IN RE PATENT APPLICATION OF CELGENE CORP.

◆ First Instance Docket: (2015) JingZhiXingChuZi No. 2069

◆ Second Instance Docket: (2017) JingXingZhong No. 1642

CASE 15 :

City of Beijing

[Headnotes]

Supplemental embodiments and test data that an applicant submits after filing date should be examined to evaluate the weight of such evidence in a particular case for the facts to be proven. The additional embodiments and test data may be used to further prove what has been disclosed in the written description, rather than to add new contents. Otherwise it would be akin to allowing the applicant to complete his invention he did not finish before the filing date, and giving patent to an invention that was not completed before the filing date is contrary to the first filing principle.

[Synopsis]

Appellant (Plaintiff below): Celgene Corp.

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

Celgene is applicant for patent on “5-substituted quinazolinone derivatives as anti-cancer agents” which cover a new compound to be used for treatment of cancer and many other symptoms.

On May 30, 2012, the State Intellectual Property Office (SIPO) issued a final rejection on the application on basis of Patent Law, Article 26(3). The PRB on July 3, 2014 rendered a decision on review under No. 73780 (the “Decision”) sustaining the SIPO rejection. Dissatisfied, Celgene filed a judicial review proceeding with Beijing Intellectual Property Court, alleging: the specification has clearly indicated the specific method of composition and structural verification data of the claimed compound, and described in detail the use and effect, as well as determinant active data. Meanwhile, Celgene in its response to the first Office Action submitted the quantitative test data. Thus, the application is in line with Patent Law, Article 26(3), and the Decision is erroneous.

Beijing Intellectual Property Court upon examination found that since both parties agree that the written description has sufficiently disclosed how to identify and prepare the compound, then the key to full disclosure of the claimed compound is its use and/or effect.

The specification did not disclose any qualitative or quantitative active data of the claimed compound, the technical effect of which is merely a research plan of Celgene without result. Meanwhile, it is insufficient that the inventor discloses in the specification a test method publicly known in the field; he must also disclose the test data through these methods to verify the effect and use of the new compound, and only by then can the invention be completed. This is dictated by the fundamental requirements for first filing and the doctrine of quid pro quo. In the absence of test data, the specification cannot be said to have fully disclosed the effect and use of the new compound by indicating multiple publicly known methods of active testing of the compound.

Based on the test data from Celgene, Beijing Intellectual Property Court found that the Board made a statement on page 7 of the Decision on the Celgene’s supplemental test data. Thus, it cannot be said that the Board paid no attention of the test data, but conducted examination in this case, which is not unfair. Secondly, the specification did not indicate any test data to show the effect and use of the compound, nor could a person of ordinary skill have practiced the invention by combining his knowledge on the date of application with prior art to recognize the effect and use, i.e., unable to practice the invention by what is disclosed in the specification. Thus, even though Celgene in response to first office action submitted supplemental test data, such data is insufficient to prove that Celgene has completed the subject matter of the invention by the application filing date with sufficient disclosure, which is a fact of insufficient disclosure.

For this reason, Beijing Intellectual Property Court dismissed Celgene’s complaint.

Celgene is dissatisfied and appeals to Beijing High People’s Court which denied the appeal and affirmed.

[Judge’s Comment]

I. On the Disclosure in the Specification

Biopharmaceutical applicants usually have reservation on test data when they file for patent applications, which lead to many problems with test data for judicial practice, especially in prosecution and invalidation of chemical compounds. Whether supplemental test data is sufficient for complete disclosure for purposes of patent application is a major problem.

This application intends to cover a new compound, for which there is no evidence to show a similar or analogous active compound in the prior art, and person of ordinary skill is thus unable to determine that the subject matter will produce the expected result. For this reason, the subject matter must rely on test result, and Celgene is obligated to disclose such test data in the specification. In this case, the specification did not indicate the use and effect and the qualitative or quantitative act data of the claimed compound.

Although the specification indicated multiple publicly known test methods, but did not indicate any data by such methods to prove the use and effect of the compound. Therefore, the specification cannot be said to have made full disclosure in patent sense.

II. About Supplemental Test Data

As to supplemental test data, the Patent Office and courts in current practices do not absolutely preclude, e.g., embodiments or test data, but will take them on case-by-case basis for examination to see if they could be used to prove certain facts. Meanwhile the first filing principle dictates that the embodiments and test data may not change the facts established by the patent specification on the filing date. In other words, the supplemental embodiments and test data may support what is in the specification, but may not add new contents, or it will be adding new matter to the application that has not been completed on the filing date. And conferring patent to an invention which has not been completed on the filing is contrary to the first filing principle.

In the case at hand, the PRB did take the Celgene supplemental test data into consideration, but the specification fails to indicate any test data for the effect and use of the claimed compound; nor can a person of ordinary skill, on the date of application, by his knowledge and cognizance, in combination with prior art, practice the invention by referring to the specification. Therefore, the supplemental test date submitted by Celgene fails to prove that the specification has achieve sufficient disclosure in patent sense.