By: Charles Lee and Vishal Khatri – A recent opinion by the ITC reiterates that a violation of Section 337 can be based on infringement of a method claim that occurs after importation of the relevant article(s).  Certain Blood Cholesterol Testing Strips and Associated Systems Containing the Same, Inv. 337-TA-1116, Commission Opinion (May 1, 2020) (“Opinion”).

Polymer Technology Systems, Inc. (“Complainant”) alleged ACON Labs and ACON Bio (“Respondents”) violated Section 337 by importing blood cholesterol testing strips and associated meters into the United States and using these products to directly infringe the asserted method claims of U.S. Patent Nos. 7,087,397 (“the ’397 patent”) and 7,625,721 (“the ’721 patent).  After ALJ Cheney issued his final ID, the Commission affirmed the ALJ’s finding of a violation of Section 337 based on Respondents’ direct infringement of certain method claims after importation and subsequent use of test strips and meters.

In its briefing to the ITC, Respondents argued that there was no violation of Section 337 because ITC precedent states that a violation must be based on articles that infringe at the time of importation, not after.  But the ITC found Respondents’ argument that “no violation exists because its products are not ‘articles that infringe’ at the time of importation” inconsistent with Federal Circuit precedent which has rejected such an argument on two earlier occasions.  The ITC concluded that the Federal Circuit had previously “repudiated a time-of-importation requirement” and held that Section 337 applies to articles that infringe after importation.  Suprema, Inc. v. International Trade Commission, 796 F.3d 1338, 1348-52 (Fed. Cir. 2015) (en banc); see also Comcast Corp. v. International Trade Commission, 951 F.3d 1301, 1308 (Fed. Cir. 2020).

The Commission then turned to its controlling statute to determine whether a violation had been established.  19 U.S.C. § 1337(a)(1)(B)(i) provides: “[T]he following are unlawful …: 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 – (i) infringe a valid and enforceable United States patent…”  (emphasis added).  Here, Respondents imported, then used the test strips and meters in the United States according to their Directions for Use.  The ITC concluded that the accused products, used according to Respondents’ instructions, perform the steps of the method claims in the ’397 and ’721 patents.  Therefore, the products are “articles that infringe”  pursuant to Section 337.


This determination by the ITC serves as a reminder that the Federal Circuit’s Suprema decision continues to be controlling precedent with respect to the assertion of method claims at the ITC.  Parties should be aware that although an article may not infringe at the time of importation, the article may still infringe and violate Section 337 by performing the steps in a patented method claim after being imported.

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Vishal Khatri is an intellectual property lawyer with more than 15 years of experience representing clients in high stakes, bet-the-company patent litigation and procurement matters around the world. He routinely represents clients in matters before U.S. district courts, the United States International Trade Commission (ITC), and the United States Patent and Trademark Office (USPTO), including Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB).