Of technologies most likely to enjoy patent protection, a large percentage disproportionately emanate from a limited number of industries. Biotechnology is one such “patent-intensive” industry. Taken together, these industries constitute a foundation for supporting the development of new biomedical technologies. Geographically rooted in metropolitan areas, biotechnology is endemic anywhere private-sector companies and institutions of higher learning are located. In many respects, densely populated cities foster innovation within collaborative industries such as biotechnology, because in addition to providing a vast network of cohorts, federal and private monies funnel to universities and businesses most capable of advancing biotechnologies.
Indeed, when considering locations where more patents are granted for biotechnologies than any other category, between 3,000 and 8,000 patents can be expected to issue on an annual basis. It is therefore not difficult to appreciate the import of patent protection for the biotech industry, at least because such patents function as commodities entrenched in today’s business commerce. The status quo, however, presently stands before a – disruptive – judiciary.
Specifically, the Supreme Court has recently engaged in a patent law “reformation” with respect to defining what constitutes patent-eligible subject matter (PESM). Before delving into any details, it is important to first appreciate that issues surrounding the scope of PESM are outside the purview of considering an invention’s novelty or non-obviousness. Whether something is eligible for patent protection is a threshold question, which, when answered in the affirmative, only then invokes further inquiry into the propriety of granting protection therefor. Nevertheless, the categorical framework defining PESM is provided in 35 U.S.C. § 101, which is coterminous with the judicially created “exceptions” to PESM, i.e., abstract ideas, laws/products of nature, and natural phenomena, proscribed from eligibility.
One such exception was addressed in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), where the Court held that naturally occurring pharmacological and metabolic correlations are outside the scope of § 101 because, inter alia, claims to such correlations would effectively preempt all applications thereof. For diagnostic and related technologies, the Prometheus decision was troubling inasmuch as patents claiming drug-dosing parameters as a function of metabolism may no longer be valid. While it is still too early to completely gauge the fallout from Prometheus, it can be said with certainty that the chilling effect on the biotech industry will be measured by degree rather than possibility.
In turn, the Supreme Court also granted certiorari in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., et al. to end the well-publicized debate over the patentability of DNA. The sole question before the Court concerns whether human genes qualify for protection under § 101. In this respect, the question granted for review may impart the fate of the respondents, i.e., Myriad Genetics, the corporate owner of patents claiming “isolated DNA” that can be used for identifying an individual’s susceptibility to breast and/or ovarian cancer. As expected, the respondents asserted that the proper question for review involved the patentability of isolated DNA. In contrast, but predictable nonetheless, the petitioners framed a broader, more provocative question, as granted by the Court. By accepting the petitioner’s premise, and apparently conflating in vitro results (isolated DNA) with in vivo manifestations (human genes), the Supreme Court seems to have set the stage for a paradigmatic shift in the biotech industry.
Indeed, if the Court determines that isolated DNA is tantamount to a product of nature, many, if not all, claims in the more than 50,000 issued patents directed to such subject matter will be in jeopardy. And the downstream impact could be costly. One possible consequence of a perturbative decision in Myriad includes a biotech community that is disincentivized from pursuing research directed to excluded subject matter. Investors may be similarly dissuaded from financing such projects. Biotech commercialization efforts, moreover, may shift abroad where protection remains for DNA-based technologies.
While an exhaustive analysis must wait until the Court proffers a decision, it is safe to assume that the preceding Federal Circuit determination (confirming eligibility for isolated DNA) will be restructured in accordance with the Supreme Court’s recent desire to reshape § 101 boundaries. Until then, we can expect to observe a more conservative approach to developing DNA biotechnologies insofar as the assurances traditionally afforded to protecting these inventions are no longer certain.
Randolph V. Clower, PhD, is an attorney with Phillips Lytle LLP, where his practice comprises intellectual property and patent law in the life sciences. He can be reached at (716) 847-5421 or firstname.lastname@example.org.