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, 25 June 2010
In short, the questions referred to the Court of Justice are as follows:
On article 3(a)
1. Regulation 469/2009 (the Regulation) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by “the product is protected by a basic patent in force” and what are the criteria for deciding this?
2. In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?
3. In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?
4. For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if one antigen of the vaccine is “protected by the basic patent in force”?For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if all antigens directed against one disease are “protected by the basic patent in force”?
On Article 3(b)
6. Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 200 1/83/EC or 200 1/82/EC which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market?
Thursday, 24 June 2010
In sum, the Court decided to make a reference to the Court of Justice for a preliminary ruling on each of the questions below:
(1) What is the test by which to determine whether “the product is protected by a basic patent in force” for the purposes of Article 3(a)?At the time of posting, the judgement was not available on Bailii, but you can read it here.
(2) Should a different test be applied in cases where the product is a multi-disease vaccine?
(3) Is it sufficient for the purposes of Article 3(a), in the context of a multi-disease vaccine, that the basic patent in force protects one aspect of the product?
(4) For the purposes of Article 3(b) may the product be limited to that part of a multi-disease vaccine as is protected by the basic patent in force?
Thursday, 17 June 2010
"In the light of the above considerations, I suggest that the Court answer the questions referred by the Bundespatentgerichts as follows:
1. Article 3 (1)(b) of Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products is to be interpreted such that an SPC for a plant protection product cannot be granted based on a marketing authorisation according to Art. 8(1) of Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market.
2. Nobody can use this interpretation of Article 3(1)(b) of Regulation (EC) No. 1610/96 to challenge the validity of a plant protection product SPC that was filed before the present decision was handed down."
Friday, 4 June 2010
Just to remind you what it is all about, here is the question the GFPC asks:
"Can a supplementary protection certificate for medicinal products be granted if the period of time between the filing of the application for the basic patent and the date of the first authorisation for marketing in the Community is shorter than five years?"
Thursday, 3 June 2010
Medicinal Products Filed in 2009
The 898 SPCs filed in 2009 and published at the end of April 2010 cover about 95 different products (active ingredients, combinations of active ingredients, or formulations).
Among these 898 SPCs, about 24.0% relate to antineoplastic agents, 2.1% to antibacterials, 2.3% to antivirals, 14.0% to vaccines, 11.0% to sex hormones, 5.9% to angiotensin antagonists, 3.1% to cholesterol and triglyceride reducers, 5.6% to glucose lowering agents.
We noted products, for which were lodged at least 18 SPCs. These products can be roughly sorted according to their therapeutic category:
· Antineoplastic agents: catumoxamab (34; 15 referring to Trion Pharma, 10 to GSF-Forschungszentrum für Umwelt und Gesundheit GmbH, 9 to Ascenion GmbH patents), gefitinib (23), degarelix (25), certolizumab pegol (18), ustekinumab (19), tocilizumab (30)
· Platelet aggregation inhibitors: prasugrel (18)
· Antihemorragics: romiplostim (19)
· Angiotensin antagonists: combination of amlodipine besylate and olmesartan medoxomil (19), combination of aliskiren and hydrochlorothiazide (34)
· Cholesterol and triglyceride reducers: combination of laropiprant and nicotinic acid (26)
· Sex hormones: combination of dienogest and estradiol valerate (21), lasofoxifene (22), bazedoxifene (22)
· Vaccines: Pneumococcal polysaccharide vaccines (69; 25 referring to Forsgren Arne, 14 to GlaxoSmithKline Biologicals, 30 to Henry M. Jackson Foundation for the Advancement of Military Medicine patents)
· Antiepileptics: eslicarbazepine acetate (18), lacosamide (37)
· Antiglaucoma: combination of brinzolamide and timolol (29).
On 5 May 2010 we noticed:
- SPCs with paediatric extension lapsed on 1 or 2 March 2010 in Austria, Belgium, Germany, Denmark, Finland, France, The United Kingdom, Ireland, Italy, The Netherlands and Sweden
- Paediatric extension until 1 December 2010 in Latvia.
Anastrozole (extension until 10 or 11 February 2011)
- Paediatric extension granted in Finland and Sweden
- Paediatric extension applications published in Austria, Belgium, Germany, Denmark, France, The United Kingdom, Ireland, Italy and The Netherlands.
Caspofungin (extension until April 2017 in most countries but September 2017 in Czech Republic)
- Paediatric extension granted in Germany, Denmark, France, The United Kingdom, Ireland, The Netherlands and Sweden
- Paediatric extension applications published in Austria, Belgium, Czech Republic, Finland and Slovenia.
Zoledronic acid (extension until May 2013 in most countries but October 2013 in Slovenia)
- Paediatric extension granted in Denmark, Sweden and Slovenia
- Paediatric extension application published in Austria, Germany, Finland, France, The United Kingdom, Ireland, The Netherlands, and Slovenia.
French decisions affecting SPCs
As usual, there are very few French decisions relating to patents. We mention three decisions relating to SPCs.
Cour d'appel de Paris dismissed on 6/11/2009 Daiichi Sankyo appeal against the decision of the Director-General of the French Patent Office (INPI) on 13 February 2009 to reject French SPC 06C0019 for an olmesartan medoxomil and hydrochlorothiazide combination, referring to EP0503785 patent.
The Cour d'appel de Paris dismissed Daiichi Sankyo's appeal because it was not possible to get an SPC for the Olmesartan Medoxomil and Hydrochlorothiazide combination, as this combination was not protected by the patent.
TGI Paris 3rd chambre, 3rd section (07/10/2009) Société ALKABELLO A/S / S.A. STALLERGENES
According to this decision, the Court revoked French SPC FR07C0033 for Extrait allergénique de pollen de fléole des prés (Phleum pratense) referring to EP0278877 and to French MA 378011-6 of 08/02/2007 (Grazax®), the French MA for Grazax® not being the first marketing authorization granted for this product as a medicinal. Indeed, an MA for Alutard® drug based on the same active ingredient has been issued on 03/05/2006.
There is no mention of revocation in the French Patent Register (probably appeal).
TGI Paris 3rd chambre, 1st section (06/10/2009) TEVA CLASSICS, TEVA SANTE, TEVA PHARMACEUTICAL Industries Ltd / SEPRACOR
According to this decision, the Court revoked, for insufficiency, the French part of all claims of Sepracor patent EP0663828 relating to use of levocetirizine for the treatment of allergic rhinitis and asthma.
The specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art: it contains no technical information supporting the statements in the application, including experiments or plausible explanations that can demonstrate the real effects involving alleged invention. The absence of any mention of research and results is the demonstration of the speculative nature of the patent application and effect of concealing the lack of inventive step.
There is no mention of revocation in the French Patent Register (probably appeal).
French SPC FR02C0024 for levocetirizine dihydrochloride referring to Sepracor patent will be no more valid if the decision is confirmed.