"Several provisions of the medicinal product SPC Regulation 1768/92 (codified as Regulation 469/2009) have been subject to interpretation and clarification by the ECJ. Because the initial administrative interpretation of a provision is undertaken by 27 national patent offices, it is not surprising that different national outcomes will result. Different outcomes may be confirmed at a national judicial level, unless a national court refers the issue to the ECJ.
Recital 14 of the plant protection product SPC Regulation 1610/96 has been subject to diverse national interpretation. This Recital also applies mutatis mutandis to the interpretation of several provisions of Regulation 469/2009. It concerns the issue of an SPC for a derivative of an active substance based on a second marketing authorisation issued for the derivative if an earlier authorisation exists for the active substance.
The article proposes the application of an existing regulatory approach to prevent disharmony within the EU. Notwithstanding the differences between EU and US law, recent US case law appears to support the appropriateness of the regulatory approach proposed in this article".
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
Monday, 29 November 2010
Wednesday, 24 November 2010
Tuesday, 23 November 2010
A qualified European Patent Attorney and Chartered UK Patent Attorney, James is a member of the Royal Society of Chemistry. His professional experience include drafting and prosecuting patent applications, managing and devising strategies for worldwide patent portfolios, due diligence exercises and obtaining non-patent IP protection for pharmaceutical products. He has also been involved in opposition and appeal work before the European Patent Office.
A member of the patent team at Olswang LLP, James is a graduate of the University of Glasgow and possesses a doctorate from Cambridge University. After obtaining post-doctoral experience at Columbia University, New York City, he worked as a medicinal chemist for a multi-national pharmaceutical company and is a named inventor on two patents derived from his research work.
We look forward to James's contributions to the blog.
Thursday, 11 November 2010
|Napoleonic Hussar: an early |
experiment in European unity?
Bayer owned a European patent covering, inter alia, a herbicide known as iodosulfuron. The application for this patent was filed on 12 February 1992; the patent issued on 11 November 1998 with an expiry date of 13 February 2012. On 13 December 1998, an application to have iodosulfuron included in Annex I to Directive 91/414 [concerning the placing of plant protection products on the market] was lodged with the German authorities by an undertaking the rights of which were subsequently acquired by Bayer. On 9 March 2000 the German authority issued a marketing authorisation to Bayer for a herbicide based on that substance, sold under the name ‘Husar’. This was a provisional MA, issued on the basis of a provision of national law designed to transpose Article 8(1) of Directive 91/414. In order to take account of Commission Decision 2003/370 [allowing Member States to extend provisional authorisations granted for the new active substances iodosulfuron-methyl-sodium, indoxacarb, S-metolachlor, Spodoptera exigua nuclear polyhedrosis virus, tepraloxydim and dimethenamid‑P], the expiry date of that provisional MA, initially fixed at 8 March 2003, was put back to 21 May 2005.
On 17 July 2003 the Bundespatentgericht granted Bayer an SPC for iodosulfuron and some of its salts and esters for the period between 13 February 2012, the expiry date of the European patent and 9 March 2015. In calculating the duration of the certificate, the Bundespatentgericht took the view that the provisional MA of 9 March 2000 was the first MA. On 25 September 2003 the Commission included iodosulfuron in Annex I to Directive 91/414 by means of Commission Directive 2003/84.
On 13 January 2005 the German authority issued a definitive MA to Bayer for Husar on the basis of the national provisions transposing Article 4 of Directive 91/414. Its expiry date was fixed at 31 December 2015.
|The word is spelled 'Husar' |
but an image search reveals
use of 'Hussar' only
Bayer challenged that interpretation of Article 3(1)(b), which it considered contrary to the general scheme of that regulation and to the practice of the competent national authorities. The Bundespatentgericht decided to stay proceedings and to refer the following question to the Court for a preliminary ruling:
‘For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must account be taken exclusively of [a MA] under Article 4 of Directive 91/414 … or can a certificate also be issued pursuant to [a MA] which has been granted on the basis of Article 8(1) of Directive 91/414 …?’Today the court ruled as follows:
"Article 3(1)(b) of Regulation ... 1610/96 ... must be interpreted as not precluding a supplementary protection certificate from being issued for a plant protection product in respect of which a valid marketing authorisation has been granted pursuant to Article 8(1) of Council Directive 91/414 ..., as amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005".Dutch speaking readers can note this decision on the excellent Boek9.nl blog here