[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]

　　Lundbeck A/S The company claims that the production and sale of generic drugs by many pharmaceutical enterprises infringe its patent rights and supplementary protection certificates, File an action for patent infringement.

　　The patent in question has a separate claim relating to the preparation of etapram (Escitalopram) Method of. On the date of the European patent application in question, Etapram is a new product, So the burden of proof is reversed.

　　The defendants were divided into two groups, One group used a supplier of the active substance involved Reddy' s (Its production process does not fall into the scope of patent protection, This has also been acknowledged by the plaintiff) , And the other group of suppliers are Natco (Lundbeck That its production process falls within the scope of patent protection) .

　　The plaintiff lost the case in the first instance, At issue in the appeal, Natco Whether the production method infringes the patent rights involved. The appeal was subsequently rejected.

　　 [conclusion]

　　Simultaneous rule (The simultaneity rule) . After determining the scope of the patent, In order to determine whether there is a tort, It is necessary to assess whether the infringing production method falls within the scope of the relevant patent rights. For that matter, It is necessary to take action against the invention patent and the alleged infringing method "Factor by factor" contrast. Only those who invent patents "all" The elements are included in the method alleged infringement, In order to establish a patent infringement.

　　The court stated that, This rule is known to the public as the simultaneous rule, Has been accepted by modern legal doctrine, Also available from "about "European patent convention" The first 69 The protocol as interpreted in the article" The first 2 It is inferred in the article. The judgment goes on to state that, A conclusion can be drawn from the above, In accordance with existing law, " 'necessary' principle, Referred to in the precedent of the Court of Admissibility of this case 'Basic condition' or 'A substantial change in quality' Etc, Is unacceptable" .

　　Equivalence test (The equivalence test) . For that matter, Judgment point, The infringing method contains all the elements of the invention patent, May constitute the same infringement (Infringement in the literal sense) Equivalent tort (Tort under the principle of equivalence) . The dispute in this case is limited to the question of equivalent infringement.

　　 (Spain) The Supreme Court held that, The lower court adopted the three-question test used by the English courts in the question of equivalent infringement——mainly Catnic Case and sum Improver case, Be appropriate. The three questions are:

　　 (1) Whether the defendant's method substantially alters the method of working on the invention described by the Plaintiff's patent? If not (namely, If the function is not affected) , Continue to answer the following questions:

　　 (2) The alternative method provided by the defendant method, On the date of publication of the plaintiff's patent, Is it obvious to those skilled in the field? If it's not obvious, namely, It's creative in itself, Is not equivalent. If it's obvious, Move on to the next question:

　　 (3) The technician, By reading the claims and specifications of the plaintiff's patent, Is it possible to understand that, The patentee wishes to adhere to the letter of the claim, Is a basic requirement of its invention? 　　The controversy over the second question above is, For the manufacture of controversial active substances, Natco Whether the alternative approach used is obvious, In other words, The enantiomer bromodiol is used as the base product, On the date of publication of the plaintiff's patent, Is it obvious that someone is skilled in this area?

　　The value of foreign judgments. Principles established by foreign courts, Like any other academic principle, It can be used in Spanish refereeing under certain circumstances. however, Apply to set aside the judgment on appeal, It must not be based solely on the fact that there is a difference between the facts found by the Spanish and English courts, It's about violating the applicable law (In this case, namely "European patent convention" and "Spanish patent law" ) . In addition, The English courts have already adjusted the rules and testing standards established by prior precedents according to the specific requirements of each lawsuit, "Therefore, Digging into the difference is pointless" .

　　 "A guide to the European Patent Office" The value of. "European Patent Office Review Guide" "just" The guidance document provided by the Bureau to its examiners. Therefore, It is not binding on the jurisdiction of the court. The Appeal Committee's findings were made as part of the European Patent Office, It should be realized that although the European Patent Office may deem a specific invention patentable, "An invalidation action for a specific patent, Claim or counterclaim, Whatever the European Patent Office decides, It is still up to the courts of the member states to decide, And when the court invalidates the patent in question, Its decision can counter the licensing decision of the European Patent Office" .

　　For patentability purposes, And for the purpose of examining the facts of infringement, Assessment of obviousness, Is different. The necessary creative review of variables deemed patentable, Be different from, Under the principle of equivalence, A test of obviousness when assessing the same variable for infringement. The two assessments pursue different goals, Therefore, Different parameters need to be considered.

　　A creative assessment to determine whether an invention is patentable, Not based on every element, contrary, The evaluation is based on the invention as a whole. Through overall evaluation, Judge the person who is skilled in the field, The invention compares to prior art (Including prior patents, And other existing literature) Is it obvious? In other words, Creativity is not a separate assessment of the technical features of an invention, It is evaluated based on the overall solution that constitutes the invention. 　　And according to the principle of identity infringement analysis, Must evaluate and compare each element one by one, Therefore, The obviousness of each element of the variable must correspond to the so-called equivalent element of the preceding invention.

　　Therefore, Conduct patentability evaluation, That might be the case: The latter embodiments have met the creative requirements, But it still infringes the prior patent. contrary, The latter product may not yet meet the creative criteria for patentability of the invention, Because of the technical personnel in this field, From the point of view of the closest existing technology on the priority date, Consider the product as a whole, Be obvious. however, This does not mean that the product infringes the prior patent, Because although it doesn't change the way the invention is implemented, But a technical feature of the claim to an invention patent is superseded, For those skilled in this field, From the prior art of the priority date of the patent sued for infringement, It's not obvious.

　　The obvious concept of what can be expected to happen. The verdict was then analyzed, The obviousness required to establish the existence of an equivalent fact of infringement. The court held that, Although it is not required that the technical personnel in the field be absolutely certain that alternative elements of the technical element of the claim can actually be achieved, But it is not enough to have a reasonable expectation that it will happen, "Because there needs to be a level of predictability" .

　　In this case, Due to the experimental nature and unpredictability of the decomposition process of experimental racemate, And the commercial production of etaprilam by using racemic bromodiol, Replacement of basic products (Bromodiol instead of cyanodiol) The availability of the same active substance, etapram, cannot be predicted by technicians in the field.

　　 [comment]

　　Although opinions may differ, In addition to settling a dispute in this case, The ruling by the Spanish Supreme Court, It is a decisive step towards the long-awaited Spanish patent infringement jurisprudence, No less than neighboring jurisdictions.

　　The judgment in this case was confirmed, Equivalent torts are legal rather than factual disputes, The conditions for a complaint are thus met. This is crucial, This is the only way to make the Supreme Court the court of last resort, The Madrid Appellate Court No 28 Chambers and the Barcelona Court of Appeal No 15 Appeal of court judgment. No previous decision by the Spanish Supreme Court has comprehensively addressed such complex conceptual issues as equivalent infringement and creativity.

　　The court made it clear in its decision, The judgments of foreign courts and the conclusions of the Appellate Board of the European Patent Office are of guiding reference value, It's not binding. In addition, The judgment takes a cautious approach to the problem of equivalent infringement of the increasingly complex drug preparation method patents. There is hope that we will witness a new era in the Spanish patent precedent system.

　　compile: Liu Dan, Esabarry Legal Counsel

　　source: Esabaril (ELZABURU) Intellectual property rights