Biotechnology Patent Law Top Ten of 2021 Experimentation, Blaze Marks, and Unspecified Ranges

Biotechnology has never demonstrated its benefits to society more than in 2021. The SARS-CoV-2 virus that caused the CoVID-19 pandemic met a formidable opponent in mRNA vaccines developed and supplied by Moderna and Pfizer/BioNTech. These vaccines are claimed in myriad – not Myriad – patents and patent applications, many of which are destined to be litigated over the coming years, not least inspired by the many billions of dollars that have been, and will continue to be, earned by their owners. While the world waits for this storm of patent litigation, federal courts continue to be busy with ownership, licensing, validity, and infringement disputes arising from other biotechnologies, including, perhaps, up-and-coming CAR-T therapies. For the fourth year in a row (of what has become a tradition), we discuss, in this article, the ten most consequential, important, and interesting court decisions involving biotechnology patents. Our top ten decisions may not be the same as top tens compiled by others. However, to quote an expression commonly heard in courts hearing patent cases, à chacun son goût. Patent decisions delivered during 2021 tackled a diverse group of doctrinal issues. As discussed in the article, these ranged from how much experimentation is to be considered undue à la In re Wands, to what level of detail of disclosure is sufficient to satisfy the ever- written description requirement, to which types of behavior may rise to the level of inducement to infringe, not to mention assignor estoppel. Patent litigations filed in federal district court rose to 3,798, a number not seen since 2016. In contrast, the 1,333 patent actions filed with the Patent Trial and Appeal Board (“PTAB“) represented a substantial decline from 2020. In short, despite the challenges of the CoVID-19 pandemic, patent litigation in 2021 evinced considerable vim and vigor. Described and analyzed in this article are the vimmiest and most vigorous of 2021 patent decisions