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
Tuesday, 14 April 2015
The date of this seminar is 21 October 2015 and it takes place in the lovely city of Munich (don't worry if you are travelling: Munich's famous Oktoberfest takes place in September). More information is available from the event organisers here. Readers of The SPC Blog are entitled to a 10% discount against the registration fee (€ 981 down from € 1,090).
To register and gain the benefit of your reduced fee (valid only for registrations until 18 September 2015), just forward this blogpost to Jean-Claude Ho here, or call him, quoting "The SPC Blog" (+49 6211 500-675).
Thursday, 9 April 2015
To refresh readers' memories, the questions referred to the court for its advice were as follows:
"1. Concerning Article 2 of the SPC Regulation, has a product been placed on the market as a medicinal product in the EEA before it has been granted marketing authorisation in accordance with the procedure for administrative authorisation laid down in Directive 81/851/EEC (or Directive 2001/82/EC) when delivery of the product has taken place in accordance with
This morning the court gave its view:(i) “special approval exemptions” granted by the State Medicines Agency to veterinarians and fish health biologists pursuant to Section 3-6 or 3-7 of the Norwegian Regulation of 22 December 1999, alternatively Sections 2-6 or 2-7 of the Norwegian Regulation of 18 December 2009, or2. If question 1 is answered in the affirmative, is such a product outside the scope of the SPC Regulation and is an SPC granted on the basis of such a product therefore invalid?
(ii) what are known as “AR 16 licences” granted by the Irish Department of Agriculture, Food and the Marine pursuant to the Irish Statutory Instrument No 144/2007 European Communities (Animal Remedies) Regulations 2007 part III “Exceptional authorisation”, point 16?
3. Concerning the interpretation of Article 2 of the SPC Regulation, should a marketing authorisation granted for a veterinary medicinal product pursuant to Article 26(3) of Directive 2001/82 be deemed to constitute an administrative authorisation pursuant to Directive 81/851 (or Directive 2001/82) within the meaning of Article 2?
(a) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12- 22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b)?5. When the medicinal product is a virus vaccine, can the scope of protection under the SPC cover not only the specific strain of the virus that is included in the medicinal product and covered by the basic patent, but also other strains of the virus that are covered by the basic patent?
(b) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12- 22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute a first authorisation to place the product on the market as a medicinal product in Norway within the meaning of Article 3(d)?
In answering this question, is it of significance whether
(a) such other strains have an equivalent therapeutic effect to the virus strain included in the medicinal product or whether the therapeutic effect is not immediately equivalent?6. If an SPC has been granted with a product definition that is not strictly limited to the specific strain of the virus authorised to be placed on the market as a medicinal product,
(b) a medicinal product based on such other strain will have to be the subject of a separate marketing authorisation with requirements for documentation of safety and effect?
(a) will such an SPC be valid, or
(b) will the SPC be valid; such, however, that the scope of protection pursuant to Article 4 does not extend beyond the specific virus strain authorised to be placed on the market as a medicinal product? "
"1. Under Regulation (EEC) No 1768/92, a supplementary protection certificate for a veterinary medicinal product may be granted in an EEA State on the basis of a marketing authorisation granted in that State pursuant to the administrative authorisation procedure set out in Title III of Directive 2001/82/EC, including the procedure for authorisation in exceptional circumstances under Article 26(3) of that directive. Such a marketing authorisation constitutes a valid authorisation and, where appropriate, may also constitute the first authorisation to place the product on the market as a veterinary medicinal product within the meaning of Article 3(b) and (d) of Regulation (EEC) No 1768/92.
Permissions granted on the basis of the first paragraph of Article 8 of Directive 2001/82/EC do not constitute a marketing authorisation within the meaning of Regulation (EEC) No 1768/92. That derogating provision strictly limits the use of the measures permitted under it, stating that it applies only in the event of serious epizootic diseases, in the absence of suitable medicinal products and after informing the EFTA Surveillance Authority of the detailed conditions of use.
The determination of whether “special approval exemptions” or “AR 16 licences”, granted respectively by Norwegian and Irish authorities between 2003 and 2011, and the provisional marketing authorisation granted in the United Kingdom in 2005 were issued pursuant to national provisions implementing the first paragraph of Article 8 or Article 26(3) of Directive 2001/82/EC depends essentially on the assessment of the facts in the national proceedings, which is a matter for the national court.
2. Pursuant to Article 4 of Regulation (EEC) No 1768/92, the scope of protection conferred by a supplementary protection certificate extends to a specific strain of a virus covered by the basic patent, but not referred to in the marketing authorisation for a virus vaccine relied on for the purposes of Article 3(b) of Regulation (EEC) No 1768/92, only if the specific strain constitutes the same active ingredient as the authorised medicinal product and has therapeutic effects falling within the therapeutic indications for which the marketing authorisation was granted. It is not relevant whether a medicinal product based on such other strain would require a separate marketing authorisation. The appreciation of such elements is a matter of fact which is to be determined by the national court.
A supplementary protection certificate is invalid to the extent it is granted a wider scope than that set out in the relevant marketing authorisation."
Thursday, 2 April 2015
AIPPI Event Report: “What’s the CJEU said this time? A review of the latest SPC musings from Luxembourg”Monday night saw AIPPI’s latest event on recent SPC judgments from the CJEU, hosted by Carpmaels & Ransford LLP. Justin Watts (AIPPI President, Freshfields) chaired the event, with insightful and topical presentations by Mike Lubienski (UCB) and Daniel Wise & Ed Oates (Carpmaels), focusing on Actavis v Boehringer (C-577/13) and Forsgren (C-631/13). Over 70 SPC enthusiasts from across the industry attended the event, which concluded with a drinks reception providing the opportunity for a chat with the speakers and other attendees.Actavis v Boehringer (noted on The SPC Blog here and on the IPKat here) was discussed against the backdrop of the earlier cases in Medeva (C-322/10), Actavis v Sanofi (C-443-12) and Georgetown II (C-484/12). In Actavis v Boehringer, an earlier SPC had been obtained for a ‘mono’ product (telmisartan), and the SPC applicant sought a second SPC based on the same patent but a later marketing authorisation to a combination product (telmisartan and hydrochlorothiazide). According to the CJEU, the parties had agreed that telmisartan “is the sole subject-matter of the invention”, and it followed that the claim to the combination was not the subject-matter of the invention. Based on this logic, the CJEU held that the combination SPC was invalid. It was discussed at the event which test should be used for determining the “subject-matter of the invention”. Must each substance in the combination product (e.g. hydrochlorothiazide), when taken in isolation, constitute the “subject-matter of the invention”, or can the combination itself be the “subject-matter of the invention” if it is inventive in its own right? Unfortunately for patent practitioners, the CJEU never considered the second question, which asked whether it is allowable to base an SPC on a basic patent that has been amended after grant. This question is relevant in view of European oppositionamendment practice, as well as recent CJEU case law suggesting that active ingredients must be adequately specified in the claims. We should therefore expect questions on this point being referred to the CJEU in the future.Forsgren (noted on The SPC Blog here and on the IPKat here) dealt with combinations of a different kind, namely where substances are present in a medicinal product not side by side but covalently linked to each other. According to the CJEU, an active ingredient (here,protein D) can indeed be the subject of a SPC even where it is covalently linked to another substance (here, pneumococcal saccharides), but the active ingredient must produce an effect “of its own”, and that effect must be “covered” by the therapeutic indications of the marketing authorisation. The potential practical implications of this judgment were discussed, as well as the many questions that it opens up. What happens if the marketing authorisation is varied to include new indications? And how does the decision align with the Plant Protection Regulation and the definition of an “active substance” in the recent Bayer CropScience case (C-11/13, noted on The SPC Blog here)?In summary, this was a stimulating meeting of practical relevance for those interested in SPCs. Being the third of its kind, these rapid response SPC meetings are always well attended and have become a bit of speciality for the AIPPI UK group.
Friday, 27 March 2015
Thursday, 26 March 2015
Wednesday, 25 March 2015
This blogger believes that FORUM Institut and Management Forum were once related, but wonders whether it is time for their branding to diverge a little ...
Tuesday, 24 March 2015
The EMA’s reliance upon the Notification Date for calculating periods (data exclusivity and orphan market exclusivity) running from the date of a MA is confirmed in the answer to question 12 in “EMA Procedural advice for users of the centralised procedure for generic/hybrid applications” (see this link).Thanks, Mike!
The EMA’s practice on this point was the basis of one of the arguments in my article from October 2011. The legal basis for that practice is Article 297(2) of the Treaty on the Functioning of the EU, which is a point noted in my article from October 2014.
The FDA does not appear to be inclined to follow the ruling in Depomed (see this link), and so it will be very interesting to see what Teva does in respect of the ruling in T140/12 – and whether the CJEU will eventually get to rule on this aspect of orphan marketing exclusivities.
Monday, 23 March 2015
Case T-140/12, a General Court of the European Union ruling in Teva v European Medicines Agency (EMA). In short, Teva sought an order to annul the EMA’s refusal to grant its application for marketing authorisation (MA) for imatinib Ratiopharm, a generic version of (Novartis's) orphan drug product imatinib (trade name Glivec), in so far as it concerned therapeutic indications for the treatment of chronic myeloid leukaemia (CML).
The matter is essentially about orphan drug exclusivity and the interpretation of Regulation 141/2000 on orphan medicinal products. There is, however, a parapraph in the decision that should be of interest for the readers of this blog. Paragraph 12 mentions that
“Pursuant to Article 8 of Regulation No 141/2000, the period of market exclusivity enjoyed by the medicinal product imatinib, marketed under the commercial name Glivec, in so far as concerns the CML therapeutic indications — the original marketing authorisation for which took effect on 12 November 2001 — expired on 12 November 2011”.It turns out that 12 November 2001 is the date of notification of the MA (the grant date being 7 November 2001). This suggests that the determination of periods of Regulatory Exclusivity for centrally approved products could be affected by the “grant date v notification date” debate, and further suggests (if the decision is transposed to SPC cases) that, for centrally approved products, the date of notification of the MA is de facto the date referred to in §1 of Article 13 of SPC Regulation 469/2009, as already argued at length by Mike Snodin (see e.g. the post on this blog of 30 October 2014).
Let’s hope that the judges in Seattle Genetics (on which see earlier posts here and here) will share this view!
Friday, 20 March 2015
To register and gain the benefit of your reduced fee (valid only for registrations until 8 April 2015), just forward this blogpost to Jean-Claude himself at firstname.lastname@example.org, or call him, quoting "The SPC Blog" (+49 6211 500-675) and specifying which event(s) you would like to attend.
1. 'Supplementary Protection Certificates', the sixth edition of FORUM's English SPC seminar with Dr Christopher Brückner, the author of the SPC commentary (participants will receive the latest edition on top of course documentation). Date: 7 and 8 May 2015; venue: Frankfurt. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,200 instead of € 1,340).
The Frankfurt coat of arms
2. 'SPC for Beginners', the fourth edition of FORUM'S basic SPC seminar in English, once again with Dr Christopher Brückner. Date: 6 May 2015; Venue: Frankfurt. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 880 down from € 980).
This blog is always pleased to learn of events for which discounts are available for its readers.
Friday, 13 March 2015
 EWCA Civ 966 [on which see The SPC Blog post here and note by Sebastian Moore and Jonathan Turnbull here], on the basis that, in that case, while the requirements for an extension had not been met at the date of application, they had still been met before the date of expiry of the related SPC and it was the case that matters in relation to the extension of an SPC had to be decided before that SPC expired. This was so even if the decision was taken on the last day of the SPC's existence because, once the SPC expired, others were entitled to enter the market and the interest of third parties (i.e. generic pharmaceutical companies) had to be taken into account.
In Dr Cullen's own words:
"55 I accept that the applicant has to carry out the studies in the paediatric population first and get approval from the EMEA. This involves a commitment of time and resources up front. I accept that if the applicant carries out the necessary steps, then they should be entitled to the reward without taking too restrictive a view of how and when the applicant meets the requirements to qualify for an extension to the SPC.An applicant for a paediatric extension has 28 days in which to appeal.
56 However, I do not take this to mean that this should extend beyond the expiry date of the SPC. I think that it is reasonable to expect that matters in relation to an extension to an SPC are decided before the SPC expires, even if this decision is taken on the last day of the SPCs existence! Once the SPC expires, others are entitled to enter the market. Because of this, I think that, after the expiry date of the SPC, one must take account of the interest of third parties. Knowing when the SPC will expire is important for the entry of third parties, such as generic medicine companies, into the market because once the SPC expires; they are free to bring their own versions of the medicines comprising this active ingredient to market. If an application for an extension to a granted SPC was still considered to be capable of rectification after the expiry date of the SPC and the grant of an extension could be back-dated, this would, in my view, introduce uncertainty and, even, the potential for abuse. It would not be clear in such a situation when the paediatric studies would have to be completed by and when the updated MA would be available. There needs to be some clarity as to when matters are complete and others can enter the market. This seems to me to represent an appropriate balance, as referred to in recital 10 of the SPC regulation, to take account of all the interests at stake “in a sector as sensitive and complex as pharmaceuticals” while also making sure that research into paediatric uses of medicines is given the necessary incentive".