An intellectual property litigation legal team from McDermott, Will & Emery successfully represented The Burnham Institute and Integra LifeSciences, obtaining a significant victory related to patent infringement in the context of biomedical research.
On June 6, 2003, the U.S. Court of Appeals for the Federal Circuit upheld a holding that Merck KGaA directly infringed and induced infringement at The Scripps Research Institute and remanded the $15 million damage award against Merck to the trial court for further consideration. On appeal, McDermott, Will & Emery represented The Burnham Institute, the owner of the infringed patents, and Integra LifeSciences, the exclusive licensee of the patents.
The patents at issue claim compositions and methods relating to peptides containing the amino acid sequence Arg-Gly-Asp (RGD Peptides), which control cell adhesion to other cells and substrates in vitro and in vivo. The infringing acts consist of a series of experiments performed by scientists at The Scripps Research Institute pursuant to a sponsored research agreement with Merck KGaA.
This decision marks the first time the Federal Circuit has had to decide whether pre-clinical experiments are exempt from liability for infringement under the Hatch-Waxman Act provision that “it shall not be an act of infringement” to carry out activities which are covered by patent claims “solely for uses reasonably related to the development and submission of information” to the FDA (the 271(e)(1) or FDA Exemption). The experiments in question were primarily directed to identification of the best among several possible drug candidates for future clinical testing under the FDA process.
This decision is a significant victory for owners of biomedical research tool patents, because it establishes that the FDA Exemption does not apply to general biomedical research to identify new pharmaceutical compounds. The Court stated that the expansive interpretation urged by Merck would effectively vitiate the exclusive rights of patentees owning biotechnology tool patents. The proceedings on remand will set an important precedent regarding how damages for infringing pre-clinical research are to be calculated.