In AstraZeneca AB (Sweden) vs China National Intellectual Property Administration
(CNIPA), (Intellectual Property Tribunal of the Supreme People’s Court of China (SPC), (2019)
SPC IP Admin. Final 33), the SPC established the standard for accepting supplementary
experimental data by CNIPA in patent invalidation process.

Facts of the case
This case concerns an invention patent with patent number 200610002509.5 and
named Novel Crystalline Form and Non-crystalline Form of Triazolo [4, 5-D]
Pyrimidine Compound, and the patentee is AstraZeneca AB. Shenzhen Salubris
Pharmaceuticals Co., Ltd. submitted a request to declare the patent to be invalidated,
on the ground that claims 1-4 of the patent do not have inventiveness. To prove the
inventiveness, AstraZeneca AB submitted rebuttal evidence. CNIPA held that the
relevant rebuttal evidence cannot prove that the patent has an unexpected technical
effect, and the patent does not have inventiveness. As a result, CNIPA issued its
decision to invalidate claims 1-4 of the patent.
AstraZeneca AB was not satisfied and filed a lawsuit with Beijing Intellectual
Property Court, which held that, firstly, the experimental data in the rebuttal evidence
was completed after the filing date of the patent; secondly, only the Background
section of the specification of the patent alleged that the claimed compound high
potency for the claimed purpose and has a “surprisingly high metabolic stability and
bioavailability.” The patent specification neither mentioned nor provided any
experimental data about the technical effects, and persons skilled in the art can’t
confirm the alleged technical effect based on the specification. Thirdly, the rebuttal
evidence is an experiment completed by an attester itself who has a relationship with
AstraZeneca AB, and that the specific scenarios of experimental condition and
experimental data cannot be corroborated by other evidence. Therefore, this case
cannot rely on the technical effect described in the rebuttal evidence to determine the
technical problem actually solved by the patent. AstraZeneca AB appealed to the SPC
on the ground that the rebuttal evidence which serves as the supplementary
experimental data shall be accepted.
Legal Issues
The SPC held that it is unavoidable that patent applicants do not incorporate certain
specific experimental data into their original application documents due to the
difference in perception of prior art, the difference in understanding of the inventive
point of technical solution, and the inconsistency in the grasp of cognitive level of
those skilled in the art. As far as inventiveness is concerned, the inventiveness of a
pharmaceutical compound can be based on the structures or configurations of the
compound per se or can be based on the pharmaceutical effects. The aforesaid
pharmaceutical effects can be pharmaceutical uses, i.e. indications, or can be efficacy
of the pharmaceuticals, i.e. activity, toxicity, and stability of the pharmaceuticals as
well as velocity of controlled release. Any non-obvious technical contribution to the
aspects above can be used as a basis to determine the technical problem that is
actually solved by the technical solution such that the technical solution would meet
the standards of inventiveness for patent-granting. It is difficult for the applicant to
precisely foresee the inventive point on the filing date or the priority date.
Even if the applicant could give a precise forecast of the inventive point, there would
be possibly different facts and data required to prove the non-obvious technical
contribution due to the different understanding of prior art and the different choices of
the closest prior art in respect to the same technical problem. Taking sufficiency of
disclosure as another example, because examiners and petitioners for invalidation
may both have different understandings on patent application documents and may
both have different choices of the closest prior art to that of the patent applicants, the
former may therefore question whether the patent application meets the requirement
of sufficiency of disclosure. Under the circumstances above, the patent applicants
need to rely on supplementary experimental data submitted after the filing date or the
priority date to prove that their patent applications are eligible for granting. Therefore,
the supplementary experimental data submitted by the patent applicant after the filing
date shall be examined.
Of course, allowing patent applicants to submit supplementary experimental data after
filing date or priority date and examining them does not mean that such data must be
accepted for sure. Considering the impact on priority claims over inventions and the
need to ensure compliance to the rules on sufficiency of disclosure at the time of
patent filling, there is a need to avoid these problems when accepting supplementary
experimental data.
First, the original patent application documents shall clearly describe or implicitly
disclose the to-be-confirmed fact that is intended to be directly proved by
supplementary experimental data, and this is a positive requirement.
Second, the applicant cannot remedy the deficiencies inherently and naturally present
in the original application by the supplementary experimental data. The
supplementary experimental data shall be normally used when the to-be-confirmed
fact is to serve as a supplementary proof for the legally required fact which needs to
be eventually proved by the applicant. However, the supplementary experimental data
shall not be independently used to prove for the contents that are not disclosed in the
original application, or to overcome the deficiencies inherently present in the original
application, such as insufficiency of disclosure.
In this case, the original patent application documents described a technical effect of a
surprisingly high metabolic stability and bioavailability. But a person skilled in the art
cannot confirm the compound of Claim 1 actually has the said effect merely based on
the original patent application. The supplementary experimental data provided by
AstraZeneca AB intended to prove that the to-be-confirmed fact is authentic, i.e. the
compound of Claim 1 does have a surprisingly high metabolic stability and
bioavailability, so as to prove inventiveness in a further step. Therefore, the
supplementary experimental data was not used to overcome the deficiencies
inherently present in the original application and shall be accepted.
The court held that, in the field of pharmaceutical research and development, in
particular for the R&D of a novel pharmaceutical, the subjects of R&D are relatively
centralized. Therefore, the sources where the supplementary experimental data come
from are also relatively centralized. The fact that the provider of the relevant
supplementary experimental data and the patent applicant or the patentee has a
relationship of interest such as employment or the like is in line with the convention
or practice of R&D, and these facts shall not be the sole ground for not accepting
supplementary experimental data.
In view of the above, the original judgment for not accepting the supplementary
experimental data submitted by AstraZeneca AB was erroneous and has been
corrected by the appellant court.
Points of Significance
Courts should accept supplementary data where the original patent application
documents have clearly described or implicitly disclosed the to-be-confirmed fact that
is intended to be directly proved by the supplementary experimental data, and where
the data is not intended to remedy deficiencies present in the original patent
application.

Chinese Supreme People’s Court held that a former employee’s invention belongs to the former employer if the invention was made within 1 year after employment termination, and within the employee’s scope of employment, see Guangzhou Wanfu Biotechnology Co., Ltd. v. Shenzhen Libang Precision Instrument Co., Ltd. (2019) Supreme Law Zhimin Final No. 799. The case is related to Chinese patent application number 201610201438.5 and titled “blood gas analyzer and its blood gas biochemical test card”.

Since its inauguration on January 1, 2019, the Intellectual Property Tribunal of the Chinese Supreme People’s Court has accepted a total of 5104 cases and concluded 4124 cases. Among them, 2905 civil cases of second instance were accepted and 2,277 were concluded; 908 cases of administrative second instance were accepted and 614 were concluded. The IP Tribunal has a database of more than 360 technology experts and investigators in 30 technology fields. The IP Tribunal has 39 judges and 44 judge assistants. All the judges have graduate degrees including 42% Ph.D, 37% science and technology background and 21% overseas study experience.

Effective January 15, 2021, China National Intellectual Property Administration (CNIPA) will allow submission of data after filing date. This is particularly important to pharmaceutical patent applicants.

According to amended Examination Guideline (EG), submission of additional experimental data is allowed for the purpose of (1) proving sufficiency of the disclosure or (2) proving inventiveness.

The sufficiency of disclosure is determined by the original specification and claims, according to EG 3.5.1. However, later submitted data should be considered and the technical effects proved by the supplementary experimental data should be obtainable by those skilled in the art from the disclosure of the original patent application.

In addition, the supplementary experimental data can be submitted to prove inventiveness. Similarly, the technical effects proved by the supplementary experimental data should be obtainable by those skilled in the art from the disclosure of the original patent application.

Example 1:

Compound A is claimed, and the specification describes the preparation example of compound A, the blood pressure lowering effect and the experimental method for determining the blood pressure lowering activity, but the experimental result data is not recorded. In order to prove that the specification is fully disclosed, the applicant supplemented the blood pressure lowering effect data of Compound A. For those skilled in the art, according to the original application documents, the blood pressure-lowering effect of Compound A has been disclosed, and the technical effects to be proved by the supplementary experimental data can be obtained from the disclosure of the patent application documents. It should be noted that the supplementary experimental data should also be reviewed when reviewing creativity.

Example 2:

The compound of general formula I is claimed. The specification describes the general formula I and its preparation method, the preparation examples of a number of specific compounds A, B, etc. in the general formula I and also records the anti-tumor effect of general formula I and the determination of anti-tumor effects. The experimental method and experimental result data of tumor activity, the experimental result data is recorded as the IC50 value of the compound of the example on tumor cells is in the range of 10-100 nM. In order to prove the inventiveness of the claims, the applicant submitted comparative experimental data, which showed that the IC50 value of compound A was 15nM, while the compound of comparative document 1 was 87nM. For those skilled in the art, according to the original application documents, Compound A and its anti-tumor effects have been disclosed, and the technical effects to be proved by the supplementary experimental data can be obtained from the disclosure of the patent application documents. It should be noted that at this time, the examiner also needs to further analyze whether the technical solution requested by the claim meets the requirements of creativity in conjunction with the supplementary experimental data.

In summary, submission of supplementary experimental data is allowed and applicant should take advantage of this procedure to better protect their intellectual property rights in China.

On November 16, 2020, the Chinese Supreme Court issued the “Provisions on Evidence in Civil Litigation of Intellectual Property Rights”. This judicial interpretation will be effective as of November 18, 2020.

The Provisions focus on evidence submission, evidence preservation, judicial appraisal, and protection of trade secret in intellectual property civil litigation, and aimed at reducing the burden of proof by intellectual property right holders.

See http://www.court.gov.cn/fabu-xiangqing-272241.html

https://euipo.europa.eu/tunnel-web/secure/webdav/guest/document_library/contentPdfs/law_and_practice/decisions_president/EX-20-02_en.pdf

Effective March 3, 2020, Chinese National Intellectual Property Administration (CNIPA) will no longer issue patent certificates in paper format unless a registered user specifically requests for one at http://cponline.cnipa.gov.cn/.

The US-China Trade Deal has not been signed. However, as my previous report indicated, some aspects of the IP Agreement have occurred. The various IP rights covered by the IP Agreement are summarized as follows:

TRADE SECRET

The Chinese Anti-Unfair Competition Law protects trade secrets. On April 23, 2019, the Standing Committee of the National People’s Congress revised the Chinese Anti-Unfair Competition Law. The revised Article 9 expands the means of improperly obtaining commercial secrets, increases the statutory obligation of confidentiality, and incorporates the implementation of infringement by other natural persons, legal persons and unincorporated organizations other than the operator into the subject of infringement. The revised Article 11 adds punitive damages compensation and significantly increases the maximum amount of statutory compensation and administrative fines. New Article 32 focuses on the allocation of burden of proof specifically for trade secret cases, which significantly reduces the requirements of the right holder’s proof.

INTELLECTUAL PROPERTY ISSUES RELATED DRUG AND PATENT TERM EXTENSION

On January 4, 2019, the Standing Committee of the National People’s Congress released the latest version of the proposed Amendment to the Chinese Patent Law. The proposal to amend Article 42 of the original Chinese Patent Law to read: “The duration of the patent right for inventions is twenty years, the duration of the patent right for utility models is ten years, and the duration of the patent right for designs is fifteen years are counted from the date of application. To compensate for the time required for the review and approval of the listing of innovative drugs, the State Council may decide to extend the term of the patent right for invention patents for innovative drugs that are marketed simultaneously in China and abroad, with the extension period not exceeding five years. The total effective patent right period after the launch of an innovative drug does not exceed fourteen years. ”

GEOGRAPHICAL INDICATIONS

On November 27, 2019, the China National Intellectual Property Administration revised the Measures for the Protection of Foreign Geographical Indication Products, which mainly involved three aspects. The first aspect is to clarify the two channels for foreign geographical indications to apply for protection in China, namely, under the treaties signed between China and foreign countries or the international treaties to which they have jointly participated, or according to the principle of reciprocity. The second aspect is to increase the number of changes and revocations after protection, allowing changes and revocations. The third aspect is to clarify the application channels for the protection of foreign geographical indication products, and to stipulate more comprehensive rules of procedure to enable foreign geographical indication products to be applied for, reviewed and regulated and protected.

CRACK DOWN ON PIRACY AND COUNTERFEITING ON E-COMMERCE PLATFORMS

The E-Commerce Law (effective January 1, 2019) stipulates that operators of e-commerce platforms shall establish rules for the protection of intellectual property rights, strengthen cooperation with intellectual property rights holders, and protect intellectual property rights in accordance with law. If the intellectual property right holder believes that their intellectual property rights have been infringed, they have the right to notify the operator of the e-commerce platform to take necessary measures such as deletion, blocking, disconnection, termination of transactions and services. The notice should include preliminary evidence that constitutes infringement. After receiving the notification, the operator of the e-commerce platform shall take necessary measures in a timely manner and forward the notification to the sellers or alleged infringers on the platform; if the necessary measures are not taken in a timely manner, the e-commerce platform shall bear joint and several liabilities with the sellers or alleged infringers on the platform. If the sellers or alleged infringers on the platform is damaged due to the wrong notification, the IP right holders shall bear civil liability according to law. If the wrong notification is issued in bad faith, causing losses to the sellers or alleged infringers on the platform, the IP right holders shall be liable for compensation.

The proposed Amendment to the Chinese Patent Law released on January 4, 2019 (Article 17) provides that patentees or parties of interest may, on the basis of the verdict, adjudication, mediation made by the People’s Courts, or the order to stop infringement made by the administrative offices, notify the internet service provider to delete, block or break the link of infringing products. The internet service provider which does not take necessary measure after receiving the notice, should be held jointly liable together with the internet user who infringes the patent right, for the enhanced damage.

FIGHT AGAINST MALICIOUS REGISTRATION OF TRADEMARKS

The Chinese Trademark Law amended on April 23, 2019 forbids maliciously applying for trademark registration and hoarding trademarks for profit. Article 4 of the Chinese Trademark Law stipulates that applications for the registration of malicious trademarks not for the purpose of use shall be rejected. During the trademark opposition period, anyone can file an opposition with the Trademark Office. For a registered trademark, any unit or individual may request the Trademark Office to declare the trademark invalid. As for a trademark agency, if it is known or should be known that the trademark applied for registration by the client is a malicious trademark registration, it shall not accept its application. Otherwise, the administrative department for industry and commerce shall have the right to impose administrative penalties in accordance with the provisions of Article 68.

STRENGTHEN JUDICIAL ENFORCEMENT & PROTECTION OF IP

Article 63 of the Chinese Trademark Law revised on April 23, 2019 stipulates that, in the trial of trademark disputes, the People’s Courts shall, at the request of the right holder, order the destruction of goods that are counterfeit registered trademarks, except under special circumstances; materials and tools that are mainly used for the manufacture of counterfeit registered trademarks are ordered to be destroyed without compensation; or under special circumstances, the aforementioned materials and tools are prohibited from entering commercial channels without compensation. Products with counterfeit registered trademarks shall not enter commercial channels after only removing counterfeit registered trademarks.

Notably, on November 24, 2019, the General Office of the State Council issued the Opinions on Strengthening the Protection of Intellectual Property Rights, which, among other things, incorporates the protection of intellectual property rights into the performance evaluation of the local governments.

It appears that changes are happening since the start of the US-China trade negotiations. The negotiations probably speed up the adoption of the relevant positive changes. If these changes were planned before the negotiations and would occur anyway, then the IP Agreement may be less effective. The hard part of any trade agreement is implementation and transparency. IP owners should seek wise counsel to chart a specific IP strategy to protect their innovation and creation in U.S., China and on a worldwide basis.

“China and the United States have reached consensus on strengthening intellectual property protection in several aspects, including protection of trade secrets, intellectual property issues related to drugs, extension of patent validity, geographical indications, crackdown on piracy and counterfeiting on e-commerce platforms, and crackdown on piracy and counterfeiting production and export of products, combating malicious registration of trademarks, and strengthening judicial enforcement and procedures of intellectual property.” Wang Shouwen, Deputy Minister of Commerce and Deputy Representative of International Trade Negotiations

The Beijing, Tianjin, Hebei, Jiangsu, Shandong, Guangdong, Chongqing, Sichuan, Hubei, Zhejiang, Anhui, and Shanghai Intellectual Property Offices of the 12 Chinese provinces and municipalities jointly signed the “Provincial and Municipal Intellectual Property Administrative Cooperation Agreement” in Shanghai. According to the agreement, relevant provinces and cities will further cooperation in terms of clue transfer of intellectual property administrative protection cases, assistance in investigation and enforcement, joint law enforcement protection, mutual recognition and sharing of results, etc., and enhance work synergy.

According to the agreement, the Twelve Provinces and Municipal Intellectual Property Offices will further open channels for the transfer of relevant case leads, strengthen cooperation in case investigation and evidence collection, processing of document delivery, and implementation of processing decisions, and promote the establishment of a mutual recognition mechanism for intellectual property infringement determination, the city’s key trademark protection mutual recognition list, etc., and strengthen the sharing of service resources such as intellectual property infringement dispute inspection and appraisal, arbitration and mediation, and overseas rights protection assistance.

In addition, the relevant provinces and cities will also carry out joint enforcement and handling of major events such as the Expo, the Canton Fair, the Winter Olympics, exhibitions, the Internet, and professional markets, as well as major and difficult cases, and crack down on intellectual property infringements.