Weekly Statement: An Analysis of the Protection Boundary of Pharmaceutical Patent Rights and Related Recommendations

Original title: "Weekly Statement" A brief review of the protection boundary of pharmaceutical patent rights and related proposals to analyze the protection boundary of pharmaceutical patent rights and improve the drug patent link system, a brief review of Astellas Pharmaceutical Co., Ltdand Madison Pharmaceutical Co., Ltd., Lianyungang Runzhu Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltdinfringement of invention patent dispute author: Lu Liyan Longan Law Firm Partner Patent Lawyers China Medical Insurance Chamber of Pharmaceutical Seeking Industry Branch Of the Patent Industry Branch is mainly engaged in biotechnology and pharmaceutical industry, patent application and patent applicationFamiliar with the regulatory rules of the Pharmaceutical FDA/CFDA, specializing in equity design and planning of pharmaceutical start-up projects, and has experience in successful financing of angel wheel, A-round and B-round pharmaceutical projectsMrLu studied at the School of Law of East China University of Political Science and Law and the School of Pharmacy of Shanghai Jiaotong University1 The present case is another case of patent infringement brought by the defendant for patent registration during the validity period of the patent in question, and on May 22, 2018, the Nanjing Intermediate People's Court of Jiangsu Province issued a first-instance judgment rejecting the plaintiff's claim and finding that the defendant's application for registration of the drug in question did not constitute patent infringementThis case will extend to explore the current scope of the protection of Chinese medicine patent rights in China and how to improve the drug patent link system, to achieve not only to encourage the development of new drugs, but also to stimulate the development of the first generic drug, while limiting excessive generic drug development behavior2 Case Background Information Related to the Patent "Two-Fangky acetylide Compound" is China's No200680025545.1 invention patent, the patentee is the Board of Directors of the University of California (hereinafter referred to as the University of California)The application date for the patent in question is March 29, 2006 and the authorization date is April 18, 2012The generic name for the compound protected by the patent claim 3 is entrirideThe two plaintiffs were the exclusive licensees of the patents involved, and in 2015 the two defendants filed a drug registration application with the State Food and Drug Administration for the patent editing of the patented compound ethexalamineThe plaintiff held that the defendant's above-mentioned production, sale and use of the patented product enherusamine compound serotonin compound violated the provisions of Article 11 of the Patent Law and constituted patent infringement3 The focus of the dispute is whether Astellas Co., Ltdand Madison Co., Ltdare qualified as the plaintiff's litigation subject, whether the alleged infringing products fall into the scope of protection of the patents involved, whether the two defendants' applicationford registration of the drugs involved in the case violates the relevant provisions of the Measures for the Administration of Drug Registration, whether the two defendants' alleged infringements constitute patent infringementRelated factual issues surrounding the point of contention 3.1 On 12 August 2005, the Board of Trustees of the University of California, Berkeley, entered into an Exclusive License Agreement with Mediweson And its wholly-owned subsidiary, Mediweson Prostate Therapy, and subsequently signed a supplementary agreement, the first, second, third and fourth, The patentee grants exclusive license rights to U.Spatents and corresponding foreign patents, including PCT patents filed internationally under the INTERNATIONAL filing number PCT/US2006/011417, as well as the right to grant exclusive or non-exclusive sub-licensing to third parties3.2 On February 16, 2017, Charles ELee, General Counsel and Vice President of the Board of Trustees of the University of California, Charles EFRobinson signed the statementAccording to the statement, the BOARD of Directors of the University of California, Medi-Wesson, and its wholly-owned subsidiary, Madison Prostate Therapy, have entered into an "exclusive license agreement" to confirm that Madison May may, without the participation of Madison Prostate Therapy, file a patent infringement lawsuit in China with its sub-licensor against infringers that infringe scopyrightu No200680025545.13.3 In 2015, the two defendants jointly submitted to the State Food and Drug Administration application for registration of the ingredients of enmyluamine (drug name: Enmyruamine, acceptance number: CXHL1500217 Su), the defendant is the state Food and Drug Administration to apply for registration of Enmesamine capsules (drug name: Enmeluamine capsule, acceptance number: CXHL1500218 su)Both applications were approved for clinical trials in May 20164.1 Court View 4.1 Astlyand Corporation, Mediweson Corporation, as the plaintiff's litigation subject in this case, Mediweson Corporation and its wholly-owned subsidiary Madiweson Prostate Therapy Company and the ucproletics of the university of California, the patent eligible for the case, and Madison Andion and its wholly-owned subsidiary, Madison Prostate Therapy, and Astellas Corporation, signed a "cooperation agreement" on the licensing of the patents involvedAt the same time, the board of trustees of the University of California confirmed that Madison and Astellas may jointly file a lawsuit in China against patent infringement seeking in China without the participation of Madison Prostate TherapyTherefore, with the express authorization of the patentee involved, Astellas And Madison, as interested parties, have the right to sue for the infringement of the patent involved4.2 Whether the allegedinfringing product falls into the scope of protection of the patent involved 3 is a subordinate claim, which is mainly expressed as: the compound of claim 1, which has an RD162'-style structureThe parties have no objection to the same chemical structure of the allegedly infringing product as the RD162' formulaIn this case, on the basis of the facts established by this Court, it can be concluded that the two conditions of "alkyl" and "carbon connected to them together with the carbon connected to them are cyclkyl" in the definition of R1 and R2 in question are considered to be select-type conditions, rather than the conditions that must be met at the same time as understood by the two defendants, for the following reasons: 1) from the formulation of the patent specification in question Paragraphs of the patent specification in question, paragraphs 0028, and 0029, all document that "R1 and R2 are independently methyl, or the carbon atoms connected to them together are ringal alkyls of 4 to 5 carbon atoms", which gives a clear indication that R1 and R 2 Either independently select methyl (alkyl containing one carbon atom) or independently select the conclusion that the carbon atoms connected to them together are ringal alkyl for four to five carbon atoms; The sub-claims related to claim 1 in the patent in question are claims 2, 3, and 4, and the three sub-claims are called R1 and R2, respectively, the carbon atoms connected to them are the ringal alkyl, methyl, and connected to them Together, the carbon atoms are cyclic alkyls of five carbon atoms, and it can also be seen that the two conditions of "alkyl" and "carbon connected to them together are cyclkylal" conditions are selectors; The carbon atom connection method in the alkyl is chained, the carbon atom connection mode in the ring alkyl is ring-shaped, the two modes of connection are mutually exclusive and cannot exist at the same time; 4.3 Whether the two defendants apply for registration of the drugs involved in the case is in violation of the relevant provisions of the Measures for the Administration of Drug Registration and whether they fall within the scope of the trial in this case, the Court considers that the Drug Registration And Administration, article 3, Article 5 and Article 18, stipulates that the Drug Registration means that the State Food and Drug Administration shall, in accordance with the application of the drug registration applicant, examine the safety, effectiveness and quality control of the drugs to be listed for sale, and decide whether to approve the approval process for their application The State Food and Drug Administration is in charge of the national drug registration and is responsible for the approval of drug clinical trials, drug production and imports Where a patent dispute occurs in the course of drug registration, it shall be resolved in accordance with the relevant laws and regulations on the patent Accordingly, the Measures for the Administration of Drug Registration are the departmental regulations issued by the State Drug Administration, and whether the actions of the drug registration applicants violate the provisions of the Measures and fall within the scope of administration The case is a patent infringement dispute, should be handled by the court in accordance with the relevant patent laws and regulations, so whether the two defendants apply for registration of drugs involved in the case is in violation of the relevant provisions of the Measures for the Administration of Drug Registration does not fall within the scope of the trial of this case, the Court is not concerned 4.4 Whether the alleged infringement of the two defendants constitutes patent infringement, the Court of Justice considers that the available evidence cannot prove that the defendant Runzhu Company has committed the act of selling the patented compound enhelyumines involved for the purpose of production and operation, and that the two defendants manufacture and use the patented compounds involved in the case for the need to obtain clinical approval for the registration application for etheluamine drugs, in line with the provisions of Article 69 (5) of the Patent Law, and therefore does not constitute patent infringement The two defendants have only now obtained clinical approval for the enmesyamine drug, and the available evidence does not prove that the two defendants, during the patent protection period in question, have the possibility of manufacturing, using, promising to sell and selling the allegedly infringing products for the purpose of production and operation Therefore, the two plaintiffs' claim that the two defendants' application for registration of the drugs involved constitutes their alleged immediate infringement has no factual and legal basis, and the Court does not support it 5 Viewpoint and Revelation 5.1 The design of the necessary patent system on the protection of patent rights in the field of biomedicine should be moderately restricted is through "open protection", but at the same time, the intellectual property system is also a tool to balance private rights and public interests The listing of drugs or devices in the field of biomedicine should go through a large number of animal experiments, human experiments, to strictly verify its safety, effectiveness and quality stability, and because its products affect people's lives and health, therefore, the patent in the field of biomedicine, appropriate restrictions on their rights to promote innovation in the field of medicine has a positive significance, the author suggests to further improve the relevant system in the following areas 1) Use patents for scientific research and experiments The particularities of the pharmaceutical industry, the exploratory research stage, such as the discovery of new compounds, new targets and other scientific research is significant, but in the field of pharmaceutical industrialization, formulation, process optimization and the establishment of quality standards, scientific research is no longer significant, more to meet regulatory and commercial requirements How to define the boundaries of scientific research and experiments is also the focus of practice; Although the Bolar exception system encourages generic drug companies, it is necessary to make the system more specific today, such as supplementing the "proposed infringement" system and increasing the market exclusivity or data protection period after the success of the first imitation challenge; A technological achievement whose protected value base does not exist if it is not actively transformed and benefited society For some emergency drugs, orphan drugs, rare disease drugs, etc involving people's livelihood and public health, there should be more specific operating rules; The development and listing of drugs sometimes involve sized patent pools of many patents, including the basic patents of compounds, as well as process patents, crystal patents, application patents, new formulation patents, etc., for patent holders who are actively industrialized, a certain mechanism (such as compulsory cross-licensing) should be established so that drugs can effectively advance the listing process without patent issues 5.2 Optimize China's drug patent link system, achieve the encouragement of innovation and first imitation, limit excessive imitation from several recent drug patent infringement cases, such as the previous weekend study of the stone pharmaceutical group Enbipu Pharmaceuticals v Lizhu Group Limin Pharmaceuticals patent infringement case, this issue of Astellai Pharmaceutical Co., Ltd., Madison Medical Co., Ltd v Zhengda Tianqing Pharmaceuticals and Runzhu Pharmaceuticals Enhelynamine patent infringement case All involve generic pharmaceutical companies after filing a registration declaration, by the patentee or the original research and pharmaceutical companies to file infringement proceedings According to Article 69 5 of the Patent Law: "In order to provide the information required for administrative approval, the manufacture, use, import of patented drugs or patented medical devices, as well as the manufacture and import of patented drugs or patented medical devices specifically for them." "The filing of a drug registration application by a pharmaceutical company is an act of patent infringement exemption (i.e the Bolar exception) The author believes that China's drug patent link system should be further systematic design at the operational level, such as the introduction of similar to the U.S Code 35 271e(2) "proposed infringement" system design, and then with a certain incentive mechanism, such as market exclusive period or data protection period, will better encourage imitation, while restricting excessive imitation behavior, better balance between generic drugs and the interests of the original research and public More authors' articles: 1, the creative evaluation of drug impurity patents --A brief evaluation of the patent invalidity of the chlorever-flat degradation 2, whether the new use of drug metabolites invention has creativity? ---- a brief assessment of the treatment of methylene-small-grade-based alcohol-based liver disease review administrative litigation case 3, the declaration materials (drugs / medical devices) can be used as the basis for determining product infringement? -- Brief evaluation of tb diagnostic kit patent infringement case 4, whether the functional qualification of peptide compounds is supported by the specification --A brief evaluation of the TB diagnostic compound patent invalidity case 5, the drug preparation of the auxiliary material combination creative judgment -- a brief evaluation of Nima Shuli drug composition patent invalidity case 6, the impact of approximate compounds on creative evaluation -- a brief evaluation of the patent invalidity of the patent of the villez collapse and the solution 7, the same drug compound new crystal creative evaluation of the new crystal-type acid Can the crystal claim be supported by the specification--Brief evaluation of Novartis's new crystal patent review case 9, whether the composition of drug compositionised is creative--Jane evaluates Hengrui's invalid hefluoricele eye drops patent case 10, compound patent's creative impact on crystal patent and the importance of claim layout --Jane's evaluation card gress sylwed patent invalid case 11, new compound patent full disclosure on the effect of experimental data requirements -- Creative Judgment of Patent Drug Taste Substitution of Chinese Medicine Preparations --Short Evaluation of the Patent Invalidity case of The U.S Patent of The Infraction of The U.S Of The Bacteria, Patent Legal Protection of Human Embryonic Stem Cell Differentiation Methods--Short Evaluation of Multi-Energy Stem Cell Differentiation Method Patent Application Dismissed Review Case 14, "Joint Drug Use" Patent Creative Evaluation and "Commercial Success" Application in Creative Judgment--Short Evaluation of Antimicrobial Combination Drug Patent Invalidity Case 15 The application of the evidence, evidence and liability determination principle of patent infringement of pharmaceutical preparation process - Brief evaluation of Lilly and Changzhou Watson Pharmaceutical Patent Dispute situ, the subject qualification of drug patent infringement and the application of Bolar exception principles - Brief evaluation stone pharmaceutical group Emp Pharmaceutical Co., Ltd and Lizhu Group Limin Pharmaceutical Factory infringement of invention patent dispute