In recent years, the biotechnology industry has surpassed a market worth of $200 billion dollars, with over 1.4 million jobs dependent on that market. However, the biotechnology industry is also uniquely dependent on the patent system to protect the huge investments of time and money required to bring new research to the market. Increasingly, courts have improperly used the Patent Act's Section 101 subject matter eligibility requirement as a functional barrier for new biotechnological patents, creating substantial uncertainty in the validity of many patents. In particular, the courts have utilized judicially created exceptions to allowable subject matter--laws of nature, natural phenomenon, and abstract ideas--to invalidate a wide variety of biotechnology patents. This improper use has resulted in a tangled and confusing body of law, and a merging of Section 101 subject matter eligibility and Section 103 obviousness requirements for a valid patent. Recently, the Federal Circuit has begun to push back against this improper use, providing limiting principals in the use of Section 101 and the judicial exceptions. Instead of using Section 101 as a new functional barrier to patent validity, the Federal Circuit has properly delineated between the subject matter eligibility and obviousness requirements. This allows for more predicability in the validity of patents, and clarity for those seeking to patent a new biotechnological invention.
Casey M. Olesen,
Rapid Litigation Management Ltd. v. CellzDirect, Inc.: Limiting the Use of Subject Matter as a Functional Barrier to Patent Eligibility in the Biotechnology Industry,
Me. L. Rev.
Available at: https://digitalcommons.mainelaw.maine.edu/mlr/vol69/iss2/6