PATENT INVALIDITY ADMINISTRATIVE PROCEEDINGS BETWEEN NOVARTIS AND PATENT REEXAMINATION BOARD

◆ First Instance Docket: (2016) Jing73XingChu No. 985

CASE 13 :

City of Beijing

[Headnotes]

Evidence in patent invalidity proceedings. The examining authority may refer to relevant provisions of the judicial proceedings, taking into consideration the evidence of record and probability of fact to be proven, balancing the weight of evidence adduced by parties, to admit more credible evidence.

[Synopsis]

Plaintiff: Novartis Holdings Inc. (Novartis)

Defendant: State Intellectual Property Office, Patent Reexamination Board (PRB, or the Board)

Third Party: Hanson Pharma (Hanson)

Novartis is a joint patentee of the invention patent for “Treatment of Gastrointestinal Stromal Tumors” (“the patent”), the inventive point of which is the discovery of new use of imatinib mestylate in treating diseases of gastrointestinal stromal tumors. The patent claims are drafted in “Swiss-type” method. Upon request by Hanson, the Board made the decision at issue, finding lack of inventiveness of the patent, and invalidating all the claims. Novartis, dissatisfied, filed suit in Beijing Intellectual Property Court, demanding a remand.

Upon examination the court sustained the decision for lack of inventiveness, found the Board’s invalidity proceedings consistent with the law, and dismissed plaintiff’s complaints.

[Judge’s Comment]

The so-called “Swiss-type” claim is an exception to the general principle under Chinese Patent Law that medical treatment may not be patented, for the purpose of giving some room and incentive to the necessary protection of creative medical uses, and balancing the interests of both the public and proprietors. Because this case relates to the manufacture and sale of the medicine for treatment of gastrointestinal stromal tumor, and also involves determination of the publication date for references, as well as determination of inventiveness for new medical uses, it attracts wide attention in society. 

According to the Patent Law and relevant provisions, “inventiveness” means prominent substantive character and notable progress in light over prior art, i.e., on the basis of ascertaining the differences between the patented invention and the prior art, according to the technical problem for the subject matter, to determine whether the subject matter as whole is obvious or not to a person having ordinary skill in the art. In examining inventions in the chemical field, it has to be taken into consideration, apart from ordinary determination, the unique aspect of such inventions.

The court in this case is of opinion: (1) it would be insufficient to claim results from merely in vitro test or animal test; it must reach the level of human treatment, which does not necessarily mean it must achieve absolute clinical result; instead, it would be, as long as a person having ordinary skill in the art (PHOSITA) could have reasonable expectation of success on the drug. (2) Due to complexity of the oncological drug research, a PHOSITA might easily be interested to any positive data, and try on it for any useful purpose. Therefore, even if the prior art does not disclose specific test type and test data, but a PHOSITA may, based on the level of skill and the prior art, when motivated by the information disclosed by the prior art to use a particular compound for treatment of such patient, form reasonable expectation on its success, it may be said that the prior art has disclosed the subject matter of the invention.

As for claim 1 of the patent, its effect on gastrointestinal stromal tumor (GIST) should be more than in vitro test or animal test. It must reach in vivo level for GIST. The PRB interpretation of claim 1 is correct, but “in vivo level on GIST patient” does not mean absolute success on clinical test phase; it only means that a PHOSITA may have reasonable expectation of the success.

Novartis contends that the rate of success for tumor drug research is very low, but the demand for the drug is tremendous. Under such circumstances, a PHOSITA would be motivated to try even with extremely low expectation of success. But such generalized motivation not based on any technical teaching, is not “the motivation in patent sense” which, in the absence of any scientific, empirical (as with test data), would produce reasonable expectation for success. On this the court disagreed that precisely because of the complexity of the research for oncological drugs, a PHOSITA would pay great attention to any positive information, and would try on it. Thus, although reference 1 did not disclose any test type and test data, but a PHOSITA admittedly, based on his knowledge and reference 1 disclosure, would come up with the patented subject matter without creative effort.

This case clarifies the interpretational rule for “Swiss-type claims” and the standard for determining inventiveness for second medical use of drugs, being relatively useful as a guidance for future cases.