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The European Commission's ruling clears the way for Sanofi's blockbuster drug to enter the German market

The market for cholesterol-lowering drugs is dominated by two products——Amgen Inc Repatha The active ingredient marketed under the brand name and Sanofi under Praluent Drugs marketed under trade names.

Since the 2016 Since last year, Amgen has been arguing patent infringement, Trying to stop Sanofi from getting into 6 European countries and other countries such as the United States and Japan Praluent. In some cases, The court ruled in Amgen's favor.

however, Recently in a German court Praluent The battle brought a dramatic turn of events. The Duesseldorf High District Court rejected Amgen's application in a second instance. This means that 2019 There was no objection to the first judgment in 2000. Therefore, Courtesy of Sanofi, sales, use, Import and possession Praluent Did not violate the No EP2215124 The German part of the European patent, Therefore, Amgen is not entitled to injunctive relief and damages.

Therefore, The proceedings have now been concluded. Sanofi can distribute it in Germany Praluent. France's Sanofi has been working with Regenerics of the United States. Sanofi is owned outside the United States Praluent The exclusive right of, And the regeneration is owned within the United States Praluent The exclusive right of. Both companies are defendants in the Dusseldorf lawsuit.

The role of the European Patent Office precedes the Dusseldorf ruling, European Patent Office (EPO) A decision was made by the appeals Committee of. The committee although granted Amgen the active ingredient Evocumab (evolocumab) The first EP2215124 European patent, But a considerable degree of restriction has also been made. EPO The judge affirmed the patent.

Therefore, The patent continues to protect Amgen's active ingredient. but, Due to lack of creativity, The judge placed great limitations on the patent, So that the basis for the Dusseldorf infringement action ceased to exist. Many experts believe that, The appeals panel's ruling could have a similar impact on lawsuits in other European countries.

2019 years 7 month, The district court in Dusseldorf condemned Sanofi and Regenerator for violating the No EP2215124 Patent no. The court issued an injunction, Amgen has paid nearly as much to enforce the injunction 2000 A premium of ten thousand euros. Therefore, Sanofi and Regeneren can no longer be sold or manufactured in Germany Praluent. In response to the alleged infringement, Sanofi applied to the federal patent Court for a compulsory license. but, Sanofi's request failed.

Sanofi has made several points in the process of reforming German patent law, Calls for more rigorous proportionate testing of automatic bans and consideration of third party interests. Anjin 2016 Launched an attack on Sanofi in 2000. Sanofi and Regenerics EPO File an objection to Amgen's patent. Lilly (Eli Lilly) Etc joined the attack on the patent. but, 2018 years 12 month, EPO The dissenting division in The Hague upheld Amgen's patent. Both parties have appealed against the decision.

(Compiled from www. juve-patent. com)

Reprinted from China Intellectual Property Network   translation: Rason group proofread: Wang Dan

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Patent infringement rights protection

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