Volume 49, Issue 1
2017 Writing Competition 1st Place winner:
Notice function of biologic drug patents
A Comparison of Small Molecule and Biologic Drug Patents’ Notice Function
Ying Chen, Boston University School of Law
The notice function of a patent, a notion that the public should receive clear warning of a patent’s boundary before they are found infringing it, is an essential element in patent law that ensures fairness and promotes innovation. This paper aims to examine the public notice function of biologic drug patents, in comparison with small molecule drug patents.
The notice function is generally well served in pharmaceutical and biotech industries.1 Both pharmaceutical and biotech patents have well-defined terminologies that help reduce the imprecision caused by language,2 experts in both fields are confident in predicting subsequently added patent claims,3 and neither field is plagued by large quantities of weak patents. However, there are nuanced differences between biologic drug patents and small molecule drug patents due to the dramatic differences in terms of synthesis, structure, complexity, and cost of the two types of drugs.
The notice function of biotechnology patents is limited by several issues, including the uncertainty of written description doctrine, the fragmented property right, and the lack of patent listing. The Federal Circuit imposed more stringent written description requirement on biotechnology than on any other industry.4