Last Friday the Court of Justice of the European Communities made an Order in Case T‑52/09 R, Nycomed Danmark ApS v European Medicines Agency (EMEA), this being (i) an application for suspension of the operation of the EMEA’s decision of 28 November 2008 rejecting the application for a product-specific waiver concerning an ultrasound echocardiographic imaging agent for diagnostic purposes (perflubutane) and (ii) for the grant of interim measures. One of the arguments raised by Nycomed to try to get its waiver was that, if the marketing authorisation were delayed, it could not recoup its investment because of the limited patent life, even though the patent term could be "extended" by an SPC. Although this was no more than a side argument in Nycomed's effort to get a Community Marketing Authorisation (CMA), it did touch on the issue of patent term extension and therefore merits a brief mention here. Nycomed argued as follows: "44 ... that delay also means that it will lose part of the effective protection period of the patents granted in respect of Imagify. The 20-year protection period for Imagify commenced on 27 February 1997 with the filing of the first patent application and will therefore lapse on 27 February 2017. The applicant cannot derive the benefits accruing from that protection before obtaining the CMA. The patent protection period may of course be extended beyond the 20-year period through the grant of a supplementary protection certificate, but the effective period resulting from the refusal to grant the waiver sought will still be shorter than that which the applicant would have obtained had the waiver been granted.The Court was unimpressed. In the absence of "serious and irreparable" damage no interim measure might be ordered. What it says is worthy of note, though, if only because of its position regarding the nature of any damage suffered by a rights holder in relation to the loss of a portion of protection of its patent rights:
45 ... any delay in the launching of a patent-protected product will have considerable
impact on that product’s life-cycle turnover. Later market entry for the product will delay sales, and the potential turnover should not be calculated from the first year, when sales are modest, but rather in the year before loss of exclusivity, when product sales are peaking. In addition, a change in the order of entry of Imagify into the market in relation to other products will have a significant impact on the applicant’s market position if it reaches the market as manufacturer of the second ultrasound perfusion defect imaging product instead of the first, as is currently envisaged.
46 With respect to the irreparable nature of the alleged damage, the applicant acknowledges that Article 72(2) of Regulation No 726/2004 lays down a system of non-contractual liability for the EMEA, similar to that provided for by Articles 235 EC and 288 EC for the Community institutions. It submits, however, that it is not possible to compensate economically for the loss in turnover and profits and the
shortening of the protection period for its patent through the award of damages.
Entitlement to damages for loss suffered is subject to a set of conditions relating to the unlawfulness of the conduct alleged against the Community institution, the presence of damage and the existence of a causal link between the conduct and the damage complained of".
"63 ... the applicant argues that the damage suffered if the interim measures sought are not granted will be caused by the delay in introducing Imagify onto the market and by the loss of a corresponding portion of the protection period of its patents. It emphasises the significant impact of that delay on its position in the market for cardiac diagnostic products and the need for it to introduce Imagify onto that market as the first ultrasound imaging product in order to prevent another pharmaceutical company from gaining an edge and obtaining a CMA for a competing product, thereby acquiring a market share that it would not be able to acquire with Imagify present on the market.
64 However, the damage caused by such a delay in placing the product in question on the market, far from being able to be considered certain or, at the very least, sufficiently probable, is purely hypothetical in nature in that it presupposes the occurrence of future, uncertain events ... There is no certainty whatsoever that that product will be introduced onto the market, as it depends on the Commission’s granting a CMA, for which the applicant has expressly stated it ‘will be applying’ ... after successfully completing the validation procedure pending before the EMEA. In respect of that future authorisation procedure before the Commission, the applicant has not asserted, and even less established, that it would lead to the granting of the CMA, in the sense that the granting of that authorisation would be merely a formality.
....
67 With respect to the nature of the alleged harm, the applicant states that, during the period in which the placing on the market of Imagify is delayed, it will risk a loss in turnover and profits on sales of Imagify as well as a shortening of the effective protection period of the patents granted for the product, as any delay in launching a patent-protected product has a considerable impact on the turnover achieved for that product.
68 The applicant is thus alleging damage which must be regarded as being purely financial, in that it consists in loss of the income likely to result from future sales of a patent-protected product".
After posting a bit about the Netherlands in the last few weeks, and because the tulip season is on, the SPC Blog is devoting a little bit of time to the Netherlands Patent Office site.
The attention of The SPC Blog has just been drawn to a decision of the Intellectual Property Office in the UK, summarised here and downloadable in full here, in which hearing officer Dr Cullen refused an application for a paediatric extension in respect of an SPC granted on 13 October 1995 in force from 9 July 2007. The active ingredient for which the SPC was granted was Losartan, as a potassium salt, used in treating hypertension in humans through its action as an antagonist of the angiotensin II receptor. The product was marketed in the UK under thevbrand name COZAAR by Merck & Co., Inc., a licensee under the SPC."An application for a paediatric extension of granted certificate SPC/GB/95/010 was filed. The preliminary view of the examiner was that this application did not meet the requirements of Article 8(1)(d)(i) of Regulation (EEC) No. 1768/92 as it did not include a copy of the statement of compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of EC Regulation (EC) No. 1901/2006. This view was upheld by the Hearing Officer who considered the relevance of Articles 8, 23, 24, 29 and 36 of Regulation (EC) No. 1901/2006 and IPO decision BL O/035/09 (Merck & Co. Inc) [see SPC Blog note here for comment and link to the decision]. He further found that the application did not fulfil the condition of Article 8(1)(d)(ii) of Regulation (EEC) No. 1768/92 to prove that the product was approved for use in all EU member states. This he found to be an explicit requirement under Article 36(3) when the Mutual Recognition Procedure (MRP), as set out in Articles 32-34 of Directive 2001/83/EC, is used to gain approval forThe full decision is 25 pages long and I've not yet had a chance to read it in full, so the blog will return to it soon for fuller discussion and analysis.variation of the marketing authorisation. The documents supplied, a commission decision under Article 29 of Regulation (EC) No. 1901/2006, a preliminary variation assessment report from the national competent authority of the reference member state and an opinion from the Paediatric Committee of the European Medicines Agency (EMeA) on compliance with an agreed completed paediatric investigation plan were not sufficient to meet the requirements under Article 36 of Regulation (EC) No. 1901/2006 regarding a statement of compliance with an agreed completed paediatric investigation plan and that the product was approved for use in all EU member states".
After posting a piece on the recent Escilatopram case in the Netherlands (Tiefenbacher et al. v Lundbeck), the SPC Blog received the following comments by Jaap Bremer of BarentsKrans N.V., who along with Marleen van den Horst represented A.E. Tiefenbacher GmbH and Centrafarm B.V., two of the claimants in the case: "The Dutch Court clearly distinguished its judgment from the UK decision and the distinction was justified by new experimental evidence as well as expert evidence provided by Tiefenbacher. The expert evidence was actually very interesting. In the UK case, Kitchin J heavily relied on the interpretation by Prof Davies, Head of Chemistry at Oxford University, of certain organic chemistry rules called the "Baldwin Rules", which were created by Davies predecessor at Oxford, Prof. Baldwin. In the Dutch proceedings, Tiefenbacher managed to have Prof Baldwin act as a expert witness to explain his own rules. He had not been involved in the UK proceedings. This lead to a very interesting confrontation in the Courtroom between the current Oxford Chemistry Professor and his predecessor. The explanation of the Baldwin Rules by Sir Baldwin himself (to set straight what went astray in the UK) was a very important factor in getting the Dutch Court to distinguish the case from Kitchin J's decision. "
Two forthcoming upmarket patent conferences have competitions attached to them for which the prize is free admission. The first of these conferences, C5's 8th Annual Maximising Pharma Patent Lifestyles Conference, takes place at the Grosvenor Hotel, London, on 14 and 15 May. The conference is preceded by pre-conference workshops on 13 May, one of which is a Master Class on SPCs. The organisers are also offering "buy one delegate place, get one workshop place free".
The Dutch first instance decision in ratiopharm et al v Lundbeck, concerning the validity of Lundbeck’s escitalopram patent (EP 066) has now been handed down by the Hague District Court. The court held that all the claims of Lundbeck’s escitalopram patent (and Lundbeck’s Dutch Supplementary Protection Certificate which was based upon it) were invalid for lack of inventive step.
On 26 March 2009, the Netherlands Patent Office handed down its decision on Memantine. Here's a short English summary of the case:
Synthon requested that the Octrooicentrum revoke the certificate or revise the date of the certificate based on the earlier marketing authorisations that were not granted in accordance with directive 65/65. The Netherlands Patent Office denied this request. In their view it follows mainly from the recitals in the preamble that the relevant first marketing authorisation is an authorisation in accordance with directive 65/65, i.e. for a medicinal product which has been tested thoroughly for quality, safety and efficacy.
Thanks to Martijn de Lange from the Netherlands Patent Office for informing us about this decision.
Just in case you missed out on the German Patent Court decision on Memantine of 11 December 2007, you can get it here.
Just when you think things in the wonderful world of SPCs can't get any more exciting than they already are, they do. Yesterday we reported on the reference in Synthon v Merz Pharma. On the same day the Curia website posted the information that there is to be yet another reference of a preliminary question for a ruling by the Court of Justice of the European Communities. This time the reference comes from Lithuania, from the Lietuvos Aukščiausiasis Teismas in Case C-66/09 Kirin Amgen, Inc. v Lietuvos Respublikos valstybinis patentų biuras. The questions referred are as follows: "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 Lithuania as the date of its accession to the European Union?
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?"
Mr Justice Floyd (Patents Court, England and Wales) has just given judgment this morning in Synthon BV v Merz Pharma GmbH & Co KGaA (no neutral citation has yet been allocated and the judgment is still subject to editorial corrections)."1. The question which arises in this action is: can one obtain an SPC in circumstances where the product has been placed on the market in the Community without the need to do safety and efficacy testing as prescribed in 65/65, or indeed at all? The defendant Merz Pharma GmbH & Co. KGaA (“Merz”) says that you can. The claimant Synthon B.V. (“Synthon”) says that you cannot.Who is right? It seems we may have to wait a while to find out, since the judge concludes as follows:
2. Merz is the proprietor of SPC No GB 02/046 (“the SPC”) granted on 14th August 2003 in respect of a compound called memantine. Although the SPC was granted on the basis of EU wide marketing authorisations granted in 2002, memantine had already been on the market in Germany (but not in the UK) for a quarter of a century. By this action Synthon seek revocation of the SPC on a number of grounds, or a declaration that it has zero term".
"85. ... I will exercise my discretion to refer the questions of law which arise on the interpretation of the SPC Regulation to the ECJ. I invite the parties to make submissions as to the wording of the reference, following which I will make an order directing a reference to the Court".The SPC Blog will provide a note on this decision soon. In the meantime, since it's not yet available on the excellent BAILII website, you can read it via the blog here. The blog will also keep track of this case as it travels to Luxembourg and back.
