Merck Sharp & Dohme Ltd, R (on the application of) v Licensing Authority & Ors

Under Directive 2001/83/EC, Article 10 provides the code governing reliance on data submitted for an earlier authorised medicinal product. A generic applicant may cross-refer where its product is essentially similar to a developed product, even if that developed product has been authorised for less than six or ten years and is not essentially similar to the original product. A change in dose or posology may fall within the proviso to Article 10(1)(a)(iii), including where it produces more than one difference from the original product. The protection period cannot be extended merely by the form of the innovator’s application or by the expense of development. Where the European Court of Justice has already stated the governing principles clearly, no further reference is required.

Merck Sharp & Dohme Ltd challenged the Licensing Authority’s acceptance of applications for generic alendronate 70mg. The applications relied on data submitted for Fosamax Once Weekly 70mg, which had been developed from Fosamax 5mg and 10mg. The claimant argued that the difference in dose schedule, strength, bioavailability and the use of a full application created an unresolved issue under Article 10 of Directive 2001/83/EC.

The Administrative Court had to decide whether the principles stated by the European Court of Justice in Generics (Case C-368/96), Novartis (Case C-106/01) and APS (Case C-36/03) applied, and whether a further reference was necessary.

1. The claim for a further reference was rejected. The principles stated in Generics, Novartis and APS were clear and applicable. The domestic court’s task was to apply those principles to the facts.

2. Article 10 of Directive 2001/83/EC is the relevant code governing cross-reference to data submitted for an earlier authorisation. The identity of the person relying on the data is immaterial.

3. A developed product is within the proviso to Article 10(1)(a)(iii) where its differences from the original product are expressly identified there, or generally entail or imply a difference identified in the proviso. A change in dose or strength generally entails a change in the timing or regularity of administration and may therefore include a change in posology.

4. The proviso is not confined to a single difference. A product may differ from the original in strength, posology and other respects without losing the benefit of the abridged or hybrid abridged scheme. If a generic product is identical or essentially similar to the developed product, requiring fresh data would not advance safety or efficacy and would impose unnecessary testing.

5. The procedure used to authorise the developed product is immaterial. An innovator cannot obtain an additional protection period merely because it made a full application rather than a hybrid abridged application. Nor can development cost or difficulty justify additional protection beyond the periods and protections recognised by the Directive and intellectual property law.

6. Fosamax Once Weekly 70mg was a development of Fosamax 5mg and 10mg falling within the proviso. The generic companies therefore needed no further data. The proposed fourth reference was refused.