Enter to open, tab to navigate, enter to select
ITC Rules That Digital Data Sets are Articles
Practical Law Legal Update 0-564-7985 (Approx. 4 pages)
ITC Rules That Digital Data Sets are Articles
by Practical Law Intellectual Property & Technology
| Published on 14 Apr 2014 • USA (National/Federal) |
In In re Certain Digital Models, Digital Data, and Treatment Plans for Use in Making Incremental Dental Positioning Adjustment Appliances, the Appliances Made Therefrom, and Methods of Making the Same, the International Trade Commission concluded that digital data are articles that are processed within the meaning of Section 337(a)(1)(B) of the Tariff Act of 1930. It therefore affirmed an administrative law judge's initial determination that digital data sets and treatment plans for orthodontic treatments that are generated in Pakistan and then transmitted into the United States violated this statute.
On April 9, 2014, in In re Certain Digital Models, Digital Data, and Treatment Plans for Use in Making Incremental Dental Positioning Adjustment Appliances, the Appliances Made Therefrom, and Methods of Making the Same (337-TA-833), the International Trade Commission (ITC), with one commissioner dissenting, affirmed-in-part, modified-in-part and reversed-in-part the administrative law judge's final initial determination. Importantly, the ITC concluded that digital data sets are "articles" that are "processed" within the meaning of 19 U.S.C. § 1337(a)(1)(B) of the Tariff Act of 1930. The ITC issued a cease-and-desist order, rather than an exclusion order, prohibiting the importation into the US of certain digital models, digital data and treatment plans for use in making dental appliances.
In 2012, Align Technology, Inc. filed a complaint with the ITC asserting that ClearCorrect Operating, LLC (CCUS) and ClearCorrect Pakistan (Private) Ltd. (CCPK) violated section 337 of the Tariff Act by, among other things, importing into the US certain digital models, digital data and treatment plans for use in making incremental dental appliances that infringe certain of Align's patents.
Certain of the asserted patents are directed to different orthodontic methods, including methods of:
- Making a number of dental appliances that incrementally reposition a patient's teeth to a final desired position.
- Planning dental treatment by producing digital data sets.
- Producing a number of digital data sets by moving some of the tooth boundaries relative to the other teeth in a visual image to produce a final data set.
CCUS creates digital data sets by scanning stone models of a US patient's dental impressions, which represent the patient's initial tooth arrangement. This information is transmitted from the US to Pakistan where they are manipulated by CCPK to create a treatment setup. CCPK then transmits the treatment setup to CCUS which sends the treatment setup to the dentist for approval. If the dentist in the US approves the treatment setup, CCPK creates digital data sets of intermediate tooth positions so that dental appliances can be made that move the teeth from their initial position to the final position. CCPK then electronically transmits the digital data sets to CCUS by uploading them onto the CCUS server.
The relevant portion of Section 337(a)(1)(B) at issue in this case provides that the following activities are a Section 337 violation:
The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that . . . are made, produced, processed, or mined under, or by means of, a process covered by the claims of a valid and enforceable patent.
The parties disagreed on the correct statutory interpretation. Specifically:
- CCUS and CCPK argued that:
- the statutory term "articles" must be tangible objects, not digital data; and
- the term "processed" cannot include data processing by a computer where data is the only product because data, information and electronic transmissions are not physical goods that had been manufactured.
- Align, and the ITC investigative attorney, argued that:
- the plain meaning of the term "processed" includes data processing on a computer; and
- no definition of that term limits it to the use of physical items so the term "articles" may be digital data.
The ITC analyzed the plain meaning and the legislative history of the Tariff Act and relevant caselaw to conclude that digital data sets are "articles" that are "processed" within the meaning of section 337(a)(1)(B) of the Tariff Act of 1930. Specifically, the ITC explained that:
- The term "processed" refers to something that has been subjected to a treatment or change according to a series of actions, which may be the result of a patented process. The ITC thus concluded that, in this portion of the statute, Congress was trying to comprehensively cover all ways in which a method patent can be infringed.
- The legislative history is consistent with this interpretation.
- ITC cases are in accord with its understanding that the term "processed" means treated.
In further explaining its rationale, the ITC noted that the digital data sets in this case are directly representative of teeth and are processed or treated through a series of interpolations in a manner analogous to physical manipulation of a mold of teeth. It therefore concluded that the digital data set of teeth are treated or manipulated in the same manner as a plaster cast of teeth.