Medeva BV v The Comptroller General of Patents

For an SPC, “product” has the same meaning in Articles 1(b) and 3(a) of the SPC Regulation. For a medicinal product containing several active ingredients, only those relevant to whether the product falls within the scope of a basic patent claim are protected. Combination vaccines receive no special treatment. A marketing authorisation must authorise the relevant product. An examiner’s opinion is not an appealable decision under section 97 of the Patents Act 1977.

Medeva appealed against the refusal of five SPC applications concerning combination vaccines based on a patent claiming a synergistic combination of pertactin and filamentous haemagglutinin.

Four applications failed because the products contained active ingredients beyond those protected by the patent. The fifth failed because the relevant marketing authorisation did not authorise a product consisting of the patented combination. The court also considered whether Medeva’s appeal had been filed prematurely, before the Comptroller issued a decision.

1. Appeal dismissed. The products in applications 09/015, 09/016, 09/017 and 09/019 were not protected by the basic patent for Article 3(a) purposes. The product accepted under Article 1(b) was the whole combination of active ingredients. It could not then be treated as only pertactin and filamentous haemagglutinin for Article 3(a). “Product” had to have the same meaning in both provisions.
2. For a combination product, the court applied the approach in Takeda Chemical Industries Ltd’s SPC Applications (No 3) [2004] RPC 1 and Gilead Sciences Inc.’s SPC Application [2008] EWHC 1902 (Pat). The relevant ingredients are those which bear on whether the product falls within the scope of a claim of the basic patent. Only those ingredients are protected.
3. A combination vaccine was not a special case. Vaccine combinations required testing for compatibility, stability, efficacy and safety. The possibility of harsh results, or the influence of national health policy, did not justify different criteria.
4. Application 09/018 also failed under Article 3(b), since no authorisation existed for a product consisting of pertactin and filamentous haemagglutinin. The issue for application 09/016 was accepted as curable by amendment.
5. The appeal had been filed prematurely. The examiner’s letters expressed an opinion and invited a response; they were not decisions and the examiner had no authority to refuse an SPC application on behalf of the Comptroller. The later decision enabled the appeal to be heard, but the original filing was premature.

The appeal was dismissed in relation to all five applications.

1. UK Intellectual Property Office: The Deputy Director, acting for the Comptroller, refused the five SPC applications on 16 November 2009.
2. High Court (Patents Court): The appeal was dismissed after the Comptroller’s decision was issued. The court held that the original appeal had been filed prematurely.