Sanofi-Aventis Deutschland GmBH v. Genentech, Inc. and Bio gen IDEC Inc. (U.S. Court of Appeals for the Federal Circuit No. 2011-1397)

摘要

The '522 and '140 patents, assigned to Sanofi, arose from the same patent family and share the same single-page written description, which discloses enhancer elements derived from human cytomegalovirus ("HCMV").1 Enhancers are discrete segments of DNAcapable of enhancing the expression of one or more functionally associated gene(s) by upregulating transcription—the process of synthesizing RNA from a DNA template. Generally speaking, enhancers recruit and locally concentrate certain proteins neededfor transcription, leading to increased production of RNA from associated genes. The resulting abundance of RNA, once translated, yields correspondingly abundant protein expression. Enhancers are often found immediately upstream of enhancer-activated genes, but they can also function if placed downstream or even thousands of base pairs away from a gene. Once identified, enhancers often have considerable practical utility and have been adopted in the biotechnology and pharmaceutical industries to boost production efficiency for protein-based products. For example, by linking an enhancer to a gene encoding a biologic drug, researchers can often significantly improve yields from cells expressing that gene.