China: Patent Issues For Life Science Companies In China

Last Updated: 18 December 2017
Article by Wenhui Zhang and Stephen Zou

China has become one of the most important markets for life science companies, not only because it has the largest population in the world and its economy has grown rapidly in the past three decades, but also because the Chinese government has been encouraging innovation and strengthening patent enforcement.

This chapter discusses hot topics such as unpatentable subject matter, post-filing data and double patenting, using recent case studies to help foreign applicants and practitioners to understand existing patent practice in China.

Unpatentable subject matter

The Patent Law specifies certain types of subject matter as unpatentable, as follows.

Scientific discoveries

Scientific discoveries are not patentable. Naturally existing materials without involvement of any technical treatment belong to scientific discoveries.

However, a microorganism *per se* constitutes patentable subject matter when it is isolated in a pure culture and possesses a particular industrial use. Similarly, a gene or DNA fragment *per se*can be patented if:

  • it is isolated from nature for the first time;
  • its sequence is unknown in the prior art; and
  • it can be definitely characterized and industrially exploited.

Methods for the diagnosis or treatment of diseases

Methods for the diagnosis of diseases are unpatentable in China. In determining whether a method involves diagnosis of a disease, two elements are considered:

  • Whether it is practiced on a living human or animal body; and
  • Whether its immediate purpose is to obtain the diagnostic result of a disease or health condition.

If the immediate purpose of a method is to obtain information from the living human or animal body only as an intermediate result – rather than to obtain a diagnostic result or determine a health condition– or the method is a way of processing such information, it is patentable.

In Re-examination Decision 92668 the invention related to a method of detecting porcine circovirus type 2(PCV2) on the basis of the ORF2 antigen functional domain. The invention was rejected since it fell within the scope of a method for the diagnosis of diseases. The examiner reasoned that PCV2 was an important infected pathogen for porcine multi-systemic wasting syndrome (PMWS), and the claimed method could be used to determine whether a pig had that disease.

The applicant filed a request for re-examination. The Patent Re-examination Board withdrew the previous rejection, reasoning that a pig infected with PCV2 does not necessarily:

  • suffer from PMWS(many factors are involved in the development of PMWS, including immune stimulation and susceptibility of the host); or
  • show the symptoms of PMWS.

Therefore, the immediate purpose of the claimed method was not to detect PMWS.

Methods for the treatment of diseases are unpatentable in China. In practice, such claims are generally redrafted into Swiss-type use claims, since this is the only format allowed for medical use inventions.

In the recent *Cubit*case, the Supreme Court delivered its opinions on novelty-conferring technical features. It held that only the technical features of an indication and those associated with the manufacture of the medicament are considered in evaluating the novelty and inventiveness of a Swiss-type use claim. Other technical features, such as those purely associated with the administration of the medicament (eg, interval of administration, subject and dosage), are not considered.

Animal and plant varieties

Animal and plant varieties are unpatentable in China. These include embryonic stem cells, as well as animals at the various stages of formation and development, including germ cells, oosperms, embryos and plant reproductive materials (including seeds).

However, somatic cells, tissues, organs(except embryos) and processes for producing animal and plant varieties (except for essentially biological processes) are patentable in China. Whether a process is an 'essentially biological process' depends on the degree of human technical involvement in the process. If human technical involvement is the decisive factor for achieving the result or effect of that process, the process is not essentially biological.

Plant cells were previously patentable. However, present practice holds that plant cells belong to the category of reproductive materials and thus fall into the unpatentable category of plant varieties.

In Re-examination Decision 54915, the invention related to a plant cell. The application was rejected on the grounds that plant cells are unpatentable since they are plant varieties. The applicant filed a request for re-examination.

In the re-examination proceedings, the board held that plant varieties include not only plants *per se* at different development stages, but also plant cells, tissues or organs as reproductive materials. The board held that the factors for consideration included the natural characteristics of the plants and the specific recitation on plant cells, tissues or organs in the description. After the applicant amended the subject matter from "plant cells" to "a method for producing plant cells", the board withdrew the final rejection.

Although plant varieties are not patentable, plant variety protection is possible in China.

Post-filing data

Post-filing data or supplementary data submitted after the date of filing has been a hot topic in China for a long time. Whether post-filing data or supplementary data can be accepted in China will be discussed in the following section, respectively for the possibility of overcoming the enablement, inventiveness and support issues.

Enablement requirement

The 'enablement' requirement (also known as sufficient disclosure) specifies that "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".

In the past, post-filing data would not be considered if it addressed a non-enablement issue; hence, arguments had to rely on the original disclosure of the application and the prior art. However, in recent cases post-filing data has been more commonly considered in addressing non-enablement rejections. And in some cases, arguments based on prior art (ie, that the effect of the claimed technical solution is predicable from the prior art)are also possible.

In Re-examination Decision 80658 the invention related a specific peptide. Its description outlined how to prepare and identify the claimed compound, as well as biological assay methods to test the bioactivity being described. However, it disclosed no activity data.

The application was rejected at the substantive examination stage due to non-enablement. The examiner held that:

  • the description provided no data to prove the therapeutic effect of the claimed compound; and
  • the technical effect of the claimed compound could not be predicted from the prior art, as it was a new compound.

The applicant filed a request for re-examination before the board and argued that the technical effect could be predicted from the state of the art. In filing the request, the applicant also submitted several prior art documents to support its arguments.

After considering the applicant's arguments and the state of the art, the board found that the technical effect of the claimed peptide could be predicted based on the prior art, since it shared the same main structure as the prior art peptides and there was an established structure-activity relationship in the state of the art. Thus, the claimed peptide was disclosed sufficiently and the final rejection was withdrawn.

Inventiveness requirement

Submission of post-filing data is very common for establishing inventiveness in the life sciences field. However, under local practice, the requirements for the post-filing data submitted for this purpose are very strict.

In the Supreme Court's recent *Takeda* case, the patent related to a combination of two known anti-diabetes treatments and was challenged on the grounds that the claimed combination did not involve an inventive step. In invalidation proceedings, the patentee submitted supplemental data showing the unexpected technical effect of the combination.

The Patent Re-examination Board invalidated the patent. The first and second-instance courts upheld the decision, since the authenticity of supplementary data was not recognized.

After retrial, the Supreme Court delivered its opinion on post-filing data to establish inventiveness. It held that post-filing data does not belong to the contents recorded and disclosed in the original application. If an applicant or patentee intends to establish the inventiveness of the claimed technical solution over the prior art by submitting comparative experimental data, as a prerequisite for consideration the data must be directed to the technical effect that has already been clearly recited in the original application.

This case demonstrates that post-filing data may be filed to address the issue of inventiveness in China. However, the post-filing data must at least point to the technical effect recited in the original application. In practice, the technical effect to be proved must generally be validated with experimental data in the original description.

Support requirements

According to the guidelines, "the claims shall be supported by the description" means that the claimed technical solution should be one which is:

  • sufficiently disclosed in the description; or
  • generalized from the contents which are sufficiently disclosed in the description.

The guidelines do not specifically stipulate whether supplemental data will be accepted to overcome the support issue. In determining whether the claims are supported by the description, the examiner generally considers the contents sufficiently disclosed in the description and the state of the art. In the past, submitting supplemental experimental data to overcome the support issue was not permitted. However, the trend seems to have altered in recent cases.

In Re-examination Decision 8661 the invention related to a feed which prevented infectious diseases in fish caused by viruses. One of the limitations was that it contained a sulfated polysaccharide with a proportion of mixture from0.5 g/kg to5.0 g/kg. The numeric scope 0.5 to 5.0 was rejected as too broad in view of the description. The applicant filed a request for re-examination and submitted supplementary data.

The board overturned the rejection and took a positive view of the supplemental data. Although supplementary data filed after the filing date is not considered to be a portion of the description and cannot be incorporated into the description, it can be used as evidence to corroborate the feasibility and effect of the technical solution in the description.

In practice, it is possible to submit supplemental data as evidence to support the scope of the claims. However, the extent to which supplemental data will be considered varies among different examiners.

Double patenting

According to the Patent Law, only one patent right will be granted for identical inventions; where two or more applicants have filed separately, it will be granted to the applicant that filed first.

The term 'identical invention-creation' refers to a claim that has the same scope of protection in two or more applications or patents. If the scope of protection of a claim in one application or patent is identical with that of a claim in the other application or patent, they are identical inventions. If the contents of the descriptions of two applications or patents are identical, but the scope of protection of their claims is different or overlapped, the inventions are not identical. Therefore, in practice the double-patenting issue can generally be addressed by amending a claim to one with a different scope of protection from the other.

In some important cases (eg, where a specific compound has entered the clinical stage) applicants have pursued a narrow scope or specific compound claim/specie in the parent application and a much broader genus claim in the divisional application. This strategy incurs no double-patenting issues in China. Further, applying this strategy can better balance fast grant and a broad scope of protection.


The patentability requirements on medical use inventions are relatively high, so only limited technical features will be considered in the evaluation of patentability. Regarding the submission of post-filing data, the requirements for enablement and support issues are relaxing; however, the requirements regarding inventiveness remain strict and post-filing data must be directed to the effect validated in the original description. It is easy to achieve the balance of fast grant and a broad scope of protection for an important case by making use of the relaxed double patenting requirements.

Understanding the above practices will be helpful for building strong patent portfolios and tailoring local patent prosecution strategies that are suitable forChina.

This article has been published on Life Sciences 2016, Intellectual Asset Management

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
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
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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