Intellectual Property Law

We reported last summer on the Supreme Court?s decision in Merck KgaA vs. Integra Lifesciences I, Ltd., in which the Court held that the exemption to infringement under 35 U.S.C. section 271(e)(1) should be given a broader application than that adopted by the Court of Appeals for the Federal Circuit. The safe harbor provision of section 271(e)(1) states that it is not infringement to use a patented invention for uses ?reasonably related to the development and submission of information? to the FDA or like governmental agency. According to the Supreme Court, that section covers an accused infringer who uses a patented compound in research that if successful would be appropriate to include in a submission to the FDA. Because the Federal Circuit applied a much narrower ?solely for uses related to? submissions standard, the Supreme Court remanded.

The case has made its way back to the Federal Circuit, which heard arguments last week on whether Merck?s use of Intergra?s patented compound was within the scope of section 271(e)(1) exemption as defined by the Supreme Court. Not surprisingly, Merck asserted that its activities were within the safe harbor as they were on the exempted experiments side of the ?bright line? drawn by the Supreme Court. Also not surprisingly, the Federal Circuit expressed some skepticism that the line drawn by the Supreme Court is at all bright. A substantial portion of Merck?s argument involved responding to the Court?s question regarding the possible application of the safe harbor to ?research tool? patents, which the Supreme Court had commented on in a footnote in its opinion.

Because the case had first come to the Federal Circuit following a jury verdict in favor of Integra, Integra?s argument to the Federal Circuit this time focused on that verdict and suggested that the appellate court had to defer to the jury?s factual finding that Merck?s experiments were not exempt. Integra contended that the jury instructions were consistent with the Supreme Court?s construction of section 271(e)(1), a position that prompted questioning from the court.

The Federal Circuit?s decision on remand may not be the last word on this case. We will let you know what happens.

Today's Blogger: Bob Sloss