08
Apr
By Barry Herman
On April 6, 2010, the ITC issued a notice granting Amgen, Inc.’s motion for partial termination of the investigation in Certain Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoietin (Inv. No. 337-TA-568).  In addition, the ITC requested briefing on issues relating to summary determination and to remedy, the public interest and bonding.

By way of background, on May 12, 2006, the Commission instituted an investigation based on a complaint filed by Amgen asserting a violation of Section 337 in the importation into the United States, sale for importation, or sale within the United States after importation of certain products and pharmaceutical compositions containing recombinant human erythropoietin by reason of infringement of certain claims U.S. Patent No. 5,441,868 (the ‘868 patent), U.S. Patent No. 5,547,933 (the ‘933 patent), US. Patent No. 5,618,698 (the ‘698 patent), U.S. Patent No. 5,621,080 (the ‘080 patent), U.S. Patent No. 5,756,349 (the ‘349 patent), and U.S. Patent No. 5,955,422 (the ‘422 patent).  The notice of investigation named Roche Holding Ltd. of Basel, Switzerland; F. Hoffman-La Roche, Ltd. of Basel, Switzerland; Roche Diagnostics GmbH of Mannheim, Germany; and Hoffman La Roche, Inc. of Nutley, New Jersey (collectively, “Roche”) as respondents.

On August 31, 2009, after a remand of the original investigation from the United States Court of Appeals for the Federal Circuit (see our May 1, 2009 post for more details), Amgen moved for summary determination that Roche violated Section 337 by importing and using a pegylated erythropoietin product that infringed claims of the ‘868 patent, the ‘933 patent, the ‘698 patent, and the ‘422 patent. Amgen also requested a limited exclusion order that would preclude importation of Roche’s product regardless of the party seeking to import such product.  Roche did not oppose Amgen’s motion for purposes of this investigation.  The Commission Investigative Staff (“OUII”) also did not oppose Amgen’s motion, but indicated that the motion did not resolve an asserted claim of the ‘349 patent or certain asserted claims of the ‘933 patent.

On December 22, 2009, Amgen moved to terminate the investigation with respect to certain claims of the ‘933 patent, the ‘080 patent, and the ‘698 patent.  In addition, on December 31, 2009, Amgen filed a supplemental motion for summary determination with respect to an asserted claim of the ‘349 patent.  Roche did not oppose these motions.  OUII did not oppose Amgen’s motion to terminate the investigation in part, but did oppose Amgen’s supplemental motion for summary determination.

According to the April 6 notice, the Commission has determined to grant Amgen’s motion to terminate the investigation with respect to claims 4, 5, and 11 of the ‘933 patent, claims 4 and 6 of the ‘080 patent, and claims 4 and 5 of the ‘698 patent.  The Commission has determined that further briefing is necessary to decide the motion for summary determination.

The parties were requested to brief their positions on the following issues:
1)   How does the United States Court of Appeals for the Federal Circuit’s decision in Amgen Inc. v. F Hoffman-La Roche Ltd, 580 F.3d 1340 (Fed. Cir. 2009), vacating certain aspects of the decision by the United States District Court of Massachusetts in Amgen Inc. v. F Hoffinan-La Roche, Ltd., No. 05-12237-WGY (D. Mass. Oct. 2, 2008), affect Amgen’s original motion for summary determination filed on August 31,2009, for each asserted claim?  With respect to this issue, the parties were asked to address the Commission’s February 3, 2009 opinion in Certain Semiconductor Integrated Circuits Using Tungsten Metallization and Products Containing Same, Inv. No. 337-TA-648.

2)   If the Commission can proceed with respect to any claim(s), the parties were asked to explain whether the Commission should apply the principles of claim or issue preclusion to the district court case and what standard the Commission should apply.

3)  Can the Commission apply claim or issue preclusion to the permanent injunction order issued by the district court on December 22,2009, and if so, to what effect?  With respect to this issue, the parties were asked to address whether the signed stipulation formed part of the district court’s judgment, and, if so, does Amgen rely on the stipulation for claim or issue preclusion?

4)   If the Commission denies Amgen’s motions for summary determination with respect to any claims, how should the Commission proceed with respect to those claims?

The Commission also asked for written submissions that address the form of remedy, if any, that should be ordered, on public interest, and bonding.  If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the Commission noted that the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so.
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