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The purpose of this is to compensate patentees for the time during which they were not able to exploit their inventions as a result of the need to secure regulatory approval before putting the product onto the market. The regulation came into effect on 2 January 1993 for all then EEC Member States except Spain, Portugal and Greece, for which the regulation will come into effect on 2 January 1998. Typically, 12 years may elapse between discovery or invention and medicinal use, reducing the effective patent term to eight years. This situation has, the Commission says, ‘arisen as a result of the interference between two types of administrative procedure (which) imposes heavy penalties on pharmaceutical research, which is therefore discriminated against as compared with other technological sectors’. Additionally there is provision in the Community for health authorities to grant what is effectively a period of non-patent exclusivity for new drugs. This is done by the health authority agreeing for a given period not to grant approval for any generic drug unless the generic manufacturer submits all of the same test data as the initial applicant. The relevant directive provides that Member States shall provide such exclusivity for a minimum period of six years. As a practical matter, however, most have adopted a term of 10 years. Extensions of patents will be effected by the grant of ‘supplementary protection certificates’ for periods of up to five years after the end of the normal patent term. Subject to this five-year limit, extensions will be for a period of five years less than the delay occurring between the filing of the application giving rise to the patent was granted. The regulation will have retroactive effect to cover some products already on the market. In general such retroactive effect covers drugs that first obtained marketing approval on or after 1 January 1985, although different dates apply for Denmark and Germany (1 January 1988) and Belgium and Italy (1 January 1982). It should be noted that the extension of protection effected by the supplementary certificate is restricted to products that have been granted marketing approval and do not provide for extension of protection for any other subject-matter that might fall within the scope of the patent claims.
DOI link for The purpose of this is to compensate patentees for the time during which they were not able to exploit their inventions as a result of the need to secure regulatory approval before putting the product onto the market. The regulation came into effect on 2 January 1993 for all then EEC Member States except Spain, Portugal and Greece, for which the regulation will come into effect on 2 January 1998. Typically, 12 years may elapse between discovery or invention and medicinal use, reducing the effective patent term to eight years. This situation has, the Commission says, ‘arisen as a result of the interference between two types of administrative procedure (which) imposes heavy penalties on pharmaceutical research, which is therefore discriminated against as compared with other technological sectors’. Additionally there is provision in the Community for health authorities to grant what is effectively a period of non-patent exclusivity for new drugs. This is done by the health authority agreeing for a given period not to grant approval for any generic drug unless the generic manufacturer submits all of the same test data as the initial applicant. The relevant directive provides that Member States shall provide such exclusivity for a minimum period of six years. As a practical matter, however, most have adopted a term of 10 years. Extensions of patents will be effected by the grant of ‘supplementary protection certificates’ for periods of up to five years after the end of the normal patent term. Subject to this five-year limit, extensions will be for a period of five years less than the delay occurring between the filing of the application giving rise to the patent was granted. The regulation will have retroactive effect to cover some products already on the market. In general such retroactive effect covers drugs that first obtained marketing approval on or after 1 January 1985, although different dates apply for Denmark and Germany (1 January 1988) and Belgium and Italy (1 January 1982). It should be noted that the extension of protection effected by the supplementary certificate is restricted to products that have been granted marketing approval and do not provide for extension of protection for any other subject-matter that might fall within the scope of the patent claims.
The purpose of this is to compensate patentees for the time during which they were not able to exploit their inventions as a result of the need to secure regulatory approval before putting the product onto the market. The regulation came into effect on 2 January 1993 for all then EEC Member States except Spain, Portugal and Greece, for which the regulation will come into effect on 2 January 1998. Typically, 12 years may elapse between discovery or invention and medicinal use, reducing the effective patent term to eight years. This situation has, the Commission says, ‘arisen as a result of the interference between two types of administrative procedure (which) imposes heavy penalties on pharmaceutical research, which is therefore discriminated against as compared with other technological sectors’. Additionally there is provision in the Community for health authorities to grant what is effectively a period of non-patent exclusivity for new drugs. This is done by the health authority agreeing for a given period not to grant approval for any generic drug unless the generic manufacturer submits all of the same test data as the initial applicant. The relevant directive provides that Member States shall provide such exclusivity for a minimum period of six years. As a practical matter, however, most have adopted a term of 10 years. Extensions of patents will be effected by the grant of ‘supplementary protection certificates’ for periods of up to five years after the end of the normal patent term. Subject to this five-year limit, extensions will be for a period of five years less than the delay occurring between the filing of the application giving rise to the patent was granted. The regulation will have retroactive effect to cover some products already on the market. In general such retroactive effect covers drugs that first obtained marketing approval on or after 1 January 1985, although different dates apply for Denmark and Germany (1 January 1988) and Belgium and Italy (1 January 1982). It should be noted that the extension of protection effected by the supplementary certificate is restricted to products that have been granted marketing approval and do not provide for extension of protection for any other subject-matter that might fall within the scope of the patent claims.
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