Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. .... A product which is made by a patented process will, for purposes of this title, not be considered to be so made after (1) it is materially changed by subsequent processes; or (2) it becomes a trivial and nonessential component of another product.
In the case of Bayer AG v. Housey Pharmaceuticals Inc., the Court of Appeals for the Federal Circuit was faced with the question of whether this provision of the statute enabled the owner of a patent for a method of screening for substances having particular properties to prevent importation into the United States of a pharmaceutical composition identified by the patented process or to prevent importation into the United States of data generated by the patented process. The answer was “no” in both cases.
The court took the second issue first and concluded that the key question was whether the alleged infringement could be regarded as products made by a patented process. The court concluded that, as a matter of statutory construction and after reviewing the legislative history of the relevant provision, the term “product” had to be construed as being confined to “tangible products and not mere information.” The claim to infringement by importation of data therefore failed.
So far as the claim to infringement by importation of a pharmaceutical composition was concerned, the key question was whether this was made by the patented process. The court concluded that what was intended by the statute was that:
the process must be used directly in the manufacture of the product and not merely as a predicate process to identify the product to be manufactured. A drug product, the characteristics of which were studied using the claimed research processes, therefore is not a product “made by” those claimed processes:
March 2004 Index