The SPC blog
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
Monday, 1 August 2016
(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?
(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?
This case arose because Merck Sharp & Dohme filed an SPC application one day before patent expiry but only had the "End of Procedure Communication" but not a marketing authorisation.
Tuesday, 5 July 2016
As SPCs are granted in the UK under an EU regulation, which will no longer apply after Brexit, in the future it will be necessary for the UK to enact legislation to create some form of equivalent protection. Presumably this will not be at the top of the list of priorities for our new PM, and possibly we will adopt the current EU legislation into UK law, but without appeal to the CJEU for obvious reasons. The possibility remains that any new protection could be of a different scope, but this seems an unlikely outcome given that there will apparently be some other things to do as well. After Brexit the UK courts will not be bound by the existing CJEU decisions, or be able to refer questions on SPCs to the CJEU, and we may have divergent opinions on similar legal issues between the UK and EU as we move forward. Given the view of some of the UK judges on the opinions of the CJEU, this could be rather interesting.
There will also need to be a new mechanism for extending the SPC term after appropriate paediatric studies, assuming the UK looks to maintain equivalent protection with the rest of the EU.
SPCs already granted by the UKIPO should be unaffected, but could potentially have a different validity if the law that applies to them is interpreted differently by a court free from the constraints of CJEU decisions.
Finally, this will all have to be subject to any new or transitional approval regime, given that the EMA may cease to have any jurisdiction in the UK.
All in all, Brexit has placed the UK in a position that arguably is more complex than SPC case law….and that's saying something.
Rob and Catherine
Thursday, 30 June 2016
Saturday, 18 June 2016
The study's purpose is stated as follows:
The contracted study shall evaluate whether a new European SPC title, with the current or broader scope within the field of pharmaceutical and plant protection products, with improved provisions, is required to meet the requirements of current and expected innovative market developments in the EU.Details of the tender can be found here.
With this primary purpose, the study shall evaluate the current SPC framework in terms of its legal efficiency in meeting its stated objectives given the development of directly affected and related product markets.
It shall also suggest whether the existing SPC rules need to be recalibrated given identified limitations.
The results could serve as a basis for an impact assessment for a future proposal by the Commission to recalibrate the existing EU SPC rules.
Wednesday, 6 April 2016
The Israel PTO recently accepted that for the purpose of calculating the duration of IL PTEs the EMA MA notification date shall be taken into account. This development changes the practice of the IL PTO and comes only a few months after the IL Patents Commissioner held that the EMA MA grant date should be used.Many thanks to Liad for sharing the news with us!
The Israeli PTE system is unique and is based on a series of linkages to the expiry dates and extension periods of the US PTE and SPCs granted in any of the EU-5 countries (United Kingdom, Italy, France, Spain and Germany). In addition, the Israeli PTE must end no later than 14 years from the earliest date in which a regulatory approval was obtained in either the Unites States or the EU-5 countries.
In the matter of IL PTE petition for Apixaban (Eliquis®) published on September 16th, 2015, the IL Patents Commissioner held that for the purpose of calculating the duration of IL PTEs the EMA MA grant date rather than the EMA MA notification date will be used. As a consequence, the PTE for Apixaban (Eliquis®) will expire in Israel two days earlier than would have been the case if the EMA MA notification date started the 14 year count. The IL Commissioner justified his decision by referring to the lack of uniformity between different European Patent Offices on this issue (i.e., whether the EMA grant date or the EMA notification date should be used to calculate the duration of SPCs under Article 13 of Regulation No 469/2009). However, the IL Commissioner was not apprised of the opinion of the ECJ advocate general (AG) in Seattle Genetics which was published prior to the decision in the Apixaban case. If the IL Commissioner had been apprised of the opinion of the AG, the Commissioner would have likely reached a different result.
In any event, after the CJEU published its binding decision in Seattle Genetics (case C-471/14) on October 6th, 2015, it was only a matter of time until the IL PTO would be called to reevaluate its position. In the matter of IL PTE petition for secukinumab (Cosentyx®), the IL PTO examiner initially calculated the IL PTE period based on the EMA grant date which was 4 days earlier than the notification date. The patentee argued that once the CJEU issued a final decision, which is applicable in all of the EU-5 Countries (among others), holding that the calculation of the duration of supplementary protection should be based on the EMA MA notification date – the IL PTO is bound to follow the CJEU determination. The IL PTO reevaluated its position and decided to follow the CJEU ruling, effectively canceling the IL Commissioner’ decision in the matter of IL PTE petition for Apixaban (Eliquis®).
Friday, 1 April 2016
On January 21, 2016 the Higher Regional Court of Vienna, Austria, issued a decision (34 R 104/15) on the interpretation of Art. 3(b) of Regulation 469/2009 in the light of the Neurim judgment of the CJEU (case C-130/11). In the case underlying the appeal to the Higher Regional Court of Vienna, the Austrian Patent Office had rejected an SPC application that was based on a second medical use patent (EP 0 758 900) and a Type II variation of an existing (national) marketing authorization for Botox due to which the indication protected by the selected basic patent, i.e. treatment of chronic migraine, was added to the already approved indications of Botox. The Examiner had calculated the 6-month time limit for filing the SPC application according to Art. 7(1) of Regulation 469/2009 from the date of the very first marketing authorization for Botox in Austria. In his view, the amendment by a Type II variation of a marketing authorization does not newly trigger the 6-month time limit for applying for an SPC.Many thanks to Bianca-Lucia and Klemens for sharing this decision!
However, following the considerations of the European Court of Justice in the Neurim decision C-130/11, the Higher Regional Court of Vienna ruled that a marketing authorization as amended by a Type II variation can be considered as a valid marketing authorization in the sense of Art. 3(b) of Regulation 469/2009. The Court also emphasized that patent protection and marketing authorization must harmonize in terms of content, and that earlier authorizations do not deprive the more recent authorization of a patented use from being the “first authorization” pursuant to Art. 3(d) of Regulation 469/2009, if the earlier authorization refers to areas not protected by the basic patent.
Accordingly, the Court also held that an earlier authorization granted for a use outside the scope of protection of the patent has no negative effect in so far as it does not trigger the 6-month time limit pursuant to Art. 7(1) of Regulation 469/2009. Therefore, the contested decision had to be reversed, and the Patent Office ordered to render a decision on the merits as to whether the application had been filed in due time.
Applying the principles set forth by the CJEU in Neurim, the Higher Regional Court Vienna hence confirmed that an SPC application may be filed on the basis of a Type II variation of an existing marketing authorization as “valid authorization to place the product on the market” according Art. 3(b) and “first authorization” in the sense of Art. 3(d) of Regulation 469/2009.
Friday, 18 March 2016
'Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the second edition on top of course documentation), will speak on the CJEU's referrals from 2011 to 2016 and on how to understand the decisions and which practical consequences we may expect for the future. Date: 31 May 2016; venue: Basel.
More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (CHF 1,160 down from CHF 1,290).
To register and gain benefit of your reduced fee, just forward this blogpost to Jean-Claude himself at email@example.com, or call him, quoting "The SPC Blog" (+49 6211 500-675).
Friday, 11 March 2016
"The German Federal Patent Court (BPatG) has handed down recently the decision for the SPC case Leibniz-Institut für Neue Materialien gemeinnützige GmbH (14 W (pat) 45/12). This decision of December 8, 2015 concerns the application of Regulation 469/2009 to medical devices.
In Short: The BPatG emphasised that an SPC is not granted for a medicinal product as such (or as in the present case: for a medical device), but only for an active ingredient or for a combination of active ingredients, respectively, of a medicinal product. The term "active ingredient" means that the product exerts a pharmacological, immunological or metabolic action of its own. Moreover, currently, the BPatG does not seem to grant SPCs for medical devices based on Regulation 469/2009 at all.
The Case: The Leibniz-Institut für Neue Materialien gemeinnützige GmbH ("Leibniz") filed an SPC application in Germany for the medical device product "aminosilane-coated iron oxide nanoparticles" based on EC Design Examination Certificate no. 11870GB411100614 granted under the Medical Device Directive (MDD) 93/42/EEC. Aminosilane-coated iron oxide nanoparticles are used for the local treatment of solid brain tumours. The method is based on the principle of introducing the magnetic nanoparticles directly into a tumour and then heating them in an alternating magnetic field. As a result of the treatment, tumour cells are either irreparably damaged or sensitized for additional therapies. The therapeutic effect is achieved by physical means.
The German Patent and Trademark Office (GPTO) rejected the SPC application essentially on the grounds that the product is not a medicinal product but a medical device and that the EC Design Examination Certificate which is governed by MDD 93/42/EEC is allegedly not a valid marketing authorisation under Article 3(b) of Regulation 469/2009. The GPTO excluded also application of Regulation 469/2009 to medical devices by analogy. In the UK, the corresponding SPC application was rejected for similar reasons. The Hearing Officer held that a product, which had not been subject to an administrative authorisation procedure, is excluded by Article 2 of Regulation 469/2009 (see post dated 8 August 2014).
In Germany, Leibniz appealed against the rejection decision and argued inter alia that, on one hand, the product is a medical device according to Article 1(2)(a) of MDD 93/42/EEC owing to its physical effect, on the other hand, the product is a medicinal product according to Article 1(a) of Regulation 469/2009, since the product is administered in view to restoring or improving physiological functions in humans. The appellant pointed out that according to Regulation 469/2009, the term "active ingredient" is not limited to products having a pharmacological, immunological or metabolic action.
Grounds for the BPatG’s Decision: The BPatG did not share Leibniz’s view. It held that it must be assessed first, if the scope of Regulation 469/2009 is opened. The BPatG mentioned that according to Article 2, application of Regulation 469/2009 requires inter alia that the "aminosilane-coated iron oxide nanoparticles" constitute a product in terms of Article 1(b) of Regulation 469/2009. The BPatG admitted that the term "active ingredient" is not defined in the Regulation. Therefore, the Court reviewed relevant CJEU case law including the recent decision Forsgren, C-631/13 of 15 January 2015, concerning the interpretation of Article 1(b) of Regulation 469/2009 with respect to an active ingredient that is covalently bound to other active ingredients forming part of a medicinal product. The BPatG is of the opinion that in Forsgren, the CJEU has finally clarified that only substances producing a pharmacological, immunological or metabolic action of their own are active ingredients in terms of Regulation 469/2009 (cf. CJEU, Forsgren, C-631/13 of 15 January 2015, paragraph 25).
As outlined above, the therapeutic effect of the product "aminosilane-coated iron oxide nanoparticles" is achieved by physical means. Thus, under consideration of Forsgren, the BPatG concluded that aminosilane-coated iron oxide nanoparticles are not a product according to Article 1(b) of Regulation 469/2009, since said nanoparticles are not substances producing a pharmacological, immunological or metabolic action of their own. As a result, the BPatG decided that in the present case, already for this reason the scope of Regulation 469/2009 is not opened. Consequently, any remaining questions were not assessed and the appeal was rejected.
It is important to note that ground 6 of the decision seems to reflect the current position of the BPatG concerning the grant of SPCs for medical devices based on Regulation 469/2009. The BPatG indicates that, in principal, section 16a paragraph 1 of the German Patent Act includes the option of extending the type of products for which an SPC may be granted by additional regulations. The Court acknowledges that the effective patent protection for medical devices is insufficient for recovering the investment put into research owing to the necessary preclinical and clinical studies and the authorisation procedure. Both aspects led to the introduction of SPCs for medicinal products for human use and for veterinary medicinal products. However, the Court points out that only the legislators are competent to create a similar regulation for medical devices. In contrast, the Courts are barred from extending supplementary protection to medical devices. Thus, at present, at least the 14th division of the BPatG does not seem to be willing to grant SPCs for medical devices based on Regulation 469/2009."
Many thanks to Ulrike and Raphael for sharing this decision!