**: Yakudu
Written by: Pills
Recently, the core patents of blockbuster drugs such as upadacitinib and semaglutide have been declared invalid by the CNIPA, which has attracted major attention in the industry. According to Novo Nordisk, a lawsuit has been submitted to the Beijing Intellectual Property Court for the invalidation of the semaglutide patent. At present, no relevant official website of AbbVie has been retrieved, but the industry speculates that there is a high probability that it will be appealed.
This article was searched through the China Judgments NetworkFocusing on the administrative dispute over the invalidation of drug invention patents in 2023, we try to analyze what kind of development and judicial decisions will be made when the relevant patents are declared invalid by the CNIPA and the lawsuit will be brought to the courtTry to pass the case, the CNIPA hears the patent case and the court hears the administrative dispute of invalidation, and the focus is on **.
After collation, this series of articles focuses on the invalidation of empagliflozin crystal form and litigation judgments, and the invalidation of ceftiamidine crystal form and litigation judgments, in order to provide some thoughts for the industry.
Table 1For details of the patents involved in the two drugs, invalidation and litigation, please refer to: China Judgment Network, CNIPA China Patent Examination Information Retrieval Platform.
Empagliflozin patent case
Drug profile
Empagliflozin is a small molecule SGLT2 inhibitor developed by Boehringer Ingelheim. At present, the highest stage of research and development of the drug is approved for marketing for ** chronic renal insufficiency, heart failure and type 2 diabetes.
Empagliflozin was approved by the US FDA in 2014 and in China in 2017. According to the BI annual report, the global sales of the drug in 2022 will be 20$6.6 billion.
Introduction to Patents
Patent Application No.:cn200680011591.6
Application Date:
Theoretical expiration date:
Patentee:Bellinger Ingheim International ***BI).
Technical Field:Crystal form, preparation method and its use in the preparation of drugs.
Nullity and Proceedings
Figure 1Important time nodes of empagliflozin patent invalidation and litigation procedures, reference: China Judgment Network, China Patent Examination Information Retrieval Platform of the State Intellectual Property Administration.
Invalid Procedure
Invalid Requestor:Jiangsu Haosen, Hangzhou, China and East China.
Main legal basis:Article 26 of the Patent Law, Article 22 (3) of the Patent Law.
Decision: Proclamation of Article 200680011591Invention No. 6 is null and void
Decision Day:
Key Points of Decision:To determine whether the specification provides a clear and complete explanation of the technical solution for which protection is sought, it shall be subject to whether it can be realized by a person skilled in the technical art. If a person skilled in the art can realize the technical solution, solve its technical problems, and obtain the expected technical effect without spending creative labor in accordance with the contents recorded in the specification and in combination with the ordinary technical knowledge in the art, the specification shall be deemed to have made a clear and complete description of the technical solution. A technical solution does not have an inventive step if the prior art gives the inspiration that the distinguishing features between the technical solution of the invention and the closest prior art are applied to the closest prior art to solve the technical problems existing therein. In general, if the distinguishing feature is a customary means of solving the technical problem in the art, it may be considered that there is an inspiration in the prior art to apply the distinguishing feature to the closest to the prior art to solve its technical problem.
Follow-up relief:If the parties are dissatisfied with this decision, they shall file a lawsuit with the Beijing Intellectual Property Court within three months from the date of receipt of this decision.
Table 2The core opinions of all parties in the invalidation procedure of the empagliflozin case are presented, reference: invalidation decision No. 47428 (this table only displays the core opinions, please check the original text for details).
Litigation Procedures
Plaintiff:Bellinger Ingheim International ***BI).
Defendant:State Intellectual Property Office of the People's Republic of China.
Cause of action:Administrative disputes over the invalidation of invention patents.
Verdict:The plaintiff's claim was dismissed.
Judgment Date:
Brief process:Dissatisfied with the decision of the State Intellectual Property Office to invalidate all the patents involved in the case, the original research institute sued the Beijing Intellectual Property Court within the statutory time limitWhere there are errors in the determination of facts and the application of law, the respondent decision shall be revoked in accordance with law. After the trial by the court, the court ruled that the defendant's decision was conclusive, the applicable laws and regulations were correct, the legal procedures were complied with, and the review conclusion was correctThe plaintiff's cause of action could not be sustained, and the court did not support it and rejected the plaintiff's claim.
Follow-up relief:If you are not satisfied with this judgment, you may appeal to the Supreme People's Court of the People's Republic of China within 15 days from the date of service of this judgment (no relevant information has been disclosed yet, and relevant enterprises can track it).
Table 3The core opinions of all parties in the judicial procedure of the empagliflozin case are presented, reference: Case No. (2021) Jing 73 Xingchu No. 10634 (this table only displays the core views, please check the original text for details).
Reflections and Enlightenment of the Engaliflozin Case
CNIPA's consideration of supplementary test data in patent invalidation
First of all, supplementary experimental data is commonly used in drug patents, which refers to the experimental data submitted by the patent applicant and patentee to prove that the patent application complies with China's patent authorization regulations (inventiveness, sufficient disclosure, etc.) in the drug patent application, examination, reexamination, invalidation procedure and subsequent judicial review procedures, and the experimental data not recorded in the original patent specification.
Secondly, Chapter 3 of Part II of the Patent Examination Guidelines revised in 2020Section 5 stipulates that "the examiner shall examine the experimental data submitted by the applicant after the filing date in order to meet the requirements of Article 22(3) and Article 26(3) of the Patent Law." The technical effect proved by the supplementary experimental data shall be obtained by a person skilled in the art to which he belongs from the contents disclosed in the patent application
Furthermore, it can be seen from the empagliflozin case that the original research institute submitted supplementary test dataThe CNIPA did not refuse to accept the experimental data submitted by the plaintiff after the application date, but reviewed it. However, CNIPA clearly states that the fundamental purpose of allowing supplemental experimental data is to provide a reinforcing proof of the technical effects (or conclusions) that have been clearly stated in the specification, but it is not intended to remedy information that was not disclosed at the time of writing. Specifically, in this case, the patent specification only describes the inhibitory effect of the compound on SGLT, especially selectively on SLGT2. In this case, the counter-evidence claim that the inhibitory activity of SGLT-1 is reduced does not comply with the above-mentioned examination guidelines, which stipulate that "the technical effect proved by the supplementary experimental data shall be obtained by a person in the technical field from the disclosure of the patent application".
The CNIPA hears the patent invalidation and the court hears the administrative dispute over the invalidation of the invention patent, focusing on the invalidation of the invention patent
First of all, the CNIPA hears patent invalidation casesThe focus is on whether the granted patent meets the conditions for patent grant, and whether the granted patent can be invalidated in accordance with Article 65, Paragraph 2 of the Implementing Rules of the Patent Law. In the trial, the main consideration is whether the subject is qualified, whether the procedure is legal, and whether the subject matter complies with the provisions of the Patent Law, such as whether it satisfies the novelty of Article 22, Paragraph 2, the inventive step of Article 22, and the practicability of Article 22, Paragraph 4 of the Patent Law. In practice, the grounds for novelty and inventive step have long been the top priority in invalidation examinations, and the basis for satisfying Article 26, Paragraph 4 of the Patent Law, such as the unclear scope of protection of the claims and the fact that the claims are not supported by the description, is also increasingly applied to patent invalidation.
Secondly, the court hears the administrative dispute case of invalidation of invention patentThe focus is on whether the evidence for the decision made by the administrative organ is conclusive, whether the applicable laws and regulations are correct, whether the legal procedures are complied with, and whether the review conclusion is correct. Based on the above, and in accordance with Article 70 of the Administrative Litigation Law, in judicial practice, where a court makes a judgment to revoke an invalidation review decision or order an administrative organ to make a new decision, there are mainly the following four situations:
Violation of legal process.It is worth mentioning that whether it is patent invalidation or the first instance of the Beijing Intellectual Property Court, there is still room for remedy, and the dissatisfied party can still appeal to the Supreme People's Court and unremittingly pursue legal principles and truth.Insufficient primary evidence There is new evidence that affects the determination of evidence.
The primary evidence is insufficient to support the invalidity review decision.
Applicable Laws and Regulations Errors.
References:
1. China Judgments Network
2. CNIPA's China Patent Examination Information Retrieval Platform.
3. Patent invalidation decision No. 47428
4. Administrative Judgment Case No. (2021) Jing 73 Xingchu No. 10634.
5. Novo Nordisk's 2020 financial report discloses: semaglutide has submitted a lawsuit to the Beijing Intellectual Property Court.
*Disclaimer: This article is only to introduce the research progress in the field of medical diseases or briefly describe the research overview or share relevant information about medicine, and is not and will not make a recommendation of ** or diagnostic solutions, nor does it constitute any recommendation for related investment. If there is any omission in the content, please feel free to communicate and point it out!