United States: USPTO Report On Patent Eligible Subject Matter

On July 25, the USPTO published a report titled "Patent Eligible Subject Matter: Report on Views and Recommendations From the Public." The report attempts to synthesize public comments on the appropriate boundaries of patent eligible subject matter.

The report includes a section reviewing the historical development of patent subject matter eligibility in the U.S. This section includes a discussion of the Supreme Court's Bilski, Mayo, Myriad and Alice decisions, as well as the Federal Circuit's application of the Supreme Court's framework.

Next, the report reviews international approaches to defining patent eligible subject matter. This section includes a review of the patent eligibility laws in Europe, Japan, Korea and China. Also included here is a discussion of how the laws affect specific technologies, with a focus on life sciences and computer-related technologies. In this respect, the report notes that there was a general consensus that two industries have been most directly affected by the recent Supreme Court jurisprudence, namely, life sciences and computer-related technologies. According to the report, this stems from the fact that innovations in these fields are often closely linked to the judicial exceptions, i.e., abstract ideas, laws of nature and natural phenomena.

Criticism of the Alice/Mayo two-step framework was especially strong among representatives of the life sciences community. According to the report, nearly all participants from the life sciences industry expressed concern with the recent holdings of the Supreme Court, which reportedly have seriously harmed thousands of companies through patent invalidations or the prospect thereof. Several commentators asserted that the new eligibility test is disproportionately impacting the biopharmaceutical sector, given the industry's reliance on patent rights to cover the enormous investment costs associated with developing new medicines and bringing them to the market. In addition, the effect of the Court's recent jurisprudence is said to extend beyond biopharmaceutical drug products. Several members of the public complained about the inability to obtain patents on diagnostic innovations under the Mayo two-step test, and warned of the impact this could have on healthcare, particularly in the emerging field of personalized medicine.

In contrast to the life sciences field, those in the computer industry were more sharply divided in their views of recent Supreme Court precedent. Some members of the public welcomed the Court's intervention in the law of patent eligibility. Far from sounding the "death knell" for software innovation, several members of the public argued that Alice instead addresses the very real problem of abusive patent litigation driven by overly broad patents. Others characterized Alice as striking an appropriate balance between innovators and downstream users of computer-implemented inventions.

The largest section of the report is a summary of public views on patent eligible subject matter. This includes a review from the perspectives of life sciences and computer-related technologies. Finally, the public recommendations are summarized. These are divided into three categories: (1) allow judicial developments to continue; (2) take administrative measures; and (3) push for legislative reform. The proposed legislative reforms include (a) replace the two-part test with a technological or useful arts test; (b) expressly define exceptions to eligibility; (c) distinguish eligibility from other patentability requirements; and (d) establish research exemption to infringement.

As noted, several legislative proposals called for the elimination of the two-part Mayo/Alice eligibility test in favor of a technological or useful arts requirement. Acknowledging that patents should be reserved for contributions to the technological or useful arts, these proposals suggest that the patent eligibility standard be focused on whether what is claimed is indeed a technological or useful invention. In addition, seeking to restore "the historic availability of patent protection for medicines and diagnostics," representatives from the life sciences industry advocated that Congress should make patents available to all "technological inventions, i.e., inventions contributing to the technological arts."

Time will tell where all of this will lead. As they say, stay tuned for further developments.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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