?"If anyone has some helpful hints, can he or she please post them as a comment below this blogpost?
Wednesday, 15 September 2010
The database, which is updated every night, offers access to searchable full text for all patent documents, as well as bibliographic data, information about classification, status, fees and registration, and links to File Inspection. The website adds:
"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".
Thursday, 2 September 2010
What was this about? In short, Kirin Amgen owned a 1994 European patent for Aranesp, which was extended to Lithuania. In June 2001 Kirin Amgen obtained a Community marketing authorisation and then lodged an application for an SPC with the Lietuvos Respublikos valstybinis patentų biuras (the Lithuanian Patent Office), accompanying the application with its Community marketing authorisation. The SPC having been refused initially and on several appeals, Kirin Amgen maintained that the fact that it held a Community marketing authorisation was sufficient to obtain an SPC in Lithuania: it did not exceed the six-month period for lodging its application, because that period had to be calculated from 1 May 2004, the date upon which the Republic of Lithuania acceded to the European Union. The Lietuvos Aukščiausiasis Teismas (Supreme Court of Lithuania) stayed the proceedings before it and asked the Court of Justice for a preliminary ruling on the following questions:
‘(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  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)".