The neg is understating the mass uncertainty Alice/Mayo causes. It’s empirically proven to be unique.

Never, in the history of the American-patent system, has there been a time of less clarity regarding patentable subject matter.155 The lack of clarity and predictability is directly attributed to the judiciary. The Supreme Court reached far beyond the statutory language of Section 101, blurring the lines, and adding new ones. In its opinions, the Court has been incoherent and provided no guidance for untangling the lines of precedent justifying its decisions.156 These decisions have led to a rise in subjectivity.157 Some have said the only determining factor in subject matter eligibility rests on selection of the panel.158

In response to this lack of clarity, the Patent and Trademark Office (PTO) and courts rejected and invalidated countless patents covering innovation in various fields, namely, biotechnology, pharmaceuticals, and life sciences following Alice. 159 In an attempt to track the rate of these invalidations, a researcher conducted periodic reviews of the average invalidation rate among the three court levels at one-, two-, and five-years post-Alice. 160 The data showed that a year after Alice the average rate of invalidation was 82.9%. 161 The rate declined in both the two-year and five-year points, holding at 78.2% and 56.2%, respectively.162 Though declining, an invalidation rate of over 50% does not breathe confidence into investors or inventors.

To further quantify the effects, two researchers conducted a study focusing on the invalidation of personalized medicine patents.163 The data showed a sharp increase of subject matter invalidations following Mayo, with growth continuing after both Myriad and Alice. 164 More specifically, 86.4% of the office decisions issued by the PTO post-Mayo included rejections for subject matter eligibility, as opposed to 15.9% pre-Mayo. 165 In another study surveying Section 101 rejection data provided by the United States PTO, researchers found an uptick of rejections in both the software, including biotechnology, and medical diagnostic art units.166 Particularly in the software and biotechnology art units, the month after Alice was decided, Section 101 rejections increased from 25% to 81%; the level of rejections remained fairly consistent at or around 75% for the remaining months of data.167 Similarly, in the month after Mayo, the medical diagnostic art unit saw an increase in Section 101 rejections from 7% to 32%; the level of rejections continued to rise, reaching a peak of 64% post-Alice. 168 Consequently, the United States is no longer the leader in patent protection rights.169

The Mayo/Alice test has developed a reputation for being uncertain and overly restrictive.170 Moreover, there is no consistency in how the test is applied and interpreted,171 and the test is overly restrictive by invalidating patents across nearly every sector.172 However, even the Court warned against allowing the interpretation of Section 101 and application of the Mayo/Alice test to significantly impede innovation, which it clearly seems to be doing, particularly in the healthcare space.173