The Florida Bar

Florida Bar Journal

Import Patent Infringement: The Section 337 Investigation

Out of State Division

Unlike a registered trademark or copyrighted materials, a patent is not filed with U.S. Customs and Border Protection. Import infringement of a patent is investigated by the International Trade Commission (ITC). Only after infringement is found to exist is an exclusion order granted to be enforced by Customs and Border Protection and/or a cease and desist order issued.

Section 337 of the Tariff Act of 19301 declares that the infringement of the following are unlawful import practices: a U.S. patent or a U.S. copyright registered under Title 17, a registered trademark, and other rights not addressed here.2 In cases involving infringement of these intellectual property rights, there is no injury requirement.

Background on §337
Under §337, the ITC conducts investigations into allegations of certain unfair practices in import trade. Most §337 investigations involve allegations of patents or registered trademarks. The regulations are mostly procedural. However, the practitioner must research and be prepared to prove or defend allegations of unfair trade. Section 337 investigations are initiated by the commission following the receipt of a complaint that complies with the commission’s rules. Once an investigation is instituted, the chief administrative law judge assigns an administrative law judge to preside over the proceedings and to render an “initial determination” as to whether §337 has been violated.

The commission also assigns an investigative attorney from the commission’s Office of Unfair Import Investigations (OUII), who functions as an independent litigant representing the public interest in the investigation. In the notice announcing initiation of an investigation, the commission identifies the entities that may participate in the investigation as parties, namely, the complainants that allege a violation, the respondent or respondents that are alleged to have violated §337, and the OUII staff attorney. Section 337 investigations are conducted in accordance with procedural rules similar to the Federal Rules of Civil Procedure. These commission procedural rules (found in 19 C.F.R. Part 210) are typically supplemented by a set of ground rules issued by the presiding administrative law judge.

A formal evidentiary hearing on the merits is conducted by the presiding administrative law judge in conformity with the Administrative Procedure Act.3 The parties have the right of adequate notice, cross-examination, presentation of evidence, objection, motion, argument, and other rights essential to a fair hearing. Following the hearing on the merits of the case, the administrative law judge issues the initial determination (ID) that is then certified to the commission. The commission may review and adopt, modify, or reverse the ID, or it may decide not to review the ID. If the commission declines to review an ID, the ID becomes the final determination of the commission. If the commission determines that §337 has been violated, the commission may issue an exclusion order barring the products at issue from entry into the U.S., as well as a “cease and desist” order directing the violating parties to cease certain actions. The commission’s exclusion orders are enforced by U.S. Customs and Border Protection. Commission orders become effective within 60 days of issuance. Appeals of commission orders are heard by the U.S. Court of Appeals for the Federal Circuit. Also, the president has the authority to veto exclusionary orders.

Filing a Complaint
Before drafting a complaint, bear in mind that once it has been filed, the public version of the complaint and any other public document filed in the matter can be accessed via the commission’s electronic document information system (EDIS). The ITC allows the filing of a redacted copy as the public version.

Paper Filing
Paper documents are filed with Docket Services at 500 E Street, S.W., Room 112-A, Washington, D.C. 20436. When a case is before the commission, a filing in paper form requires an original and 12 copies.4 When a case is before an administrative law judge,5 filing in paper form requires the submission of an original and six copies of a document. Documents will not be accepted for filing if an insufficient number of copies are submitted. Also note that when filing in paper form, the original signed copy of the document, as well as one additional copy, should not be stapled, bound, or hole-punched so it can be scanned. All documents submitted for filing must be accompanied by an EDIS cover sheet, which must be filled out online on the EDIS website: The cover sheet contains certain information about the document, including the date of submission, the name of the signatory, and whether the document contains confidential business information and is used to index the documents in EDIS. There is a coding manual to assist parties with coding documents for EDIS.6

Filing Evidentiary Documents
Documents presented for filing must conform to the commission’s Rules 210.4 and 201.8. Some public documents may be filed electronically in portable document format (PDF). The electronic document information system is an electronic repository of the official record of documents filed at the commission. When a complaint is based upon the alleged infringement of certain intellectual property rights, the commission’s rules require that it be accompanied by background materials relating to the rights asserted.7 In patent-based cases, the rules require that the complaint be accompanied by a certified prosecution history for each asserted patent. Additionally, the complainant must submit copies of license agreements if the complaint relies on license agreements to establish standing or that a domestic injury as defined in §337(a)(3) exists, or is in the process of being established as the result of domestic activities of one or more licensees.8

Electronic Filing and Signing
Some documents may be filed electronically. Such documents are “signed” through the use of a password-protected registration protocol. The signatory must be a registered user and such document shall be deemed “signed” when either the document is physically signed by the signatory and scanned in optical format or is signed by the use of an “e-signature.”

Each document is required to be captioned with information about the pertinent proceeding, to have a standard typeface, and to be accompanied by a certificate of service. There is also a rule similar to Fed. R. Civ. P. 11, whereby a signature on a document is deemed to constitute a certification as to the propriety of filing the document and the veracity of the contents of the document.9

Proof of Filing
To obtain a date-stamped copy of a document filed, provide an extra copy of the document, a letter requesting a date-stamped copy, and an addressed return envelope with the postage prepaid. Those filing a document electronically will receive both a printable notice of electronic receipt and a notice of electronic filing via email. The notice of electronic filing will verify the effective filing date and time.

Confidential Information Filings
A complainant who requests confidential treatment of the contents of a complaint must also file the requisite number of copies of a redacted (“public version”) complaint for use by the respondents and the commission. The government of a foreign respondent will receive only the public version of the complaint. To avoid unnecessary copying costs, the commission recommends that complainants prepare, when possible, a single public version of the complaint and place all confidential information in the accompanying exhibits rather than in the text of the complaint.

Service of Exhibits on Filing of Complaint
The complainant has the obligation to serve each respondent represented by counsel with materials covered in 19 C.F.R. §210.12(c)-(h), such as the prosecution history for each asserted patent that was not included as an exhibit to the complaint, but were filed with the complaint within five days of service of notice of appearance and an agreement to be bound by the protective order. Claim charts purporting to show infringement of each asserted independent claim of the patents at issue are also required.

Confidential Document Filing — Protective Orders
Confidential business information is protected in §337 investigations by the protective order issued by the administrative law judge. Confidential documents must be filed in paper form over-the-counter at docket services with an EDIS cover sheet and are to be marked and must state how and by whom they are to be handled. Although protective orders permit a party’s outside counsel to have access to confidential business information, they usually do not permit a party’s in-house counsel to have access. Protective orders not only contain provisions to protect confidential business information, but also contain provisions to protect the confidential business information of nonparty entities that supply confidential information pursuant to a commission subpoena. A party seeking confidential business information from a nonparty should provide a copy of the protective order to the nonparty supplier of information.

Service of Process
The general rule on service is that all documents filed with the commission must be served on all other parties, but not on any other entity unless the complaint is accompanied by a motion for temporary relief. The general rules on service are found at 19 C.F.R. §§210.7 and 201.16. The rules concerning service of a complaint accompanied by a motion for temporary relief are located at 19 C.F.R. §§210.54, 210.56, and 210.55. If the commission institutes an investigation, the commission itself serves the complaint and notice of investigation on the entities that it names as respondents to the investigation, as well as the embassy of each foreign proposed respondent. If a complaint is accompanied by a motion for temporary relief, the commission serves the complaint and motion on the respondents, but it also requires the entity filing the complaint and motion to serve an advance copy of these items by messenger, courier, express mail, or other equivalent. The complainant must also be served on the Washington, D.C., embassy of the country in which the foreign respondents are located. This is for notice only if the foreign country is directly involved in the unfair commercial activity, in which case the Foreign Sovereign Immunities Act10 ( or its exceptions) might apply.

For service of documents other than complaints, consult the ground rules. The ground rules usually require that the parties serve two paper copies of each document on the presiding administrative law judge, but not by facsimile, in the absence of prior permission to do so. The ground rules also typically specify the method of service between the parties ( e.g., overnight courier).

Institution of the §337 Investigation
Once a complaint is filed, the OUII examines the complaint for sufficiency and compliance with the rules and makes a recommendation to the commission about the requested investigation. The OUII’s examination may result in a request for supplementation or amendment of the complaint. The commission normally determines whether to institute a §337 investigation within 30 calendar days. If a motion for temporary relief is involved, the commission will normally decide within 35 calendar days. If an investigation is instituted, a notice defining the scope of the investigation is published in the federal register. In addition, the commission serves a copy of the complaint and notice of investigation on all of the respondents named in the investigation as well as on the embassy for the respondents’ countries. On a decision not to investigate, all entities named in the complaint will receive written notice of the commission’s action. Decisions not to institute an investigation are rare.

Investigation Procedure
Section 337 investigations follow the Administrative Procedure Act11 and the commission rules,12 which are similar in many respects to the Federal Rules of Civil Procedure. In addition, the judge typically issues a set of ground rules for the conduct of the investigation. These ground rules provide detailed instructions on matters such as the time for responding to motions, the method for asserting a privilege, the number of copies required of evidentiary exhibits, the use of translators, and the procedure for arranging telephone conferences. These ground rules help to keep an investigation on schedule and must be followed.

Settlements and Consent Orders
The commission rules provide that a party may move to terminate an investigation as to one or more of the respondents on the basis of a licensing or other settlement agreement, including an agreement to present the matter for arbitration.13 So a complainant in a patent-based investigation may enter into a license agreement with one of the respondents and file a motion to terminate the investigation as to that respondent. However, the judge and, ultimately, the commission must conclude that the agreement is not contrary to the public interest. If not, the investigation may be terminated, in whole or in part, on the basis of such a motion. The rules also provide that an investigation may be terminated on the basis of a consent order.14 Consent orders are typically entered upon the joint request of the complainant and a respondent in the form of a motion that contains the parties’ joint proposed consent order.

For those considering a settlement, the commission has a voluntary pilot mediation program for §337 investigations.15 All §337 investigations are eligible for participation in the program, and the administrative law judge may nominate a particular §337 investigation for inclusion in the program, or a party may individually or jointly request to participate as well. There is no charge for mediation. Any submissions for the mediator are confidential and are not part of the record and will not be shared with other parties, any administrative law judge, or the commission in any way. The mediator communicates about mediation only with the supervisory attorney for docket services. The supervisory attorney does not communicate with the administrative law judges, the OUII, general counsel, or the commissioners about the substance of mediation proceedings. Mediations are not a cause for extensions of time in proceedings before the administrative law judge. The administrative law judge may require attendance at mediation sessions.16 Required attendance at a mediation session will not extend beyond one day.

Applications for Subpoenas: A Deviation from Federal Rules of Civil Procedure
The procedures involved in the issuance of subpoenas at the commission differ from the current practice of most courts in that one must apply for the issuance of a subpoena. The administrative law judge rules on all such applications and may issue subpoenas when warranted.17 Thus, it is important to advise the judge on why the issuance of a subpoena is proper. Additional instructions concerning subpoenas may be given by the administrative law judge in the ground rules. Subpoenas are enforced, if necessary, by the commission in a federal court.

Hearings on the Merits
Evidentiary hearings are held by the administrative law judges in Washington, D.C. The dates of such hearings are usually set in a schedule issued by the judge early in the investigation. If a hearing is rescheduled, the judge will issue an order with the new dates. The length and timing of hearings may vary from case to case. An investigation is usually scheduled to be completed in 16 months or less and is set by the judge’s order. If the judge seeks to establish a longer target date, he must issue an initial determination that is subject to review by the commission. Initial determinations regarding §337 violations typically contain an opinion, findings of fact, and conclusions of law.

The Initial Determination on the Merits
Within 45 days after publication of a notice of investigation, the administrative law judge sets a target date for completion of the investigation. In general, the standard involves a consideration of the complainant’s likelihood of success on the merits of the case, harm to the domestic industry in the absence of temporary relief, harm to respondents, and the public interest. The administrative law judge’s initial determination is then subject to review by the commission.

Temporary Exclusion and Cease and Desist Orders
A complainant may request that the commission conduct expedited temporary relief proceedings and issue a temporary exclusion order and/or a temporary cease and desist order during the course of the investigation.18 There are substantial additional pleading and proof requirements when expedited temporary relief is requested. The commission rules require that requests for temporary relief must be made in a motion that is accompanied by a memorandum of law in support of the request. The motion must also be accompanied by affidavits that support the factual assertions made in the motion, as well as by all evidence in the complainant’s possession at the time of filing that the complainant intends to rely upon in support of the motion.

Following the receipt of a properly supported motion for temporary relief, the commission will determine whether to institute “temporary exclusion order” proceedings (TEO proceedings). In the event the commission institutes TEO proceedings, the motion for temporary relief will be forwarded to an administrative law judge for adjudication. Notice that the motion is filed with the commission and not directly with the judge until after the commission decides to initiate a TEO proceeding.

In a typical TEO proceeding, the parties conduct a few weeks of discovery, and, thereafter, the judge holds an evidentiary hearing on the merits of the motion, receives briefs from the parties on the evidence and the law, and issues a determination on the merits of the temporary relief motion. If the motion is granted, the judge will issue an initial determination which is subject to review by the commission. The commission will determine whether to accept the initial determination and whether to grant temporary relief. In determining whether to grant a request for temporary relief, the commission applies the standard employed by the U.S. Court of Appeals for the Federal Circuit in reviewing lower court decisions granting preliminary injunctions.

Federal Circuit Standards
When a patentee sues for infringement and moves under 35 U.S.C. §283 for the extraordinary relief of a preliminary injunction, the patentee’s entitlement to such an injunction is a matter largely within the discretion of the trial court.19 The factors the trial court considers are of longstanding and universal applicability. As the Supreme Court has stated, there are four factors to consider: “A plaintiff seeking a preliminary injunction must establish [1] that he is likely to succeed on the merits, [2] that he is likely to suffer irreparable harm in the absence of preliminary relief, [3] that the balance of equities tips in his favor, and [4] that an injunction is in the public interest.”20

In assessing whether a patentee is entitled to an injunction, the trial court must view the matter in light of the burdens and presumptions that will inhere at trial.21 As set out in Technology Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir. 2008), an issued patent comes with a statutory presumption of validity under 35 U.S.C. §282. A patent enjoys the same presumption of validity during preliminary injunction proceedings as at other stages of litigation.22 Because of this presumption, an alleged infringer who raises the invalidity of a patent as an affirmative defense has the ultimate burden of persuasion to prove invalidity by clear and convincing evidence, as well as the initial burden of going forward with evidence to support its invalidity allegation.

Once the challenger presents initially persuasive evidence of invalidity, the burden shifts to the patentee to present contrary evidence and argument. Ultimately, the outcome will depend on whether the party challenging the patent’s validity has carried its burden of persuasion to prove by clear and convincing evidence that the patent is invalid. The trial court “does not resolve the validity question, but rather must. . . make an assessment of the persuasiveness of the challenger’s evidence, recognizing that it is doing so without all evidence that may come out at trial.”23 Hence, it is not res judicata as to the validity of the patent. While the attorney should always consult a patent litigation attorney, when request for temporary relief is made, the participation of such an attorney should be viewed as indispensable.

Review by Commission of Initial Determination
A party may petition for commission review of an ID if they believe that it 1) contains a clearly erroneous finding of material fact, 2) contains an erroneous legal conclusion, or 3) affects commission policy. Other parties may file responses within 60 calendar days after service of the ID on the parties. The commission decides whether to review some or all of the ID. Those portions that are not reviewed become the commission’s determination by default. Note here that inaction by the commission constitutes an affirmation. If the commission decides to review some or all of an ID, it may affirm, set aside, or modify the portions of the ID under review.24

Enforcing Exclusion and Cease and Desist Orders
U.S. Customs and Border Protection procedures for implementing exclusion and seizure orders are found at 19 C.F.R. §12.39. There are two types of exclusion orders; general exclusion orders and limited exclusion orders. A general exclusion order directs U.S. Customs to exclude all infringing articles, without regard to source. A limited exclusion order directs exclusion of infringing articles that originate from a specified firm.

A cease and desist order directs a respondent to cease its unfair acts, including selling infringing imported articles out of U.S. inventory. Unlike exclusion orders, cease and desist orders are enforced by the commission, not by U.S. Customs and Border Protection.25

Presidential Review Period
Once the commission issues remedial orders, the president may, within 60 days, disapprove them for policy reasons. During this 60-day period, called the “presidential review period,” infringing articles may enter the United States if the importer posts a bond with U.S. Customs and Border Protection in an amount determined by the commission. Similarly, activities prohibited by a cease and desist order may continue if a bond is posted. If the president does not disapprove the commission’s remedial orders within the 60-day review period, infringing imports may no longer be imported and the complainant may seek to have bonds forfeited to it. In 2005, the president delegated the authority to veto commission exclusion orders to the U.S. trade representative.26

The ITC procedure seems simple enough, especially when the patent is relatively simple. But today patents can be very complicated and infringement much less obvious. It may take experts to explain the patent and how infringement is accomplished. The practitioner must, therefore, prepare for expert witnesses including a patent law expert. The patent law expert may be needed to establish that the patent actually reflects the technology or process protected.

1 19 U.S.C. §1337.

2 19 U.S.C. §1337(a)(1)(B)-(E).

3 5 U.S.C. §§551 et seq.

4 19 C.F.R. §210.4(f)(2)(ii).

5 19 C.F.R. §210.4(f)(2)(i).

6 U.S. International Trade Commission, EDIS Coding Manual,

7 See Rule 210.12(c)-(g); 19 C.F.R. §210.12(c)-(g).

8 See Rule 210.12(a)(9)(iv); 19 C.F.R. §210.12(a)(9)(iv).

9 Rule 210.4(b)-(d); 19 C.F.R. §§210.4(b)-(d).

10 Foreign Sovereign Immunities Act of l976, Pub. L. 94-583, 90 Stat. 289l, 28 U.S.C. §§1330, 1332(a), 1391(f), and 1601-1611.

11 5 U.S.C. §§551 et seq.

12 19 C.F.R. Part 210.

13 Commission Rules 210.21(a)(2),(b), and (d), 19 C.F.R. §§210.21(a)(2), (b), and (d).

14 Commission Rule 210.21(c).

15 See U.S. International Trade Commission, Mediation Program for Investigations Under Section 337 of the Tariff Act of 1930,

16 5 U.S.C. §§556(c)(6) and (8).

17 Rule 210.32; 19 C.F.R. §210.32.

18 1 [9 C.F.R. Subpart H.

19 nentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997).

20 Winter v. Natural Res. Def. Council, Inc., 129 S. Ct. 365, 374 (2008).

21 Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal, 546 U.S. 418, 429 (2006) (“[T]he burdens at the preliminary injunction stage track the burdens at trial.”).

22 Canon Computer Sys., Inc. v. Nu-Kote Int’l, Inc., 134 F.3d 1085 (Fed. Cir. 1998).

23 New England Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878, 882-83 (Fed. Cir. 1992).

24 Commission Rules 210.43-210.45, 19 C.F.R. §§210.43-210.45.

25 19 U.S.C. §1337(f)(2) (provides for civil penalties for violations).

26 7 0 Fed. Reg. 43251 (July 26, 2005).

Clayton J. Joffrion of New Orleans, LA, has been a member of the Florida and Louisiana bars for over 21 years. He received his J.D. from Loyola University in New Orleans and an LL.M. in international law from the University of Miami. His primary focuses include imports, non-tariff barriers to trade, and foreign laws.

This column is submitted on behalf of the Out of State Division, Ward P. Griffin, president.

Out of State Division