United States: User Intent Required to Infringe Claim Reciting Administering a Nutraceutical to a "Human is in Need Thereof"

The U.S. Court of Appeals for the Federal Circuit upheld the construction of a claim to a method of treating a specific disease by administrating an over-the-counter formulation to a "human in need of thereof" to require that those consuming the claimed formulation do so specifically intending to treat the claimed disease. Christian J. Jansen, JR., v. Rexall Sundown, Inc., Case No. 03-1069 (Fed. Cir. September 8, 2003).

The asserted claims relate to a method of treating macrocytic megaloblastic (i.e., pernicious anemia). This condition is caused by either vitamin B12 or folic acid deficiency. Jansen tried but failed to obtain claims to a method of treating any anemia with a formulation of both compounds. After 20 stubborn years of prosecution, spanning seven generations of continuation applications, Jansen finally obtained U.S. Pat. No. 4,945,083 (the `083 patent) by a showing of commercial success for vitamin B12 and folic acid formulations in treating and preventing pernicious anemia. However, in order to obtain allowance, Jansen was forced to restrict his claims to a "method of treating or prevention macrocytic megaloblastic anemia" limited to a "human in need thereof."

Rexall markets a non-prescription supplement having vitamin B12 and folic acid in proportions claimed by the `083 patent. However, Rexall expressly markets the product only for the maintenance of blood homocysteine levels. Jansen sued Rexall for the inducement of and the contributory infringement of the `083 patent.

The district court did not adopt Jansen’s position that all people are "humans in need" of treatment or prevention of macrocytic megaloblastic anemia. It construed the claim phrase, "treating or preventing macrocytic megaloblastic anemia" to require that the human taking the claimed composition do so with the specific intent of treating macrocytic megaloblastic anemia. The court noted that there was no evidence on record that Rexall’s customer had the required state of mind and, as such, granted its motion for summary judgment of non-infringement. Jansen appealed.

The Federal Court affirmed, finding that the lower court did not add any limitation not compelled by the language of the claims themselves. First, the Court held that particular emphasis should be placed on the limitations "treating or preventing macrocytic megaloblastic anemia" and "a human in need thereof" because their addition to the claims made them allowable. Second, because these limitations were simultaneously added, the Court noted that the limitations should be read together and, therefore, the term "thereof" refers only to the treatment of macrocytic megaloblastic anemia. Third, the court construed the term "need" to require a need that is "recognized and appreciated," because "otherwise the added phrases do not carry the meaning that the circumstances of their addition suggest they carry." Any other interpretation would result in the claims covering almost any physical condition and would, therefore, amount to a recapture of subject matter disclaimed during prosecution.

Jansen argued that even under Rexall’s claim construction, their labeling and advertising information were sufficient circumstantial evidence of customer-direct infringement to defeat a motion for summary judgment. The Court disagreed, indicating that the theoretical possibility that customers were using Rexall’s formulation for treating macrocytic megaloblastic anemia is insufficient to create a genuine issue of fact.

Practice Note: This decision should be of particular interest to those holding patents relating to methods of using "nutraceuticals." Patentees should be aware that because such products do not require a prescription from a physician, it is difficult to ascertain and document the intent of the consumer purchases them over-the-counter. As such, enforcement of method of use claims against manufacturers marketing their products for other purposes is likely to be difficult.