SMU Science and Technology Law Review

Article Title

Biotechnology Patent Law Top Ten of 2022: Inducement, Clear Error, and Interferences Galore


Five-year anniversaries are symbolized by a product of natural biotechnology: wood. This article marks the wood anniversary of the “Top Ten Biotechnology Patent Cases” series that began in 2018. Imagining the world in 2018 is challenging, in part because it was, indeed, a different world. There had not been a major pandemic in one hundred years. Inflation was low. The economy hummed along. No individual war appeared to threaten more than regional stability. O tempora, o mores! The year 2022 was quite different. SARS-CoV-2 continued to stalk the land, having had a monumentally mortiferous effect for several years. High inflation was rampant. The economy was still recovering from one of the deepest declines in history, with imbalances across many sectors. Moreover, eastern Europe had let slip the dogs of war, threatening peace worldwide.

Biotechnology also has seen changes of significant magnitude. Venture capital investment in biotechnology was small compared to what it is now. Efficient genome editing was restricted to first-generation CRISPR-Cas9 systems, while now it may be accomplished using more powerful and accurate methods, like base editing and prime editing (the latter offering hope for treatment in almost 90% of genetic diseases). Courts had declared that diagnostic methods did not constitute patentable subject matter, which remains the case today, although clever draftswomen continue their efforts to obtain claims protecting such methods to some extent.

Over the course of 2022, courts decided a generous selection of cases covering a wide variety of biotechnology patent law issues. These cases ran the gamut, from patent doctrines concerning satisfaction of the written description requirement for antibody claims to mechanisms for augmenting patent terms using either Patent Term Extension, or Patent Term Adjustment, or both. This article has chosen ten of the most important, though, as is the case every year, our choice of only ten was difficult, and, by necessity, left worthy cases on the cutting room floor.


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