403 Forbidden

In determining whether a patent infringement is established based on the doctrine of equivalents (“DOE”), attention should be paid to which feature in a claim is compared against which feature of an accused infringing product. Only those features of a product that are not identical to their counterparts in the claim should be taken into consideration for the purpose of DOE. Determination under DOE is different from the determination on inventiveness during patent prosecution – the requirement of “three substantially, one ordinarily” should be met.

Functional features play important role in the determination of identity or similarity between two designs. When judging whether a design is similar to a prior design, functional features should be considered as “having no influence on the overall visual appearance of a design’s product,” so as to avoid the possible situation of “monopolizing a product’s function on the pretext of protecting a product’s design.”

With reference to new protein inventions, applicants always define biological sequences by the combination of homology and function, so as to obtain a broader scope of protection. However, considering that the association between the primary structure and the function of a protein is highly unpredictable, thus defined protein claim is always considered as not supported by the description and not conforming to Article 26.4 of the Chinese Patent Law. Therefore, discussions in this filed focuses on a proper manner to define a new protein patent and subsequently obtained protection scope. This is the first case for successful enforcement of biological patent in China, which clarifies a feasible definition of new protein patent, i.e. defining homology, origin (species), and function simultaneously. Furthermore, this case provides directions to judgment of future invalidation and infringement cases of new protein patents.

This case clarifies that in the determination of inventiveness of a crystalline compound, the wording “structurally similar compounds” specifically refers to compounds having the same central part or basic ring, and has nothing to do with comparison between microcrystalline structures. The microcrystalline structure difference shall be considered only if it brings unexpected technical effect.

The highlight of this case is the confirmation that generally a close-ended claim of a chemical composition shall be construed as the composition merely consisting of the indicated components, and including no other components but impurities in a normal amount, while adjuvants do not belong to the impurities.

With reference to inventive step of compound claims, it is stipulated in the Guidelines for Patent Examination that for a compound NOT similar in structure to a known compound, it will be regarded as inventive when it has a certain use or effect where a compound that IS similar in structure to a known compound, it might be regarded as inventive only if it has an unexpected use or effect. As can be seen, it is important to judge whether a compound is structurally similar to a known compound. This case clarifies that in the determination of inventiveness of a crystalline compound, the wording “structurally similar compounds” specifically refers to compounds having the same central part or basic ring, and has nothing to do with comparison between microcrystalline structures. The microcrystalline structure difference shall be considered only if it brings unexpected technical effect.

The patentee, HU Xiaoquan, owns a patent for invention No. ZL 200410024515.1, titled “Process for the Preparation of an Injection of Adenosine Disodium Triphosphate and Magnesium Chloride,” wherein claim 2 recites the additional technical features, “a freeze-dried powder injection of adenosine disodium triphosphate and magnesium chloride for injection, consisting of adenosine disodium triphosphate and magnesium chloride at the ratio by weight of 100 mg to 32 mg.”

This case highlights the premise to admit the post-filing experimental data for determination of inventiveness, i.e. such data should direct to the technical effect described in the original application documents.

The patentee, Takeda Pharmaceutical Co.,Ltd. (hereinafter “Takeda”), owns a invention patent No. ZL96111063.5 titled as “Pharmaceutical Composition for Use in Treatment of Diabetes” (hereinafter “the patent concerned”). Claim 1 was “pharmaceutical composition useful for prophylaxis or treatment of diabetes, diabetic complications, glucose or lipid metabolism disorders, which comprises an insulin sensitivity enhancer selected from pioglitazone or a pharmacologically acceptable salt thereof, and Sulfonylurea as insulin sensitivity enhancers.”

Experimental data is vital to the patentability requirements of inventiveness, support, and enablement for chemical/medical application. During the substantive examination, the applicant may intend to supplement experimental data to support inventiveness after filing, which is called “post-filing experimental data”. It is controversial whether post-filing experimental data shall be admitted. This article discusses admission of post-filing experimental data, as well as the binding effect of examination result in other countries based on analysis on an actual case.