Takeda Chemical Industries -v- Comptroller General of the Patent Office
It is possible in certain circumstances to extend the duration of patent protection for a medicinal product by a period of up to five years by applying for a Supplementary Protection Certificate ("SPC"). The aim of a SPC is to compensate the patent owner for the time lost, in terms of patent protection, in conducting lengthy clinical trials and obtaining market authorisation.
The SPC takes effect on expiry of the basic product patent and may be granted for a patented active ingredient or under certain circumstances a mixture of active ingredients (combination therapy). Where a patent covers several active ingredients, which have been incorporated into different products, each of which was the subject of a regulatory procedure, separate SPCs must be sought for each active ingredient.
In the recent case of Takeda Chemical Industries -v-Comptroller General of the Patent Office ([2003] EWHC 649 (Pat), the court rejected an application for a SPC for a combination drug therapy where only a basic product patent covering one active ingredient existed.
Takeda Chemical Industries owned two patents for the compound Lansoprazole (Zoton™), for use in the treatment of infections caused by the bacteria H. pylori and other upper gastrointestinal tract infections. Takeda also had a product licence for the use of Lansoprazole, when used in combination with certain antibiotics. Takeda Chemical Industries applied to the Patent Office for a SPC covering the combination of Lansoprazole and an antibiotic compound. The Patent Office refused to grant the SPC, and Takeda appealed the decision. The Court affirmed the Patent Office refusal to grant the SPC, because Article 3(a) of the SPC Regulation (EEC/1768/92) specified that the product had to be protected by a basic patent in force, whereas, even though the combination therapy would infringe the patent, the Takeda patents only covered the Lansoprazole element of the combination.
The case demonstrates that combination therapies will not be granted a SPC, unless a previous patent exists for the combination.
Contact
For further information, please contact Stephen Whybrow by telephone on +44 (0) 20 7367 2175 or by e-mail at [email protected], or Nick Beckett by telephone on +44 (0) 20 7367 2490 or by e-mail at [email protected], or Aasim Qureshi by telephone on +44 (0) 20 7367 3620 or by e-mail at [email protected].
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