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

Friday 28 January 2011

At last, a date for our next seminar!

Please mark your diaries -- there is a date at last for this year's SPC Blog seminar, and it's Tuesday 21 June. Cancel your appointments, change your holidays, book your flights and prepare to enjoy yourselves as only true enthusiasts for supplementary protection certificates can. It doesn't matter if you are on the product originating side, a generic manufacturer, an academic, an administrator, a business consultant or a private practitioner: you are equally welcome.

Once again we are grateful to Olswang LLP for giving us the use of its lovely 7th floor venue. If there's no snow we might even be able to go out on to the patio for the reception ...

Further details of the programme will be posted on this weblog as soon as they are available.

Thursday 27 January 2011

Memantine -- now in English too!

Yesterday The SPC Blog posted this piece ("Memantine in Belgium") on the Belgian ruling in Merz/Synthon on the Memantine SPC. Steven Catoor (Hoyng Monegier, Brussels), who supplied us earlier with the original text, has now been able to let us have an unofficial but very helpful English translation, which you can read here. Thanks, Steven, from all of us!

Wednesday 26 January 2011

Memantine in Belgium

From Steven Catoor (Hoyng Monegier, Brussels) comes news of the decision of the judgment of the Brussels Commercial Court of 11 January 2011 on the Belgian SPC for memantine (Synthon v Merz). The judgment is in Dutch but Steven hopes to provide us with an unofficial English translation shortly.  Says Steven:
"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.

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".
I hope this is useful to you.

Thursday 20 January 2011

Paediatric extensions and transitional provisions: a question of timing

The SPC Blog learns from Martin Paltnoi (Managing Director, MPA Business Services Ltd) that there may be some confusion regarding the timing of forthcoming paediatric extensions. He explains as follows:
"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.

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".
Thanks, Martin!

Monday 17 January 2011

The missing Daiichi judgment, now available

The SPC Blog's trained trackers will do their
best to hunt down missing decisions!
An email from Cabinet Michèle Lavé sparked off a bit of borrowing around this weekend from The SPC Blog team.  Michèle wrote:
"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!

Friday 14 January 2011

Novartis/Teva settlement in Denmark: the terms

The SPC Blog thanks Mette Clausen Hygum (Plesner, Copenhagen) for letting us have the following note, the contents of which are self-explanatory:

The parties in the Danish case Novartis AG and Novartis Healthcare A/S v Teva Denmark A/S concerning the scope of protection of Novartis's SPC for Valsartan, have agreed to end the case on the terms proposed by the Danish Maritime and Commercial Court.

Following a preliminary injunction case against Teva concerning Novartis's patent covering (amongst others) the active ingredient Valsartan, Novartis filed a declaratory action against Teva claiming that Teva should acknowledge that Novartis' SPC for the active ingredient Valsartan not only protected products containing Valsartan as the only active ingredient but also products containing a combination of Valsartan and one or more other active ingredients.

Teva refused to give such acknowledgement and claimed that Novartis' SPC only protected products containing Valsartan and thus not Valsartan in combination with other ingredients.

Only a few weeks before the oral hearing in September 2010 Teva announced that for commercial reasons Teva would not market any products containing Valsartan before expiry of the SPC. The reason for the decision was, according to Teva, that the Danish Medicines Agency, following a re-evaluation of the reimbursement for the antihypertensive products acting on the renin system [1], had decided to remove the general reimbursement for various products, including products containing Valsartan and Hydrochlorothiazide.

Based hereon Teva claimed that the case should be dismissed as there was no actual commercial dispute between the parties.

The oral hearing was held on the 15 September 2010 and the case was afterwards ended in accordance with the proposal from the court, which reads as follows:
"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"

[1]       The reason was that losartan was out of patent protection which is why several companies have launched generics at a price compared to that of the generic ACE-inhibitors.

Tuesday 11 January 2011

SPCs and the "Salt" Problem No.2 -- No.2!

At the back end of November, The SPC Blog excitedly announced the publication of an article, 'SPCs and the “Salt” Problem No.2', by Dr Herwig von Morze, leaving readers with nothing more concrete to sample than the article's abstract.

Now, thanks to some prodding from readers, some effort on the part of Dr von Morze and a little kindness of the publishers, The SPC Blog has secured permission to publish the article in full here.

Note: this work was originally published in the Intellectual Property Quarterly (IPQ), Issue 4, 2010, and is reproduced with the permission of Sweet & Maxwell.

Tuesday 4 January 2011

What's Brown, Curley and writes about Pandora's Box?

"Reflections on the Erbitux® decision: Combination Products, Combination Therapies and SPCs" is the title of a Case Comment published today in Lawtext's bimonthly Bio-Science Law Review (volume 11, issue 2, at p.54).  The authors are Chartered Patent Attorney and European Patent Attorney Andrew Brown together with Duncan Curley (Solicitor and Director, Innovate Legal).  The BioSLR has kindly allowed The SPC Blog to make this note available to its readers here.  More details of the journal can be found here.

The authors conclude as follows:
"The preamble to the SPC Regulation contains the following recital (10), which states that:

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.

Will the ECJ open the box?
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.
See also The SPC Blog here.