Deficits in IP law uniquely spillover into innovation broadly.

In the body of our letter in response to this Notice, we reference prior responses of our Section as well as the Mossoff Statement with respect to this question. As noted by Professor Mossoff on pages 2-3 of his testimony and in the citations in footnote 9, other jurisdictions began taking advantage of the uncertainty and unpredictability in U.S. patent eligibility jurisprudence several years ago. As noted in footnote 9 of the Mossoff Statement, China, for example, relaxed rules on software patentability beginning in 2017, and in the biotech field of technology research and development dollars have been reported as shifting to China. Thus, the uncertainty and unpredictability in patent eligibility appears to be weakening U.S. leadership, and importantly signals to other countries that subject matter that was globally accepted as patent eligible subject matter now can be denied protection in the U.S. without violating Trade-Related Aspects of Intellectual Property Rights (TRIPS).18 If Pandora’s box on subject matter eligibility has been thrown open, the diminution of global rights in intellectual property may be inevitable.

As a specific example of a significant difference in the treatment of substantially identical patent claims in corresponding patent applications in the U.S. and Europe, the second real world example laid out in the body of our letter is directly on point. In contrast to the fate of Sequenom’s U.S. patent which was found to be subject matter ineligible, Sequenom’s counterpart European Patent EP 994 963 (whose claims 1 and 18 are substantially identical to claims 1 and 21 of U.S. Patent No. 6,258,540) twice survived third-party challenges and were upheld as patentable by the European Patent Office. The German Federal Supreme Court expressly ruled that it would not follow the U.S. approach to subject matter eligibility: “unlike the U.S. Supreme Court (in 566 U.S. (2012) – Mayo v Prometheus), … a teaching that involved performing a technical act which used a discovery to achieve a specific outcome was patentable, regardless of whether the teaching also contained ‘inventive added value’ above and beyond the use of the naturally occurring correlation discovered.”

As illustrated by the latter example and the broader explanation in the Mossoff Statement, the United States may now or soon stand as an outlier with no other competitive country finding similar, critical areas of research to be ineligible subject matter for patenting.19 Thus, a risk exists that over time, this will erode the United States leadership in critical technologies.