The Patents and Plant Variety Rights (Compulsory Licensing) Regulations 2002.

These Regulations implement Article 12 of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions (OJ No. L 213, 30.7.98, p. 13). Part II regulates compulsory patent licenses; Regulation 3 states that where a person cannot acquire or exploit plant breeders’ rights or a Community plant variety right in a new variety without infringing a prior patent, he may apply in accordance with rules to the Comptroller General of Patents for a license under the patent and on such application shall pay the prescribed fee. Regulation 7 establish conditions and 8 and 9 respectively variation and revocation mechanisms. Part III regulates compulsory plant variety license; where a proprietor of a patent for a biotechnological invention cannot exploit a biotechnological invention protected by the patent without infringing prior plant breeders’ rights, he may apply in accordance with Breeders’ regulations to the Controller of Plant Variety Rights for a license and on such application shall pay the plant breeders’ fee. The Part also clarifies conditions, variation and revocation. Part IV regulates appeals.