Extended protection for innovative pharmaceutical products in EU-supplementary protection certificates

Authors: Divya Dubey (Senior Associate) and Sadaf Mariam (Associate)

A fact  long  known - and acknowledged regarding pharmaceutical products is that the duration of negative monopoly bestowed as patent rights is not enjoyed by the  products as the period gets effectively shortened due to the  prolonged time taken to procure regulatory approvals. Recognizing this, several countries introduced patent term extensions to compensate innovative drug companies for this time lost on approval procedures. Within the European Union, this extended protection has taken the form of supplementary protection certificate, which is a right separate from patent rights, however, allows the same protection for pharmaceutical products after the expiry of basic patent rights.

 Supplementary protection certificates

Supplementary protection certificates are sui generis rights, meaning they are standalone rights and do not extend the term of the basic patent which covers a certain product,  rather take effect on expiry of the patent. These rights are meant for both medicinal products and plant products. The regulation governing medicinal products (EC No. 469/2009) is known as the Medicinal SPC regulation. SPCs are also granted for paediatric products under the Paediatric Use Regulation (EC No. 1901/2006).  This allows for a further six month extension on products which were the subject of clinical trials for paediatric patients.   Although SPCs were originally introduced in 1992, the aforementioned regulation was actually formally codified only in 2009. It encompasses a total of 23 articles which lay out the definitions and demarcate its scope. However, certain terms have not been clearly defined in the articles, which have led to litigation in both the national as well as the Court of Justice for the European Union (CJEU).

SPCs are individually granted by the national patent offices of member states of the EU. Although SPCs can be obtained after national authorizations, regulation (EC) No. 726/2004 also allows applicant to seek centralized marketing authorizations granted by the European Commission after a positive opinion of the European Medicines Agency (EMA). Such a centralized authorization allows granting of SPCs in all member states of the EU. The patent on the basis of which an application is made might be a national patent or an EU patent. In order for a product to qualify for an SPC, it has to satisfy certain criteria laid down in the articles of the SPC regulation. These criteria (encompassed by Article 2) are (i) the medicinal product is protected by a basic patent still in force (ii) the product was the subject of administrative authorization prior to being placed on the market. It is also necessary that application for an SPC be made within 6 months of date of obtaining market authorization or six months from date of grant of basic patent (as per Article 7). Another important criterion is that the basic patent for which an SPC can be granted protect (i) a product, (ii) a process to obtain a product or (iii) an application of a product.

Who can obtain an SPC?

Applicant for an SPC can be an entity that holds a basic patent covering the product in respect of which the SPC is sought. It can also be a licensee of such an entity. It is possible to obtain multiple SPCs from the same basic patent if the conditions for obtaining them are satisfied under article 3(a) of the Regulation.

Article 3

In case of a dispute arising from an SPC, an applicant can approach a national court of the member state in which the SPC was sought. If the question remains unresolved, the national court can, refer the case to the CJEU.  Although there are several Articles dealing with how SPC are regulated, the interpretation of some of these has lead to more litigation, such as Article 3. This article stipulates that to obtain an SPC for a product, it should

(a) be protected by a basic patent in force

(b) a market authorization to place the product on market has been granted

(c) the product has not previously been subject of another SPC and

(d) the authorization obtained as per article 3(b) above was first authorization to place product on the market.

Article 3(a) above, which requires a product to be 'protected' by a basic patent in force, has been the subject of numerous litigations, as a result of the fact that no definition of 'protected' has been provided in the SPC regulation. Several cases have grappled with scope of Article 3(a). Case C-392/97 clarified that the question of whether a product is protected under Article 3(a) is to be decided under national rules of the basic patent. In C-322/10, the CJEU said that an SPC cannot be granted for a product if it has active ingredients that are not specified in the wording of the claims of the basic patent. In case of combination products, in a number cases (C-518/10, C-6/11 and C-630/10),   the court specified that the active ingredients in a product should be 'identified' in the wording of the claims. More recently, in C-121/17, the court said that in case of a combination of products, the active ingredients pertaining to that product need not be explicitly mentioned in the claims to be the subject of an SPC. It is only necessary that the claims necessarily relate to the combination of these active ingredients. In the most recent case in this regard, C-650/17, the CJEU clarified that a product would be deemed to be protected by the claims of a patent if (i) it corresponds to a general functional definition used in one of the claims of the basic patent, (b) forms part of the invention protected by that patent, and (c) a person of ordinary skill in the art would be able to, at the date of filing the application, infer the product from embodiments of the patent.

Article 3(b), which requires a product to have been granted a valid market authorization in the territory where the SPC was sought, has also been the subject of clarification by the Attorney General in C-322/10. Therein, he stated that in case the authorized product (for which SPC is sought) has additional active ingredients other than those specified in the claims, the granting of an SPC shall not be precluded on the ground of having an additional active agent. The same reasoning and conclusion was also found in C-422/10.

Article 3(c), which stipulates that the product for an SPC application should not have been the subject of a previous SPC, is intended to prevent multiple SPC being obtained for the same product. In C-484/12 and C-443/12, it was clarified by the CJEU that it is possible to obtain multiple SPCs on products originating from the same basic patent if all those products are protected by the claims of the same basic patent. It is also possible for multiple parties to obtain SPCs pertaining to different aspects of the same product (such as process for manufacturing the product, therapeutic use of the product) if the other conditions laid out in the regulation for grant are satisfied.

Article 3(d) stipulates that the authorization obtained as per article 3(b) was the first authorization to place the product on the market. In C-202/05, it was held that if a product had been the subject of market authorization for a first therapeutic use, it did not qualify for an SPC for a second therapeutic use. In C-130/11, the court clarified that even if, for the product in question, a market authorization for a similar indication had already been obtained by a third party, it did not prevent the granting of an SPC for the same product under different indication if it is covered by valid patent claims.   

Conclusion

The SPC regulation is an ongoing area of litigious action as the scope and definition (of terms) in several of its Articles remains uncertain. As judgments handed down in cases continue to resolve some of these issues, much remains to be interpreted and clarified.