Questions about the codified Regulation No. 469/2009

The SPC Blog has received a few interesting questions about the new codified Medicinal Product Regulation (EC Regulation No. 469/2009) from John Miles of Potter Clarkson:

"The codified Medicinal Products SPC Regulation (Regulation No 469/2009) does not include within its text any of the apparent amendments made to its predecessor (Regulation No 1768/92) by virtue of Recital 17 of the Plant Protection Products Regulation (Regulation No 1610/96). In particular, Article 3(2) of the Plant Protection Products Regulation is not included in the codified Medicinal Products Regulation.

Article 3(2) of Reg. 1610/96 states:

"The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders. "

This point was addressed to an extent in the following extract from the Record of the third meeting of national SPC experts held at the EMEA on 26 September 2008 (the bit in bold is the question, and the bit in plain text thereafter is the answer recorded).

The Commission has reccently proposed a codified version of Regulation1768/92 including the amendments introducted by Regulation (EC) No 1901/2006, see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52008PC0369:EN:HTMLWhy does this version not include amendments that were introduced by Regulation 1610/96 (see in particular recital 17)?

Some enquiries have been received in this regard and transmitted to the Commission services competent on the codification legislation. They considered that Regulation 1610/96 did not introduce any amendment into Regulation 1768/92. Therefore, no provision originating from Regulation 1610/96 is present in the consolidated version of Regulation 1768/92.

Recital 17 of Regulation 1610/96 does no more than state that certain provisions of Regulation 1768/92 must be interpreted in accordance with certain "detailed rules" contained in Regulation 1610/96.

Regulation No 1768/92 was repealed by Regulation No 469/2009 (see Article 22). The second paragraph of Article 22 states that

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.

Does this mean that Recital 17 of the Plant Protection Products Regulation applies to the codified Regulation No 469/2009 in the same way it applied to Regulation No 1768/92 (now repealed)?

If so, is it certain the codified Medicinal Products Regulation has to be interpreted to include Article 3(2) of the Plant Protection Products Regulation?

If Article 3(2) does not apply to the codified Medicinal Products Regulation, is there anything in that Regulation to prevent the holder of more than one patent for the same product obtaining more than one certificate for that product?

Below is an extract from the Record of the first meeting of national SPC experts held on 3 February 1995 (ie before the 1610/96 Regulation came into force) which seems to indicate that the original 1768/92 Regulation should be interpreted to allow for more than one certificate in that circumstance.

First Question
After an application for an SPC has been lodged for a particular product but before the certificate is granted, may a second party lodge a separate application for an SPC in respect of the same product and obtain a certificate like the first applicant?

Answer:
The Commission representative indicated that severall applications could be lodged for a particular product, either by the same company or different companies. With regard to the admissibility of these application, the only condition to be met was that, at the date of the application, the product had not already been the subject of a certificate (Article 3(c)). Accordingly, if on the date of lodging the application a certificate had already been granted for the product on the basis of the Regulation, the new application was inadmissible under Article 3(c). On teh other hand, if no certificate had been granted, the second application was admissible.

No delegation expressed a dissenting view. "

If someone can clarify some of these points, please do so in the Comments section below.