On April 13th, Zhejiang Province officially released the first national special guidance on patent layout in the field of biopharmaceuticals, filling the gap in the systematic patent guidance rules of the domestic biopharmaceutical industry. As a major province in the biopharmaceutical industry, Zhejiang relies on its own advantages in innovative pharmaceutical companies, research institutes, and industrial chain clusters to take the lead in clarifying the full process standards for biopharmaceutical patent mining, layout, protection, and operation at the policy level. This sets the boundaries and layout strategies for patent compliance in cutting-edge fields such as large molecule drugs, cell therapy, gene drugs, and antibody drugs in China, and provides a benchmark model for the standardized development of biopharmaceutical intellectual property rights in various provinces and cities across the country.

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1、 Layout logic: Building a full chain patent protection system for biopharmaceuticals

From the core content, the biopharmaceutical patent guidelines released this time first clarify the logic of patent layout for the entire biopharmaceutical chain, breaking the previous single thinking of only focusing on product structure patents. The guidelines emphasize the layout principle of “platform patents first, bottom patent building, and hierarchical patent enclosure” for biopharmaceuticals, and clarify the seven directions of technology platforms, production processes, expression vectors, host cell lines, key site mutations, preparation methods, and indications as the core patent protection scope for biopharmaceuticals. Especially targeting the unique industry attributes of macromolecular drugs, it is emphasized that process patents, carrier patents, and cell line patents are the core barriers that cannot be replaced by biopharmaceuticals, filling the gap in the industry’s insufficient understanding of the value of process patents in the past.

2、 Differentiation strategy: customized patent strategy for multi track biopharmaceuticals

For dual antibodies ADC、 Popular macromolecular drugs such as fusion proteins are advocated to prioritize the layout of general technology platform patents, such as CrossMab dual antibody construction platform, targeted modification platform, coupling technology platform and other broad range underlying patents; Simultaneously focusing on key structures such as CDR regions, receptor binding domains, and glycosylation sites, layout specific site mutations and conservative variant patents, forming a dual layer patent barrier of “platform+structure”.

For cell therapy and gene therapy products, the key points of patent layout such as virus vectors, editing tools, preparation processes, and therapeutic uses should be standardized to avoid common problems such as target clustering and narrow protection scope;

For mRNA vaccines and drugs, core patent mining directions such as sequence design, delivery systems, and modification processes are highlighted to meet the innovative protection needs of the cutting-edge track.

 

3、 Practical guidance: Standardize the entire process of patent writing and infringement risk control

Provide clear guidance on patent writing, defining protection scope, avoiding design, and determining patent invalidity and infringement in the face of practical difficulties in the biopharmaceutical industry. The drafting of claims for biopharmaceuticals has always had problems such as vague definition of technical features, abuse of functional limitations, and difficulty in controlling scope. Based on a large number of real cases, guidelines have standardized the writing rules for process parameters, structural features, and functional limitations, guiding enterprises to reasonably delineate patent protection boundaries. This not only avoids being easily invalidated due to too wide a scope, but also prevents the formation of effective barriers due to too narrow a scope. At the same time, targeting the biosimilar drug track, clarify the positioning strategy of original drug patent layout and the avoidance design path of generic drug patents, balancing the protection of original research innovation and the healthy development of the biosimilar drug industry.

4、 Collaboration between Production and Research: Connecting the Channels of Scientific Research Patent Mining and Achievement Transformation

In addition, this guidance also strengthens the layout of industry university research collaborative patents and the direction of achievement transformation. In response to the current situation of more basic research, less patent layout, and low conversion efficiency in universities and research institutes, guidelines propose the establishment of a patent pre mining mechanism for scientific research projects, which synchronously intervenes in patent layout in the early stages of target discovery, mechanism research, and experimental verification, to avoid the loss of patent novelty in the public publication of scientific research results. At the same time, encourage pharmaceutical companies and research institutions to jointly establish patent sharing and licensing conversion mechanisms, open up channels from basic research patents to clinical translation and industrial landing, and activate the commercial value of biopharmaceutical intellectual property rights.

5. Conclusion

As the first provincial-level biopharmaceutical patent special guidance in China, its implementation has both industry demonstration significance and industry promotion value. For Zhejiang, the guidelines will standardize the patent layout behavior of enterprises within the province and assist local pharmaceutical companies in building high-value patent barriers; For the whole country, this guideline provides a reference template for each province and is expected to fill the gaps in China’s biopharmaceutical intellectual property system.

Intellectual property is the core protector of biopharmaceutical innovation. Zhejiang has taken the lead in issuing special guidelines, which is not only a precise policy based on local advantages, but also an active layout to cope with global competition in biopharmaceutical intellectual property rights. In the future, with the implementation and promotion of guidelines, China’s biopharmaceutical industry will gradually enter a new stage of specialized and systematic intellectual property development.

Zhizhongde has been deeply involved in the field of biopharmaceutical intellectual property for many years, and is well versed in the layout rules and practical pain points of biopharmaceutical patents. With policy guidance, it can provide one-stop professional services for innovative pharmaceutical companies and research institutes, including full chain patent planning, barrier construction, risk avoidance, and achievement transformation.

 

Original link: https://zjamr.zj.gov.cn/col/col1229248167/art/2026/art_cde080cdea734db69792f7206ffa2f83.html

Looking forward to working with everyone to make progress together!

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