title: Using the written description requirement to limit broad patent scope, allow competition, and encourage innovation in biotechnology.
abstract: The biotechnology research and development process is extremely expensive and companies must attract investors to this high-risk industry to pay for these costs. Biotechnology companies rely on their ability to exclude others from exploiting the benefits of their research through patent protection to attract these investors. Consequently, they seek strong patent protection for their inventions by claiming a broad scope of patent protection for their inventions. Biotechnology is an industry where the scope of protection should be limited. Science-based technologies exploit the perceived technological opportunities from recent scientific developments, concentrating the attention of many inventors on the same areas. This poses several unique problems. First, only the first of several inventors will receive a patent to the invention. Second, due to publicly available, basic techniques, the actual contribution made by the inventor may be relatively small. Finally, there is a significant risk that permitting an overbroad patent scope may permit original patentees to control a variety of improvements and a number of applications. Additionally, a broad scope of protection for an invention tends to cause underutilization of many potential inventions or improvements. By limiting the scope of protection, one allows competitors to utilize these potential inventions or improvements and encourages the advancement of the technology. Traditionally, courts have used the scope of the disclosure to limit a patent with an overly broad scope of protection. The Federal Circuit is correctly applying the written description requirement as part of the disclosure to limit broad claim scope in biotechnology patents. The written description requirement is separate from the enablement requirement and applies to all claims. By requiring a written description to allow a PHOSITA to determine the structural characteristics of the claimed invention, the Federal Circuit is able limit biotechnology patents with overly broad patent scope. Recognizing that particular technologies will become more established as biotechnology matures giving rise to different issues in setting the appropriate level of patent scope, the court allowed the written description requirement to mature in tandem with advances in biotechnology to meet these new developments.
authors.affiliation: Case Western Reserve University School of Law, USA.
authors.forename: William C
authors.initials: WC
authors.lastname: Mull
mesh_terms: D001709:Biotechnology / Q000331:legislation & jurisprudence*; D004059:Diffusion of Innovation; D004465:Economic Competition; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States