[Editor's note] Like most countries and regions in the world, The rulings of the Court of Justice of the European Union have important guiding significance and predictive value for understanding the legal norms of the European Union. Esabaril (ELZABURU) At the beginning of each year, typical cases of the Court of Justice of the European Union in the previous year are summarized and published, And a brief review of each case, In order to help customers and partners to understand the EU intellectual property norms. Given the importance of Chinese customers and partners, We try to publish the Chinese version of typical cases on a weekly basis, It is convenient for Chinese partners to learn the latest information in a timely manner.

　　 [background]

　　Pharmaceutical company Boehringer Medicines obtained Micardis Secondary protection certificate, Its active ingredient is "telmisartan" . subsequently, Boehringer Obtained medicine MicardisPlus——Contain active ingredients telmisartan and hydrochlorothiazide (Has entered the public domain) ——Marketing authorization (marketing authorisation) . Based on the marketing authorization, Boheringer Prepare to apply for drugs MicardisPlus Secondary protection certificate. But in the underlying patent, Only the active ingredients are involved telmisartan, Not mentioned telmisartan and hydrochlorothiazide Composition of. Britain's Intellectual Property Office suggested Boehringer First modify the underlying patent, Add to telmisartan and hydrochlorothiazide The contents of the composition, Then the application for auxiliary protection certificate of the composition is put forward. finally, The UK Intellectual Property Office approved it Boehringer An application for a secondary protection certificate based on an amended patent.

　　Generic drug company Actavis Objection to approval Boehringer Application for an auxiliary protection certificate of the above composition, Considers that at the time of filing an application for a dispute protection certificate, The composition does not exist in the underlying patent. Boehringer Argue that, Both EU and Member State laws allow for amendments to granted patents, Modified patent right against added composition (That is, the protected object of the secondary protection certificate) It has retroactivity.

　　In view of this, The British High Court decided to stay the case, And asked the European Court of Justice (Court of Justice) To make a preliminary determination on the following questions: (1) Whether to obtain the auxiliary protection certificate, Modify the authorized patent, Add a claim; and, (2) A patentee who has obtained a certificate of secondary protection for an active ingredient pursuant to the underlying patent claim, Whether the basic patent can be modified——Add the active ingredient to another active ingredient composition, Apply for an auxiliary protection certificate for the new composition?

　　 [conclusion]

　　The European Court ruled only on the second issue, That the issue in this case is, How to understand "Regulation of the European Parliament and of the Council on Supplementary Protection Certificates for medicinal products (The first (EC) 469/2009 No) " (Hereinafter referred to as "European Union regulation (EC) 469/2009 No" ) The first 1 article, The first 3 Article and clause 13 Provision of article, Especially the control 1 prescribed, The scope of underlying patent protection must include (The object protected by the secondary protection certificate) product "itself" .

　　Actavis Insist that, The above provisions shall be understood as, The object of protection of the auxiliary protection certificate must be the actual invention subject of the underlying patent. In other words, The product itself must constitute the core creativity of the patent, Compositions comprising the active substance already protected by the underlying patent and the subsidiary protection certificate and other substances other than the subject matter of the underlying invention shall be excluded. otherwise, Will unreasonably increase the exclusive rights provided by the auxiliary protection certificate to extend the protection period. while Boehringer Think that, As long as the product composition appears in the underlying patent claim, Is enough to prove that it should be protected.

　　The European Court of Justice analyzed that, The composition at issue in this case consists of two active ingredients (telmisartan and hydrochlorothiazide) , Due to hydrochlorothiazide It's in the public domain, Therefore, the subject matter of the invention of the underlying patent covers only the active ingredient telmisartan. Take into account the principle of balancing the interests of different groups, European court of justice ruling, The patentee shall not apply for a certificate of drug assisted protection for a composition consisting of an active ingredient of the subject matter of the sole invention for which the patent is granted and other ingredients other than those for which the patent is granted.

　　 [comment]

　　The European Court of Justice's decision was made on the basis of balancing the interests of the pharmaceutical industry with those of public health. There is no restriction on the application of a certificate of secondary protection for a composition of the active ingredient of an underlying patent with other ingredients other than the patent, It means that the interests of the pharmaceutical industry are too skewed.

　　Therefore, The European Court of Justice (ECJ) has reaffirmed its earlier decision in the dispute over the certificate of subsidiary Protection for product compositions (Actavis vs Sanofi case (Case number: C-443/12) , and Georgetown University II case (Case number: C-484/15) ) . Although the European Court of Justice did not answer definitively, The question of whether the relevant composition content can be added to the licensed patent claim to obtain an auxiliary protection certificate, Such a possibility has clearly been implicitly rejected in the conclusion of this case.

　　compile: Liu Dan, Esabarry Legal Counsel　　source: Esabaril (ELZABURU) Intellectual property rights