In a highly publicized case, the United States District Court for the Eastern District of New York tied invalidity based on prior art to the issue of patentable subject matter post-Bilski. King Pharmaceuticals, Inc. v. Eon Labs, Inc., Case No. 04-cv-5540 (E.D. N.Y., Jan. 20, 2009) (Trager, J.).
King Pharmaceuticals brought an action against Eon Labs on patents relating to methods of informing patients about and administering the muscle relaxant metaxalone-marketed by King under the brand name “Skelaxin®”-with food. Eon moved for summary judgment of invalidity of King’s patents, alleging anticipation by six prior art references and obviousness of a subset of claims. Eon’s primary argument was that, despite the fact the prior art did not explicitly disclose the claimed features “with food,” such a feature was at least inherent (or obvious) from the prior art.
A dependent claim in the contested patent added the limitation that the metaxalone is from a container with printed labeling advising of the food effect. Thus, the only difference between that claim and the prior art is the addition of the printed label. Several other claims differ from the prior art only in the content of the written material that accompanies the metaxalone. The court stated that “a variation in written material that is not functionally related to the invention does not render a known product patentable.” A third set of claims removed all physical steps and claimed a process of informing patients of the benefits of administering the drug with food.
Despite the fact that Eon alleged invalidity based on anticipation and obviousness, the court found invalidity of some claims in light of Bilski. The court held that King’s discovery of a naturally occurring side effect of the known practice of administering metaxalone with food does not entitle it to a valid patent. Furthermore, the court decided that the act of informing a patient of an inherent property is likewise unpatentable. Specifically, the claims failed the Bilski test because the act of informing another person of an inherent property of metaxalone does not transform the metaxalone into a different state or thing. The court concluded that all of the claims of the King patents are invalid under 35 U.S.C. § 102(b) or § 101 in light of Bilski.
Practice Note: This case provides an indication of how courts may apply Bilski to biotechnology and chemistry cases. In this instance, the court was quick to invalidate claims based on lack of patentable subject matter in light of Bilski.