On February 28, 2014, Baxter International Inc. of Deerfield, Illinois, Baxter Healthcare Corp. of Deerfield, Illinois, and Baxter Healthcare SA of Switzerland (collectively, “Baxter”) filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.

The complaint alleges that Johnson & Johnson Inc. of Brunswick, New Jersey, Ethicon, Inc. of Somerville, New Jersey, Ferrosan Medical Devices A/S of Denmark, and Packaging Coordinators, Inc. of Philadelphia, Pennsylvania (collectively, the “Proposed Respondents”) unlawfully import into the U.S., sell for importation, and/or sell within the U.S. after importation certain hemostatic products and components thereof that infringe one or more claims of U.S. Patent Nos. 8,303,981 (the ‘981 patent), 8,512,729 (the ‘729 patent), 6,066,325 (the ‘325 patent), 8,357,378 (the ‘378 patent), and 8,603,511 (the ‘511 patent) (collectively, the “asserted patents”).

According to the complaint, the asserted patents generally relate to hemostatic products that are used by medical providers to control bleeding during surgery.  In particular, the ‘325 patent relates to biocompatible polymeric compositions and methods of using such compositions to control bleeding while allowing for delivery of drugs and/or other biologically active agents as the composition degrades.  The ‘981 patent relates to methods for preparing and delivering biocompatible polymeric compositions, thereby allowing surgeons to quickly and efficiently prepare the composition and apply it to a target site in a patient’s body while reducing contamination risk.  The ‘729 patent relates to methods for delivering biocompatible polymeric compositions to various treatment sites to treat patients.  Lastly, the ‘378 and ‘511 patents relate to a medical delivery device for the delivery, to a target site in a patient’s body, of biocompatible polymeric compositions having properties that are beneficial for localized drug delivery.

In the complaint, Baxter states that the Proposed Respondents import and sell products that infringe the asserted patents.  The complaint specifically refers to the SURGIFLO product family as infringing products.

Regarding domestic industry, Baxter states that it makes extensive use of the inventions claimed in the asserted patents in its FLOSEAL products, and that it has made and continues to make significant domestic investments in those products.  By way of example, Baxter states that it manufactures and sells its FLOSEAL Hemostatic Matrix products in the U.S.  Baxter further states that its FLOSEAL sales have exceeded $140 million annually since 2010.

As to related litigation, Baxter states that it is currently engaged in litigation against the Proposed Respondents in the U.S. District Court for the Northern District of Illinois, where Baxter is alleging infringement of the asserted patents.  Baxter also refers to two cases in Germany involving unfair competition allegations with respect to Baxter’s FLOSEAL products.

With respect to potential remedy, Baxter requests that the Commission issue a permanent limited exclusion order and permanent cease and desist orders directed at the Proposed Respondents and others acting on their behalf.