Alice de Pastor's SPC News 2009

The May 2010 edition of Alice de Pastor's SPC News 24 is now out. We provide an excerpt below, but you can download the whole document here, which also includes statistics on SPCs relating to vaccines.


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).


Paediatric extensions

On 5 May 2010 we noticed:

Losartan
- 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.