Editor's note: TEVA and RATIOPHARM Two companies that manufacture and sell generic drugs, File a joint patent invalidation action, Request for court affirmation ROCHE Owns the drug valganciclovir (valganciclovir) European patents are invalid for lack of novelty and creativity. Read on for more details!

[background] TEVA and RATIOPHARM Two companies that manufacture and sell generic drugs, File a joint patent invalidation action, Request for court affirmation ROCHE Owns the drug valganciclovir (valganciclovir) European patents are invalid for lack of novelty and creativity. ROCHE A number of amendments to the disputed patent were proposed in the pleadings. subsequently, In accordance with "European patent convention" The first 138. 3 The provisions of the article are formally submitted for modification. Since the plaintiff did not object ROCHE Amend its patent, The court accepted the above changes at the pre-trial hearing stage.

The plaintiff argues that although the defendant has modified the patent, But the revised patent still lacks creativity, Shall be deemed invalid. The first trial decided in favour of the plaintiff, The amended patent dispute claims shall be deemed invalid. The Court of Appeal subsequently dismissed the defence appeal.

[conclusion] This is despite the fact that a large number of prior judgments have dealt with technical and legal issues of creative evaluation, The case contains procedural issues of general concern. First of all, The court analyzed ROCHE Filed in the appellate proceedings, Expert report by an expert appointed by the Italian Court (expert report) The question of adoption. Notwithstanding the uncertainties that may arise from the inability of the opposing party to raise objections, In its decision, the court finally found the evidence admissible. Although admitted as evidence, However, the court did not recognize its strength as evidence for the expert report.

Court decision, Since the report was produced in foreign proceedings, Be of the same nature as other documents in this case, However, it does not have the strength of evidence as an expert report. secondly, The court allows the defendant to contest a patent invalidation suit by modifying the patent claim. By limiting the scope of the claim protection, The patentee may eliminate the basis for an invalid action. but, Because of this, The modification of the claim means that (patentee) Default original patent does not meet patentability requirements. In this case, Judgment point, After the defendant amended his claim, Eliminated a cause of action in the case, That is, the disputed patent lacks novelty.

but, Even because ROCHE The decision to modify the claim alters one object of the action, The court still needs to review whether the amended patent meets the creativity requirement. The appellate decision upheld the grounds of the first instance that the patent lacked creativity. The court's final decision seems to have taken into account the following facts, namely ROCHE The submitted expert report analyzes novelty and creativity only for the original patent claims and not for the modified claims. Finally, When the court invalidates the patent, Citing the German Federal Patent Court's decision that the European patent in question was invalid in Germany. According to the appellate court, Although foreign judgments are not binding, The documents examined by the German court are also different from those presented in the Spanish proceedings, but "In view of (Germany) The court analyzed the validity of the same patent for the same reason, And referenced the same prior art" , The evidential value of the German verdict is beyond dispute. The German judgment also explicitly mentions the content of the amended patent.

[comment] Limiting the scope of patent rights in litigation is a defense strategy that has recently emerged, It is becoming more and more common in practice. In the first instance of this case, new "Spanish patent law (The first 24/2015 No) " Not yet in force, The act filled a gap in the law, Specify the procedure for limiting patents in litigation. As to whether restraining procedure is a remedy to eliminate invalid cause of action; Or because it implies that the defendant acknowledges that his original patent is invalid, It's essentially a trap, We have to wait and see. After the restriction behavior leads to the change of the object of dispute, Care should be taken to change the Angle of evidence accordingly. specifically, If the proceedings continue, In order to overcome the ineffectiveness of the identification, Expert evidence is required to support the amended patent.

compile: Liu Dan, The source of Aisabri Legal Counsel: Esabaril (ELZABURU)