China: Precedent Fails To Help Applicants

Jiancheng Jiang of Peksung Intellectual Property describes recent case law relating to second-use inventions, and asks whether the judgments will break through China's reliance on codified laws

In China, as in other countries around the world, methods for the diagnosis and treatment of diseases may not be granted a patent right (article 25.1 of the Chinese Patent Law). Under the examination practice of the State Intellectual Property Office (SIPO), it is possible to use the so-called Swiss-type claim format for seeking protection for a second medical use invention of a substance so as to avoid the application of article 25.1. SIPO's Guidelines for Examination explicitly provides that the claim of a second medical-use invention can be drafted as "use of compound X for preparing a medicament for the treatment of disease Y". Such a claim type is considered as a use claim as it is a method for preparing a medicament (part II, chapter 10, section 4.5.2 of the Guidelines for Examination 2010), and so does not fall within the category of methods for the diagnosis and treatment of diseases. Put another way, such inventions, in terms of their subject matter, can get patent protection under the Chinese practice.

It is generally believed that the above-mentioned provision in the Guidelines for Examination is made by drawing references from the practice of the European Patent Office (EPO). Even after the EPO terminated the use of Swisstype claims through case law (EPO Enlarged Board of Appeal decision G02/08), SIPO continues to use it. Nevertheless, SIPO examination practice in this area is different from that of the EPO.

In practice, some medical use inventions contribute to prior art, mainly in discovering a new dosing regimen of a medicament (such as a new dosage amount, or dosing interval) rather than in finding out new indications. These inventions may be valuable to companies who seek innovations in the use of an existing pharmaceutical product. As to the patent applications of such inventions, the EPO explicitly admits the patentability of the second medical use claim defined by dosing regimens (EPO Enlarged Board of Appeal decision G02/08). Nevertheless, SIPO would examine whether or not the features related to using the medicament, such as the mode, route, usage amount and interval of administration, have a limiting effect on the preparation procedure of a medicament; a distinguishing feature over the prior art that is merely embodied in the course of administering the medicament does not make the claim novel (see part II, chapter 10, section 5.4 of the Guidelines for Examination). According to this examination standard, if the distinguishing features of a Swiss-type claim are merely embodied in the course of administration but cannot define the procedure of preparation of a medicament, they may not be considered in the assessment of novelty and inventiveness of the claimed invention. This examination standard prevents most inventions in China relating to a new dosing regimen from being protected.

On this issue, however, the judicial authorities of China have made judgments that are seemingly inconsistent with the examination standard.

Chinese patent ZL94194471.9

Chinese patent ZL94194471.9 relates to a second medical use invention, of which the granted claim 1 reads as:

1 The use of 17 -(N-tert-butylcarbamoyl)-4- aza-5 -androst-1-ene-3-one for the preparation of a medicament adapted for oral administration useful for the treatment of androgenic alopecia in a person and wherein said medicament comprises about 0.05-3.0 mg dosage amount of 17 -(N-tert-butylcarbamoyl)- 4-aza-5 -androst-1-ene-3-one.

In the invalidation proceedings of the patent, the Patent Reexamination Board (PRB) presented the following opinions:

This patent differs from the prior art in that: (1) the dosage amount of the medicament defined in this patent is 0.05 to 3.0 mg; and (2) this patent defines that the medicament is orally administered. Nevertheless, distinguishing feature (1) has no limiting effect on the claim, and thus shall be deemed to be nonexistent in the assessment of novelty and inventiveness; and distinguishing feature (2), as the PRB admitted, has limiting effect on the medicament product to some extent, and thus could confer novelty to claim 1.

In its invalidation decision, the PRB detailed the grounds of these findings. As to feature (1) (0.05-0.3 mg dosage amount), the PRB deemed that it has no limiting effect on the method for preparing the medicament. The PRB held that, since the use of a substance in the preparation of a medicament substantially equates to a method for preparing the medicament, only the features of raw materials, preparation steps and conditions, the form and components of the medicament product, have a direct limiting effect on the use. Administration is a step carried out after the medicament is prepared. Therefore, the preparation and administration of a medicament are two different steps, and do not coincide in terms of time domain. In order to achieve the above-mentioned dosage amount, the medicament could be administered to a patient with a smaller dosage amount more times or with a larger dosage amount fewer times. This is common knowledge in the art. The intake dosage of a medicament would have no limiting effect on the raw materials, preparation method or indications of the medicament.

As to feature (2), the PRB deemed that although the feature also concerns the method of using the medicament, it generally implies some product features of the medicament, for example, oral administration requires the auxiliaries to be suitable for oral intake, and thereby has a limiting effect on the selection of auxiliaries. Therefore, the feature does have a limiting effect on the medicament product to some extent.

Based on the above findings, the PRB considered merely feature (2) in the assessment of inventiveness of this patent, and finally made the decision that the patent has no inventiveness.

Appeal to the Higher Court

The patentee appealed to Beijing Number 1 Intermediate People's Court. The court upheld the decision of the PRB. The patentee further appealed to Beijing Higher People's Court. The Higher Court finally judged that the first instance judgment would be upheld. Noticeably, in the final judgment, an analysis different 4 to that of the PRB and the court of the first instance was made.

Specifically, the Higher Court did not agree on the findings of the PRB in terms of the limiting effect of feature (1). In particular, the Higher Court held that a medical use invention is substantively an invention of a method for administering a medicament. The technical features concerning administration of a medicament (so-called dosing characteristics, such as dosage form and amount used), should be read into the claim. In addition, the preparation of a medicament includes all the procedures before packaging for sale, and of course includes the dosing characteristics. Under the circumstances that the patentee improves the dosage form, amount, and the like, disregarding the dosing characteristics is unfavourable to the development of the pharmaceutical industry and to meeting people's need for healthcare, and does not conform to the legislative purpose of the Patent Law (Beijing Higher People's Court Administrative Judgment (2008) Gaoxingzhongzi 378).

A rare decision

This judgment of the Higher Court attracted attention from the public. In China, cases to which the court declines to apply the provisions of the Guidelines for Examination are rare. The Higher Court seemed to deem that the dosing characteristics should be treated as a part of the procedure in the preparation of a medicament (that is, having limiting effect on a medical use claim), and thus may be considered in the assessment of novelty and inventiveness. The judgment offered a glimmer of hope to companies active in this field. The judgment may have cleared the way for seeking protection for such inventions. Nevertheless, things are not so simple. As is known, Chinese practice does not necessarily follow precedent. A court judgment is binding only on the case it deals with, and not universally. In fact, after the Higher Court's judgment, SIPO did not adopt the opinions of the Higher Court, but followed the past standard when they amended the Guidelines for Examination in 2010 to match the Patent Law, as effective from October 1 2009.

Recently, a decision made by the Supreme People's Court on Patent 99812498.2 seems to put an end to the issue.

Clarification by the Supreme Court

The case was initiated before the PRB as a patent invalidation case. Claim 1 of the patent as granted reads as:

1 Use of daptomycin for the manufacture of a medicament for treating a bacterial infection in a patient in need thereof while not resulting in skeletal muscle toxicity, wherein a dose for said use is 3 to 75 mg/kg of daptomycin wherein said dose is administered repeatedly at a dose interval of once every 24 hours or 48 hours.

In the invalidation proceedings, the PRB deemed that a prior art document discloses the same medical use of daptomycin as that claimed in the present patent, with merely the dose and dose interval being different. It is well known to those skilled in the art that the features of dosage amount, repeated administration and dose interval are information to be selected and determined according to patients by doctors in the treatment process, and so constitute information involved in administration process and have nothing to do with process of manufacturing the medicament. Therefore, dosage amount, repeated administration and dose interval have no limiting effect on the medicament per se, and cannot distinguish the medical use of claim 1 from that of the prior art. In other words, the PRB deemed that these features are distinguishing features only embodied in the administration process, and so cannot bring novelty to the use of the patent. After the case was appealed to the court, the Intermediate Court as the first instance court, and the Higher Court as the second instance court, both upheld the decision of the PRB. The patentee then requested retrial before the Supreme People's Court.

The Supreme Court, in its retrial ruling, stated that Swiss-type claims involving second medical use are of process type. Such claims exclude other other manufacturers from manufacturing the same product with the same use. In this way, the technical features of such claims should still be analysed from the process claim view. Usually, it is the raw materials, preparation steps and technological conditions, the form and components of a pharmaceutical product, and the equipment used, that have limiting effect on the claims. As to the features involving merely administering a medicament (such as the dosage amount and dose interval), if they have no direct relation with the preparation of the medicament, they are actually a particular method for applying the medicament to humans after implementing the method for the preparation and obtaining the medicament. There fore, such features have no direct and necessary relation with the method for preparing the medicament; they are not technical features of the use for the preparation of a medicament, and have no limiting effect on it.

The above decision of the Supreme Court is not very surprising, as ever since the Higher Court made the judgment on patent ZL94194471.9, judicial circles have taken different views on the judgment (Tong Shu, China Patents and Trademarks No 4, 2009, pages 50- 53). Nevertheless, the ruling is important in that it is the first time the Supreme Court has made its position clear on the limiting effect of dosing regimen features on second medical use claims. In the present case, the Supreme Court explicitly endorses the examination standard implemented by SIPO on this issue.

Beyond the codified laws

It is worthwhile to note that in the invalidation proceedings of this case, the patentee submitted the judgment of the Higher Court on patent ZL 94194471.9, and requested the PRB to examine this case according to the Higher Court's opinion. As expected, the PRB declined to follow it, and the Supreme Court did not make any comments on this issue. Understandably, China is not a common law country and has no legal tradition to stare decisis, and only the codified laws can be applied by the court in trials. Nevertheless, considering the authority of the Supreme Court in the judicial system, the attitude of the Supreme Court supporting the examination standard of SIPO on this issue will very likely be followed by lower courts in the future. It is believed that, in future, if the patentee wishes to challenge this examination standard through judicial channels, there would be only a very slim chance of success.

Originally published by

Jiancheng Jiang

Jiancheng Jiang is a patent attorney and attorney-at-law whose practice area covers drafting, prosecution, re-examination, invalidation, litigation, enforcement and strategy in a wide variety of technical IP areas, particularly biochemistry, biotechnology, pharmaceutics, and organic chemistry.

Jiancheng received his BS degree in biochemistry from Peking University, Beijing, and his MS degree in biochemistry from the Graduate School of the Chinese Academy of Sciences, Beijing. He studied European patent law at the European Patent Office and US patent law in the US, and completed integrated law courses at Renmin University, Beijing. He began to practice IP law at China Patent Agent (HK) in 1987. In 2003, he founded Peksung Intellectual Property, and is now the managing partner.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Wan Hui Da - Peksung IP Group
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Wan Hui Da - Peksung IP Group
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions