[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]

　　An English court heard a dispute over a drug patent, A brief description of the case is as follows:

　　Gilead Pharmaceutical companies have one TRUVADA medicine (A drug used to treat antiretroviral drugs in HIV-infected patients) Patent and supplementary protection certificate. The pharmaceutical Supplement Protection certificate contains two active ingredients (active ingredients) : Tenofovir dipivoxil and emtricitabine. Among them, The underlying patent claims explicitly mention the active ingredient tenofovir dipivoxil, Emtricitabine is just mentioned "Other therapeutic ingredients" .

　　Several are preparing to list in the UK TRUADA Manufacturers of generic drugs (Teva UK, Accord Healthcare And others) Initiate a lawsuit, Claim identification Gilead The Company's supplementary protection certificate is invalid. The generic companies' argument is this, The disputed supplementary protection certificate does not match "Regulation of the European Parliament and of the Council on Supplementary Protection Certificates for medicinal products (The first (EC) 469/2008 No) " (Hereinafter referred to as "European Union regulation (EC) 469/2008 No" ) The first 3 (a) The requirements specified in this article, That is, the active ingredient emtricitabine is not explicitly included in the underlying patent claims, "Other active ingredients" Is not implied and necessary (implicitly but necessarily) Refers to the active ingredient.

　　The English court of Admissibility decided to stay the case, And asked the European Court of Justice for a ruling, Clarify the standard question of interpreting the content of the claims in order to confirm the essential patent protection subject matter. specifically, Whether as long as the underlying patent claims are mentioned, Or it may imply and necessarily refer to the specific active ingredient of the relevant supplementary protection certificate, There are other criteria to consider as well?

　　 [conclusion]

　　The European Court of Justice cited its decision "European Union regulation (EC) 469/2008 No" The first 3 (a) Article provided for the interpretation of the issue made by the latest judgment (2013 years 12 month 12 day, Eli Lilly case (Case number: C-493/12) ) , reiterate, Only expressly mentioned in the underlying patent claim, Or be necessary and concrete with it (necessarily and specifically) Associate the supplementary protection certificate with the protection topic, To be considered protected by the underlying patent. For that matter, European court of justice, It should ensure that the subject matter of the supplementary protection certificate is within the scope of the underlying patent protection on which it is based, That is, it appears in the patent specification and the disclosure content of the attached drawings, And shall not exceed the scope of the invention.

　　For this reason, The European Court of Justice made that clear in its decision in this case, You need to start from the perspective of people who are skilled in the field, Based on prior art prior to the filing or priority date of the relevant patent, Verify that the following conditions are met:

　　- First of all, According to the basic patent specification and attached drawings, Whether the drug in question is included in the invention protected by the patent.

　　- secondly, All elements disclosed by this patent, Can clearly identify the drug.

　　 [comment]

　　This is despite the ruling requiring a full review of all the facts of the case by a British court of hearing, Determine if all of the above requirements are met, The European Court of Justice has finally given its opinion on the dispute. The European Court of Justice stated that, In dispute, Gilead The company's underlying patent description does not state that the invention covered by the patent specifically relates to the combination of tenofovir dipivoxil and emtricitabine for the treatment of HIV/AIDS, Therefore, A person skilled in the field cannot draw a conclusion based on prior art prior to the filing date or priority date of the patent, The patent covers both emtricitabine and tenofovir dipivoxil.

　　Court of hearing (The High Court of England and Wales) The above opinion of the European Court of Justice was adopted, in 2018 years 9 month 18 Judgment of day Gilead The company's supplementary protection certificate is invalid. Both the British Court and the European Court of Justice have held that, Since Emtricitabine is not mentioned in the underlying patent, Therefore, From the perspective of technical personnel in this field, There is no reason to believe that the active ingredients are necessarily covered by the patent. In addition, The English court also held that, All elements of disclosure under the underlying patent, The active ingredient cannot be clearly identified. That's the latter point, The court of hearing stated that, Not only is Emtricitabine not specifically mentioned in the underlying patent, It does not even belong to the particular compound class mentioned in the underlying patent, And there is no evidence that prior to the patent priority date, Emtricitabine is a known active ingredient in the treatment of AIDS.

　　Another important point to mention, Gilead Company and Teva And other generic drug manufacturers are also disputing in Spain the validity of the Spanish patent and supplementary protection certificate corresponding to the British patent and supplementary protection certificate. Gilead The company applied for an injunction at the patent Court in Barcelona, Request for prohibition Teva (And other generic drug manufacturers) Sales continue in Spain TRUVADA Generic drug. The Barcelona Court of Appeal is in 2018 years 12 month 18 Day control ECLI: ES: APB: 2018: 7829A The European Court of Justice's opinion was also adopted in the ruling, identification Gilead The company's supplementary protection certificate does not match "European Union regulation (EC) 469/2008 No" The first 3 (a) Requirement of strip, There is no likelihood of success (fumus boni iuris) , His application for a temporary injunction is therefore denied.

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