China: Beijing Courts Issued Consequential Judgments On Life-Science Patents

Last Updated: 14 August 2017
Article by David Huang

The Beijing Higher People's Court (BHPC) and Beijing Intellectual Property Court (BIPC) recently issued their judgments in a number of high-profile validity cases in the life science area. The courts' reasoning in the judgments, unless negated in future appeal or retrial proceedings, will have general consequence beyond the specific cases.

Impact of a prior-art reference on the inventiveness of a Swiss-type claim

In this case, BIPC ruled that a mere statement in a reference like "the drug has shown exciting preliminary result in treating a disease" is enough to undermine the inventiveness of a Swiss-type claim, and there is no further need for the reference to provide detailed experimental/clinical data to convince persons in the art that the drug indeed has the therapeutic effect or has the potential.

Once the judgment was issued, the court's reasoning has drawn criticisms for its apparent tension with China's emphasis on such experimental/clinical data when disclosure sufficiency of the specification is in dispute.

The patent in dispute is Novartis's patent No. 01817895.2, and its only claim is a Swiss-type one.

The judgment also touches on another interesting procedural issue on when an argument developed by the challenger during the proceedings or a line of reasoning adopted by the Patent Reexamination Board in its final decision should be regarded as going beyond the original ways of combination raised by the challenger (in which case the argument should be rejected or the line of reasoning should be nullified).

Novartis likely has appealed the Beijing Higher People's Court as of the date of this update.

Closest prior art against an "invention by selection"

This case relates to the methodology to select the "closest prior art" for the purpose of evaluating whether an invention be selection has the required unexpected result/effect and thus has inventiveness.

An invention by selection refers to one seeking protection for one or more specific instances, a smaller subset or a narrower range selected from a larger group, set or range already known in the art. One of the conditions for such an invention to have the required inventiveness is that it produces unexpected result/effect over the prior art. And the first step to evaluate whether the result/effect it produces is unexpected or not is to determine the closest prior art against which to make the comparison.

Usually, the closest prior art for such comparison is one with the typical characteristics within the original group, set or range. In this case, however, BHPC ruled that the closest prior art can be something outside the original group, set or range if evidence shows that the selected art is comparable to ordinary instances within the original group set or range.

The patent in dispute is 01815108.6 co-owned by Daiichi-Sankyo. The specific claims at the focus of the dispute seek protection of a hydrochloride and maleate of Prasugrel, i.e. specific instances of the larger group/concept of "pharmaceutically acceptable salts of Prasugrel".

In its judgment, BHPC agrees with the patent owner to compare the result/effect of hydrochloride and maleate of Prasugrel against free alkali of Prasugrel on the grounds that (1) the overall prior art is short of evidence on the result/effect of other specific examples of pharmaceutically acceptable salts of Prasugrel, and (2) from evidence on record, persons in the art have the reason to believe that free alkali of Prasugrel is comparable to pharmaceutically acceptable salts of Prasugrel.

Specification's central role in claim construction

In this case, BHPC reiterates the position that the specification of a patent is the primary dictionary and basis for construction of the claims, and this is so even if a term in dispute has a popular meaning in the art (i.e. the inventors have the right to give their own definition for such a term in the specification). Meanwhile, the court also held, if the definition given in the specification is vague or ambiguous (e.g. for poor drafting quality), the court can use extrinsic sources for the construction of the term (e.g. an industrial dictionary that gives the commonly accepted meaning of the term as understood in the art).

The case is out of a reexamination proceeding, not an invalidation action. The application in dispute is 200680040913.X owned by DuPont. The particular term as the focus of the dispute is "E-HFC-1234ze" as recited in claim 1.

The Patent Reexamination Board in the reexamination proceeding adopted the meaning as commonly understood in the art for this term in claim construction, on the grounds that the term is so commonly used in the art and its meaning is so clear that there is no further need to read the specification for its construction.

In the judicial review, BIPBC and the BHPC both held that the board was wrong for not treating the specification as the primary source for claim construction. The courts held that even for such a term, the specification as the intrinsic evidence still has precedence over extrinsic evidence.

After reiterating the central role of the specification, BHPC further held that if the definition given in the specification is ambiguous even after all the context is considered, extrinsic evidence can be used.

The specification gives this definition for the term, "E-HFC-1234ze as used herein refers to a mixture of the isomers, E-HFC-1234ze (CAS reg no. 29118-24-9) or Z-HFC-1234ze (CAS reg. no. 29118-25-0), wherein the predominant isomer is E-HFC-1234ze". BHPC held that the "or" makes the definition unclear even after the full context is considered, and in this regard, the court was not persuaded by DuPont's argument that the "or" should be understood as "and" from the context. Based on this, BHPC agreed that the term should be construed as it is commonly understood in the art when the specification fails to give a clear definition.

Originally published March 21, 2017

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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