The pharmaceutical and biotechnology industries are heavily dependent on patents as a means of securing future revenues. As discussed in Why Life Science Patents Are a Breed Apart on page 13, these industries are also subject to protracted regulatory approval processes.

In the European Union, Council Regulation (EEC) No. 1768/92 (the Regulation) concerning the creation of Supplementary Protection Certificates (SPCs) for medicinal products came into force on 2 January 1993. It was intended to compensate those bringing drug products to market for the delays incurred because of the regulatory process by providing extra legal protection at the end of a patent’s life. An SPC can be used to prevent the use of a patent-protected active ingredient (or a combination of active ingredients) in a medicinal product that has received marketing authorisation in an EU Member State.

A “basic patent” must be designated in the application for an SPC which must protect an active ingredient (or a combination of active ingredients), a process to obtain such a product or an application of such a product. If the SPC is granted, it will confer the same rights as the basic patent. However, the term of an SPC is limited. It is worked out by reference to the date of first marketing authorisation in the European Union, and it can be a maximum of five years from the date of expiry of the basic patent.

Because the Regulation is a piece of EU legislation, the national courts in the EU Member States can refer questions to the European Court of Justice (ECJ) to clarify the meaning of terms contained in the Regulation. As an example, the ECJ has ruled that, where a product in the form referred to in a market authorisation was protected by a basic patent that was in force, an SPC will cover the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent. So, if a basic patent covers an active substance and various derivatives (e.g., salts and esters), the corresponding SPC will confer protection against unlicensed production of the active ingredient and any derivatives of the active ingredient that fall within the claims of the basic patent.

Sometimes, drug products only hit peak sales near the end of the term of the basic patent. An SPC extends these “golden years”, which is why SPCs have proved so valuable to the innovative drug industry. Indeed, most small molecule drugs that are now being targeted for generic competition in Europe are subject to SPC protection. The European Commission has argued that the mere existence of SPCs deter generic drug manufacturers from preparing to launch products that are competitive with SPC-protected innovator products. Given the powerful deterrent effect of SPCs, it is perhaps not surprising that there have been numerous cases in which the researchbased industry has tried to extend the boundaries of protection conferred by them and the Regulation.

Product Development and SPCs Over the last decade, research has been concerned with developing new forms of drugs to be administered to patients. These include reformulations of existing drugs, combination therapies (co-administration of two or more drugs), optimised dosage regimes and novel drug delivery systems. The Regulation now has to cope with this new wave of products and related cases examining the type of medicinal product that can be protected by an SPC.

Takeda Chemical Industries Ltd. recently failed to convince the UK Patents Court that its combination product came under the protection of a basic patent. Takeda owned two patents to the compound lansoprazole for the treatment of acid-related disorders of the gastro-intestinal tract. Takeda applied for SPCs for various combination products consisting of lansoprazole plus any two named antibiotics. However, the use of the antibiotics in combination with lansoprazole was not disclosed or suggested in either of the patents designated by Takeda as the basic patent. The court therefore ruled that only the lansoprazole element of the combination product was protected. In its ruling, the court emphasised that the SPC system is to provide only supplementary protection to that provided by a patent. In other words, it is designed to extend only the relevant part of the basic patent monopoly.

Takeda had a basic patent monopoly for lansoprazole, but not for the combination of lansoprazole and an antibiotic. Takeda’s applications for SPCs were therefore refused. An important question came before the ECJ in 2006: What constitutes a combination of “active ingredients” for the purposes of the SPC Regulation? Gliadel treats recurrent brain tumours. Its mechanism consists of the slow release by polifeprosan of a cytotoxic active ingredient, carmustine. In the Gliadel delivery system, polifeprosan acts as a biodegradable matrix; it is not itself a therapeutically active agent. The applicant claimed that polifeprosan was an essential component of Gliadel because it contributed to the efficacy of the medicinal product. A German court referred the case to the ECJ, requesting it to interpret the Regulation and specifically to determine whether a “combination of active ingredients” could include a combination of two substances, only one of which actually has therapeutic effects, the other being therapeutically inert but necessary for the overall therapeutic efficacy of the drug. The ECJ gave its ruling on 4 May 2006. It held that a substance that does not have any therapeutic effect on its own but which is only used to obtain a certain pharmaceutical form of the medicinal product is not covered by the concept of “active ingredient” in the Regulation.

Accordingly, the “combination” of carmustine and polifeprosan in Gliadel was not eligible for SPC protection. Another case is currently pending before the ECJ. Yissum Research and Development Company of the Hebrew University of Jerusalem sought an SPC for a combination of calcitriol with an ointment base for the topical treatment of psoriasis.

Calcitriol itself was an established medicinal product that was no longer eligible for protection by an SPC. Yissum argued that, in the case of a basic patent that contained a “Swiss” form of claim (a new use for an existing compound), the “product” that is protectable by SPC should incorporate that new use. This issue has been referred to the ECJ, although a decision is likely to be at least two or three years away.

When it introduced its proposals for SPCs, the European Commission’s aim was “specifically to ensure that research based industry has a market exclusivity of sufficient length to permit recovery of their investments.” Considerable research effort is now directed towards combination products and drug delivery systems and there are a growing number of companies in Europe that specialise in these areas. Many small molecule products and biologics continue to be validly protected by SPCs in Europe.

However, the availability of legal protection under the SPC regime for novel therapies, such as combination products and drug delivery systems, is likely to continue to be tested in the national courts of the EU Member States and in the European Court of Justice.