Recently, the European Court of Justice re-established the patent protection period for the original pesticides. When the original drug is temporarily approved at the national level, it can be protected without having to wait until after the EU has completed the registration process to provide protection, thus providing longer pesticides. The period of protection. The European Court of Justice made this provision in order to restate the supplementary protection certificates (SPC) to resolve the dispute over the patent period between Hogan Lovells and Bayer CropScience. The introduction of SPC in patent protection is intended to provide products with a relatively long period of protection. Because the European Union's pesticide registration process is rather slow, it usually delays the timing of entry of a drug into the market, and the inventor cannot recover R&D investment during the remaining period of protection. After the introduction of SPC, you can buy more products for a period of protection. From the date of first registration of a product on the European market, SPC protection can be granted. After patent protection plus SPC protection, the patent holder will receive a maximum protection period of 15 years. The patent for Bayer's product iodosulfuron sodium will expire on February 13, 2012. This product was first registered in Germany in March 2000, and EU registration was completed in September 2003. Registration status in Germany changed from provisional registration to formal registration from January 13, 2005. In July 2003, the German patent department granted this product SPC protection. From the date of obtaining the temporary license of this product, that is, from February 13, 2012 to March 9, 2015, the product was protected by SPC. However, Hogan Lovells believes that Germany should not grant SPC protection to this product. The company believes that only products that are formally registered will qualify for SPC protection. Bayer argued that Hogan Lovells' interpretation of the SPC rule violated the general regulatory framework and was not in line with the official rules. The German court therefore requested the European Court to clarify the SPC provision. The European Court of Justice held that when granting a temporary product registration, member states must affirm the effectiveness, safety, environmental protection and health of this product. Therefore, obtaining a temporary license substantially eliminates more uncertainty than the value of a formal license. Temporary license means that the product gains market access for the first time, so it is considered that SPC protection should be obtained when obtaining a temporary license. However, the European Court also pointed out that according to Appendix 1 of the Agrochemical Registration Guidelines, obtaining a temporary license must be the same as the condition of a formal license.
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