High Court Provides Clarification On The Application Of The SPC Regulations To Vaccines

The High Court has upheld the decision of the IPO that a Supplementary Protection Certificate (SPC) could not be granted for a combined vaccine product containing more active ingredients than were protected by the basic patent. The news is disappointing for many innovator companies who operate in the vaccine sector who are now less likely to be able to obtain SPCs in relation to combination vaccine products.

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Background

SPCs were introduced to compensate for the long time needed to obtain marketing authorisation (MA) for certain products, including pharmaceuticals. Council Regulation 469/2009 concerning the creation of a supplementary protection certificate for medicinal products (the "SPC Regulation") provides for an additional period of protection, not exceeding five years beyond the life of the patent, which is confined to the particular pharmaceutical product which has been given the initial MA. The SPC Regulation governs the grant of SPCs in Europe. Article 3 contains certain requirements that must be met in order for a SPC to be granted, including that the product must be protected by a patent which is in force, and must be validly authorised to be placed on the market as a medicinal product.

Article 4 of the SPC Regulation provides further guidance:

"Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorization to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate."

Medeva BV v Comptroller General of Patents

The claimant, Medeva BV, owned a patent for a method of making a whooping-cough vaccine. The vaccine was not marketed as a single vaccine but in combination with other vaccines against various childhood diseases. Medeva had obtained five different MAs for the various combinations and made five applications to the Intellectual Property Office (IPO) for SPCs, one in respect of each combination which had obtained MA.

The Deputy Director refused the SPC applications on the basis that, in each MA, the list of active ingredients was far more extensive than the particular antigens which were the subject of Medeva's patent. This approach was consistent with a number of High Court decisions where the court had considered a product which comprised a...