Abstract
I
According to Part II, Chapter 3, 2.1.2.1 of the Guidelines for Patent Examination of SIPO, publications in the context of the Chinese Patent Law mean the independently existing disseminating carriers of technical or design content, which shall indicate or have other evidence to prove the date of public issue or publication. The determination of whether a document is a publication shall not be affected by the place or language of issue, the manner of acquisition, or its age. The amount of distribution, whether it has been read, or whether the applicant is aware of it, is of no relevance either. As for publications with the words “Internal Materials” or “Restricted Publication” or other similar wording, if they were really distributed in a restricted scope and required to be kept confidential, they are not regarded as publications in the context of the Chinese Patent Law. The printing date of a publication is regarded as the date of disclosure, except where the date of disclosure can be evidenced otherwise. Where only a specific month or year is indicated as the printing date, the last day of the month or year shall be regarded as the date of disclosure.
As evidence for patents in dispute, drug standards have their own particularity, which is mainly shown in the following:
(1) China's drug standards are national and compulsory, with a formation process including reporting, examination and approval, promulgation, compilation, release, and other aspects. The technical and administrative documentation pertaining to this process constitutes different forms of drug standards with differing levels of access available to the public. (2) Historic changes in drug supervision agencies, as well as in the relevant laws and regulations, have led to diverse types and different formats of drug standards. (3) Although there are various laws, regulations, and regulatory guidelines related to drug standards, no clear and specific stipulation is provided to clarify public accessibility to the drug standards. This article discusses the Chinese law relating to the determination of different levels of public access in drug standard evidence, based on some relevant SIPO Reexamination Board decisions (hereinafter referred to as “SIPO decisions”).
I. Categories of Drug Standards in China
China's administrative framework for drug standards has undergone two reforms, which can be divided into three periodic stages. The Pharmaceutical Affairs Regulations implemented in 1978 divided drug standards into three categories, namely: national standards created with reference to the Chinese Medicine Dictionary; Ministry of Health standards; and local standards examined and approved by provincial health administration departments. The Drug Administration Law introduced in 1984 considered both the Chinese Medicine Dictionary and Ministry of Health standards as national standards, so drug standards were effectively divided into two categories, national and local. The Drug Administration Law revised in 2001 canceled local standards except where applied to the preparation of Chinese herbal medicines. Previous local standards were either abolished or collected and reissued by the drug administration department of the State Council, and upgraded to national standards. 1
Besides the statutory standards, industrial and corporate standards are also encouraged; according to Article 6(2) of the Standardization Law implemented in 1989: “Where national standards or industrial standards exist, the state encourages enterprises to develop and apply corporate standards that are stricter than the national or industrial standards.”
The state also implements a registration system to manage and administer imported drugs, and requires that quality standards for imported drugs be submitted for approval.
As discussed above, a number of drug standards coexist for a variety of historic and administrative reasons. For convenience in analysis, therefore, this article will subdivide drug standards into the five categories described above, namely, the Chinese Medicine Dictionary; drug standards promulgated by drug administration departments under the State Council (called departmental standards for short); local drug standards; standards of drug enterprises; and imported drug standards. The publication status of each category for the purpose of prior art status determination will be discussed based on relevant cases.
II. Determination of The Publication Status of Different Types of Drug Standards
A. Chinese Medicine Dictionary
The Chinese Medicine Dictionary is a publication approved and issued as a book by drug administration departments under the State Council. As it contains an imprint and publication date, there is no dispute about its status as a publication.
B. Drug standards promulgated by drug administration departments under the State Council
Departmental standards are a relatively complex category because there are many elements in their development process. Departmental standards will appear in different forms during the formation process, but common forms include: collections of departmental standards; promulgated unbound official standards; promulgated unbound trial standards; and promulgated unbound revised drug standards. These will be described in order.
1. Collections of departmental standards
Collections of departmental standards are official but informal publications. Usually, “edited by xxx” or “in year xxxx” is indicated on the cover or title page, but neither the publisher nor the specific time of printing or publishing is given.
According to the stipulations of Wei Yao Zheng Fa (1992) No. 351, Notice About Matters Related to Regularization of Quality Standards for New Drugs: “Official departmental standards for new drugs are to be collected by the Pharmacopoeia Commission every three months and publicly released to the provinces, autonomous regions and municipalities directly under the Central Government of the State.” From this it can be seen that official departmental standards for new drugs are public documents because they are publicly released after collection.
Collections of departmental standards may also include “trial standards.” According to an investigation of bookstores and shopping websites, various collections of standards, many of which also include trial standards, are on public sale. Therefore, collections of departmental standards are public publications whether they contain trial standards or not.
One category of departmental standards includes local standards that have been upgraded to national standards. According to the stipulations regarding cancellation of local drug standards in the Drug Administration Law revised on December 1, 2001, the China Drug Administration compiled The Collections of National Standards for Chinese Traditional Patent Medicines (Local Standards for Chinese Traditional Patent Medicines That Are Upgraded to National Standards) (13 volumes) between 2001 and 2002. All of the petitioners in Reexamination Board invalidation decisions Nos. 9902, 13754, 13954, and 14035 cited the drug standards given in the above collections as evidence, showing that the collections had a great impact on the patent stability of drugs in the field of traditional Chinese medicine. In the decisions, the Reexamination Board ruled that although the promulgated drug standards documented the recipients of the originals and copies, this did not mean that the collections were disclosed only to those recipients; and it could not be proved that they were internal documents, not publicly released and not accessible to the public. 2 Therefore, collections of local standards that have been upgraded to national standards are also in the public domain and qualify as publications for prior art status determination.
General collections of departmental standards only indicate “year” on the cover or title page, so it should be presumed that December 31 of the indicated “year” is the publication date of the standards. If any evidence shows a date of release time before December 31, the publication date should be deemed to be the specified release date.
Another special category of departmental standards is the “National New Drug Registration Data Disc.” The petitioners in the Reexamination Board invalidation decision No. 8420 presented the National New Drug Registration Database (1985–2000 edition) as evidence of prior art. The decision ruled that since the date clearly indicated in the attached “License for Using the Search Disc” was October 2001, registration of the database had been approved for publication by the China Drug Administration Center for Drug Evaluation on that date. It was therefore presumed that the publication date of the database disc was October 2001.
2. Promulgated unbound trial drug standards and regularized standards
Whether promulgated unbound trial drug standards and regularized standards are publications accessible to the public is a complicated question, which should be answered based on an analysis of the characteristics of each particular standard, including nature of documentation, scope of promulgation, method of implementation, disclosed details, as well as other aspects.
According to the Drug Administration Law, Measures for Examination and Approval of New Drugs, and Drug Registration Regulation, the formation process of promulgated drug standards is as follows: When drug manufacturers declare registered drug standards, the provincial drug administration department conducts a preliminary examination, reviewed by the provincial Institute for Drug Control. The standards will become trial standards after examination and approval by the drug administration department under the State Council, and they will later become official standards after reporting and approval on expiry of the trial period. 3 The trial standards and regularized standards in the process of formation will be released to provincial drug administration and control bodies for supervision and management, although other enterprises may not have access to them. The announcement of trial standards and regularized standards may be required, but generally only drug name, analytical methods, character, and some other content are announced, not including specific prescription and preparation methods, etc.
Therefore, during the procedures of patent invalidation, promulgated unbound trial and regularized drug standards should not be considered as published documents. They do not qualify as prior art, and the novelty and inventiveness of the patent in dispute should not be destroyed based on these standards documents.
Reexamination Board invalidation decision No. 7275 is such a case. The petitioner submitted the promulgated (98) Wei Yao Biao Zi Z-037, National Standards (trial standards for new drugs that are transferred into official standards) of the Ministry of Health of the People's Republic of China. During examination, the Board found that for “prescription” and “preparation method,” new drug quality standards for traditional Chinese medicines can adopt a format either of full or partial disclosure. The counter evidence submitted by the patent holder recorded a simple prescription of the “TongXinLuo Capsule,” but it did not include preparation methods, while the petitioner's evidence was a detailed prescription and specific preparation method of the “TongXinLuo Capsule.” Based on careful consideration of the evidence submitted by both parties, the determination was made that the evidence of “prescription” and “preparation method” was a promulgated drug standard accessible only to specified recipients. Its scope of accessibility was specified, and it could not be assumed that the public could access it if they wanted to. This holding was upheld by the court of first instance and the court of last instance. 4 According to the published authoritative interpretation by the State Food and Drug Administration (SFDA) Registration Department, both tentative standards and regularized standards belong to registration standards of enterprises and are unpublished. Whether the registration standards are for imported drugs or domestic drugs, they are only issued to provincial drug administration and inspection agencies for supervision and management. Other companies cannot access the documents. Therefore, the interpretation of the SFDA Registration Department upholds the above viewpoint—that is, unbound drug standards promulgated by drug administration departments should be considered unpublished. 5
3. Promulgated unbound revised drug standards
Generally, promulgated unbound revised drug standards constitute amendments to original regularized drug standards based on feedback on drug use, following the drug producer's application after regularized drug standards have been implemented for a period of time. Generally, by this time, production of the drugs in question has been proliferated to several enterprises, so the scope of release of the promulgated revised drug standards covers all the enterprises with conditions to produce the drug, as well as relevant regulatory departments. Therefore, promulgated unbound revised drug standards should be considered to be open to the public, and the promulgation date is the disclosure date unless there is other evidence proving that the revised standards have not been disclosed.
Invalidation decision Nos. 8566 and 11647 involve national drug standards No. 2002ZFB0227 (revised) with reference to “Liuwei Dihuang Capsules” promulgated by the China Drug Administration. Promulgated drug standard No. 2002ZFB0227 is based on the revision of the Ministry of Health drug standard No. WS3-B-1518-93, dated October 16, 2002, and stamped with the seal of the China Drug Administration. Besides the main recipients, recipients of copies included the Institute for Provincial Drug Control (including autonomous regions and municipalities directly under the central government), the People's Liberation Army General Logistics Department (PLA GLD) Health Department Institute for Drug and Instrument Control, Sichuan Huatai Pharmaceutical Co., Ltd., Guizhou Kinglion Senfon Pharmaceutical Co., Ltd., and relevant production units. Its “implementation provisions” column clearly indicates that the standard should be implemented from the implementation date and the original standard abolished simultaneously. Drugs produced before the implementation date should continue to be tested according to the original standard. Except for Sichuan Huatai Pharmaceutical Co., Ltd. and Guizhou Kinglion Senfon Pharmaceutical Co., Ltd., other production enterprises should send the first three batches to the provincial Institute for Drug Control for inspection and registration with the Pharmacopoeia Commission when implementing the revised standard.
For the publication status of the evidence, the above invalidation decision confirmed that from the time of issuance of the promulgated standard No. 2002ZFB0227, all the enterprises producing the drug (other than declaration units) and enterprises with the production conditions, became aware of the information recorded in the promulgated document. In addition, since the purpose of the promulgated national drug standard (revised) was to mandate unified compliance, relevant departments and enterprises had no obligation to maintain confidentiality. Therefore, the promulgated document was actually open to the public. The promulgation date clearly indicated was October 16, 2002, so that date should be deemed to be the publication date for prior art purposes. Whether any given drug administration department or enterprise actually received it after that date does not affect the already existing open status.
C. Local drug standards
Local drug standards are divided into collections of local drug standards and unbound local drug standards, as follows:
1. Collections of local drug standards
Collections of local drug standards combine multiple approved drug standards of multiple local drug manufacturers within a given period into a single volume, aiming at standardizing the management of local drug production and sales. Different from collections of departmental standards, they are issued by relevant provincial government administration departments. After collection, they should be reported to higher-level departmental administration for recording, then issued to relevant administration departments in other regions in a timely fashion. Collections of local drug standards are provided or sold by the local drug approval authority. The reading room of the Pharmacopoeia Commission for public reading also provides the collections. Similar to collections of departmental standards, therefore, collections of local drug standards are also public documents.
The Reexamination Board made invalidation decision No. 6380 based on the collections of local drug standards, confirming that the latter were published documents. Both Beijing No. 1 Intermediate People's Court and Beijing Higher People's Court upheld the decision.
2. Unbound local drug standards
Generally, unbound local drug standards exist in the form of appendices to written replies where a provincial government health administration department approves a declaration unit's production. The standards indicate to which units they will be distributed. Generally speaking, such units are relevant medicine administration departments and they are specific units. Therefore, unbound local drug standards are generally not considered published unless there is evidence showing that they have been disclosed without restriction.
D. Drug enterprise standards
Drug enterprise standards are non-mandatory and limited to the enterprises in the form of internal information. Generally, they cannot be accessed by the public. In the absence of other evidence, therefore, the standards should be considered undisclosed documents.
E. Imported drug standards
According to the Guidelines for Imported Drug Registration and Inspection, imported drug standards can be divided into imported drug registration standards, revised imported drug registration standards, and collections of imported drug review standards. Collections of imported drug review standards are kept by the National Institute for the Control of Pharmaceutical Products and Biological Products (called NICPBP for short) and are not sent to other units; imported drug registration standards and revised imported drug registration standards are generally distributed to the Institute for Drug Control of Ports by NICPBP. These are confidential documents, not disclosed to other units and individuals; 6 therefore, whether collected or not, imported drug standards are unpublished documents.
An invention-creation for which a patent is applied for does not lose its novelty where it was disclosed by any person without the consent of the applicant.
III. Illegal Disclosure
Another condition that could possibly occur is that the government department or staff illegally discloses the documents online or to a single or several units or individuals. According to Article 24(3) of Patent Law and Article 30(4) of Implementing Regulation of the Patent Law, the documents should be deemed as unpublished, if within six months of the date of application. The government department or staff who illegally discloses the documents is bound to bear the responsibility of malfeasance.
IV. Conclusion
By analyzing relevant laws and regulations, and SIPO invalidation decisions, the publication status of different drug standards can thus be summarized. If the drug standards used as prior art evidence for patents in dispute come from the Chinese Medicine Dictionary, collections of drug standards released by the State Council drug administration department, unbound revised drug standards, or collections of local standards, all will be deemed to be publications useful as prior art evidence. The publication date is the indicated date of printing or publishing or the time of signature of enacted documents; for collections where only the year is indicated, the publication date is deemed to be December 31 of that year; if the month and year are indicated, the disclosure date is the last day of the given month. If the drug standards used as evidence for patents in dispute are unbound trial drug standards and promulgated regularized standards, unbound local drug standards, standards of drug enterprises, or imported drug standards, they are not considered prior art publications.