CNIPA (China National Intellectual Property Administration) and the Chinese courts have been challenged for years for their strict practice on accepting post-filing data during prosecution, invalidation and administrative litigation proceedings. Such practices render the patent applications difficult to be granted with broad scope, or the relative high rate of patent being revoked in the invalidation procedure. However, the latest judicial interpretation and the cases decided by the supreme court and the CNIPA give the chemical and pharmaceutical patent holder more expectation on acquiring stable patent right, and such new practices on accepting post-filing data will add much value to the chemical and pharmaceutical patents, and even boost the innovation in chemical and pharmaceutical industry.
Latest Policy and Law Update on Data Supplementation
A. China-US Economic and Trade Agreement
Data supplementation is one of the key issues discussed in the first stage of China-US Economic and Trade Agreement (“Agreement”) executed on Jan. 15, 2020, as CNIPA is stricter in accepting post-filing data for chemical and pharmaceutical patents than the U.S. and EP patent practice.
For the China-US Economic and Trade Agreement executed on Jan. 15, 2020, Article. 1.10 on Data Supplementation states that “China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step, during patent examination proceedings, patent review proceedings, and judicial proceedings”. Subsequently, China domestic legislation in 2020 have responded to such article in the Agreement.
B. Provisions of the Supreme Court on Several Issues concerning the Adjudication of Administrative Cases on Granting and Affirming Patent Rights
To echo the above Article. 1.10 of the Agreement on Data Supplementation, the Chinese Supreme Court promulgated Provisions of the Supreme Court on Several Issues concerning the Adjudication of Administrative Cases on Granting and Affirming Patent Rights (“Provisions”) taking effect on September 12, 2020. Article 10 of the Provision is specific related to the data supplementation.
Article 10 of the Provision: Where a drug patent applicant submits supplementary experimental data after the date of application and claims that the patent application should be proved as conforming to Article 22.3, Article 26.3 and other provisions of the Patent Law by relying on such data, the People's Court shall examine such data.
However, such article only specifies that the court shall examine the supplementary experimental data, it is unclear from this article that what standards the court will adopt to accept such supplementary data.
C. Chinese Patent Examination Guideline
Later on January 15, 2021, the amended Chinese Patent Examination Guideline (“Guideline”) took effect with seemingly clearer standards for accepting supplementary data for chemical and pharmaceutical patent.
The Guideline specifies that (1) the examiner shall examine the experimental data submitted by the applicant after the application date regarding Article 22.3 (inventive step), Article 26.3 (insufficient disclosure) of the patent law; (2) the technical effect proved by the supplementary experimental data shall be able to be obtained by one skilled in the art from the contents disclosed in the patent application.
The Guideline further gives two examples to demonstrate the standards for post-filing data acceptance. One example is about a patent application claiming to protect compound A, while the specification discloses the experimental method of measuring the activity of lowering blood pressure, but without recording the experimental result data. In such situation, the post-filing data submitted by the applicant on the blood pressure lowering effect of compound A to overcome the objection of insufficient disclosure is acceptable, since such data is obtainable from the method disclosed by the specification. In the other example, the anti-tumor effect of Compound A and other compounds under the general formula has been exemplified with solid data in the specification. The data supplemented by the applicant to show the inventive step of the patent by comparing the anti-tumor effect of Compound A with that in the reference, is acceptable.
However, by reading the Guideline, it is still unclear whether the court or CNIPA would allow the applicant or patentee to submit post-filing data to prove the assertive technical effect, that is, the effect is merely mentioned but without data to confirm the effect in the specification. In many previous cases, the supplemental data filed by the patentee after the filing date to prove such unconfirmed technical effect in the patent document are not acceptable, such as AstraZeneca v. PRB (2018- JingXingZhong-6345), Boehringer Ingelheim v. PRB (2017-JingXingZhong-2470) decided by the Beijing High People’s Court, etc.
The latest cases decided by the Supreme court and the CNIPA present clearer standards on the acceptance to the supplemental data filed by the patentee to prove such unconfirmed technical effect in the patent document.
Facts of AstraZeneca’s Invalidation Administrative Litigation Case (related to “Ticagrelor”)
AstraZeneca’s patent (200610002509.5) related to a crystalline form of a triazolo(4,5-d) pyrimidine compound (AstraZeneca’s product “Ticagrelor”) was invalidated for lack of inventive step. During invalidation proceeding, the patentee submitted evidence of data for metabolic stability and bioavailability made by the patentee’s employee to manifest the surprising effects of the Ticagrelor. However, such data is not considered by the Patent Reexamination Board (PRB), as the panel of PRB takes the position that (i) surprisingly high metabolic stability and bioavailability effect are merely asserted in the background of the patent, without any data in the original patent document to prove these effects; (ii) supplemental data is made after the priority data, and results made by patentee’s employee are inevitably subjective. Therefore, the patent is invalidated by PRB for lack of inventive step, without taking supplemental data into consideration. Such decision was confirmed by Beijing Intellectual Property Court.
Although the decision made by the Beijing Intellectual Property Court was upheld by the Supreme Court in the second instance on October 26, 2020 (2019-Supreme Court Zhixingzhong-33), the Supreme court takes a different view towards the acceptances of post-filing data. By referring to Article 10. of Provisions as the legal basis, the Supreme Court clarifies the standards for post-filing data acceptance as (i) if the facts to be proved by the post-filing data are clearly recorded or implicitly made public in the specification, the applicant can be identified as having completed the relevant research, therefore such acceptance of the data does not violate the principle of first to file; and (ii) supplementary data shows the facts to be proved in the specification is true.
By adopting the above standards, the supplemental data submitted by the patentee was considered by the Supreme Court, since the metabolic stability and bioavailability effect have been asserted in the patent and later proved by the supplemental data. Although the decision of the first instance court was still upheld by the Supreme Court for the reasons that the supplemental data in this case is not convincing enough to manifest the surprising effects compared with those in the prior arts, this is the first case to apply Article 10 of the Provisions and set a clear standard for the post-filing data acceptance with guiding value for the similar cases in the future.
In a later invalidation case Jingxin Pharmaceutical v. Richter Gedeon NYRT. (Invalidation Decision No. 47087) decided by the CNIPA on November 27, 2020, the patent was upheld based on the post-filing data submitted by the patentee. CNIPA’s attitude of accepting post-filing data to prove the asserted technical effect is quite the same as the standards set by the above case of Ticagrelor.
It is good to see that CNIPA and courts are no longer adhere to the previous strict standards for accepting supplemental data, that is to say, for technical effects merely asserted in the specification without specific embodiment, supplementary data can be used to manifest the inventive step over the prior art under the current standards. But it should be noted that the effects still need to be recorded in the patent document in order for the data supplementation to prove such effect.
Post filing data could also be used to overcome the insufficient disclosure objections. In an administrative litigation case related to pfizer’s product Lipitor, PRB & Beijing Jialin Pharmaceutical Co., LTD v. Warner-Lambert Company LLC (2014-Xingtiziti- 8) decided by the Supreme Court in 2015, the standards for post-filing data acceptance under insufficient disclosure objection are stated: regarding the post-filing data for manifesting insufficient disclosure, if it can be proved that the invention can be realized through the contents disclosed in the specification with the knowledge level and cognitive ability of one skilled in the art prior to the filing date, the supplemental data shall be considered and should not be rejected simply because the data is submitted after the filing date; when considering the acceptance of experimental evidence, first of all, the experimental conditions and methods involved in the experimental evidence should be directly obtained or easily thought of by one skilled in the art through reading the instructions before the filing date or the priority date; Secondly, in the subject, it should be based on the knowledge level and cognitive ability of one skilled in the art. The standards set in the Lipitor case is quite similar as that in the Ticagrelor case, as the technical effect or technical solution manifested by the supplemental data shall be obtainable from the original patent application based on knowledge level and cognitive ability of one skilled in the art before the application date or priority date. Both standards shall meet the principle of first to file.
The promulgation of the Provisions in 2020 and the cases decided by the Supreme Court have clarified the standards for the acceptance of the post-filing data. Allowance of data supplementation during the prosecution or invalidation proceeding for the chemical or pharmaceutical patent can also improve the grant rate of patent application, as well as the stability of patent which will reduce the risk of patent being invalidated. Clarifying the standard of supplementary experimental data is a response to the long-waited expectation of the booming pharmaceutical industry, which will not only encourage innovation, but also greatly improve the transaction value of the chemical or pharmaceutical patents.