Potential IPR Probe of Recombinant Factor VIII Products Evaluated for Public Interest Issues
The International Trade Commission is requesting comments no later than May 1 on any public interest issues raised by a Section 337 intellectual property rights infringement complaint filed on behalf of Baxter International Inc., Baxter Healthcare Corporation and Baxter Healthcare SA against certain recombinant factor VIII products. Comments should address whether the issuance of exclusion orders and/or cease and desist orders pursuant to this complaint would affect the public health and welfare in the U.S., competitive conditions in the U.S. economy, the production of like or directly competitive articles in the U.S., or U.S. consumers. In particular, the ITC is interested in comments that:
- explain how the articles potentially subject to the orders are used in the U.S.;
- identify any public health, safety or welfare concerns in the U.S. relating to the potential orders;
- identify like or directly competitive articles that the complainant, its licensees or third parties make in the U.S. that could replace the subject articles if they were to be excluded;
- indicate whether the complainant, its licensees and/or third-party suppliers have the capacity to replace the volume of articles potentially subject to the requested orders within a commercially reasonable time; and
- explain how the requested orders would impact U.S. consumers.