NO REFERENCE ON DOSAGE DIFFERENCES FOR ECJ

Here's one from today that BAILII did pick up: R (on the application of Merck Sharp & Dohme Ltd) v Licensing Authority [2005] EWHC 710 (Admin), an Administrative Court ruling of Mr Justice Moses.

Merck held marketing authorisations for three medicinal products used to treat osteoporosis. The first of those products ("A") was authorised by the European Community in 1993, while the third ("B") was authorised in 2000. Three generics companies sought marketing authorisation for a generic product ("C") which was a copy of B. Under Directive 2001/83 an applicant for marketing authority has to supply a full set of data in order to show the safety and efficacy of the product, but not in certain circumstances in which it could refer to data submitted in respect of a previously authorised product. Where authorisation was sought for a product ‘essentially similar’ to another product authorised for (in the UK) ten years, under Art.10(i)(a)(iii) of the directive, an applicant could refer to data already submitted in respect of the other authorised product.

The generics companies relied on the data submitted on A and B in seeking marketing authorisation for C. Although A and B contained the same active ingredient, they were not essentially similar within the meaning of the directive, since their schedule of dosage differed. The Licensing Authority accepted that the generics companies were not required to submit any further data, but Merck argued that such an approach was unlawful and sought a reference to the European Court of Justice (ECJ). In Merck's opinion this issue was as yet unresolved, particularly with regard to differences in dosage.

Moses J dismissed Merck's application, holding that the principles enunciated by the ECJ in the earlier decisions (Case C-368/96 R v The Licensing Authority ex parte Generics, 3 December 1998, Case C-106/01 R (on the application of Novartis Pharmaceuticals UK Ltd) v The Licensing Authority, 29 April 2004 and Case C-36/03 Approved Prescription Services Ltd v The Licensing Authority, 9 December 2004) were clearly applicable in this case. Although it was true that a change in dosage had not been considered before, it was for the court of justice to interpret the EC Treaty and the relevant principles by which it was to be interpreted, and for the domestic court to apply those principles to the particular case. No new issue of principle arose in this case.

The IPKat knows how much money is at stake when a proprietary pharma product is handed to the manufacturers of generic products. That's why companies like Merck find it so efficacious to buy time by pressing even fairly weak arguments as far as they can go. Merpel says, but doesn't Merck make generic products too?

More on generics here, here and here