By: Robert R. Sachs
The Supreme Court’s actions to invalidate the patents at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012) and Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., 569 U.S. ___ (2013), unequivocally demonstrate that the USPTO has failed to properly prevent patents on laws of nature from issuing. Similarly, the Food and Drug Administration does not appear to understand the significance of its role as potential steward of biological laws of nature in approving new therapeutics, many based on what we now know to be patented laws of nature. In view of this melancholy state of affairs, I have a very modest proposal.
Firstly, the Food and Drug Administration should be renamed the Laws of Nature Administration (LONA), given its key role in overseeing the development and approval of therapeutics which necessarily involve laws of nature. The agency’s new name will impress upon both its officers and the general public the importance of the agency’s role in safeguarding “basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972).
Secondly, a new face needs new procedures as well, so instead of filing for a New Drug Application (NDA), companies will henceforth file a New Law of Nature Application, or more mellifluously, N-LoNAs. The relevant Code of Federal Regulation provisions, principally 21 C.F.R. § 314 (New Drug Applications) and § 321 (Investigational New Drug Applications) will need to be revised to include a requirement that the respective application specifically identify any laws of nature that the drug sponsor is making use of or has discovered. Since NDA applicants must already list patent information for inclusion in the Orange Book, identification of laws of nature imposes only minor additional disclosure requirements. See, 21 C.F.R. § 314.53.
Thirdly, responsibilities of this magnitude deserve their own cabinet seat, so there should be a new Department of Nature along with a Secretary of Nature (apologies, of course, to whichever Supreme Being previously held this office de facto) with broad authority for the regulation of all scientific research. After all, laws of nature are “free to all men and reserved exclusively to none,” Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948), and “even a narrow law of nature (such as the one before us) can inhibit future research.” Prometheus, at p. 20. A centralized executive function is necessary to ensure the freedom of future scientists to conduct their research without being inhibited by artificial patent monopolies on laws of nature.
Fourthly, while patent reform was passed in September 2011, legislative changes are needed to fully comport with the Supreme Court’s policy rationale. Currently, reexamination proceedings are limited to questions of prior art and compliance with § 112; patent eligibility under § 101 cannot be raised in either ex parte or inter partes proceedings.[1] Section 101 eligibility can only be challenged in post-grant review, but this is limited only to patents with an effective filing date after March 16, 2013. Thus, there are many thousands of patents that claim laws of nature, but which cannot be challenged except through costly litigation. This oversight can be readily corrected by Congress, given the vital importance of this issue and the bipartisan relationship demonstrated in the passage of the America Invents Act.
Fifthly, given the precedent set by Section 18 for “Transitional Post-Grant Review” for so-called covered business method patents, a complementary provision can be envisioned for laws of nature patents, allowing those who have been sued with a law of nature patent to seek an immediate stay of the litigation, and then review of the USPTO of the patent under § 101, as well as §§ 102, 103, and 112. Such an approach clearly provides for greater judicial economy, consistent with the Supreme Court’s vision in Prometheus, because again “courts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature,” Prometheus, at op cit. 20, so having the USPTO decide the issue is desirable. Of course, that the USPTO issued an alleged law of nature patent to begin with does not detract from the force of this argument, as the Office has since been clearly instructed by the Supreme Court as to the proper mode of analysis.
I can think of no one objection that will possibly be raised against these proposals, unless it should be urged that the number of patents will be thereby much lessened. This I freely own, and it was indeed one principal design in offering it to the world. Indeed, Judge Richard Posner has authoritatively told us, “there is a general concern that too many patents are being issued.” R. Posner, “Why There Are Too Many Patents in America,” The Atlantic, July 12, 2012, so anything that reduces the number of patents generally, and patents on laws of nature specifically, must be a Good Thing. These proposals are simple, efficient, and an expedient way to protect the laws and mysteries of the universe from privatization and corporate exploitation. To amend a phrase that many of us grew up with: “It’s not nice to patent Mother Nature!”[2]
[1] 35 U.S.C. § 302 states that a request for reexamination may be filed “on the basis of any prior art cited under the provisions of section 301.” 37 C.F.R. §§ 1.552, 1.906 limit the basis of ex parte and inter partes reexamination respectively to “patents or printed publications” and § 112 for subject matter added or deleted in the reexamination proceeding.
[2] So that my arguments are not taken out of context, let me be absolutely clear: The foregoing demonstration is an extended reduction ad absurdum showing what follows from Prometheus’ holding. My apologies to Jonathan Swift.
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