Integra v. Merck: A mixed bag for research tool patents.

Research tool patents that cover technology used to discover drugs and drug candidates, are an important source of revenue for many biotechnology companies and academic research institutions in the U.S. Biologic research tools are products and processes used in experimental research, such as drug discovery. Examples of research tool patents include patents directed to receptors or other peptides used in screens to identify ligand-binding activity; patents directed to enzymes and patents directed to nondiagnostic and nontherapeutic antibodies used in screening assays. Thus, advancement in many fields is centered on research tools, and the use of biologic research tools is typically a first step in the chain of modern drug discovery. There are two competing policy interests in patent law: an inventor's interest to have exclusive rights to his or her invention, and the interest of the public to benefit from the progress of knowledge and technology. The U.S. Congress enacted the Hatch-Waxman Act of 1984 to balance these competing interests in the pharmaceutical area. Three principal components of the Act are patent term extension, Abbreviated New Drug Application (ANDA) filing and a research exemption.