Artist Bjørn Bjørnholt

Judgments from the CJEU - SPC’s on combination products – an initial review

Jan Mondrup Pedersen M.Sc. Chemistry and Physics, Ph.D. Synthetic Organic Chemistry Patent Attorney T +45 33 63 93 43 E jmp@pv.eu November 2011

24 November 2011

- The judgments from the Court of Justice of the European Union (CJEU) regarding certain aspects of SPC’s on combination products, i.e. pharmaceuticals (particularly vaccines) comprising two or more Active Product Ingredients have now been published.

- These judgments are not only highly relevant for applicants with existing or upcoming SPC applications but they also have an impact on claim drafting for European patents for these product types in general.

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The cases

The two cases:

C-322/10 (Medeva) and

C-422/10 (Georgetown University)

The cases were originally joined but were then split up in connection with the judgments since they relate to slightly different situations.

Without going into detail, the following slides will explain the conclusions of the cases.

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C-322/10 Medeva

1. Article 3(a)…must be interpreted as precluding the competent industrial property office of a member state from granting an SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent…

2. Article 3(b)…does not preclude the competent industrial property office of a member state from granting an SPC for a combination of two active ingredients, corresponding to that mentioned in the wording of the claim of the basic patent…where the medicinal product for which the marketing authorization is submitted…contains not only that combination of the two active ingredients but also other active ingredients.

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C-422/10 Georgetown University

Article 3(b)…does not preclude the competent industrial property office of a member state from granting an SPC for an active ingredient, …where the medicinal product for which the marketing authorization is submitted…contains not only that active ingredient but also other active ingredients. [This is just a “single API” version of Medeva point 2].

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Impact and interpretation

The consequences of the judgments put briefly in an exemplary way are as follows:

- To have an SPC granted for a combination A+B, the combination A+B must be mentioned in the claims of the basic patent. The same goes for A+B+C etc.

- To have an SPC granted for a combination A+B, the combination A+B must be mentioned in the claims, however it is not a problem that the approved product contains for example e.g. A+B+C+D+E.

- To have an SPC granted for A, it is not a problem that the approved product contains e.g. A+B+C+D+E.

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Impact and interpretation (2)

- Since novel vaccines are often combination products and are often further combined with known vaccines in the final products, these judgments are highly relevant for companies involved in developing vaccines, but also for the pharmaceutical industry in general.

- The first point of the Medeva judgment is highly relevant for patent drafting in the pharmaceutical industry, as drafters should provide basis for claim relating to any conceivable combination products, that may be relevant in the future. This will without doubt result in some very long lists of API’s and API combinations in future patent applications relating to pharmaceutical products.

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Impact and interpretation (3)

- The judgments are still open to some interpretation. For example, the Danish Patent and Trademark Office has had the practice so far, that a mention of the combination A+B in the description of the basic patent was sufficient, since one could have this combination included in the claims via administrative re-examination in any event. Such practice may no longer be acceptable in view of point 1 of the Medeva judgment.

- The judgments have brought som clarity to how the national Patent Offices should interpret article 3a and 3b of the SPC regulation, and certainly the ”infringenment test” will no longer be applied after the Medeva point 1 ruling. The exact implementation of the rulings, however, remains to be seen.

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