Pages 96-104

WORKING SESSION

Latest case law concerning supplementary protection certificates

WORKING SESSION

Latest case law concerning Supplementary protection certificates

Chair: Martine Regout (BE)

İlhami GÜNEŞ

Judge, Civil Law Court for IPR, Izmir

Supplementary protection certificates in EU law: a compensation mechanism and Turkey's position

I. Introduction

The exclusive right granted by a patent is not indefinite and, although it is restricted to a statutory period of twenty years, it is very difficult, indeed virtually impossible, in certain areas of industry for protection to be made to commence at the same time as the commercialisation of the patented product - however much the patent holder may wish for this.

Most countries envisage a statutory trial period for pharmaceuticals before they are placed on the market. Factors such as the patent application acceptance process, administrative requirements, extensions to the product development process and, especially, the need for authorisation to put products on the market impact on the effective patent protection period. In the pharmaceutical and agricultural chemicals sector, the requirement for lengthy testing in order to determine whether new pharmaceuticals or pesticides and herbicides are effective and safe reduces the effective patent protection period. This lengthy testing and registration process may last as long as eight years.

In the pharmaceutical sector, the cost of bringing a new product to the market may be as high as 800 million dollars, a
substantial amount of which is spent on clinical testing.1

The European Commission has adopted directives in the area of human and veterinary medicaments. Certain delays frequently occur before products are brought to the market. When a pharmaceutical is under patent, the patent protection period is reduced and the benefit that may be made of it is frustrated.

The supplementary protection remedy affords supplementary protection that may be granted in the case of patents obtained particularly in the fields of human pharmaceuticals, plant protection products and veterinary medicaments. A supplementary protection certificate (SPC) is a sui generis industrial property right. The aim of such certification is to enable the pharmaceutical industry to obtain effective patent protection. It facilitates the conducting of clinical studies and testing, and the obtaining of authorisation to put products on the market.

Supplementary protection starts on expiry of the relevant patent protection period. This type of right may be obtained for various biological active substances in human or veterinary medicaments and plant protection products, as well as their derivatives. It extends the monopoly rights period for compositions with one or more patented-protected active substances.

There is a general debate on product definitions in SPCs and on the subject of patent protection and SPCs. SPCs may be obtained for national and European patents.

II. Relevant EU legislation

SPCs sit on the boundary between patent law and administrative/regulatory law; but knowledge of patent law principles and local regulatory law is also required. SPCs were created and are governed by the following EU regulations:

• EU Council Regulation No. 1768/92 concerning medicinal products and EU Parliament and Council Regulation No. 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products
• EU Council Regulation No. 1610/96 concerning plant protection products
• EU Council Regulation No. 1901/2006 concerning medicinal products for paediatric use

III. Purpose of the system

The basic aim of adopting these certificates is to encourage innovative efforts such as patents. Most countries provide for a regulatory framework for the testing of pharmaceuticals prior to them being placed on the market. That is why the European Union introduced the above-mentioned regulations. Often, there will be substantial delays prior to the product coming on the market. Clearly, where a pharmaceutical is the subject of a patent, this reduces the effective term of protection and often would make its exploitation uneconomic.2 The normal twenty-year duration of patents undergoes a de facto reduction in the pharmaceutical sector. Depending on the type of patent, the de facto protection period may vary from thirteen years under molecule patents to between fourteen and sixteen years under other patents. Justice thus demands an extension of this nature if the patent holder is to derive effective benefit from protection.

IV. Conditions for obtaining a supplementary protection certificate

1. Criteria

The protection provided by an SPC extends to the "product" covered by the authorisation and any use of that product as a medicinal product that has been authorised before expiry of the SPC. The product is defined as the "active substance" (in the case of plant protection) or "ingredient" (in the case of medicinal products) for which approval has been gained.3 SPCs are intellectual property rights that are based on and similar in nature to patents. According to EU Parliament and Council Regulations 1768/92 and 469/2009:

(i) the patent protecting the product must still be in force;

(ii) the product must have a valid approval or authorisation to be placed on the market;

(iii) the product must not yet have been the subject of a supplementary protection certificate;

(iv) the authorisation to place the product on the market must have been granted for the first time.

The above-mentioned regulations apply in all EU member states. However, SPCs are only valid on a country-by-country basis in the country where they have been obtained.

The basic patent may by itself be a patent for a process to obtain a product or products. It may protect a preparation, defined as being a solution or mixture consisting essentially of two or more substances, at least one of which is an active substance, for a plant protection product. The subject and scope of the supplementary protection is the same as that of the basic patent and is also subject to the same limitations and obligations. So it is important to define a few terms here. Basic patent means a patent protecting (i) a product as such, (ii) a process to obtain a product or (iii) an application of a product; product means the active ingredient or combination of active ingredients of a medicinal product; and medicinal product means the substance presented for treating or preventing disease in humans.

The term "active substance" or "active preparation" is construed to mean a substance for which authorisation to enter the market has been obtained and which is protected by patent, and generally its closest derivatives, particularly in the form of an ester or a salt. However, this is with the proviso that the active substance in question is not a new active substance. The SPC covers one product/patent only. A separate SPC must be additionally obtained for each individual product.

It has been suggested that the most appropriate interpretation of the definition of a product protected by a basic patent is that protection will be conferred on the active ingredient however formulated and for any therapeutic use covered by a marketing authorisation granted before expiry of the certificate.4

2. Entitlement

The owner of the basic patent and his successors are also entitled to obtain an SPC. Even if this is not clearly stipulated in the Regulation, according to the prevailing view there is no absolute requirement for the applicant to be the holder of the authorisation to enter the market. However, if a licensee has obtained authorisation, application may be made on behalf of the patent holder for supplementary protection. Certain problems may arise if other persons have obtained process patents containing novelty and inventive steps for the same active substance. According to the Regulation, if a product is already the subject of an SPC, no additional SPC can be issued. If a party holds a process patent and, after having obtained authorisation to market the product, acquires an SPC, the other patent holder may not obtain an SPC even if he relies on a prior right.

Even though the Regulation has not made specific provision concerning the status of existing licences, as it is stated in Article 5 of the Regulation that the certificate is subject to the same limitations and the same obligations as the basic patent, it is accepted that licensees will also benefit from the period protected by the certificate.

3. Lifetime of a supplementary protection certificate

The SPC has been devised to compensate for the time lost by virtue of regulatory procedures imposed on the manufacture and sale of such products. On the other hand, an SPC normally has a lifetime of five years, and this may be extended to at most five and a half years depending on the applicable approval process for the market entry of clinical data compiled where human medicinal products are concerned. The certificate takes effect at the end of the lawful term of the basic patent.5

4. Exploitation of a supplementary protection certificate

The supplementary protection certificate is accepted by all European Union member states under the relevant Regulation. However, as it has no unified effect, application must be made for a certificate on a national basis. The rights granted under an SPC are subject to the same limitations and obligations as applied to the basic patent. An SPC will therefore be subject to licences of right if the patent would have been subject to such a licence prior to its expiry.6

There exist mechanisms with regard to SPCs in all European Union member states. However, separate application needs to be made in each country. An SPC is valid only in the country in which it is obtained.

5. CJEU decisions

The CJEU7 takes important decisions on the interpretation of Regulation No. 469/2009. In practice there are problems in establishing what is meant by the terms "product", "active ingredient" and "combination of active ingredients". The CJEU, in its interpretation of the term "product", has consistently defined this as "active substance or active ingredient".

Certain decisions assume importance for SPC strategy. In the Eli Lilly v HGS decision, the court refrained from a broad interpretation in the matter of protection under a valid basic patent. A product may be defined specifically enough such that the claims are in functional terms. In Actavis v Sanofi and Georgetown II, on the other hand, it was stated that it is possible for a separate SPC to be obtained for each basic patent. The court has also, in these decisions, made assessments regarding the duration of SPCs. The court has established a new criterion for the issuing of SPCs: if the SPC is inconsistent with the purpose of Regulation No. 469/2009, it can be refused.

V. Patent exploitation and the supplementary protection remedy in Turkey

Within the pharmaceutical sector's competitive research environment, leaving aside the difficulty in obtaining a patent, the administrative problems in ensuring that a patent effectively serves its holder's interests make SPCs necessary. At the same time, according to the Competition Authority's latest reports, it takes an average of seven months for generic medicines to enter the market in Turkey once the patent protection period expires. This period can be as short as four months in the case of commercially successful medicines.

As Turkey is not yet a member of the European Union, it is not bound by EU legislation on SPCs. This means that there are no mechanisms in Turkey enabling SPCs to be applied for and obtained.

However, according to the Competition Authority's reports, since it has been ascertained that the potential lost patent life incurred for administrative authorisation reasons by patent-holder pharmaceutical companies is fairly insignificant, there is no need for a supplementary protection period.8 However, this matter falls within the realm of domestic political preferences.

VI. Conclusion

Supplementary protection is key to the pharmaceutical industry and has now been made more easily available by the CJEU.9 It is very important for industry because up to 80% of the total revenue for a major pharmaceutical product can be generated in the SPC system.

However, issues remain. Until 2012 there was uncertainty surrounding the application of SPCs to combination products. Two important CJEU decisions, Medeva10 and Novartis v Actavis11, have clarified these difficult issues and provide a reasonably workable solution to those who wish to obtain and enforce SPC protection for vaccines and other combination products. From case law it can be inferred that the CJEU refrains from opening a path to evergreen patents and on the other hand attaches importance to the therapeutic effect of excipients in combination products. Even if protected by a basic patent, a product must fall within the scope of the claims either expressly or implicitly, but then the claim must necessarily and specifically be understood to relate to the product.

From comments made on the Eli Lilly case, it is clear that the CJEU needs to consider reform on the issue.

Bibliography

1. Catherine Katzka, "Interpretation Of The Term 'Product' in EU Council Regulations 1768/92 and 1610/96 on Supplementary Protection Certificates", Journal of IP Law, 2008, Vol. 3 No. 10.

2. Guy Tritton, Intellectual Property in Europe, 2002 London.

3. C. Emin Gülergün/H. Deniz Karakoç/ C. Atalay Hatipoğlu, 27.03.2013 Tarihli Rekabet Kurumu Sektör Araştırma Raporu (Report of Competition Authority).

4. Gertjan Kuipers/Tjibbe Douma/ Margot Kokke, "European Union: Recent Developments Regarding Patent Extensions (SPCs And Pediatric Extensions)", Bio-Science Law Review, Vol. 12, Issue 4.

5. Lionel Bently/Brad Sherman, Intellectual Property Law, 2002 Oxford New York.

6. www.curia.europa.eu