China: Insights on drafting pharmaceutical patents from the "Supreme People’s Court’s Annual Report of Intellectual Property Cases"

Last Updated: 5 June 2013

In April 2013, the Supreme People's Court ("SPC") issued the"Supreme People's Court's Annual Report of Intellectual Property Cases", in which the SPC included 34 typical intellectual property and competition cases from 2012 and summed up 37 issues of application of law with universal significance. In this regard, we made a summary of the patent cases related to the pharmaceutical industry in the report, for the purpose of assisting pharmaceutical enterprises in drafting patent applications.

Case A: The Interpretation of Close-ended Claims and the Application of the Doctrine of Equivalents for Close-ended Claims

The Supreme Court held the opinion that close-ended claims should be generally construed as compromising of indicated compositions and excluding other ingredients, and impurities are allowed with normal amount. However, excipients are not impurities. If the patentee chose close-ended claims, he clearly held that any unmentioned component is out of the protection scope of the patent right. Moreover, the doctrine of equivalents of judging different technical features should no longer be applied in such scenario.

  • Case Brief: The patent named "Adenosine triphosphate disodium and magnesium chloride frozen powder injection and its manufacturing method" with the application No. 200410024515.1 has a close-ended claim 2, which seeks protection of a freeze-dried powder injection, comprising of adenosine triphosphate disodium and magnesium chloride, with a weight ratio of 100 mg to 32 mg. Two companies have sold drugs containing adenosine triphosphate disodium, magnesium chloride and other excipients, among which the weight ratio of adenosine triphosphate disodium and magnesium chloride is the same as claim 2 of the patent. The patentee therefore filed a civil lawsuit, and the first instance court did not support the non-infringement defence of these two companies, arguing the existence of excipients. The second instance court revoked the judgment made by the first instance court, based on the No. 13268 Invalidation Decision issued by the Patent Reexamination Board. The Retrial Board revoked the judgment made by the second instance court and sustained the judgment of the first instance court. The SPC revoked the judgment of the first instance court and the pleadings of the patentee. According to the SPC, adverse consequences resulting from claims drafted in an inappropriate way causing the loss of a wider scope of protection that could have been possible should be borne by the patentee.

Case B: The Requirements for Acceptance of Additional Experimental Data Submitted after the Application Date Regarding the Examination of Creativeness of a Patent

The SPC pointed out that in the examination of inventiveness, if the applicant submits experimental data after the application data to prove unexpected technical effects realized by the technical solution of the patent, such data can only be accepted if the technical effects to be proved are clearly disclosed in the original application documents of the patent.

  • Case Brief: The invention patent of Company A, "a pharmaceutical compound for treating diabetes" was declared invalid because of a creativeness problem in the patent invalidation procedure. In this process, Company A presented the experimental data to the Patent Reexamination Board to prove that the technical scheme of the patent has unexpected effects. But the Patent Reexamination Board did not adopt this experimental data. Subsequently, Company A filed for administrative litigation. Both the courts in the first instance and second instance upheld the decision of the Patent Reexamination Board. Furthermore, the Supreme People's Court rejected Company A's application for retrial.
  • The description is required to sufficiently disclose inventions or utility models. Chemistry is a science of experiment, and the influencing factors of invention results could be various, integrating and complicated.
  • According to the prior art, if persons skilled in the art cannot predict the functions or technical effects of the claimed technical solution, the description shall record the corresponding experimental data clearly and completely, so that persons skilled in the art may utilize the technical solution, solve the technical problems and reach the expected technical effect. Technical solutions and technical effects undisclosed in the specification shall usually not be deemed as legal grounds for the judgment of patentability. When the applicant submits experimental data after the application data to prove the inventiveness of the patent in comparison of prior art, such data can only be accepted if the technical effects to be proved are clearly disclosed in the original application documents of the patent.

Case C: Examination of Creativeness of Compounds with New Crystal Structure

The SPC held that only the technical effects from the records in the original application documents, or which can be directly concluded from the original application documents may be taken into consideration while determining the inventiveness of a patent." Also, the SPC pointed out that"compounds of similar structures" referred in the "The Guidelines for Patent Examination" ("Guidelines") only specifically mean compounds with identical basic core structures or basic rings and do not involve the comparison of the compound's microscopic crystal structure itself.

  • Case Brief: Company B's No. 1817143.5 patent claim aims to protect a crystalline compound. The Patent Reexamination Board declared the patent was wholly invalid on the grounds that the patent does not have the requisite inventiveness because the existing technology disclosed that this compound presently exists in other crystal structure, and the original application document failed to prove the technical effect of this compound. Both the first and second instance court supported the invalidation decision, and the SPC revoked the retrial appealing of the patentee.
  • Microscopic crystals structures of crystalline compound are varied from case by case. A compound in the solid state may have different solid crystalline forms based on two or more different molecules arrangements. However, not all changes in microscopic crystal structure will inevitably lead to prominent substantive features and obvious progress. Therefore, it cannot be concluded that the compound is not similar in structure only based on its difference in the microscopic crystal structure, and therefore exempt from describing the creativeness of the patent from the prior art (has unexpected technical effects).
  • The SPC held that "compounds of similar structures" referred in the Guidelines only specifically mean compounds with identical basic core structures or basic rings and do not involve the comparison of the microscopic crystal structure itself. Though crystalline compounds may show different physical or chemical characters due to their different molecular arrangements, but they are still within the field of compounds. Therefore, the regulations regarding the compounds provided in the Guidelines can be applied to determine the inventiveness of compounds with new crystal structures. The technical effects achieved by the crystals are the key factors contributing to their inventiveness. Only the technical effects from the records in the original application documents, or which can be directly concluded from the original application documents may be taken into consideration while determining the inventiveness of a patent.

KWM Comments:

  • If possible, the invention patents of chemical fields, especially those of pharmaceutical fields should adopt open-ended claims, and disclose the technical effects sufficiently in the description in order to have a broader protection scope, and to enforce the patent right efficiently.
  • When the applicant submits experimental data after the application data, he should confirm whether the corresponding technical effects to be proved are clearly disclosed in the original application documents of the patent.
  • If the technical effect of a patent is difficult to predict for the persons skilled in the art, we recommend recording the corresponding experimental data clearly and completely in the specification.
  • For examination of creativeness of compounds with new crystal structure, the SPC pointed out that "compounds of similar structures" referred in the "The Guidelines only specifically mean compounds with identical basic core structures or basic rings and do not involve the comparison of the compound's microscopic crystal structure itself.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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