How can enterprises prevent drug preparation process from infringing on others' patents? The Supreme People's Court gives a guiding case.

Drug patent is one of the most economically valuable patent types. In recent years, the number of drug patent infringement disputes has increased significantly. Infringement of other people's patents will not only increase the economic burden of enterprises due to damages, but also have a negative impact on corporate image. MedicineWhether the business is improving.Its preparation process, orProductionNewof medicineproducts, all should be thoroughly investigated beforehand, through patent search, analysis.Whether there is a relationshipitsProductsProduction methodrelated patents,If relevant patents exist,To further determineScope of patent protectionto prevent infringement of the patent rights of others. ForDrug preparation processBecause the defendant in the relevant patent infringement dispute, the preparation process is different from the patent method involved in the burden of proof, drug manufacturers should take certain measures to prevent the adverse consequences caused by insufficient proof.

2013Year7Month25On the same day, Lilly sued the Jiangsu High Court that Lilly owned the case.91103346.7The patent for the invention of the method, the drug Olanzapine prepared by the patented method in question is a new product. Watson produced and marketed the drug olanzapine using a preparation method that fell within the scope of the patent protection in question,Request the court to order Watson to compensate its economic losses in RMB1.5Billions of dollars.

(I) on the scope of protection of the patent rights involved.

Paragraph 1 of Article 56 of the Patent Law stipulates:"The scope of protection of the patent right for an invention or utility model shall be subject to the content of its claims, and the specification and drawings may be used to interpret the claims." In this case, Lilly requested protection of the patent claims involved.1In the method, the claim adopts an open writing method, which only limits the three-ring reduction and.N-Methylpiperazine and substituted groups, the scope of protection covers all the use of the tricyclic reduction and.N-methyl piperazine inQThe preparation method of generating olanzapine by substitution reaction at the group is within the scope of protection, regardless of the reaction starting material, solvent and reaction condition. Based on this, the key to determining whether Watson's Olanzapine preparation process falls within the scope of patent protection in question lies in twoThe comparison of the reaction routes of the technical scheme, and the specific reaction starting materials, solvents, reaction conditions, etc. are not included in the scope of infringement comparison.

(II) on the actual preparation process of olanzapine used by Watson

Paragraph 2 of Article 57 of the Patent Law stipulates:"Where a patent infringement dispute involves an invention patent for a new product manufacturing method, the unit or individual manufacturing the same product shall provide proof that the product manufacturing method is different from the patented method." In this case, the parties do not object to olanzapine as a new product referred to in the Patent Law, and Watson shall bear the burden of proof that its olanzapine preparation process is different from the patented method involved. Specifically, Watson should provide evidence that the reaction route of the olanzapine preparation process it actually used did not fall within the scope of patent protection in question, and Watson asserted that it was self-contained.2003has been used since2008The production of olanzapine was supplemented with a filing process to the State Drug Administration in 2012 and submitted its2003Year and2008Annual olanzapine batch production records,2003year,2007Year and2013Evidence such as the annual production procedures and the Drug Supplement Application Approval document proves the actual use of the Olanzapine preparation process.

The Supreme Court held that Watson could prove2003It has been used during the period from the year to the expiration date of the patent in question.2008The reaction route of the annual supplementary filing process produces olanzapine. First, the Watson Company2008The reaction route of its olanzapine preparation process was clearly recorded in the "Supplementary Application for Registration of Olanzapine Drugs" submitted by the State Food and Drug Administration.The Technical Appraisal Report also considers in its appraisal conclusion“Watson Company2008The preparation process of olanzapine filed with the State Food and Drug Administration in is feasible.”. Therefore, in the absence of other evidence to the contrary, it should be presumed that Watson2008The annual supplementary filing process is the actual preparation process of olanzapine after it has obtained the Drug Supplementary Application Approval.Secondly, from the research and development stage to the actual production stage, the long-term technology accumulation process is usually to continuously optimize and adjust the reaction conditions and operating details for the defects found in the actual production while maintaining the stability of the basic reaction route. Thus, Watson has since1999Year is owned with its2008The same Olanzapine preparation process as the reaction route of the supplemental filing process in2008It is unlikely that other preparation processes with completely different reaction routes will be used to produce olanzapine before supplementing the filing process. Finally, the State Food and Drug Administration2010Year9Month8The "Approval Conclusion" column of the "Drug Supplementary Application Approval" issued by Japan to Watson Company records: "The changed production process will only adjust the solvents and reagents used in its preparation process on the basis of not changing the original synthesis route", that is, the State Food and Drug Administration confirmed that Watson Company2008The annual supplementary filing process is the same as its previous preparation process reaction route.

Basically, the Supreme People's Court compared the reaction route of Watson's olanzapine preparation process and the method patent involved, and believed that the difference between the two lies in different reaction steps, different key intermediates, and corresponding technical characteristics that do not belong to basically the same technical means. The technical effects achieved are quite different and do not constitute equivalent characteristics. Therefore, the Olanzapine preparation process of Watson Company did not fall into the scope of patent protection involved.

The case is a guidance case issued by the Supreme People's Court, reflectingDrug preparation processThe difficulties and hotspots of patent infringement disputes are heard by courts at all levels across the country.Patent Infringement Disputes over Drug Preparation Processit has certain guiding significance,In the absence of other evidence to the contrary, it shall be presumed that the filing process of the accused infringing drug in the drug administration department is its actual preparation process. If there is evidence to prove that the filing process of the accused infringing drug is not true, the technical source, production procedures, batch production records, filing documents and other evidence of the accused infringing drug shall be fully examined, and the actual preparation process of the accused infringing drug shall be determined according to law.

For pharmaceutical manufacturers, ifPharmaceutical preparationMethods The patentee sued its patent infringement, the enterpriseFiling process in the drug administration departmentis the most critical evidentiary material, therefore, not only to itsDrug preparation processTo conduct a comprehensive patent search analysis to avoid falling into the scope of protection of other people's patent rights, and should be truthfully toDrug preparation process for the record of drug administration department. In the production process,Batch production records, production procedures,Drug Supplementary Application ApprovalSuch as documents to do a good job of management, timely filing. Documents such as the Notice of Application for On-site Inspection of Drug Production, the Notice of Application for On-site Inspection of Drug Production and the Report on On-site Inspection of Drug Registration and Production sent by the drug supervision and administration department shall be properly kept, and these documents may be favorable evidence that the preparation process of the enterprise is different from the patented method.