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Alice-Mayo wrecks medical innovation

Adam Mossof January 8, 2020 GMU Law Prof, Visiting Intellectual Property Fellow Heritage Foundation, and a Senior Fellow at the Hudson Institute LEGAL MEMORANDUM No. 257 | EDWIN MEESE III CENTER FOR LEGAL & JUDICIAL STUDIES Congress Should Reform Patent Eligibility Doctrine to Preserve the U.S. Innovation Economy https://www.heritage.org/sites/default/files/2020-01/LM257.pdf (ermo/sms, Acc:7-5-2024) [MSDI-JE-wk1]

These high rates of rejections of patent applications are not merely a departure from historical U.S. practices. They signal that the U.S. has closed its patent system to innovators, especially compared to China and Europe.

A recent study of patent applications between August 2014 and September 2017 found that well over 1,000 patent applications were abandoned after receiving initial or final rejections by an examiner at the USPTO who found the claimed inventions or discoveries to be unpatentable under the Alice-Mayo framework. What makes these rejected patent applications important is that, in contrast to the U.S., the patent applications for the same inventions and discoveries were granted by China, the European Patent Office, or both.26

Given past U.S. leadership relative to other world economies, this data represents a disturbing trend for the future of the U.S. innovation economy, especially compared to countries like China. Since 2014, patent applications at the USPTO for important inventions in the diagnosis and treatment of breast cancer, lung cancer, gynecological cancer, liver disease, diabetes, ultrasound imaging (used in neonatal care and in other medical treatments), and others were rejected under the Alice-Mayo framework. These same inventions and discoveries were secured with patent protection by China, the European Patent Office, or both.27 The signal this sends to inventors and companies is not just that the U.S. has changed course from its own past innovation policy, but that it is diverging from other countries that already have or are developing patent systems securing reliable and effective property rights in cutting-edge innovations.

The high rates of invalidations and rejections is also revealing because the Alice-Mayo framework is often accused of being indeterminate and providing little predictability for inventors or lawyers in how a judge or examiner at the USPTO may choose to apply it. Yet it does appear to offer some predictability: the odds of receiving or keeping a patent under the Alice-Mayo framework are not in your favor if you are innovating new products and services in computer software, Internet technologies, cryptology, medical diagnostics, medical devices, and other inventions driving the U.S. innovation economy today.

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