PECULIARITIES OF THE PROTECTION CONFERRED TO MEDICAMENTS IN EUROPE

Transcription

1 PECULIARITIES OF THE PROTECTION CONFERRED TO MEDICAMENTS IN EUROPE. When launching medicaments on the European market, pharmaceutical companies should be aware of the possibilities and legal consequences involved by their own or third party s IP rights in this highly competitive field of business. Moreover, the balance between IP rights, the principle of free trade and the public interest should be kept in mind when seeking commercial success in the pharmaceutical sector in Europe. Therefore, in the following article an overview of peculiarities concerning the protection conferred to medicaments relating to patent term extension, parallel imports and exhaustion of IP rights, as well as generic medicaments in Europe will be given. In particular, this article might be suited as a basis for practitioners in the field of pharmacology to deal with strategic questions on commercial exploitations of existing IP rights and of medicaments already put or to be put on the European market. by Dr. Ralf Perrey and Dr. Konstanze Lenhard Published in the Journal of the Patent and Trademark Office Society (JPTOS) in June 2009, Vol. 91, No. 5 Page 1 of 2

2 1. Introduction Regarding protection of medicaments in Europe, there are some peculiarities that affect the scope, enforcement or the duration of the respective intellectual property rights. Some of said peculiarities apply only to medicaments protected by patent rights and not to any other patented subject matter, and some apply only to medicaments per se. For example, as far as medicaments having a marketing authorization in the European Union (EU) are concerned, there are certain exclusive rights conferred to the data needed for obtaining said marketing authorization, regardless a whether they are protected by a patent or not. As a consequence, said data can only be used for obtaining a marketing authorization for generic medicaments after a certain period of time. The reasons for this can be found in the general understanding that the patent protection of medicaments has to be adapted to the special interest of the public in a continuous development of new or improved drugs. Further, the time consumed by the approval procedure to obtain a marketing authorization mandatory in each state in which a medicament is put on the market should not unduly delimit the time of protection for said medicament in order to keep the development of a medicament attractive and reward it with an adequate patent protection. However, (i) the development of improvements of an already patented medicament should not be hindered by said patent, and (ii) the principle of free trade within the EU should be observed. Thus, regarding patented medicaments in Europe, the proprietor s rights derived from the patent system must be balanced out against the principal of free trade within the EU and the public interest regarding the availability of medicaments. In order to harmonize the requirements set out in the national laws of the EU member states and the jurisdiction interpreting said law, the Council of the EU, i.e. the European Council (EC), together with the European Parliament, has enacted EC Regulations and EC Directives, the adherence of which is monitored by the European Court of Justice (ECJ). In the following, peculiarities concerning the protection conferred to medicaments relating to patent term extension, parallel imports/exhaustion of patent rights, and generic medicaments in Europe will be discussed. 2. Supplementary Protection Certificate In Europe, a national patent generally has a term of 20 years starting from the filing date. In order to at least partially compensate for the time lost to obtain a marketing authorization for a medicament, the Council of the EU has adopted the Council Regulation (EEC) No. 1768/92 of June 18, 1992, concerning the creation of a Supplementary Protection Certificate (SPC) for medicaments, wherein the requirements for a patent term extension are stipulated. While said Regulation entered into force in each EU member state on January 2, 1993, the non-eu member states in Europe, like Switzerland, Iceland, Liechtenstein, or Norway, have provided similar national provisions for obtaining a patent term extension for pharmaceutical products. 2.1 Obtaining an SPC In order to obtain an SPC, several prerequisites have to be met. In particular, the product to be subject to an SPC must be covered by a basic patent in force; a valid authorization to place the product on the market as a medicament has to be granted; the product must not already have been the subject of an SPC; and the above valid authorization must be the first authorization to place the product on the market as a medicament. Page 2 of 10

3 The application for an SPC has to be filed within six months from the date when a marketing authorization for the medicament has come into validity. If the authorization is granted before the grant of the patent, the application for an SPC has to be filed within six months from the date of the grant of the patent. In the case of European patents granted under the European Patent Convention (EPC), the above six months term begins with the publication of the grant in the European Patent Bulletin according to Art. 97(4) EPC. 2.2 Subject Matter of an SPC Regarding the subject matter for which an SPC can be obtained, it is stipulated in Art. 4 of the Regulation EEC No. 1768/92 that the protection conferred by an SPC extends only to a patent-protected product covered by the marketing authorization and for any use of a product as a medicament that has been authorized. In this context, according to Art. 1 (b) of the above Regulation, the term product means the active ingredient or combination of active ingredients of a medicament. In a recent judgment (C-431/04), the ECJ has stated that an SPC cannot be granted for socalled formulation patents or combinations, in which only one component of a formulation has a pharmacological effect and an SPC has already been granted for the component having the pharmacological effect. According to established national case law, it is not possible for the same applicant to obtain two SPCs for the same product, since it is stipulated in Art. 3 (c) of EEC No. 1768/92 that no SPC can be granted in a member state of the EU if the product has already been the subject of an SPC in the same member state. This is further emphasized by Art. 3 (2) 1 st sentence of EEC No. 1610/96, which stipulates that the holder of more than one patent for the same product shall not be granted more than one certificate for that product. According to paragraph (17) of the preamble of EEC No. 1610/96, Art. 3 (2) of said Regulation is also valid for the interpretation of Art. 3 of EEC No. 1768/92. However, it should be noted that two SPCs can be obtained for the same product if said product is protected by two patents owned by different persons, as outlined in the judgment C-181/95 of the ECJ. In another recent judgment (C-202/05) the ECJ has stated that an SPC cannot be granted for the use of a pharmaceutically active component, but only for the component as such. Further, according to the judgment C-31/03 of the ECJ, the grant of an SPC on the basis of a medicament for human use is precluded if a marketing authorization for that product as a veterinary medicament has already been granted. 2.3 Term of an SPC As a general rule, since the implementation of the SPC in Europe aims at compensating for the time lost to obtain a marketing authorization for a medicament, the term of an SPC depends on the date of issuance of the first marketing authorization within the European Economic Area (EEA). Further, in its judgment concerning the joined cases C-207/03 and C-252/03, the ECJ made clear that a marketing authorization in Switzerland, which is not a member of the EEA, is also considered to be a first marketing authorization for the calculation of the SPC duration. The above decision is based on the fact that a marketing authorization in Switzerland is automatically effective in Liechtenstein which is a member of the EEA. Accordingly, a marketing authorization obtained in Switzerland becomes effective in the EEA. Regarding the calculation of the patent term extension by the SPC, it should be noted that Page 3 of 10

4 such an extension can only be obtained for a maximum of five years. If the first marketing authorization within the EEA is issued less than five years after the filing date of the corresponding patent, no extension of the patent term can be obtained and therefore no SPC is granted. If the period of time between the filing date of the patent and the issuance of the first marketing authorization within the EEA is more than five years, the patent term is extended for the respective number of years minus the first five years. However, the maximum extension of the patent term obtainable via an SPC is five years. For example, if the marketing authorization was issued eight years after the application date of the patent, an SPC is granted for three years, and if the marketing authorization was issued thirteen years after the application date of the patent, an SPC is granted only for five years, i.e. the maximum extension. In order to stimulate adequate research and development concerning medicaments for the pediatric population, the Council of the EU has adopted EEC No. 1901/2006 of December 12, 2006 on medicaments for pediatric use. It is stipulated in said EEC that the proprietor of an SPC or a patent that qualifies for the grant of an SPC can obtain an additional six months extension of the duration of an SPC if certain prerequisites on medicaments for pediatric use are fulfilled. The most important prerequisite is a completed pediatric investigation plan agreed by the Paediatric Committee of the European Medicines Agency. If an SPC has already been granted, the application for an extension of duration should be filed not later than two years before the expiry of the SPC, or for the first five years following the entry into force of EEC No. 1901/2006 (which was January 26, 2007) not later than six months before expiry of the SPC. countries for which an SPC has been obtained, it is clearly outlined in Art. 5 of EEC No. 1768/92 that the SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and obligations. Accordingly, the provisions of the national law of the EU member states concerning the effects of a patent and exceptions thereto apply mutatis mutandis to an SPC being granted for a pharmaceutically active component on the basis of a respective patent. Thus, an SPC confers to its proprietor the same rights as a patent. It should be noted that in case of an SPC term extension conferred to an SPC protecting a medicament for pediatric use, the effect of the respective SPC does not change. As a consequence, the scope of protection does not seem to be restricted to pediatric applications of the medicament. 2.5 Nullity of an SPC Nullity of an SPC can be obtained by filing a nullity action with the respective authority in charge thereof in each member state of the EU. In Germany, for example, the nullity action must be filed with the German Federal Patent Court. Reasons for nullity of an SPC are the reasons laid down in Art. 15 of EEC No. 1768/92 which stipulates that an SPC shall be invalid if (a) (b) it was granted contrary to the provisions of Art. 3 of the above Regulation, i.e. if the basic requirements for granting an SPC are missing; the basic patent has lapsed before its lawful term expires; 2.4 Protection conferred by an SPC Regarding the applicability of the legal situation and jurisdiction concerning the infringement of an SPC in the European (c) the basic patent is revoked or limited to the extent that the product for which the SPC was granted would no longer be protected by the claims of the basic patent or, after the basic patent has Page 4 of 10

5 expired, grounds for revocation exist that would have justified such revocation or limitation. The legal action against the validity of an SPC can be filed alone or together with the filing of a nullity action against the basic patent. No time limit is laid down in the above regulation for filing a nullity action against an SPC; for example, in Germany it may be filed even after the expiration of the SPC, which also applies for filing a nullity action against the basic patent. 3. Parallel Imports and Exhaustion of IP Rights If a patent proprietor holds patents in various countries, he may prohibit the parallel import of the patent-protected goods by a third party, i.e. the import of products from one country to another country by a third party, where patent protection for said products exists, without permission of the patent proprietor. While there are no binding regulations within the EU for the EU member states, the national legal systems of most of the European states prohibit parallel imports. 3.1 The Principle of Exhaustion Patent exhaustion which is comparable to the first-sale doctrine in the U.S.A., does not have to be codified in the national law of the member states of the EU and therefore is in general considered to be a juridical doctrine. As a general principle in all member states of the EU, the rights conferred by a patent are exhausted if the patented product is brought on the domestic market by the patent proprietor or by others with his consent. The exhaustion only occurs in the country where the patented product is brought on the market, but not in foreign countries where a patent exists as well. It is a general principle of the jurisdiction in most of the European states that parallel imports of patented products from third countries infringe a domestic patent right and can be prohibited by the patent proprietor. In this context, it should be noted that in Great Britain instead of the principle of exhaustion, the theory of implied license is adopted. This theory of implied license means that the acquirer implicitly obtains, by the acquisition of patent-protected products from the patent proprietor, a license by silent consent to further distribute and use the patented product. 3.2 Exhaustion within the European Union The principle of the national exhaustion of patents is not unlimitedly applicable for the member states of the EU. Otherwise, the principle of free trade between the member states of the EU, as stipulated in Art. 30 and 36 of the EC Treaty, would be violated. In particular, it should be noted that in the context of parallel imports and the principle of the national exhaustion of a patent right, the EU is considered as a single country. If a product has been brought on the market in any member state of the EU with the consent of the patent proprietor, then the patent proprietor cannot prohibit the distribution and sale of the products in another member state of the EU where a patent of the patent proprietor exists. There is no exhaustion in a member state of the EU in case of (i) a parallel import of a product from a non-member state of the EU or (ii) a parallel import of a product from a member state of the EU, wherein the product concerned was not brought on the market in this state by the patent proprietor or by a third party with the proprietor s consent, which may be the case if there is no patent protection in the export country but in the import country. However, if a patent-protected product was put on the market in one member state of the EU by the patent proprietor or by a third party with the proprietor s consent and is then Page 5 of 10

6 imported to another member state of the EU where patent protection exists, a parallel import cannot be prohibited, since the patent protection is exhausted within the EU. A prohibition of said parallel import would contravene the principle of free trade according to the Art. 30 and Art. 36 of the EC Treaty. For example, if patent protection for a product exists in Germany but not in France and the product is produced in France and then exported to Germany, the question arises as to whether the German patent is infringed by said imported product. The answer to said question depends on who produces the product in France: (i) If the product is produced or put on the market by the proprietor of the German patent or by a third party with the proprietor s consent, then the patent right of the proprietor is exhausted within the EU. Anyone can import the product into Germany without infringing the German patent. (ii) If, however, the product is produced or put on the market in France by a third party without the consent of the proprietor of the German patent, the import of the product into Germany would infringe the German patent. The above has been confirmed by the ECJ in its judgment C-187/80, in which the ECJ has outlined that the right of the patent proprietor derived from a patent protection lies essentially in an exclusive right for first placing the product on the market. The ECJ has further emphasized in the above judgment that the inventor has to accept the principle of free trade of the product within the common market of the EU. Further, the ECJ has stated in its judgment C- 19/84 that Art. 30 and Art. 36 of the EC Treaty preclude the application of national provisions enabling a patent proprietor to prevent the importation and marketing of a product lawfully marketed in another EU member state by the patent proprietor himself, with his consent, or by a person economically or legally dependent on him. 3.3 Parallel import of medicaments Pharmaceutical companies often have patent protection for a medicament in various European countries and therefore often produce and/or market their products in many different countries within the EU or EEA. In order to take advantage of the price differences existing within the European medicament market, third parties who are not the proprietors of respective patent rights purchase a medicament in one EU or EEA member state, where the price for a medicament is relatively low, and import said medicament to another EU or EEA member state, where the price for said medicament is higher. Beside the doctrine of patent exhaustion within the EU as outlined above, a marketing authorization has to be obtained for the imported medicament before it can be sold in the import state. To this end, a so-called simplified procedure for obtaining a marketing authorization in the import state within the EU has been established in the member states of the EU. This simplified procedure requires a significantly reduced level of detail for the grant of a marketing authorization about the medicament that has been imported by a third party. In order to take advantage of the simplified procedure, the imported medicament must be essentially identical with a medicament already having a valid national marketing authorization in the import state. The above described simplified procedure is based on the judgment C-104/75 of the ECJ, which has been affirmed by a recent judgment of the ECJ (C-112/02). It should be noted that regarding the parallel import of medicaments from a new member state of the EU, i.e. a state which entered the EU on or after May 1, 2004, to an old member state of the EU, i.e. a state which Page 6 of 10

7 entered the EU before May 1, 2004, a socalled special mechanism is provided. In particular, this special mechanism stipulates that if a medicament is imported from a new EU member state and said medicament is protected by a patent in the import state, the proprietor of said patent can prohibit the parallel import if, on the application date of said patent, no patent protection for the medicament could have been obtained in the export state. This is particularly relevant for new EU member states which did not provide any patent protection for medicaments per se in the recent past. 3.4 Repackaging of medicaments Regarding the repackaging of medicaments labeled with a trademark for the parallel import into an EU member state by a third party, the respective trademark rights of the proprietor are set out in Art. 7(2) of the First Council Directive 89/104/EEC. The basic principle of exhaustion is laid down in Art. 7(1) of the above Directive stipulating that a trademark shall not entitle the proprietor to prohibit its use in relation to goods that have been put on the market in the EU under that trademark by the proprietor or with his consent. However, it is explicitly outlined in Art. 7(2) of the above Directive that the proprietor may oppose to the further commercialization of goods labeled with his trademark if the condition of the goods is changed or impaired by a third party after they have been put on the market by the trademark proprietor. In the judgment C-348/04 the ECJ stipulates that Art. 7(2) of the above Directive is to be interpreted as meaning that the proprietor of a trademark may legitimately oppose further commercialization of a pharmaceutical product imported from another member state of the EU in its original internal and external packaging with an additional external label applied by the importer, unless - it is established that reliance on trademark rights by the proprietor would contravene the ban on prohibiting free trade; - it is shown that the new label cannot affect the original condition of the product inside the packaging; - the packaging clearly states who overstickered the product and the name of the manufacturer; - the presentation of the overstickered product is not such as to be liable to damage the reputation of the trademark and of its proprietor; thus, the label must not be defective, of poor quality, or untidy; and - the importer gives notice to the trademark proprietor before the overstickered product is put on sale, and, on demand, supplies him with a specimen of that product. Therefore, the exception of Art. 7(2) of the above Directive applies to medicaments that are repackaged or relabeled when imported from one member state into another member state of the EU in addition to the principles of exhaustion of patent rights as outlined above. 4. Generic Medicaments In order to obtain an authorization to place a product as a medicament on the market, a manufacturer must conduct clinical tests and trials to prove the safety and effectiveness of the product. Producers of generic versions of existing medicaments, however, may infringe an existing patent protecting said medicament if they carry out clinical trials with said medicament. 4.1 Experimental Use Exemptions In order to avoid patent infringements by a producer of generic versions of existing medicaments when carrying out the necessary clinical trials, the EU member states have integrated into their national law various experimental use exemptions in respect to the scope of protection conferred by a patent protecting a medicament. Based on the finding that generic medicaments account for a major part of the pharmaceutical market, their access to the Page 7 of 10

8 European market should be facilitated. Further, the period for protection of data relating to pre-clinical tests and clinical trials should be harmonized within the EU. Therefore, the Council of the EU and the European Parliament have enacted Directive 2004/27/EC of March 31, 2004 amending Directive 2001/83/EC on the Community code relating to medicaments for human use. In particular, Art. 10 (6) of Directive 2001/83/EC has been amended so that conducting the necessary studies and trials to obtain a marketing authorization of a generic medicament and the consequential practical requirements shall not be regarded as contrary to protective rights. The above exemption from the rights conferred by patents within the EU theoretically covers all steps in the manufacture of a generic medicament, like chemical syntheses, pre-clinical tests, or any tests necessary for determining the biomedical properties of the medicament. However, the exact boundaries of the above exemption will have to be determined by the jurisdiction of the ECJ. The above amendment of Directive 2001/83/EC came into force on April 30, 2004 and has been implemented in the national law of various EU member states, such as Germany, the United Kingdom, France, Belgium, or Italy. For example, Section 11 No. 2b. has been introduced into the German Patent Act, which stipulates that the effects of a patent do not extend to studies and experiments and the practical conditions resulting therefrom which are required for obtaining a marketing authorization for a medicament in Germany. Concerning the legal situation in the non-eu member state Switzerland, it should be noted that a new statutory research exemption has recently been included in the Swiss patent law, which came into effect on July 1, Therefore, the recent changes in the Swiss patent law seem to approximate the legal situation in Switzerland regarding the experimental use exemption of products being protected by a patent to the legal situation given in EU member states. In this context, it should be noted that according to the new Swiss patent law, the regulations under the new law seem to be binding for every patent in force at the time the new Swiss patent law entered into force, i.e. July 1, 2008, as well as to pending patent applications. 4.2 Data Exclusivity Regarding data exclusivity of an approved medicament, Art. 10 (1) of Directive 2001/83/EC states that the applicant for a marketing authorization of a medicament is not required to provide the results of preclinical tests or clinical trials if the applicant can demonstrate that the product is a generic version of a reference medicament authorized within the last eight years. This also applies if the application for a marketing authorization of the generic product is submitted in a different member state of the EU than the member state which granted the marketing authorization for the reference product. However, as a marketing protection for the reference medicament, Art. 10 (1) of Directive 2001/83/EC further stipulates that the above generic product may not be placed on the market until ten years have elapsed from the initial marketing authorization of the reference product. The above marketing protection may be extended for one additional year if the holder of the marketing authorization for the reference product obtains an authorization for one or more new therapeutic indications which bring a significant clinical benefit in comparison with existing therapies during the first eight years after the first authorization. Additionally, Directive 2001/83/EC provides a further marketing protection for medicaments. In particular, medicaments having a marketing authorization are classified into either a medicament subject to medical prescription or a medicament not Page 8 of 10

9 subject to a prescription, according to Art. 70 of Directive 2001/83/EC. If a change of the above classification regarding a medicament also called Over the Counter (OTC) switch has been authorized on the basis of significant pre-clinical tests or clinical trials, the data of said tests and trials cannot be used for the change of classification of another medicament, e.g. a generic medicament, for one year after the authorization of the first change of classification, according to Art. 74a of the Directive 2001/83/EC. 4.3 Orphan Drug Exclusivity In order to provide an incentive for the pharmaceutical industry to develop medicaments for less frequent diseases, the European Parliament and the Council of the EU have adopted Regulation (EC) No. 141/2000 on orphan drugs. According to Art. 8 of the above Regulation, if a marketing authorization is granted for an orphan drug in the EU, no member state of the EU is allowed to accept an application of a third party for grant or extension of a marketing authorization for the same therapeutic indication in respect of a similar medicament for the next ten years. However, the above period of ten years can be reduced to six years if at the end of the fifth year the criteria of an orphan drug status as defined in the above Regulation are not met by the medicament anymore, particularly if the medicament is sufficiently profitable not to justify the maintenance of a marketing exclusivity anymore. 5. Conclusions As a result of the efforts to adapt the patent protection of medicaments to the special interest of the public regarding the continuous development of new or improved drugs, particular measures affecting the scope, enforcement or the duration of protection conferred to medicaments patented in Europe are provided in the national law of the member states of the EU, EC Regulations, and EC Directives, the adherence of which is monitored by the ECJ. In order to at least partially compensate for the time lost to obtain a marketing authorization for a medicament, an extension of the patent term for a protected medicament can be obtained via an SPC. The term of an SPC depends on the date of issuance of the first marketing authorization within the EEA and is five years as a maximum. Parallel import of medicaments meaning the import of patent-protected products by third parties from one country to another country where patent protection exists, without permission of the patent proprietor, is prohibited by the national legal systems of most European states. However, it should be noticed that due to the requirement of free trade within the EU, in the context of parallel imports and the principle of the exhaustion of patent rights, the EU is considered to be a single country. In case a marketing authorization for an essentially identical medicament exists in the import state, the requirements for obtaining a marketing authorization for a parallel imported medicament are facilitated. If a medicament is repackaged for parallel import by third parties, certain rules have to be considered so that not only patent rights but also trademark rights are not infringed. In order to avoid the risk of patent infringement for a producer of generic versions of existing medicaments when carrying out the clinical trials necessary for obtaining a marketing authorization for the generic medicament, the member states of the EU have integrated into their national law various experimental use exemptions from the scope of protection conferred to patented medicaments. These national experimental use exemptions now have to be in line with European law stipulating that conducting the necessary studies and trials for obtaining a marketing authorization for a generic medicament and the consequential practical requirements shall not be regarded as Page 9 of 10

10 infringing a patent protecting the medicament. Additionally, the EU has provided data exclusivity as well as orphan drug exclusivity for medicaments launched on the market for the first time in order to ensure a certain period of marketing protection for medicaments before a marketing authorization can be obtained by third parties for a generic medicament relying on the clinical data provided for said medicament. In summary, the legislation as well as the jurisdiction within the EU aim at balancing out (i) the protection conferred by intellectual property rights, such as patents or trademarks, in order to reward efforts of the pharmaceutical industry resulting in scientific progress, (ii) the principal of free trade within the EU and (iii) the public interest in the availability/benefit of medicaments. This balancing out results in several peculiarities only specific to medicaments that must be observed for their commercialization in Europe. Page 10 of