A recent review of the scene in Europe -- and especially France

Alice de Pastors (Cabinet Alice de Pastors) has kindly prepared for this blog a shortened version of her firm's SPC-News 22 -- which was circulated in May of this year -- regarding medicinal SPCs in Europe. Alice writes:

* What is the situation in May 2008?

Supplementary Protection Certificates in Europe are governed
– in the 27 EU countries, Norway and Iceland by EEC Regulation 1768/92, amended by Regulation 1901/2006 of 12 December 2006 relating to medicinal products for paediatric use
– in Switzerland by National law of 3 February 1995.

* Medicinal Product SPCs in Europe from 1991 to 2007

About 10,925 SPC applications for medicinal products regulated by EEC Regulation 1768/92 or National laws were filed in European countries from January 1991 to December 2007, and published up to the end of March 2008. The graph below shows, for each country, the number of SPCs filed from 1991 to 2007, according to their status.

1991-2007 SPCs

M1 = SPC applications
M2 = granted SPCs in force
M3 = granted SPCs not yet in force
M4 = expired, lapsed, invalid SPCs
M5 = rejected or withdrawn SPC applications

The situation differs from one country to another due to the importance of the markets and/or to the applicable laws and/or to the date of entry in force of the EU Regulation:
– fewer than 20 SPCs in force in Bulgaria, Estonia, Lithuania, Malta, Poland, Romania, Slovakia, Czech Republic, Iceland, Slovenia, Hungary, Latvia, Cyprus
– fewer than 100 SPCs in force in Greece, Portugal, Spain, Norway, Finland, Ireland, Denmark
– fewer than 150 SPCs in force in The Netherlands, Germany, Austria, Luxembourg, Switzerland, Sweden, Belgium, UK
– more than 150 SPCs in force in France and Italy.
The graph below shows the number of SPCs filed from 1991 to 2007, according to ATC code (first level) of the products and to the SPC status.

* Medicinal Product SPCs in Europe in 2007

1,245 SPCs filed in 2007 were published at the end of March 2008. The graph below shows the number of SPCs for each country.

Medicinal Product SPCs filed in 2007

The EU SPC Regulation entered in force in Bulgaria and Romania on 1 January 2007. 87 SPCs were filed in 2007 and published in Romania and 23 SPCs in Bulgaria.

Which medicinal products?

The 1,245 SPCs filed in 2007 and published at the end of March 2008 cover about 170 different products (active ingredients, combinations of active ingredients, or formulations).

► Of these 1245 SPCs, about 38% relate to influenza or papillomavirus vaccines, 9% to glucose lowering agents, 6.6% to immunosuppressive agents and 6.3% to veterinary products.
► We noted 33 products, for which at least 10 SPCs were lodged.

Recent French decisions affecting SPCs

Decisions relating to Chiron EP0181150 and EP0318216 patents

Four decisions of Cour de cassation (3/04/2007)

These decisions confirmed the decisions of the Cour d'appel de Paris rejecting Chiron's appeal against the refusal by the French Patent Office of four SPC applications (01C0023, 01C0024, 01C0025, 01C0026) because these applications related to products neither used for treating or preventing disease, nor administered with a view to making a medical diagnosis but to test reactants for in vitro diagnosis.

Decision affecting Triflucan® drugs

Cour de cassation (3/04/2007)

In this decision the Cour de cassation set aside the Cour d'appel de Paris judgment of 12 October 2005 without ordering a new trial; the Cour de cassation considered that National SPC 92C0372 was invalid because the product had already been the subject of the certificate 92C0371.

Decisions affecting Fosamax® and/or Fosavance® drugs

Two decisions of TGI Paris relate to French SPC 96C0032 referring to French patent FR2525223:

TGI Paris (15/02/2008) MSD Somerset Ltd/Teva Classics, Teva Santé
TGI Paris (15/02/2008) Arrow Generiques, EG Labo, Ratiopharm / MSD Somerset Ltd
In these decisions the Court revoked, for lack of inventive step, the claims relating to pharmaceutical compositions suitable for the treatment of urolithiasis and inhibiting the bone reabsorption comprising a biphosphonic acid, and specifically 4-amino-1-hydroxybutan-1,1 biphosphonic acid. If these decisions are confirmed, SPC 960032 will no longer protect Fosamax® and/or Fosavance® drugs (these decisions are open to appeal).

Decision affecting aceclofenac

TGI Paris (22/02/2008) S.A. Laboratorios Almirall, S.A.S. Almirall/Merck Generiques, S.A.S. Qualimed, S.A.S. Pharm’Depo, Merck Farma y Quimica.

In this decision the Court revoked French SPC 98C0017, referring to EP0119332, due to the fact that the SPC was filed by a person other than the owner of the patent at the filing date. In fact Prodes filed SPC 98C0017 in 1998, but Prodes was no longer the owner after 25 January 1985, when the patent was transferred to Prodesfarma SA.