How Alice Affects Bioinformatics Patent Applications?

Abstract

The U.S. Supreme Court’s decision regarding patent-eligible subject matter in Alice Corp. v. CLS Bank has been in effect for more than five years, and it has made a significant impact on inventions in the life science industry. Statistics have shown that patent applications and allowance rate decreased significantly after Alice due to legal uncertainties created by this decision.

This work develops a causal empirical study (using difference-in-difference regressions) of Alice and carefully explores how this decision impacts patent examiners and patent applicants in bioinformatics. We deploy and analyze patent application data between 2012 and 2016 for all the U.S. Patent and Trademark Office (“PTO”) office actions in bioinformatics and manufacturing devices, a total of 0.14 million patent office actions and patentee responses. Patent applications in bioinformatics are defined as broad and narrow according to specific technology centers or art units and compared with the patent applications in manufacturing devices before and after Alice.

We find that applicants in bioinformatics, regardless of the broad or narrow definitions, received more Sec. 101 rejections after Alice, and they are positively associated with Alice-based rejections. Alice-based rejections are not always positively associated with other types of statutory rejections (i.e., Sec. 102, Sec. 103, and Sec. 112 rejections). Moreover, applicants gradually filed fewer patent applications, compared to the time period before Alice, with the greatest reduction in patent applications occurring in June 2014, when the Alice decision was delivered by the Supreme Court. In addition, patentees received many more Sec. 101 rejections based on Alice, but these applicants also faced difficulties in overcoming these rejections, especially in the sub-areas of data processing and combinatorial chemistry technology in bioinformatics.

Due to the high costs of patenting on bioinformatics imposed by Alice, this study suggests legislation by Congress is the best hope to bring more certainty to this area of patent law.