3. UNCERTAINTY – Alice/Mayo exponentially increased risk in the already extremely risky biotech industry. No matter how smart immigrants are, they won’t take obscene risk for minor rewards.

Criticism of the Alice/Mayo two-step framework was especially strong among representatives of the life sciences community. Indeed, nearly all participants from the life science 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.317 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.318 According to a trade association, “developing a new medicine takes between 10 and 15 years of work and costs an average of $2.6 billion of investment in [research and development].”319 Thus, a national law association argued that without patent protection, “emerging businesses and universities would be at risk with respect to their ability to attract needed investment, and established businesses would risk losing an important mechanism for protecting their investment in new products.”320

Representatives from the life sciences industry noted that natural products and their derivatives form the basis for many biopharmaceutical innovations.321 Therefore, some members of the public argued that, contrary to the Court’s decision in Myriad, the act of isolating a natural product should be sufficient for patent subject matter eligibility, at least when isolation permits the product to be used or applied in a new or different way. 322 Regarding the scope of eligible subject matter after Myriad, one representative from the biotechnology industry offered the following anecdote from one of his member companies: “I couldn’t get a claim to a laundry detergent enzyme but I could get a claim to a method of washing laundry in a washing machine using a washing liqueur that contains the enzyme.” 323 He explained that, “at the end of the day, everyone understands that claim scope is vastly different under these circumstances and has very different commercial applications.”324 Citing a recent study by the National Institutes of Health, one commentator estimated that about 75 percent of antibacterial drugs and 80 percent of anti-cancer drugs approved by the FDA between 1981 and 2010 would be unpatentable under a strict application of the Myriad test.325

The effect of the Court’s recent jurisprudence extends beyond biopharmaceutical drug products. Several members of the public complained about their inability to obtain patents on diagnostic innovations under the Mayo two-step test, and warned of the impact this could have on health care, particularly in the emerging field of personalized medicine.326 One participant reported that even if diagnostic patents could be obtained under the Mayo two-step test, they are limited to greatly reduced—perhaps commercially impractical—claim scope.327 For example, he stated that instead of claiming ten biomarkers used in a molecular diagnostics test, they are forced to claim the specific algorithm in which the biomarkers are combined.328 He explained that while companies that develop new chemistry to detect a molecule or a new machine for implementing that chemistry probably do fine, the content makers—the companies that “take those platforms and implement them in a very specific way to detect a new cancer or prognose a cancer using specific biomarkers”— are really struggling.329 Such anecdotal evidence was validated by studies of an academic. According to her research, although there has been no real decline in the number of diagnostic patent applications filed since the Mayo decision, there has been a measurable narrowing of claim scope as determined by claim length. 330 She attributed the steady rate of patent application filings to the fact that the diagnostic industry is heavily dominated by non-profit and public entities that are not as dependent on patents.331