Takeda Chemical Industries Ltd v Patent Office

For supplementary protection, a combination of active ingredients must itself be protected by the basic patent. It is insufficient that one component infringes, since that would extend the patent monopoly to products never protected by the patent. The marketing authorisation must likewise authorise the relevant product. An authorisation for one compound, even with an indication that it may be used alongside antibiotics, does not authorise the antibiotic combination. The supplementary protection certificate regime extends existing patent protection; it does not create protection for a different monopoly.

Takeda appealed against the refusal of six applications for supplementary protection certificates under the SPC Regulation. The applications concerned lansoprazole used with specified antibiotics to treat H. pylori. Takeda relied on patents protecting lansoprazole and on a varied marketing authorisation covering lansoprazole for the relevant indication.

The issues were whether the combinations were protected by a basic patent for the purposes of Article 3(a), and whether the varied authorisation was a valid authorisation to place the relevant product on the market under Article 3(b). A further issue had been remitted and resolved in Takeda’s favour, but was not in dispute on this appeal.

1. Appeal dismissed. The applications failed under both Article 3(a) and Article 3(b) of the SPC Regulation.

2. Article 3(a) requires the product for which protection is sought to be protected by the basic patent. A combination of lansoprazole and an antibiotic was not itself protected merely because the combination would infringe through the presence of lansoprazole. The patents protected lansoprazole, not every combination containing it.

3. The purpose of the Regulation is to provide supplementary protection for the relevant part of the patent monopoly. It does not provide protection for a different monopoly, such as the monopoly over lansoprazole combined with antibiotics. The Swedish courts’ decision in A/B Hassle (Case number 3248-1996) supported the same conclusion.

4. Article 3(b) also required an authorisation for the relevant product. The original and varied licences authorised lansoprazole as such. They did not authorise the marketing of the antibiotic component or of the combination. A combination product would require an authorisation directed to that combination.

5. A later licence expressly covering lansoprazole and two specified antibiotics would have satisfied Article 3(b), on the Comptroller’s accepted position. That issue did not arise because the current applications failed under Article 3(a) and concerned the earlier authorisation.

The appeal was therefore dismissed.

• High Court (Patents Court): appeal from the Comptroller General of the Patent Office dismissed. An earlier remittal by Laddie J had resolved a third issue in Takeda’s favour, but that issue was not pursued on this appeal.