The Supreme Court issued a draft for soliciting opinions on the "provisions on several issues concerning the Application of Law in the trial of Patent Civil cases involving Drug listing Review and examination and approval." what new provisions are worth paying attention?

10 of 2020Month17The Standing Committee of the National People's Congress issued a decision to amend the patent law. Article 76 was added to the decision. The main content is that in the process of drug listing review and approval, the relevant parties can sue the people's court and request a judgment on whether the drug-related technical scheme applied for registration falls within the scope of protection of others' drug patent rights. The pharmaceutical supervisory and administrative department under the State Council may, within the prescribed time limit, make a decision on whether to suspend the approval of the marketing of the relevant drugs in accordance with the effective judgment of the people's court.

The type of cases established by the law is similar to the confirmation of non-infringement of patent disputes, but there are obvious differences. The Supreme Court issued regulations on the trial of such cases (draft for comments), many of which are not only for the court to hear such cases. Guiding significance also has an important impact on the pharmaceutical industry.

Provisions of the 1. on competent courts

The draft stipulates that the first instance civil cases involving the examination and approval of drug marketing shall be under the jurisdiction of the Beijing intellectual property Court. If the parties (referring to the right holders, interested parties and applicants for drug marketing license of the relevant patent) file a patent lawsuit for drug marketing review and approval, and then file a lawsuit for infringement of patent right or confirmation of non-infringement of patent right, how should the trial court be determined?

For the same patent right and the drug applied for registration, before the drug is approved for marketing, the time for the party to file a lawsuit for infringement of the patent right or confirm that the patent does not infringe the patent right is after the time for filing a patent lawsuit involving the drug's marketing review and approval. At the same time, if the former is not filed in the Beijing Intellectual Property Court, it shall be transferred to the Beijing Intellectual Property Court. After the drug regulatory department under the State Council has approved the drug for registration in accordance with the law, if the party concerned files a lawsuit for infringement of the patent right or confirms that it does not infringe the patent right, it shall not be transferred.

2. special provisions on evidence

The draft opinion stipulates that in addition to meeting the conditions for prosecution, the parties concerned shall also submit the following evidentiary materials: (1) information on the relevant patents registered on the patent information registration platform of listed drugs in China; the relevant information on the application for registration of drugs published by the information platform of (II) national drug review institutions and the statement that they do not fall within the scope of relevant patent protection; (III) preliminary evidence on whether the technical solution of the drug applied for registration falls within the scope of protection of the relevant patent right. At the same time, the applicant for drug marketing license shall submit to the people's court a copy of the technical data declared to the national drug review agency and corresponding to the determination of whether it falls within the scope of protection of the relevant patent right during the first instance defense period or when it files a lawsuit.

The link between 3. court proceedings and administrative adjudication proceedings

The amendment to the new Patent Law stipulates that the parties concerned may also apply to the Patent Administration Department of the State Council for an administrative ruling on patent disputes related to the drugs applied for registration. If the party concerned files an application for examination and approval of patents and administrative adjudication involving drug marketing at the same time, will these two procedures affect each other?

The draft opinion stipulates that if the parties claim that the litigation referred to in Article 76 of the Patent Law should not be accepted or the application for suspension of the litigation referred to in Article 76 of the Patent Law on the grounds that the Patent Administration Department of the State Council has accepted the application for administrative adjudication referred to in Article 76 of the Patent Law, the people's court No support.

It can be seen that the opinion draft holds that the court trial should not be affected by the administrative ruling, but if the results of the court judgment and the administrative ruling are inconsistent, which result should be taken by the drug regulatory department of the State Council, which may lead to contradictions in reality.

Impact of 4. Effective Judgment Results on Patent Infringement or Confirmation of No-Infringement Disputes

The drug regulatory department of the State Council may, within the prescribed time limit, make a decision on whether to suspend the approval of the marketing of the relevant drugs in accordance with the effective judgment of the people's court. After the court decision takes effect, can the right holder still file a patent infringement or confirm non-infringement lawsuit?

The draft opinion stipulates that after the drug is approved for marketing in accordance with the law, if the effective judgment determines that the relevant technical solution of the drug applied for registration falls within the scope of relevant patent protection, the patentee or interested party may file a separate patent infringement lawsuit. In a lawsuit against the same patent right and the drug applied for registration for infringement of patent right or confirmation of non-infringement of patent right, the people's court generally supports the party's claim to determine whether the technical scheme of the accused infringing drug falls within the scope of protection of the relevant patent right according to the effective judgment. However, unless there is evidence to prove that the technical scheme of the accused infringing drug is inconsistent with the relevant technical scheme of the drug applied for registration or the cause of the new claim is established.

After the court decision takes effect, the right holder may file a patent infringement lawsuit or confirm a non-infringement lawsuit, but it will be affected by the effective decision.

At present, the draft is in the process of public consultation and suggestions for revision. People from all walks of life canBefore December 14, submit amendments to the Supreme Court by written mail or email, and the public shall be subject to the final release of the document. The relevant trial regulations formulated by the Supreme Court in response to this new cause of action are undoubtedly of great significance. It will have an important impact on the listing of drugs (especially generic drugs). Relevant pharmaceutical companies should pay enough attention to it in order to better Deal with the risks of patent litigation that may arise in the review and approval.