China: Feasible Way To Define A New Protein Patent And Subsequently Obtained Scope Of Protection Novo Nordisk Vs. Longda Co.,Ltd. And Boli Co.,Ltd. (Article No. 24 From "China Patent Case Review 2015" By Beijing East IP Ltd.)

Thermostable Glucoamylase

Novo Nordisk vs. Longda Co.and Boli Co.- Feasible Way to Define a New Protein Patent and Subsequently Obtained Scope of Protection (Civil Judgments (2012)Jin Gao Min San Zhong ZiNo.41 and 42 by the Tianjin High People's Court on October 31, 2013)

With reference to new protein inventions, applicants always define biological sequences by the combination of homology and function, so as to obtain a broader scope of protection. However, considering that the association between the primary structure and the function of a protein is highly unpredictable, thus defined protein claim is always considered as not supported by the description and not conforming to Article 26.4 of the Chinese Patent Law. Therefore, discussions in this filed focuses on a proper manner to define a new protein patent and subsequently obtained protection scope. This is the first case for successful enforcement of biological patent in China, which clarifies a feasible definition of new protein patent, i.e. defining homology, origin (species), and function simultaneously. Furthermore, this case provides directions to judgment of future invalidation and infringement cases of new protein patents.

The patentee Novo Nordisk from Denmark possesses an invention patent titled "Thermostable Glucoamylase" with the patent number No. ZL98813338.5 (hereafter referred to as "the involved patent"). In 2001, Novo Nordisk sued Shandong Longda Bioproducts Co., Ltd. (hereafter referred to as "Longda Co.") and Jiangsu Boli Bioproducts Co., Ltd.(hereafter as "Boli Co.") for infringing its patent to the Tianjin Second Intermediate People's Court.

In June of 2011, the above two alleged infringer companies filed a Request for Invalidation to the Patent Reexamination Board (PRB) to invalidate the involved patent, respectively. The patentee amended claims of the involved patent during the invalidation procedure.

Amended claim 6 reads as "an isolated enzyme with glucoamylase activity, which is at least 99% homologous with the full length sequence shown in SEQ ID NO: 7 and has a PI below 3.5 determined by isoelectrical focusing." This is a typical technical solution defined by the combination of homology and function of a polypeptide. However, only two polypeptide, the one as shown in SEQ ID NO:7 and the one encoded by SEQ ID NO:34, are verified in the embodiments to have glucoamylase activity. Apart from this, there is no experimental data in the description related to the defined homologous polypeptides. Therefore, the PRB held that those skilled in the art cannot determine that all polypeptides defined by homology to specified sequence, e.g. polypeptides from different origins, will all have the alleged function and can achieve the objective of the present invention. In addition, there is no corresponding experimental data in the description. Therefore, the PRB concluded that technical solutions related to homology are not supported by the description.

The amended claim 10 further defines the enzyme as derived from a filamentous fungus of the genus Talaromyces, wherein the filamentous fungus is a strain of Talaromyces emersonii. The amended claim 11 further defines that the filamentous fungus is Talaromyces emersonii CBS 793.97. T. emersonii and Talaromyces emersonii CBS 793.97 obviously belong to the same species. The PRB held that an active gene with a specific function normally will only has one sequence in organisms of the same species, and its mutant sequences with very high homology will have the same function. Therefore, given that the glucoamylase activity of the enzyme derived from Talaromyces emersonii CBS 793.97 is verified in the description, those skilled in the art can foresee that polypeptides derived from T. emersonii and having at least 99% sequence homology will have glucoamylase activity.

Therefore, the PRB concluded that claims 10 and 11 can be supported by the description.

In summary, the PRB issued the No.17956 Examination Decision of Request for Invalidation, announcing claim 6 (homology + function) as invalid, and maintaining claim 10 (homology + species of original strain + function) as valid.

The First Instant Court tried the corresponding infringement case based on the above valid claim 10. The patentee submitted an appraisal conclusion made by a judicial appraisal institute agreed by both parties, indicating that the accused infringing product has the same technical feature with claim 10 in aspects of protein sequence and isoelectric point. The patentee further submitted a search report made by the Patent Searching and Consulting Center of the SIPO, indicating that the accused infringing protein cannot originate from other organisms than T. emersonii. The accused infringer failed to prove that accused infringing enzyme with the above protein sequence originated from other strains.

Therefore, the First Instant Court held that Longda Co. and Boli Co. did infringe upon Novo Nordisk's patent, and should pay the plaintiff economic lost and other fees, which are more than RMB 2.2 million in total (around USD 350,000).

Longda Co. and Boli Co. unsatisfied with the decision of the first instance and appealed. The Tianjin High People's Court concluded that the facts identified in the first instance are clear and the laws applied are proper, and rejected the request for the appeal and affirmed the judgment of the first instance.


During the invalidation proceeding of this case, the PRB clarified that a claim merely defined by "function + homology" cannot be supported by the description when experimental data proving function of homologous proteins are not sufficiently provided. More importantly, the PRB clarified that a definition by "function + homology + original species" can be supported by the description, which was affirmed by the court. This fact provides clear and positive teaching to applicants in the biology field who have doubts on how to properly obtain a good scope of protection. Furthermore, as the very first case of successful patent enforcement in the biology field, the detailed procedure of evidence preservation and judicial appraisal and provision of a number of evidences are essential to the positive result of this case, and of course enlightened other patent owners.

In the prosecution of bio-related invention applications, the U.S. is always considered to have the easiest criteria. However, in the decision of AbbVie v. Janssen Biotech and Centocor Biologics made by the United States Court of Appeals for the Federal Circuit on July 1, 2014, the antibody of claim 29 defined by "function + indexes" was invalidated for not disclosing any structural features common to the members of the genus, and lacking sufficient representative embodiments.1It is also recited in the decision that functional claim limitations are patentable only if they are linkable to structure. As can be seen, stricter criteria on support issue becomes a new trend worldwide. Under this trend, more attention should be paid to representativeness, numbers and types of embodiments when drafting claims so as to ensure better protection.

1 United States Court of Appeals for the Federal Circuit: ABBVIE DEUTSCHLAND GMBH & CO. v. JANSSEN BIOTECH, INC., 2013-1338,-1346, decided: July 2, 2014

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.

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
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