Introduction

With the rapid development of biotechnology, the number of patent applications for biological materials such as microorganisms and cell lines has been on the rise. However, due to the unique characteristics of biological materials, they face many unique challenges in the process of patent protection. A series of regulations, including the Patent Law of the People's Republic of China and its Implementing Regulations, as well as the Measures for the Preservation of Biological Materials for Patent Purposes, have effectively balanced the conflict between technical disclosure, patent protection, and public interest by standardizing the procedures for the preservation of biological materials. This article will explore the importance of biological preservation in patent applications and its impact on patentability by analyzing relevant legal provisions and typical case examples.

I. Relevant Legal Provisions

 (1) Ensuring sufficient disclosure

According to Article 26(3) of the Patent Law, applications involving biological materials must meet the requirement of sufficient disclosure. If the biological material cannot be obtained through conventional means, the applicant is required to submit it to a preservation institution recognized by the China National Intellectual Property Administration, such as the China Center for Type Culture Collection (CCTCC), China General Microbiological Culture Collection Center (CGMCC), or the Guangdong Microbial Culture Collection Center (GDMCC), and indicate the preservation information in the application documents, including the name of the institution, address, and preservation number. This measure ensures that the public can obtain the material through legal means after the patent is granted, thereby verifying the feasibility of the technical solution.

 (2) Standardizing Preservation Procedures and Responsibilities

1. Time Requirements

The applicant must complete the preservation within four months from the filing date of the patent application at the latest and submit the preservation certificate and viability certificate.

2. Responsibilities of the Preservation Institution

The preservation institution is responsible for the long-term preservation of biological materials, with a minimum preservation period of 30 years from the filing date. In addition, the preservation institution is also responsible for providing samples and maintaining confidentiality. Before the patent is published, the preservation institution shall not disclose any information related to the preserved biological material to any third party in order to protect the applicant's intellectual property rights.

3. Handling of Special Situations

If the biological material dies or is contaminated during the preservation period, the applicant may resubmit the same biological material within four months from the date of notification, and the preservation institution will continue to preserve it. After the preservation period expires, the right holder may retrieve the preserved biological material or negotiate with the preservation institution for disposal.

II. Case Analysis: The Impact of Biological Preservation on Patentability

 (1) Patent Invalidity Case："Pseudomonas aeruginosa Mannose-Sensitive Hemagglutinin Pilus Strain" (绿脓杆菌甘露糖敏感血凝菌毛株)

The invention patent titled "Pseudomonas aeruginosa Mannose-Sensitive Hemagglutinin Pilus Strain" owned by Beijing Wan [Last Name] Biopharmaceutical Company was challenged by Dai Mou[Last Name] with an invalidation request on the grounds that it lacked inventiveness. After review, the National Intellectual Property Administration upheld the validity of the patent, but Dai Mou[Last Name] was dissatisfied with the decision and further initiated an administrative lawsuit.

Controversial Focus: The prior art disclosed the preparation method of the same strain, but did not preserve the strain.

Court Judgment: During the appellate proceedings, the Supreme People's Court held that the prior art only disclosed the preparation method of the strain, but did not preserve the biological material. Moreover, the method contained multiple random factors, and the skilled in the art could not obtain the biological material of the patent in question by repeating the method. Therefore, the patent possesses inventive step, and the court ultimately dismissed the appeal and affirmed the original judgment.

Case Enlightenment: This case clarified the importance of biological material preservation in the determination of inventiveness. When the prior art does not preserve the biological material and cannot obtain the material through other means, the patent application is considered to have inventiveness.

(2) The Patent Infringement Case of "Pure White Enoki Mushroom Strain"(纯白色真姬菇菌株)

The invention patent titled "Pure White Enoki Mushroom Strain" owned by Shanghai Feng[Last Name] Biotechnology Company, which claimed the scope of protection by the microbial preservation number. The company alleges that Tianjin Lv[Last Name] Agricultural Technology Development Co., Ltd. and others have infringed its patent rights by selling mushroom products and has therefore initiated litigation.

Controversial Focus: Whether the infringement determination depends on the preservation number and identification method.

Court Judgment: The court of first instance found the infringement to be established. The Supreme People’s Court, during the appellate proceedings, held that the appraisal method was reasonable and credible, and that the accused infringing product fell within the scope of protection of the patent in question. Consequently, the court dismissed the appeal and affirmed the original judgment.

Case Enlightenment: This case clarified the scope of protection limited by the microbial preservation number and the rules for infringement determination. The identification method combining SCAR molecular markers with morphological and ITS sequence analysis was deemed reasonable and credible.

(3) The Special Nature of International Preservation

Taking a Japanese priority case as an example, the patent application, based on Japanese priority, had the biological material preserved in Japan and then transferred to international preservation after the priority date, which was not disregarded during the Chinese examination process.

Case Enlightenment: China strictly follows the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, requiring that the international preservation date must not be later than the filing date or the priority date, highlighting the importance of procedural compliance.

In addition, China has designated CCTCC, GDMCC, and CGMCC as official preservation institutions, while preservation institutions in other countries (such as ATCC in the United States and DSMZ in Germany) need to be recognized through the Budapest Treaty. China does not accept preservation by non-treaty institutions unless converted into an international deposit under the Budapest Treaty. Countries such as China, Japan, and South Korea all require preservation to be completed before the filing date or the priority date, while some European and American countries allow subsequent submission, but with corresponding risks. Applicants involved in multinational cooperative research and development can effectively avoid disputes over ownership by planning international preservation strategies in advance.

III. Conclusion

In practice, the preservation of biological materials is not only a clear requirement of the patent law but also a critical factor in ensuring the industrial applicability and inventiveness of applications. Applicants must strictly follow the preservation procedures to ensure the long-term preservation and accessibility of biological materials, and fully disclose relevant information in the specification to meet the patent law's requirements for technical disclosure. With the continuous development of biotechnology, the importance of biological preservation in patent applications will further emerge, and related legal practices will continue to improve to better adapt to the innovation and development needs of the biotechnology field.