Information for Importers and Resellers: The U.S. International Trade Commission’s General Exclusion Order Relating to Electric Skin Care Devices, Brushheads and Chargers, and Kits Containing Same
On February 6, 2017, the International Trade Commission (ITC) issued a General Exclusion Order (GEO) prohibiting all imports, sale for importation, or sale within the United States after importation of electric skin care devices, brushheads, or kits containing same, that infringe PBL’s U.S. Patent Nos. 7,320,691 and 7,386,906.
The GEO is the end result of the ITC’s Investigation No. 337-TA-959 (“ITC Action”), initiated by Pacific Bioscience Laboratories, Inc. (“PBL”) in April 2015. The GEO prevents any product covered by one or more of claims 1, 4-6, 16, 22, 31, 33, 39-41, 42, 44-46, and 49 of U.S. Patent No. 7,320,691 (herein, “the ’691 Patent”) or claims 1, 2, 4, 54, and 7-15 of U.S. Patent No. 7,386,906 (herein, “the ’906 Patent”) from being imported into the U.S., sold for importation into the U.S., or sold after importation into the U.S. The GEO applies regardless of the manufacturer and even if PBL has not contacted the manufacturer or identified the product or manufacturer in the ITC Action or other court filings.
The ’691 Patent (available here) is directed to devices for cleansing and treating skin and covers, among other things, the oscillating movement provided in PBL’s Clarisonic products. The ’906 Patent (available here) is directed to a multi-element construction of brushheads and covers, among other things, brushheads usable with PBL’s Clarisonic products.
For more detailed information on the ITC Action please click on the following link:
You will need to create an EDIS account with the ITC, login in, click on the Search tab, click on the “Search by Investigation” and enter the number 959 in the “Investigation Number” field and click on the “Search” button.
In addition to the ITC Action, PBL also initiated fifteen patent infringement lawsuits in the U.S. District Court for the Western District of Washington against importers and sellers of electric skin care devices, each of which has been resolved. A list of the actions can be found here.
PBL created this website in 2017 to assure that importers and resellers were not caught unaware of the prohibitions set forth in the GEO.
FAQs for the ITC Action and U.S. District Court Lawsuits
- What is the United States International Trade Commission (“ITC”)?
The ITC is an independent quasi-judicial federal agency with broad investigative responsibilities regarding international trade. Among other responsibilities, the agency investigates the effects of dumping, subsidized imports, and infringement of intellectual property rights on domestic industry. The ITC adjudicates allegations of intellectual property infringement to determine infringement and any impact on domestic industry. The ITC has the authority to issue exclusion orders that direct U.S. Customs to stop infringing products from entering the U.S. and to issue cease and desist orders against named importers and others that engage in unfair competition.
See www.usitc.gov for more information about the ITC.
- How does the ITC adjudicate patent infringement complaints?
When a complaint alleging intellectual property infringement is filed, the ITC reviews the complaint and decides whether to institute an investigation. When instituted, the ITC assigns an Administrative Law Judge (ALJ) to preside over the investigation, including discovery, trial, and related proceedings. At the end of the investigation, the ALJ determines whether the intellectual property, such as a patent, is infringed and valid, and whether the complainant has shown a "domestic industry,” and issues what is called an “Initial Determination” (“ID”). Where infringement is found, the ALJ recommends remedies. The ID is then reviewed by the ITC, which subsequently issues a final determination (“FD”) that may affirm, overrule, modify, or simply take no position as to each of the ID’s findings, conclusions, and recommendations. The FD is the subject to review by the President of the United States.
Potential remedies that can be implemented in the FD include general exclusion orders (GEOs) that direct U.S. Customs to exclude imports of infringing products from all worldwide sources, limited exclusion orders that direct U.S. Customs to exclude imports of infringing products from a certain entity (LEOs), and cease and desist orders that direct named parties to cease certain activities (C&DOs)
For more information regarding the ITC’s investigation of infringement complaints, see https://www.usitc.gov/intellectual_property.htm.
- Why did Pacific Bioscience Laboratories (PBL) file the ITC Action?
PBL is the original developer and maker of the Clarisonic System, a line of highly successful sonic-frequency skin cleansing devices. The success of the Clarisonic System has resulted in multiple infringing and counterfeit skin care devices.
Prior to filing the ITC Action (Investigation No. 337-TA-959), PBL had filed infringement complaints against two entities – Nutra Luxe MD, LLC (“Nutraluxe”) and Pretika Corporation (“Pretika”) –in the U.S. District Court for the Western District of Washington. The Pretika matter settled before trial when Pretika agreed to withdraw its products from the U.S. market. The Nutraluxe matter was tried before a jury and resulted in a final adjudication that Nutraluxe infringed the ’691 Patent and PBL’s trade dress.
Since at least the time of these previous disputes, and because of the continued success of the Clarisonic System and the well-established widespread consumer demand for the skin care products, additional entities entered the U.S. market with infringing – and in several cases identical – electric skin care devices, brushes and chargers thereof, and kits containing same.
Consequently, PBL filed the ITC Action, which alleged, among other things, infringement of one or more of PBL’s ’691 Patent, ’906 Patent, and trade dress by 21 importers and distributors. Concurrently, PBL filed district court complaints against each of the importers and distributors in the U.S. District Court for the Western District of Washington.
PBL has made substantial investments in R&D and manufacturing in the U.S. to produce high quality, innovative electric skin care devices and brushheads. And the ITC Action is part of PBL’s worldwide efforts to protect the company and its customers from unfair competition of all types, including the sale of electric skin care devices that infringe PBL’s intellectual property.
- What happened during the ITC Action?
PBL initiated the ITC Action by filing a Complaint in April 2015 (and an amended Complaint in May 2015) against 21 companies that manufacture, import or distribute electric skin care devices in the U.S. The Complaint alleged infringement of the ’691 Patent, the ’906 Patent, U.S. Design Patent No. D523,809 (“the D’809 Patent”), and the Clarisonic Trade Dress.
Settlements, Consent Orders, and Defaults
As shown in the following chart, each of the 21 Respondents named in the Complaint defaulted or was terminated from the Investigation via a Consent order or Settlement Agreement:
Following the entry of defaults, consent orders and settlement agreements, PBL moved for summary determination, which ALJ Dee Lord granted in an ID in April 2016. In the ID, ALJ Lord found that the defaulting respondents violated Section 337 of the Tariff Act of 1930 by infringing one or more of PBL’s patents and trade dress. ALJ Lord recommended that the Commission issue a GEO as to the ’691 and ’906 Patents, and LEOs and C&DOs as to certain Respondents with regard to the D’809 Patent and the Clarisonic Trade Dress.
The ITC decided to review in part the ID and reconsidered the “ID’s findings on the economic prong of the domestic industry requirement as to the patent-based allegations, all issued related to violation of the asserted trade dress, and to correct certain minor typographical errors.” Ultimately, the ITC agreed with ALJ Lord’s findings that all defaulting respondents were in violation, and issued a GEO as to the ’691 and ’906 Patents, along with LEOs and C&DOs as recommended in the ID.
The FD and GEO were issued on February 6, 2017.
After the issuance of the FD, there was a presidential review period during which time the President of the United States has the (rarely used) power to disapprove of the FD. The Presidential Review Period expired on or about April 7, 2017.
PBL intends vigorous enforcement of the GEO and will update this section as necessary.
- What products are covered by the ITC orders?
The GEO applies to any products covered by claims 1, 4-6, 16, 22, 31, 33, 39-41, 42, 44-46, and 49 of the ’691 Patent or claims 1, 2, 4, 54, and 7-15 of the ’906 Patent. With regard to the ’691 Patent, this includes devices for cleansing and treating skin that include oscillating movement of brushheads. An example of such movement can be seen in PBL’s Clarisonic products. With regard to the ’906 Patent, this includes brushheads with the disclosed multi-element construction, such as those that are compatible with PBL’s Clarisonic products.
- What is the role of the U.S. Customs and Border Protection Service (“U.S. Customs”) in enforcing ITC orders?
U.S. Customs is responsible for enforcing ITC exclusion orders. The Intellectual Property Rights Branch of U.S. Customs (“the IPR Branch”) administers enforcement of ITC orders and other intellectual property enforcements.
U.S. Customs devotes substantial resources to target, intercept, detain, and seize shipments of goods that violate intellectual property rights, both at the time of importation and after of violations are subsequently discovered. Violations of ITC exclusion orders, in particular, are punishable even after importation with seizures and very substantial fines.
For more information regarding the IPR Branch of U.S. Customs and intellectual property enforcement, see https://www.cbp.gov/trade/priority-issues/ipr.
- How do the ITC orders affect imports, distribution and sales of infringing electric skin care devices and brushheads?
The GEO prohibits all imports, sale for importation, or sale after importation of infringing electric skin care devices and infringing brushheads covered by the GEO by all importers, distributors and resellers. The GEO is not limited to the entities involved in the ITC Action.
The LEOs and C&DOs prohibit the Respondents identified therein from certain activities, such as importing, selling for importing, or selling after importing certain infringing products.
Accordingly, there are various potential consequences for importers and resellers:
- Importers that violate the GEO are subject to seizure of infringing products by U.S. Customs.
- Respondents that violate the GEO, Cease and Desist Orders, Limited Exclusion Orders, Consent Judgments, or Settlement Agreements from the ITC Action are also subject to substantial fines.
- Resellers of infringing devices or brushheads at every level of distribution can be subject to U.S. District Court lawsuits (of the kind previously filed by PBL) for monetary damages.
Importers and resellers of electric skin care devices and brushheads for electric skin care devices should take precautions to avoid infringement. Importers and resellers that seek further information should consult with their attorneys, import specialists, or directly access the ITC documents relating to the PBL action at https://edis.usitc.gov/edis3-external/home.svc.
- Why did PBL file both ITC complaints and U.S. District Court lawsuits?
PBL filed a complaint at the ITC because ITC exclusion orders can be very effective when numerous vendors import large volumes of infringing products.
Even though ITC orders can be very effective in excluding infringing imports, PBL also filed concurrent lawsuits in U.S. District Court to reserve its ability to collect damages for past infringements, to include new patent claims not included in the ITC action, and to obtain injunctions that prohibit unfair competition.
PBL expects that it may have to file additional District Court lawsuits in the future to enforce the patents covered in the recent GEO.
The ITC actions and District Court lawsuits underscore the responsibility that all companies in the distribution chain have to avoid infringement. Extending the lawsuits to U.S. distributors and wholesalers assures that resellers that profit from infringements will be responsible for any damages, especially if their suppliers withdraw from the U.S. market to avoid financial responsibility.
- What if suppliers promote their products as “non-infringing” or “outside the scope” of the GEO?
PBL will continue to take whatever legal actions may be required to protect PBL and legitimate resellers from patent infringement and other unfair competition. Such actions may include ITC enforcement proceedings, working with CBP to support GEO enforcements and U.S. District Court lawsuits.
Resellers should be cautious about claims that products avoid patents because they may avoid only some patents but not others. Claims that products avoid patents are much easier to make than to substantiate. Resellers are responsible for avoiding infringement, even if their suppliers claim that their products are “non-infringing” or “outside the scope” of the GEO. Accordingly, PBL recommends resellers be cautious and obtain independent legal counsel when in doubt.
- What about claims that the GEO (or LEOs / C&DOs) is not enforceable or may soon be modified?
The GEO, LEOs, and C&DOs are being actively enforced. Statements that the orders are not enforceable or may be modified have no basis in fact, and repeated efforts to challenge PBL’s patents have failed. Accordingly, PBL recommends that resellers be cautious regarding rumors and obtain independent legal counsel when in doubt.
- How can I obtain additional information?
PBL hosts this web site to provide relevant and timely information. Questions regarding the ITC or U.S. Customs enforcement or proceedings should be directed to those entities. PBL recommends that importers and resellers consult independent counsel for any required legal advice. Questions appropriate for PBL can be directed to email@example.com.
This website was created by Pacific Bioscience Laboratories, Inc. and does not express the official position of any judicial or enforcement agencies.