Atripla was granted a marketing authorisation on 13 December 2007. The rationale for the product was described by the European Medicines Agency as follows: rationale for the fixed combination of efavirenz, “The emtricitabine and tenofovir DF is to simplify HIV-treatment regimens and to improve adherence to therapy by providing combination antiretroviral therapy for administration as a single, once-daily tablet. The individual active substances are already approved to be used together in combination therapy of HIV-1 infected patients.” The SPC Regulation The SPC Regulation enables the proprietor of a patent for a medicinal product to obtain an SPC extends the duration of the patent with respect to that product so as to compensate the proprietor for the effective loss of patent term caused by the need to obtain a marketing authorisation before the product can be marketed. The SPC Regulation includes the following recitals: Medicinal products, especially that are the result of long, costly research “[3] will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research. [4] At the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. [5] This situation leads to a lack of protection which penalises pharmaceutical research. [6] There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection. [7] A uniform solution at Community trial should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market. [8] Therefore, the creation of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A Regulation is therefore the most appropriate legal instrument.” Articles 1, 3, 4 and 5 of the SPC Regulation provide, so far as relevant:
Atripla was granted a marketing authorisation on 13 December 2007. The rationale for the product was described by the European Medicines Agency as follows: “The rationale for the fixed combination of efavirenz, emtricitabine and tenofovir DF is to simplify HIV-treatment regimens and to improve adherence to therapy by providing combination antiretroviral therapy for administration as a single, once-daily tablet. The individual active substances are already approved to be used together in combination therapy of HIV-1 infected patients.” The SPC Regulation The SPC Regulation enables the proprietor of a patent for a medicinal product to obtain an SPC extends the duration of the patent with respect to that product so as to compensate the proprietor for the effective loss of patent term caused by the need to obtain a marketing authorisation before the product can be marketed. The SPC Regulation includes the following recitals: “[3] Medicinal products, especially that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research. [4] At the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. [5] This situation leads to a lack of protection which penalises pharmaceutical research. [6] There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection. [7] A uniform solution at Community should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market. [8] Therefore, the creation of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A Regulation is therefore the most appropriate legal instrument.” Articles 1, 3, 4 and 5 of the SPC Regulation provide, so far as relevant: trial
UK-Hand-Down-Teva-v-MSD-judgment.docx