Bayer (Bayer) Won a major victory at the Stockholm Patent and Market Court in Sweden. Before this, The court had confirmed the involvement of the blockbuster drug Beryl (Xarelto) Patent for. In Belgium and Germany, The pharmaceutical company has also recently successfully defeated a number of generic drug manufacturers.

This year2month, The Stockholm Patent and Market Court explicitly upheld Bayer's decisionEP1845961European patent No, The move means rival Sandoz (Sandoz) Failed to invalidate Bayer's patent in Sweden.

EP1845961Patent No. 1 relates to rivaroxaban (rivaroxaban) The once-daily dosing regimen. Rivaroxaban is the active pharmaceutical ingredient in the anticoagulant Beryl. The drug is one of the German pharmaceutical giant's best-selling products, It can be used to treat thromboembolic diseases.

Market exclusivity for Beryl

Because it can be used to protect the essential patents of the relevant active ingredients (Number asEP1261606) already2020years12Month due, Therefore, in order to continue to provide more protection for Beryl throughout Europe, Bayer needs to make the most of itEP1845961Patent No. In fact, After the basic patent expires, Bayer has been making use of supplemental protection certificates (SPC) Lepobailital, But that protection will also be there2024years4month1Date due.

In other words, After this, Bayer needs itEP1845961To maintain Beryl's market exclusivity. The patent relates to a once-daily regimen of biarital. therefore, Generic drug companies from all over Europe (Such as Sandoz, etc) Is trying to destroy the patent, To pave the way for generic drugs. Up to now, No infringement proceedings have been filed in Sweden.

In addition, The presiding judge in Sweden said, Sandoz now owes Bayer the cost of the lawsuit. Here and now, The company has filed an appeal with the Court of Patent and Market Appeal in Stockholm.

Sandoz suffered a setback in Belgium

The Swedish case is not isolated. Bayer is competing with a number of generic drugmakers across Europe for Beritor. meanwhile, The media is also watching in Germany, France, Netherlands, Austria, Lawsuits in Sweden and England. Only at the European Patent Office (EPO) A place, There is15Company pairEP1845961Patent No. 2 was challenged. In addition, There have also been lawsuits involving the blockbuster drug in the United States.

Based on information obtained by the media, recent, Confirmed at the Corporate Court in BrusselsEP1845961After the validity of the patent, Bayer also won a favorable ruling in Belgium. Sandoz is likely to appeal the decision, And observers think so.

Last year11month, The District Court in The Hague also dismissed Sandoz's caseEP1845961Invalidation lawsuit filed on patent No. Dutch judge's ruling, The generic version of rivaroxaban is in2024years4Entering the market after October will constitute a pairEP1845961Infringement of patent No.

New developments in Germany

Although the federal patent court has not yet ruledEP1845961Ruling on the validity of the patent in Germany, But it's in1The patent was provisionally deemed valid in October. however, Before making a final judgment, The court can still change this provisional opinion in accordance with the relevant legal provisions.

The court will2025years6Trial of the corresponding invalid litigation cases. Hexal, Accord, Genepharm, Krka, Abdi Pharma, Polpharma, STADAandratiopharmThe company isEP1845961Patent No. 2 took legal action against Bayer.

however, With an eye toEP1261606No. Basic patentSPCWill be in4Monthly expiration, These positive initial comments are very important for Bayer. Bayer hopes to take advantage laterEP1845961To prevent generic drugs from entering the market. (Be compiled fromwww. juve-patent. com)

TRANSLATORS: Liu Peng　proofread: Wu Xian



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