Patents: Supplementary Protection Certificates 2003 developments

Combinations required to be protected by a basic product patent

It is possible in certain circumstances in effect to extend the duration of patent protection for a medicinal product for a period of up to 5 years by applying for a supplementary protection certificate (SPC). The aim of an SPC is to compensate the patent owner for the time lost, in terms of patent protection, in conducting lengthy clinical trials and obtaining a marketing authorisation. The SPC takes effect on the 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).

In the case of , the Court rejected an application for an SPC for a combination drug therapy where only a basic product patent covering one active ingredient existed.

Takeda owned two patents for the compound lansoprazole for use in the treatment of upper gastrointestinal tract infections. Takeda also had a product licence for lansoprazole, when used in combination with certain antibiotics. Takeda applied to the Patent Office for an 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. 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. Jacob J stated “the so called “combination” of lansoprazole and an antibiotic would only infringe because of the presence of the lansoprazole. In truth, the combination is not as such “protected by a basic patent in force”. What is protected is only the lansoprazole element of that combination. It is sleight-of-hand to say that the combination is protected by the patent. The sleight-of-hand is exposed when one realises that any patent in Mr Alexander’s sense protects the product of the patent with anything else in the world. But the patent is not of course for any such “combination”.”

The case demonstrates that combination therapies will not be granted an SPC, unless an underlying patent exists for the combination itself.