[exclusive] from the perspective of classic patent reexamination / invalidation cases, the destructive effects of various standards on the novelty and / or creativity of drug patents

The examination of patent novelty and creativity is based on the existing technology As far as the field of drugs is concerned, whether various types of quality standards constitute the existing technology has always been a key point of the examination of drug patents Recently, on January 4, 2019, the Patent Reexamination Board of the State Intellectual Property Office announced the invention patent No 03117612.7 of Guizhou Taihe Pharmaceutical Co., Ltd (patent name: Traditional Chinese medicine preparation and its preparation for the treatment of cardiovascular and cerebrovascular diseases) on the basis of the compilation of national standards for traditional Chinese Medicine of the State Drug Administration - part of national standards for the rise of local standards for traditional Chinese Medicine - division of internal medicine and cardiology Methods) some of them are invalid, which once again attracts the attention of the author Based on the typical cases disclosed in the evaluation of typical cases of pharmaceutical patent protection published by intellectual property press and edited by Zhang Qingkui, this paper briefly discusses the destructive effect of relevant quality standards on the novelty and / or creativity of pharmaceutical patents combined with the recent relevant reexamination / invalidation cases Classic case 1: administrative dispute case of patent invalidation of Tongxinluo capsule [basic information of patent involved] patent No.: zl01131203.3 patent name: patent holder of a pharmaceutical composition for the treatment of coronary heart disease and angina pectoris: Shijiazhuang Yiling Pharmaceutical Co., Ltd application date: August 31, 2001 product involved: Tongxinluo capsule, with a national sales volume of nearly $900 million in 2004 [litigation and trial process] on May 10, 2004, sun Zhefeng (hereinafter referred to as "the petitioner") filed an invalid request on the grounds of non-compliance with novelty (Law 22.2) and creativity (Law 22.3) On May 25, 2005, the Patent Reexamination Board made the invalid decision No 7275, holding that based on the existing evidence, it could not prove that evidence 1 had been disclosed before the patent application date, so the patent right was maintained If the applicant refuses to accept, he will go to Beijing No 1 middle school and Beijing high school successively Beijing No 1 middle court and Beijing High Court successively issued judgments (2005) No 1009 and (2006) No 262, maintaining the invalid decision No 7275 [main evidence and focus of dispute] when requesting invalidity, the petitioner submitted evidence 1: National Standard (trial standard for new drugs transferred to formal standard) No (98) wzbz-037 issued by the Ministry of health of the people's Republic of China This evidence belongs to the drug standard promulgation document which has not been compiled into a volume, in which the prescription and preparation method of Tongxinluo capsule are recorded, while the standards compiled into a volume do not include the prescription and preparation method The focus of this case is whether evidence 1 is a public document From the results of the review, the reexamination board, Beijing No.1 Chinese Academy of Sciences and the high court all supported that "the drug standard promulgation document not compiled into a volume" could not be regarded as a public document of course [countermeasures and Enlightenment] for drug manufacturers, if they apply for a patent, they must submit the application before the relevant contents of their drug standards, especially the relevant contents of the prescription and manufacturing law are disclosed Classic case 2: administrative dispute case of patent invalidation of Hawthorn refined lipid lowering tablet [basic information of patent involved] patent No.: zl87107980.1 patent name: Hawthorn refined preparation process patentee: Sanming pharmaceutical factory (later renamed as "Fujian Huitian biopharmaceutical Co., Ltd.") product involved: Hawthorn refined lipid lowering tablet, gyzz35020649 [litigation and trial process] In September 2001, Fujian Huitian biopharmaceutical Co., Ltd (hereinafter referred to as "Huitian pharmaceutical") found Hawthorn essence lipid-lowering tablets produced by Ningxia Qiyuan Pharmaceutical Co., Ltd (hereinafter referred to as "Qiyuan pharmaceutical") in the market, and then filed an infringement lawsuit with Fuzhou intermediate people's court During the trial of the infringement dispute, Qiyuan pharmaceutical filed a request for invalidation to the Patent Reexamination Board because the patent involved did not meet the requirements of novelty (Law 22.2) and creativity (Law 22.3) On September 5, 2003, the reexamination board made the invalidation decision No 5338 to maintain the validity of the patent involved Qiyuan pharmaceutical did not take it, and appealed to Beijing No.1 middle court and Beijing High Court successively Beijing No 1 middle court and Beijing High Court made judgments in May 2004 and September 2004 respectively, rejected the appeal and upheld the original judgment [main evidence and dispute focus] in the process of invalidation request, Qiyuan pharmaceutical submitted "the drug quality standard attached in the reply of Fujian Provincial Department of health to the drug quality standard" as the main evidence (the reply date is February 9, 1983) The focus of the dispute in this case is whether the quality standard in the above reply constitutes the prior art known to the public before the application date From the perspective of invalidity and court judgment results, the review board and courts at all levels support the view that "the said standards do not constitute the existing technology" [countermeasures and Enlightenment] when a patent is invalid, if a patent claimed by a drug standard does not possess novelty and / or creativity, the standard must be made public before the application date Generally speaking, Pharmacopoeia and drug standards (including national standards, local standards, etc., but not import registration standards) are documents open to the public For drug standards, import registration standards and enterprise standards that are not listed, if there is no other evidence to prove that they are open, they are generally considered to be As for the unpublished documents, it is not allowed to destroy the novelty and / or creativity of the patent as the prior art For patentees, if the information submitted in the process of drug Declaration contains the content of patent application, it is necessary to consider whether the information submitted will be disclosed by the relevant departments If so, a patent should be applied before the disclosure of the information Discussion 1 The influence of "CC" on "compilation into volume" or "publicity" of standards Zhang Qingkui pointed out that although the evidence 1 of case 1 is the "promulgation document", in its literal sense, the standard has been in the public state, however, because its CC unit is only limited to the research and development unit, the production unit and the local health department (Institute) and Drug Inspection Institute, and does not record the public availability of the standard, it is considered that it is not open to the public Similarly, the evidence in case II is only copied to the relevant units, i.e only to the relevant pharmaceutical administrative departments, and it can not be determined that it has been made public On the contrary, the main evidence adopted by the Patent Reexamination Board in its invalid decision No wx8566 made on August 9, 2006 is "the copy of the national drug standard (Revision) No 2002zfb0227 issued by the State Drug Administration on" Liuwei Dihuang capsule "(hereinafter referred to as the" 2002zfb0227 issued document ") Although the patentee took No 5338 invalid decision as the counter evidence, he tried to deny the publicity of 2002zfb0227 However, the Reexamination Board believes that although 2002zfb0227 is also a document issued by the administrative department to the relevant units, its CC unit includes "and all relevant production units", not limited to the relevant drug administration departments and the declaration enterprises of the standard The author found that many domestic enterprises, including Sichuan Enwei pharmaceutical, had obtained the production approval of Liuwei Dihuang capsule before 2006 by using the domestic drug database of yaozhi.com It is true that there is still something arguable about the point that "drug administration has confidentiality obligations", but there is no evidence that "other relevant production units" also have confidentiality obligations Therefore, the reexamination board determines that it belongs to the prior art that is open to the public 2 Determination of access and disclosure time although Zhang Qingkui pointed out that, like the quality standards that have not been compiled into a volume, pharmaceutical enterprise standards and import registration standards belong to confidential documents Without any other evidence to prove that they have been disclosed, they cannot be used as existing technologies to destroy the novelty and / or creativity of patents (Applications) However, in order to meet the requirements of drug registration and declaration, the above standards can be obtained by abnormal means and may be in the state of decryption In addition to the legitimacy will be questioned, the determination of public time will also be affected For example, the patentee in case 2 once questioned the legality of the way for the petitioner to obtain evidence 1, and claimed that for the documents originally in a confidential state, the disclosure time should start from the decryption time On the contrary, generally speaking, Pharmacopoeia and drug standards (including national standards and local standards) are documents open to the public, specifically publications in the sense of patent law, which can be used to destroy the novelty and / or creativity of patents (Applications) Such standards are available to the public if they want to, and the publication date is determined according to the standards in section 2.1.2.1 (publication publication publication) of Chapter 3, Part II of the patent examination guide For example, No wx13954 invalidity decision, although it is determined that the "ws-11454 (zd-1454) - 2002 standard of the State Drug Administration of the people's Republic of China" (hereinafter referred to as "ws-11454 (zd-1454) - 2002 standard") submitted as evidence is a document open to the public, but because the standard is only noted in 2002 and no specific date is specified, it is listed according to the relevant standards of the review guide The edition date is determined as December 31, 2002, which is later than the application date of the patent involved Therefore, it cannot be used as the prior art to destroy the novelty and / or creativity of the patent involved It is worth noting that although the petitioner claims that the right lower part of the promulgation document of the monograph "cold cough syrup" in ws-11454 (zd-1454) - 2002, which is closely related to the patented products involved in the case, is dated as "November 16, 2002" However, since the promulgation document of the drug standard is a government document issued by the relevant department, its main and CC units are specific and cannot be regarded as To any public, it is not in a state that the public can know In the absence of other evidence, it can not be determined that the promulgation and standards in evidence 1 have been disclosed before the date of application of this patent Similarly, in the invalid decision of wx7275, although the authenticity and legality of the "national standard (trial standard for new drugs transferred to formal standard) No (98) wjbz-037) issued by the Ministry of health of the people's Republic of China" submitted as evidence 1 have been recognized by the reexamination board, evidence 2 submitted to prove evidence 1 and stamped with the official seal of relevant departments has no date of seal, so it cannot Evidence 1 is disclosed before the application date The case of administrative dispute over patent invalidation of ganshukang included in the evaluation of typical cases of pharmaceutical patent protection is based on the recognition that the compilation of national standards for Chinese patent medicines is a publication open to the public, and the same criteria are used to determine that the publication date (December 31, 2002) is earlier than the application date of the patent involved At present, the upgrading of generic drug development from "generic prescription" to "generic standard" has become a well-known hot spot in the industry, thus spawning a large number of standard transactions Therefore, for the original research institutions of new drugs, it is an important way to avoid the adverse impact on the patent after the standards are released on the basis of close confidentiality work and advance patent layout For generic pharmaceutical manufacturers, in addition to the burden of proof in the process of patent invalidation as mentioned above, after obtaining various standards that were originally in a confidential state through "tacit and abnormal channels", they shall timely decrypt them, so as to avoid the original research party or other generic competitors applying for the technical characteristics of the existing technology not disclosed in the quality standards Wall of patent application