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It is no secret that more than a few biotech and pharmaceutical companies perform drug discovery offshore and then import the results. Holders of U.S. patents on drug discovery tools (such as molecular screening methods) have wondered for years whether data or drugs resulting from such activities constitute a “product made” under The Process Patent Amendments Act of 1988 (the “Act”). The Court of Appeals for the Federal Circuit (“Federal Circuit”) ' in a setback to the U.S. drug discovery industry ' has now held that they do not. See Bayer AG v. Housey Pharm., Inc., 340 F.3d 1367 (Fed. Cir. 2003).
The Act
The Act was passed to protect owners of U.S. process patents. Under the Act, importing, using, selling, or offering for sale in this country a product that was made abroad by a process protected by a U.S. patent constitutes infringement of that patent. 35 U.S.C. '271(g). The legislative history gives examples of products covered by the statute, but was silent as to whether data should constitute a product made by a patented process. See, e.g., M. Patricia Thayer et al., Enforcing U.S. Method Patents: How Much Protection Does 35 U.S.C. Section 271(g) Really Provide?, The Third Annual Sedona Conference on Patent Litigation, November 7-8, 2002 at 3.
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