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The difference and influence of the "presumption" judgment method of novelty of pharmaceutical crystal patent between substantive examination and invalidation procedure
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Ya-ting HAN1, Yi WANG2
Chinese Journal of New Drugs | 2023, 32(18) : 1809 - 1815
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Chinese Journal of New Drugs | 2023, 32(18): 1809-1815
The difference and influence of the "presumption" judgment method of novelty of pharmaceutical crystal patent between substantive examination and invalidation procedure
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Ya-ting HAN1, Yi WANG2
Affiliations
  • 1Chemistry Examination Department of the Patent Office, China National Intellectual Property Administration, Beijing 100088, China
  • 2Reexamination and Invalidation Department of the Patent Office, China National Intellectual Property Administration, Beijing 100088, China
Published: 2023-09-30
Outline
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The novelty examination of pharmaceutical crystal patents often requires the use of legal presumption as a method of finding out the facts. The process is complex because it involves the allocation and transfer of the burden of proof, the refutation and overturn of the presumed facts, and the use of legal techniques in the investigation of technical facts. Through typical cases, this paper compares the differences among different examination procedures in the judgment of evidence that is sufficient to challenge the novelty of pharmaceutical crystals and shift the burden of proof, and explores the reasons for the differences from the perspectives of the uncertainty of crystal acquisition, the purpose and value of the setting of substantive examination and invalidation procedures, the legal status of patents (applications), the burden of proof and the standard of proof, and further analyze the impacts of the presumption methods of different examination procedures and the performance of the parties' request and rebuttal on the grant and stability of the pharmaceutical crystal patent.

crystal  /  patent  /  presumption  /  novelty  /  burden of proof  /  standard of proof
Ya-ting HAN, Yi WANG. The difference and influence of the "presumption" judgment method of novelty of pharmaceutical crystal patent between substantive examination and invalidation procedure[J]. Chinese Journal of New Drugs, 2023 , 32 (18) : 1809 -1815 .
Year 2023 volume 32 Issue 18
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Article Info
  • Online Date:2026-03-05
  • Published:2023-09-30
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  • Accepted:2023-04-23
Affiliations
    1Chemistry Examination Department of the Patent Office, China National Intellectual Property Administration, Beijing 100088, China
    2Reexamination and Invalidation Department of the Patent Office, China National Intellectual Property Administration, Beijing 100088, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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