China: Brace Yourselves – 3d Printing IP Issues Are Here

Last Updated: 7 January 2018
Article by Edward Chalfie

Align Technology, Inc. ("Align") makes INVISALIGN® braces. It uses digital scanning techniques to scan each patient's teeth and uses those scans to create a treatment plan.  The process uses digital models of the patient's teeth at different progressions along the treatment plan.  Align then creates the braces from the digital models with 3D printing.  Align holds numerous patents on this process and the components produced and used in the process.

ClearCorrect Pakistan (Private), Ltd. and ClearCorrect Operating, LLC (of Texas) ("ClearCorrect") allegedly generated digital models of patients' teeth by infringing Align's patents in Pakistan. ClearCorrect then sent these digital files over the Internet to its related company in Texas to make physical models via 3D printing.

Align sued ClearCorrect in Texas for patent infringement. Subsequently, align filed a section 337 claim in the US International Trade Commission to stop the electronic importation of ClearCorrect's digital files into the United States over the Internet. The Texas infringement case was stayed pending the resolution of the ITC case.

On April 3, 2014, the ITC found a patent infringement violation of section 337 with respect to certain claims of five of Align's patents, and issued a cease-and-desist order against ClearCorrect. On ClearCorrect's motion, the ITC stated its order on June 2, 2014, pending ClearCorrect's appeal to the Federal Circuit.

The issue before the Federal Circuit was one of jurisdiction of the ITC.  19 USC §1337 (Section 337) gives the ITC jurisdiction over patent infringement and other IP violations "in the importation of articles... Into the United States." If the ITC finds an IP infringement embodied in such articles, it can issue an exclusion order, and since 1974 a cease-and-desist order, blocking the importation of the articles.  In this case, the ITC's Administrative Law Judge determined that ClearCorrect's digital files were "articles" within the meaning of Section 337, in that they infringed claims of Align's patents. This is the issue brought to the Federal Circuit by ClearCorrect. Align intervened in the appeal. Joining the parties in the argument were amicus briefs filed by the Electronic Frontier Foundation, Public Knowledge and the Internet Association, each arguing with ClearCorrect that digital data is not an article within the meaning of Section 337 and should pass freely over the Internet without interference from the ITC. On the other side, seeking to protect digital intellectual property, were the Business Software Alliance, the Association of American Publishers, Nokia Corporation, the Motion Picture Association of America, and the Recording Industry Association of America.

In a 2-1 decision, the Federal Circuit reversed the ITC's decision and remanded the case to the ITC.  Chief Judge Prost, writing for the Court, relied on Chevron, USA, Inc. v. National Res. Def. Council, Inc., 467 US 837 (1984) for its statutory interpretation formula.  The most important issue concept in the opinion was the consistency of the term "article" throughout the 1930 Tariff Act. Throughout the Act, "article" was seen as a material object. Further the Court thought that the 1974 authorization of cease-and-desist orders further supported the conclusion that "articles" cannot be defined to include electronic transmissions since the addition of cease-and-desist orders would not be a lesser alternative for exclusion orders but would be an expansion of the exclusion power.

Judge Newman dissented from the opinion arguing that the ITC correctly held that Section 337 is not limited to the kinds of technology that existed in 1922 or 1930. Judge Newman said "Patents are for things that did not previously exist, including kinds of technology that were not previously known.... There is no basis for excluding imported infringing subject matter from Section 337, whatever the form of the subject matter."

While this case was concerned with utility patent infringement, the result will apply to any IP infringement claims at the ITC brought against accused digital files imported into the United States via the Internet. This includes designs, trademarks and copyrights – no wonder the Business Software Alliance, the Association of American Publishers, the Motion Picture Association of America, and the Recording Industry Association of America were so eager to make their own arguments to the Federal Circuit.

Since Align chose not to file a petition for certiorari with the United States Supreme Court, we can only guess what the Supreme Court would do with this issue. Although the cases dealt with different issues and different statutes, the recent (December 6, 2016) opinion in Samsung v. Apple may give us a clue. In that case, the Supreme Court defined an "article" in the phrase "article of manufacture" as simply "a particular thing."  Presumably, this would include the ephemeral icons arranged on the screen of a smart phone, the subject of one of Apple's US design patents.

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
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