Drug companies can Sue their competitors, And demand market exclusivity for orphan drugs. This is the case of the Munich District Court against Alex (Alexion) Company and Amgen (Amgen) The company is related to Sularil, a biologic used to treat a rare blood disorder (Soliris) The result of the decision made in the dispute. Based on this result, The court confirmed an earlier preliminary injunction.

Orphan drugs can be used to treat rare diseases. In addition to being able to obtain patent protection, The drug is also available within the European Union for up to a period of time 10 Market exclusivity for a year, To further promote the development of relevant active ingredients and therapeutics.

Alexei, an American pharmaceutical company, sells the orphan drug Sularil, a biologic. Sularil is treated with the monoclonal antibody cuzumab (eculizumab) Base on, It is used to treat paroxysmal sleep hemoglobinuria (PNH) . PNH It's a rare blood disorder, It occurs when the immune system destroys red blood cells and platelets. If the patient is not treated in time, PNH Can lead to hemolytic anemia, Chronic kidney disease or thrombosis. In addition, Suleri also cures other ailments, Such as atypical hemolytic uremic syndrome (aHUS) , Generalized myasthenia gravis and optic neuromyelitis.

At present, For treatment PNH The market exclusivity period of the drug has expired.

For use across approved drug labels (cross-label use) A problem of

2022 years 8 month, Amgen announced that it has developed a treatment for the disease PNH A biosimilar of Sularil ABP 959. According to a statement from the company, ABP 959 It has the same drug dosage form as the monoclonal antibody ekuzumab licensed in the United States and the European Union, dose, Route and regimen of administration.

2023 years 4 month, Amgen's ecumizumab product ABP 959 Approval for marketing in the European Union was obtained from the European Medicines Agency.

accordingly, The biosimilar (now Bekemv Sell for a trade name) Has been approved specifically for therapeutic use PNH, As the original research drug, the market monopoly period of sularil has expired.

therefore, Alex is not right in the current lawsuit Bekemv The approval is challenged. On the contrary, The US company was concerned about how it could prevent the biosimilar from being used in other indications, This is known as cross-label use.

Cross-label use means, although Bekemv Only medical treatment was obtained PNH Market clearance, But doctors and pharmacies use it for other treatments to which market exclusives are still valid.

Ex parte preliminary injunction confirmed

Alex was the first 2023 years 5 An injunction was obtained in October from the Munich District Court, To forestall "Off-label use of drugs (off-label use) " This situation. In this way, Amgen had to take various measures, In order to ensure Bekemv It will not be used to treat any of the three indications that are still protected. Amgen appealed the decision.

now, By the presiding judge Georg．Werner (Georg Werner) Regulation of leadership 21 This ex parte preliminary injunction was reaffirmed in a ruling by the civil court.

The commercial significance of orphan drugs

For Alex, The stakes for the company are high. It is reported, Schuleri accounted for four-fifths of the innovative pharmaceutical company's revenues in the last quarter.

In this lawsuit, Amgen representatives argue, Restrictions imposed by the court to prevent cross-label use of the drug prevented Amgen from marketing the approved treatment in Germany PNH the Bekemv. therefore, Amgen does not currently market its ecuzumab products in Germany.

It can be seen that, The dispute between Albro and Amgen is not your typical patent dispute. On the contrary, The focus of the case is, In addition to asking regulators to guarantee market exclusivity for orphan drugs, Alexbrothers could, Whether it can also make corresponding claims against competitors in civil proceedings.

Interpretation of EU regulations

On the basis of "Eu Regulation on orphan medicinal Products 141/2000 Number law" Central control 8 article, In the event of marketing authorization for an orphan drug, The Community and the Member States are 10 No more marketing authorization applications for similar drugs for the same therapeutic indication shall be accepted during the year, Or grant marketing authorization, Or accept applications for extension of existing marketing authorizations.

Amgen believes that, These provisions relate only to issues where approval is prohibited under public law. therefore, It is permissible to make claims to the regulator (Such as obtaining market exclusivity for orphan drugs) . however, Amgen points out, There is no civil law prohibition claim against a competitor.

Unique judgment

however, The first 21 Judges in the civil courts have interpreted the EU rules differently. They think, Market exclusivity also includes the protection of orphan drugs from harm or infringement by competitors. The court held that, The statute is intended to establish a legal status that goes beyond mere approval.

According to the judges and lawyers involved, This is the first time that the European Court of Justice has ruled on the question of whether market exclusivity for orphan drugs can be claimed against a competitor. The United States and Japan respectively 1983 Nian Wa 1993 Similar measures have been in place since 2000 to encourage the development of orphan drugs. merely, In these countries, There has never been a case of market exclusivity being claimed against a competitor in this way.

After seeing the latest verdict, Amgen has appealed again. (Be compiled from www. juve-patent. com)

TRANSLATORS: Liu Peng　proofread: Rason group



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