Patent protection rewards an inventor with a 20-year monopoly for the public disclosure of their invention. In order to be granted a patent, an invention must meet the statutory requirements of Title 35 of the U.S. Code (35 U.S.C.), which are: patentable subject matter, adequate disclosure, usefulness, novelty, and non-obviousness. As a life scientist as well as student at UNH School of Law, I am most interested in how these statutory requirements present unique challenges to academic research, especially in the field of molecular biology (e.g. Molecular Pathology, Inc. v. Myriad Genetics, Inc. and Ariosa Diagnostics, Inc. v. Sequenom, Inc.). This post applies only to academic research in the life sciences.
Meeting the requirement for subject matter patentability
The first challenge is meeting the requirement for subject matter patentability (35 U.S.C. § 101). An invention must fall into one of four categories: process, machine, manufacture, or composition of matter. Laws of nature, natural phenomenon, and abstract ideas are patentable only if the invention has additional features that make the invention new and useful. In Molecular Pathology, Inc. v. Myriad Genetics, Inc., the Supreme Court ruled that genomic DNA is a natural phenomenon and the discovery and isolation of genomic DNA is not enough to get past this threshold. Thus, cDNA (complementary DNA), which is synthesized DNA containing only the expressed segments of a gene (exons) and not the noncoding segments (introns), is the only form of DNA that is considered patentable subject matter because genes with the introns removed are not naturally occurring DNA.
Meeting the requirement for adequate disclosure
The second challenge is meeting the requirement for adequate disclosure, which requires a well-defined description of the invention (35 U.S.C. § 112). The criteria for adequate disclosure include a description of the invention, how it is made, and how it is used. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. highlights the challenges academic research faces in meeting the adequate disclosure requirement. Universities are involved in groundbreaking discovery research that makes significant contributions to the science field and society. However, academic research focused on this fundamental discovery research often does not have an invention, and thus not eligible for patentability.
In general, universities often do not have the resources to fully develop all of their research into inventions, nor is this the desired or appropriate focus for many areas of research. Academic institutions rely on technology transfer to help companies license innovations in order to develop them further for commercialization into products such as pharmaceuticals and diagnostic tests that are immensely beneficial to society. However, companies often prefer licensing patented or otherwise protected innovations so there may be less incentive for them to invest in unprotected academic innovations. Therefore, groundbreaking fundamental academic research in the life sciences is critical and must be supported, but knowledge of the patenting process is also important for the translation of the fundamental research into products.
For more information on obtaining patent protection for academic research, read Protect Your Intellectual Property.
Amy Bonacquisti
Legal intern, UNHInnovation
