CNIPA (China National Intellectual Property Administration) and the Chinese courts have been challenged for years for their strict practices on accepting post-filing data during prosecution, invalidation, and administrative litigation proceedings. Such practices render patent applications with broad scopes less likely to succeed or much more likely to be revoked during invalidation procedures. However, the Supreme People’s Court’s latest judicial interpretation and precedents set by the courts and CNIPA create new practices that give chemical and pharmaceutical patent holders better prospects of acquiring stable patent rights. Moreover, new practices on accepting post-filing data will add more value to chemical and pharmaceutical patents and further boost innovation in the chemical and pharmaceutical industries.
Latest Policy and Law Updates on Data Supplementation
A. China-US Economic and Trade Agreement
Data supplementation was one of the key issues in the China-US Economic and Trade Agreement (“Agreement”) executed on January 15, 2020, because CNIPA had narrower criteria for accepting post-filing data for chemical and pharmaceutical patents than the US and the European Patent Office.
Article. 1.10 of the Agreement, which relates to Data Supplementation, states that “China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including the sufficiency of disclosure and inventive step, during patent examination proceedings, patent review proceedings, and judicial proceedings”. Accordingly, Chinese legislators took steps in 2020 to implement the Agreement.
B. Provisions of the Supreme People’s Court on Several Issues concerning the Adjudication of Administrative Cases on Granting and Affirming Patent Rights
To echo Article 1.10 of the Agreement, the Supreme People’s Court promulgated Provisions of the Supreme Court on Several Issues concerning the Adjudication of Administrative Cases on Granting and Affirming Patent Rights (“Provisions”), which took effect on September 12, 2020. Article 10 of the Provisions specifically relates to data supplementation. Article 10 of the Provisions states that:
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, Article 10 of the Provisions only specifies that the court shall examine supplementary experimental data. However, the standards for accepting supplementary data remain unclear.
C. Chinese Patent Examination Guideline
Later, on January 15, 2021, the amended Chinese Patent Examination Guidelines (“Guidelines”) introduced seemingly clearer standards for accepting supplementary data for chemical and pharmaceutical patents.
The Guidelines specify that: (1) the examiner shall examine experimental data submitted by an applicant after the application date regarding Articles 22.3 (inventive step) and 26.3 (insufficient disclosure) of the Patent Law; and (2) the technical effect proved by supplementary experimental data must be obtainable by one skilled in the art based on disclosures in the patent application.
The Guidelines also give two examples to demonstrate the standards for post-filing data acceptance. One example concerns a patent application claiming to protect compound A with a specification that discloses the experimental method of measuring the activity of lowering blood pressure without disclosing experimental results. In such situations, post-filing data submitted by an applicant on the blood pressure lowering effects of compound A to overcome objections of insufficient disclosure are acceptable since such data is obtainable from the method disclosed in the specification. In the other example, the anti-tumor effects of Compound A and other compounds under the general formula are 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 prior art is acceptable.
However, there remains uncertainty on whether a court or CNIPA would allow an applicant or patentee to submit post-filing data to prove an asserted technical effect, which is merely mentioned but lacking data to confirm the effect in the specification. In many previous cases, supplemental data submitted after the filing date to prove such unconfirmed technical effects in the patent document was rejected. Such cases include AstraZeneca v. PRB, (2018) Jing Xing Zhong No. 6345 and Boehringer Ingelheim v. PRB, (2017) Jing Xing Zhong 2470 decided by Beijing High People’s Court, and other cases.
The most recent cases decided by the Supreme People’s Court and CNIPA present clearer standards on the acceptance of supplemental data filed by the patentee to prove such unconfirmed technical effects in patent documents.
Data Supplementation to Overcome Lack of Inventive Step Objections
AstraZeneca’s ZL200610002509.5 patent, which concerned a crystalline form of a triazolo (4,5-d) pyrimidine compound known as “Ticagrelor”, was invalidated for lacking an inventive step. During invalidation proceedings, the patentee submitted data showing metabolic stability and bioavailability prepared by the patentee’s employee to show the surprising effects of the Ticagrelor. However, that data was not considered by the Patent Reexamination Board (PRB), which took the position that: (i) surprisingly high metabolic stability and bioavailability effects were merely asserted in the background of the patent without any data in the original patent document to prove these effects; and (ii) supplemental data was submitted after the priority date, and the results made by the patentee’s employees were inevitably subjective. Therefore, the patent was invalidated for lacking an inventive step by the PRB, without considering the supplemental data. The Beijing Intellectual Property Court confirmed the PRB’s decision.
Although the Beijing Intellectual Property Court’s decision was upheld in the second instance in Supreme People’s Court case (2019) Zhi Xing Zhong No. 33 in October 2020, the Supreme People’s Court took a different view towards the acceptance of post-filing data. By referring to Article 10 of the Provisions as its legal basis, the Supreme People’s Court clarified 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 considered to have completed relevant research, and so, acceptance of the data would not violate the first to file principle; and (ii) supplementary data shows that the facts to be proved in the specification are true.
By adopting the above standards, the Supreme People’s Court could consider the supplemental data submitted by the patentee because the metabolic stability and bioavailability effects had been recorded in the patent and later proved by the supplemental data. Although the Supreme People’s Court upheld the decision of the first instance court because the supplemental data was not convincing enough to manifest surprising effects compared with those in the prior art, this was the first case to apply Article 10 of the Provisions and set a clear standard for post-filing data acceptance to be followed in similar future cases.
In a later invalidation case, Jingxin Pharmaceutical v. Richter Gedeon NYRT (Invalidation Decision No. 47087), decided by CNIPA in November 2020, the validity of the subject patent was upheld based on post-filing data submitted by the patentee. CNIPA’s attitude of accepting post-filing data to prove the asserted technical effect followed the standards that applied in the above Ticagrelor case.
Data Supplementation to Overcome Insufficient Disclosure Objections
According to the Guidelines, a chemical product invention must be sufficiently disclosed by identifying the chemical product, at least one method of preparing the product, and proof supporting its anticipated uses or technical effects. Very few post-filing data submissions were accepted in the past due to insufficient disclosure of the preparation method or technical effects.
In administrative litigation (2014) Xing Ti Zi Ti No. 8, which concerned Pfizer’s product Lipitor and was heard by the Supreme People’s Court in 2015, the patentee submitted experimental reports during litigation to demonstrate that the Type I crystals for atorvastatin calcium trihydrate could be produced by one skilled in the art. The court intended to set a tone or establish a practical rule for accepting post-filing data under insufficient disclosure. That is, regarding the post-filing data for manifesting insufficient disclosure, if it can be proved that the invention can be realized through the content disclosed in the specification with the knowledge and cognitive ability of one skilled in the art before the filing date, the supplemental data should be considered and should not be rejected simply because the data was submitted after the filing date. Moreover, when considering the acceptance of experimental evidence: (i) the experimental conditions and methods used in collecting the experimental evidence must be directly obtainable or easily thought of by one skilled in the art who reads the instructions before the filing date or the priority date; and (ii) matters must be considered based on the knowledge and cognitive ability of one skilled in the art.
In recent years, CNIPA examiners have become more prone to raising lack of inventive step objections instead of insufficient disclosure objections during the prosecution of inventions without substantial data to manifest their technical effects. In (2018) Jing 73 Xing Chu No. 2626, a case heard by the Beijing IP court in November 2020, the applicant submitted its prior application, filed before the filing date but published after the filing date of the patent application-in-suit, as evidence that the same chemical as that found in the patent application-in-suit had an SGLT2 inhibition effect. Therefore, the crystal form of the chemical, as claimed in the patent application-in-suit, obviously had such an effect. Such evidence was rejected by CNIPA but accepted by the Beijing IP Court because: (1) the evidence showed that the technical effect described in the patent application-in-suit is a technical contribution made before the filing date; and (2) the public could identify such an effect at the time when the patent application-in-suit was published. Therefore, accepting such experimental data would neither give the applicant protection beyond his technical contribution nor affect the public interest.
In summary, the standards set in the above cases are quite similar in that the technical effect or technical solution manifested by the supplemental data was obtainable from the original patent application by the patentee before the filing date, without contravening the first to file principle, and the acceptance of such data did not affect public interests.
It is good to see that CNIPA and courts no longer adhere to very stringent standards for accepting supplemental data. For technical effects merely asserted in the specification without any specific embodiment, supplementary data can be used to manifest the inventive step over the prior art using current standards. It should, however, be noted that the effects need to be recorded in the patent document so that data supplementation can prove such effects.
Although data can be supplemented to overcome insufficient disclosure objections when certain rules are met, we strongly recommend that applicants, insofar as is possible, fully disclose experimental data related to an invention, such as the technical effect and preparation process, in the original patent document.
The Provisions and cases decided by the courts have clarified standards for accepting post-filing data to a large degree. Acceptance of post-filing data during prosecution or invalidation proceedings for chemical or pharmaceutical patents can also improve patent application grant rates and patent stability, which will reduce the risk of patents being invalidated. Clarifying the standards for accepting supplementary experimental data is a measure taken to support a long-awaited and expected boom in the pharmaceutical industry. Moreover, it will encourage innovation and significantly improve the transaction value of chemical and pharmaceutical patents.