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”

Mondaq Advice Centre (MACs)
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.