"The Court essentially (and quite logically) decided to await the outcome of the pending referral to the CJEU by the Mr Justice Floyd in the corresponding UK action (previously reported on the SPC Blog here and here). As to the basic patent invalidity claim raised by Synthon at the very last minute, the Court refers this issue to the general docket and leaves it up to the parties to arrange for a timetable to exchange submissions on the subject.I hope this is useful to you.
Nevertheless, there are a few interesting passages in the judgment.
In particular, the Commercial Court refers to the decision of the Brussels Court of Appeal in Almirall (see the SPC Blog here), a decision which was invoked by Synthon to argue that the duration of the memantine SPC should be 0 years under Article 13 of the SPC Regulation. Not only does the Court identify a series of factual circumstances which distinguish the current case from Almirall, but it also questions whether the reasoning of the Court of Appeal is in line with the Hässle and Pharmacia Italia judgments of the ECJ.
In addition, the Court opines that the ECJ’s Novartis judgment is of very little relevance in the current case given that this case concerned the interpretation of the EEA Agreement rather than the SPC Regulation".
"The European Regulation governing paediatric extension on medicinal products for paediatric use was covered by Regulation 1901/2006 of 12 December 2006, which finally came into force on 27 January 2007.Thanks, Martin!
I have noticed that an amendment to this covered by Regulation 469/2009 concerning the application of Paediatric Certificates may have gone through unnoticed by people who may be involved. Under the present system those conducting work allowing for an extension for paediatric use can file their application no later than six months prior to the expiry to the appropriate SPC. This newer Regulation alters that transitional period of which, we believe, those interested parties should be fully aware. Under Article 7 of the Regulation, Paragraph 4, the application for the duration of the Certificate for Paediatric Use for SPCs already granted shall not be lodged later than two years before the expiry of the SPC. Paragraph 5 of Article 7 indicates that this will come into effect five years from the entry into force of Regulation 1901/2006. So, from 27 January 2012 those companies wishing to make an application for an extension for paediatric use of an SPC will have to ensure that it is carried out not less than two years before the expiry of the SPC. In those instances where the duration of an SPC would be less than two years the application for that SPC and the extension for paediatric use would have to be carried out concurrently.
This is bound to cause some confusion but it would seem that those SPCs already granted prior to 27 January 2012 will still be bound by the six month period. It will be interesting to see the effect of this change and the significance to those interested parties".
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| The SPC Blog's trained trackers will do their best to hunt down missing decisions! |
"I read your post [here] dated Monday, 6 December 2010 relating to the decision EWHC 2898 (Pat) of 5 November 2010. Now, when reading the full text of this decision I noticed the following sentence "This is an application by Novartis AG to be joined as a party into the appeal brought by Daiichi and in respect of which I have given a judgment earlier this afternoon". The 6 December 2010 post says among other things "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." I was unable to find this decision on the BAILII website.
Do you know where and how I can catch the decision dealing with the appeal by Daiichi?"A little bit of digging has revealed the decision, which is still not on BAILII -- but we've uploaded it here. Thanks, Michèle, for spotting that we still hadn't picked it up!
"In continuation of the hearing held on 15 September 2010, the Danish Maritime and Commercial Court held a deliberation on the merits of the case and, on that basis, requested the Parties to enter into the following Agreement, it being understood that the Danish Maritime and Commercial Court will close its file on receiving information that the Agreement be concluded between the Parties:
(1) Teva Denmark A/S and all companies in the Teva-Group commit themselves to Novartis AG and to all companies in the Novartis-Group, not to produce, import or export, market, bring into circulation or in any way, whatsoever, use medicals containing Valsartan, alone or in combination with one or more other active ingredients, until the time where the Plaintiff’s SPC has expired, and in so far and for such time as this SPC is valid, including any period for which its validity may be extended on the basis of the Plaintiff’s application of 13 September 2010 or any other application for extension that the Plaintiff might make at any later stage.
(2) Teva must no later than on 6th October 2010 pay to Novartis the costs of the case with 450,000 DKK. In the case of delayed payment, interest must be paid in accordance with Article 8 of the Danish Act on interests on delayed payments.
(3) This Agreement enters into force immediately and is enforceable in accordance with the provisions of Article 478, Section 1, Number 2, of the Danish of Administration of Justice Act, so that it is immediately enforceable.
Done in Copenhagen this 21st September 2010 as a part of the official records of the Danish Maritime and Commercial Court
For Novartis AG and all Novartis Companies
For Teva Denmark A/S and all Teva Companies"
"The preamble to the SPC Regulation contains the following recital (10), which states that:See also The SPC Blog here.
All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should … be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.
The SPC Regulation thus seems to envisage a narrow scope of protection for SPCs, once they have been granted. But in his Erbitux® judgment, Lewison J seems to have used this reference in the preamble to justify a restrictive interpretation of the SPC Regulation when assessing eligibility, rather than the scope of protection. This is consistent with other judgments by the English courts, which have to date required correspondence between the product claimed in a basic patent as an active ingredient and the same product as an authorised medicinal product, before granting an SPC. Yet some active ingredients (such as cetuximab) are only ever authorised for use in combination therapies. In the field of biological medicines and in particular mAbs, by the time that an SPC can be applied for, there may no longer be a patent directly claiming the product itself, given the long development times of these products. A restrictive interpretation of the SPC Regulation (as seen in the Erbitux® decision) may exclude such valuable medicines from the possibility of supplementary protection in the future. Should then SPCs based upon the way in which a product is used be allowed (assuming that the granted patent protects, directly or indirectly, such use)? Whilst it is still possible for the ‘infringement’ test to prevail (given the Medeva reference), the answer to this question remains an open one. However, if a further development in the law was to allow SPCs to be granted on this basis, it will open up some further difficult questions, such as what happens when the use of the product
is changed after the initial marketing authorisation is granted, and how the issue of infringement of a certificate is to be resolved for any generic/biosimilar version of a product (given that the argument will be entirely about the question of indirect infringement). The SPC Regulation was drafted and introduced in the early 1990s, at a time when vertically integrated pharmaceutical companies relied upon novel chemistry, small molecule blockbuster products and patents to earn their revenues.
Today, the industry landscape has changed with the advent of biologics. Whilst it is interesting to observe that the English Court of Appeal has referred to the Court of Justice what is essentially a question of policy underlying the SPC Regulation (namely, whether there should be a stand-alone test for multi-diseases vaccines, in order to determine whether a product is protected by a basic patent in Article 3(a) of the SPC Regulation), we doubt whether the European Court will want to open Pandora’s box, by carving out exceptions to the SPC Regulation for novel products and treatments such as vaccines, combination therapies and even chemically-modified small molecules with improved pharmaceutical properties.8 For radical change of this kind, we suggest that there will need to be a more fundamental reform of the patent extension legislation for medicinal products in the EU.
Will the ECJ open the box?
