In Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court and held that Bayer’s patent covering its Yaz® birth control pill product is invalid as obvious. The court found a strong prima facie case of obviousness, and rejected each of Bayer’s arguments relating to secondary indicia of non-obviousness.
In Bayer Schering Pharma AG v. Lupin, Ltd., the Federal Circuit upheld the district court’s determination that the Abbreviated New Drug Applications at issue did not infringe the asserted patent related to Yasmin. In particular, the Federal Circuit agreed that the FDA had not approved Yasmin for the method of use claimed in the patent, and so filing the ANDAs could not amount to infringement of the patent.
While this case is similar to Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk A/S, in that it relates to a method of use patent in the ANDA framework, it raises different issues than those decided by the Supreme Court a day after this Federal Circuit decision was issued. (Please see this article for a discussion of Caraco.)
Pharmaceutical inventions usually require human clinical testing in order to obtain regulatory approval to market the new product. Often a patent application is filed before the invention undergoes human testing, but sometimes a human clinical trial may be started—or even completed—first. While U.S. patent law provides that a “public use” of the invention within the U.S. can constitute prior art, a clinical trial often does not qualify as prior art, either because it was not “public” (e.g., it was conducted under confidentiality) or it qualifies as an “experimental use.”
Practitioners familiar with European patent law know that the EPO takes a stricter view of prior art than the U.S. in many ways, applying an absolute novelty standard with no grace period. Still, a recent decision by the EPO Technical Board of Appeal (T0007/07) finding that a human clinical trail constituted invalidating prior art is striking. Continue reading this entry
This week the Federal Circuit heard oral arguments in its en banc rehearing of Therasense, Inc. v. Becton, Dickinson & Co. As reflected in the en banc order, the court took this case en banc in order to reconsider—and hopefully reform—the law of inequitable conduct. The court’s decision could solve the McKesson problem and rein in the threat of inequitable conduct charges that drives practitioners to submit references even when they are not believed to be relevant to patentability.