B. Article 26.3 Full Disclosure/Enablement

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1 Requirements for disclosure of utility or industrial applicability and ramifications for patent validity - China AIPPI World IP Congress, Toronto, Canada September 16, 2014 Workshop Pharma 1 Bonan Lin ( 林柏楠 ) Attorney at Law and Patent Attorney Zhongzi Law Office Beijing, China Phone: Fax: bonanlin@zhongziip.com

2 Content A. The Blue Bible B. Article 26.3 Full Disclosure/Enablement C. Article 26.4 Support D. Article 22.3 Inventiveness E. Submission of Data During Examination F. Philosophy Behind the Standards G. Recent Development

3 A. The Blue Bible The Patent Examination Guidelines (issued by SIPO) is an authoritative source for interpreting Patent Law and the Regulations. The Guidelines is also highly respected by courts. SIPO has de facto control over interpretation of a large number of articles in the Patent Law.

4 B. Article 26.3 Full Disclosure/Enablement Article 26(3) of the Patent Act: The description shall set forth the invention or utility model in a manner sufficiently clear and complete so as to enable a person skilled in the relevant field of technology to carry it out. Standard (Part II, Chapter 2, Section 2.1.3): Enablement requirement is not met if the specification only provides technical solutions without experimental verification while the technical effect to be achieved by the technical solution needs verification by experiments. For example, the invention for a new use for a known compound requires experimental evidence in the description to verify the new use and effects thereof.

5 B. Article 26.3 Full Disclosure/Enablement Standard (Part II, Chapter 10, Section 3.1): As for a chemical product invention, the use and/or its technical effect of the product shall be fully disclosed. To meet full disclosure requirement, the specification has to contain qualitative or quantitative data of experimental tests that are sufficient to convince a person skilled in the art that the anticipated technical effects/use can be achieved by the technical solutions disclosed in the patent specification, if the technical effects/use of the invention are not predicable for a person skilled in the art.

6 B. Article 26.3 Full Disclosure/Enablement Example: A patent application is directed to a pharmaceutical invention with a claim that covers a large number of compounds. The use/technical effect of the invention is described in the specification as: the compounds of the invention significantly inhibit X kinase or the compounds according to the invention significantly inhibit X kinase with IC 50 value in range of μm. Conclusion: The specification is defective for failing to meet enablement requirement.

7 C. Article 26.4 Support Article 26(4) of the Patent Act: The claims shall be supported by the description and shall define the extent of the patent protection sought for in a clear and concise manner. Standard (Part II, Chapter 2, Section 3.2.1): A claim will be found not supported by the disclosure in the specification if it covers embodiments that are not illustrated by examples (presumed by the applicant) and the technical effects of these presumed embodiments cannot be ascertained in advance.

8 D. Article 22.3 Inventiveness Technical effect that is achieved by the claimed invention is a key element in deciding inventiveness of the invention.

9 D. Article 22.3 Inventiveness Example: A patent application is directed to a pharmaceutical invention with a claim that covers a reasonable range of several hundreds of compounds. The compounds differ from prior art compounds cited by the examiner in that it has a (substituted) cyclohexyl substitution on an aromatic structure while the prior art compounds has a pyridyl substitution on the same position of the same structure. The compounds have roughly the same pharmacological activity. To overcome inventiveness rejection, the applicant submitted comparative tests data to prove additional technical effects the claimed compounds have over the prior art compounds (decreased hepatic extraction ratio, and so on).

10 D. Article 22.3 Inventiveness The comparative tests data was not accepted by the examiner because the technical effects to be proved by the tests data, as well as the tests methods, were not mentioned in the original patent specification.

11 E. Submission of Data During Examination Submission of experimental data during examination for the purpose of overcoming rejections on grounds of enablement/full disclosure requirements (Article 26.3) and support requirement (Article 26.4) are not acceptable. Submission of experimental data during examination for the purpose of overcoming inventiveness rejections is possible provided that the patent specification as filed already contains description of the technical effect to be illustrated /proved by the experimental data.

12 F. Philosophy Behind the Standards Patent applicants are presumed to be a group of selfish and greedy people. They are bad guys. They were even not honest enough to tell the truth of their invention. The understanding is that the examiners are trained and hired to fight against patent applicants who contribute to the society too less and yet want to have too large scope of protection, on behalf of the public. The examiners will feel proud of themselves when they find new ways to say no to the patent applicants.

13 F. Philosophy Behind the Standards Scenarios for the Future (EP study)

14 G. Recent Development Since late 2012: Focus of patent examination has been shifted to prior art-related issues (novelty/inventiveness) October 2013: SIPO paper issued which is widely understood to mean loosening the policy of refusing to accept tests data during examination. Current situation: no revision of Examination Guidelines, the policy has not yet been reduced to practice. The philosophy has not been changed. The examiners are still fighting against the bad guys.

15 Requirements for disclosure of utility or industrial applicability and ramifications for patent validity China Thank you very much for your patience! Bonan Lin ( 林柏楠 ) Attorney at Law and Patent Attorney Zhongzi Law Office Beijing, China Phone: Fax: bonanlin@zhongziip.com