High Court provides clarification on the application of the SPC Regulations to vaccines

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 combination of active ingredients, not all of which were the subject of the relevant basic patent.

The High Court held that there was no justification for applying a different test to vaccines, and nor was there any basis in the SPC Regulation for applying different qualifying criteria to different classes of product. Therefore, SPCs could not be granted in relation to Medeva’s patents since the MA was for a different “product” than that which benefited from patent protection.

Procedural Issues

The High Court also considered a procedural issue regarding what constituted a decision of the Comptroller that could be appealed.

Medeva applied for its patent in 1990, however, the patent was not granted until 2009. In order to qualify for a SPC the applicant must have a patent in force. Accordingly, Medeva had to act quickly to obtain the SPC before the expiry of the patent in 2010. The SPC applications were filed in April 2009, two months after the grant of the patent. In a letter dated 25 June 2009, the agents acting for Medeva indicated to the IPO that if they did not hear from it with a decision in relation to the SPC applications by 31 July 2009, they would treat this as a refusal of the applications. The examiner at the IPO responded on 31 July 2009, giving detailed reasons why he considered the applications should be refused. Medeva took the position that the letter of 31 July 2009 constituted a final decision, and on 29 August 2009 filed its notice of appeal, in which it stated that it regarded the letters of 31 July 2009 as a decision refusing the applications.

The Comptroller applied to strike the appeal on the basis that there was no decision from which to appeal. The High Court held that the letters dated 31 July 2009 merely contained a statement of the opinion of the examiner and invited a response, and were not decisions against which appeals could properly be filed, and that therefore the appeal was prematurely filed. It was also emphasised that patent practitioners should know that an examiner had no authority to make a decision on behalf of the Comptroller to refuse an SPC application.

Comment

This decision came only a month after another ruling by the IPO (Georgetown University) on similar facts, (which had referred to the Hearing Officer’s decision in Medeva), where a patentee was denied a SPC on the basis that the “product” which was the subject of the patent was not the same “product” as benefited from the MA. This case again involved vaccines in which the marketed product contained a combination of strains, which were in turn protected by individual patents.

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. Companies will need to ensure that they pay careful consideration to the scope of their MA and patent applications to increase their chances of obtaining SPC protection.

For full case reports please see:

Medeva BV v Comptroller General of Patents [2010] EWHC 68 (Pat), 27 January 2010
Georgetown University and others, BL O/401/09, 29 December 2009.