In Bayer AG v. Housey Pharm., Inc. (Fed. Cir. August 22, 2003), the Federal Circuit limited patent infringement under 35 U.S.C. § 271(g) to manufactured, physical goods not including information produced by a patented process.

Housey owns patents directed to the production of information about whether an agent is an activator or inhibitor of protein activity in which the agent is applied to cell lines having different production levels of a protein of interest.  A representative claim at issue follows.

A method of determining whether a substance is an inhibitor or activator of a protein whose production by a cell evokes a responsive change in a phenotypic characteristic other than the level of said protein in said cell per se, which comprises:

(a) providing a first cell line which produces said protein and exhibits said phenotypic response to the protein;

(b) providing a second cell line which produces the protein at a lower level than the first cell line, or does not produces [sic] the protein at all, and which exhibits said phenotypic response to the protein to a lesser degree or not at all;

(c) incubating the substance with the first and second cell lines; and

(d) comparing the phenotypic response of the first cell line to the substance with the phenotypic response of the second cell line to the substance.

Housey’s charge of patent infringement by Bayer raised a question regarding the interpretation of 35 U.S.C. § 271(g), which provides:

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 . . . .

Housey contended Bayer produced information using the Housey patented process and this information constituted a product.  Bayer countered that in § 271(g) “made” means “manufactured” and information is not a manufactured product.  The court held a product “made by a process patented in the United States” in § 271(g) must be a physical good which has been manufactured.  Therefore, § 271(g) does not cover the production of information.

Housey further argued that Bayer was liable for patent infringement under § 271(g) because:

• Bayer had used the patented process to produce information; and
• Bayer had then used this information to produce drugs.

Again, the court ruled against Housey and in favor of Bayer.

• The patented process was not directed to the actual synthesis of a drug product.
• The production of information whether the agent was an activator or inhibitor of protein activity was not a step in the manufacture of a final drug product.

So, Bayer was not liable to Housey for patent infringement under § 271(g).

September 18, 2003

Text Copyright © 2003 Bob Brill et al.

No tags