Is Messenger RNA Patent-Eligible? – Bill of Health
By Aparajita Lath
Amid ongoing patent disputes over the mRNA platform, a significant scientific question remains unanswered: whether mRNA itself even is patent-eligible.
Under patent law, an inventor may obtain a patent on “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Section 101 is subject, however, to an important implicit exception: “laws of nature, natural phenomena, and abstract ideas are not patentable.” (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012)). Such “manifestations of a nature are free to all men and reserved exclusively to none.” (Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)).
Only natural products that are markedly different from products of nature can be considered patent-eligible (Diamond v. Chakrabarty, 447 U.S. 303 (1980)). The product-of-nature exception serves an important public purpose: An overbroad conception of patent-eligibility could unduly restrict the study and productive use of resources and laws of the natural world.
To illustrate the stakes here, it’s worth highlighting the patent dispute in Association for Molecular Pathology v. Myriad Genetics.
The Myriad case involved patents over isolated human DNA, leading courts to grapple with the “product of nature” issue in the fast-evolving biotechnology space. Myriad had obtained several patents after discovering the exact location and sequence of the BRCA1 and BRCA2 genes, mutations of which can increase the risk of breast and ovarian cancer. This discovery enabled Myriad to determine the genes’ nucleoside sequence, which in turn enabled it to develop medical tests for detecting these mutations to assess a patient’s cancer risk. These patents gave Myriad the exclusive right to isolate an individual’s BRCA1 and BRAC2 genes, along with the exclusive right to create synthetic cDNA BRCA genes. Myriad’s patents were challenged as being invalid on the ground that the BRCA1 and BRAC2 genes are “products of nature.”
In the absence of scientific guidance, the Federal Circuit made incorrect assumptions about the nature and characteristics of the underlying invention. This not only affected the Court’s understanding and final outcome but also delayed resolution of the dispute, thereby affecting patient access.
The Court incorrectly assumed that isolated DNA fragments of the human genome do not themselves routinely occur in nature. Further, the Court incorrectly assumed that most biotechnology products make use of patents on naturally occurring DNA.
However, an amicus brief filed by Prof. Glenn Cohen, Gideon Schor and Vern Noviel, on behalf of Dr. Eric S. Lander before the Supreme Court revealed that these assumptions were wrong. This evidence guided the Supreme Court to better understand the scientific basis of the invention in question. The brief explained that DNA fragments do in fact routinely occur in nature (and, to that extent, are products of nature) and that the scientific community routinely uses and protects man-made DNA (cDNA), rather than naturally occurring DNA.
Guided by well-accepted scientific evidence, the Court chose a narrowly crafted decision, a middle path of sorts, which balanced the expectations of biotech innovators with public health needs. The court permitted patents on cDNA, but disallowed them for naturally occurring isolated DNA.
Similar scientific guidance is the need of the hour for the mRNA platform. Currently, patent claims to the mRNA platform are very broadly worded without much color as to the exact nature of the mRNA component and the extent to which the platform applies laws of nature.
Moderna’s patent no. 10,898,574 (titled “Delivery and formulation of engineered nucleic acids”) claims a “method of producing a polypeptide of interest in a cell” by administering “a pharmaceutical composition comprising a modified messenger RNA.” Methods that apply what the Mayo court characterized as “natural laws” are not patent-eligible. Is a method of producing a polypeptide by a cell a natural law? Further, is the mRNA, i.e., the pharmaceutical composition that stimulates protein creation, a natural product?
Pfizer, in replying to Moderna’s claims of patent infringement, characterizes mRNA as “biological material” that encodes and causes the body to make certain proteins (para 5). However, patent specifications suggest that mRNA can be synthetically created, and certain examples with steps to create mRNA involve cDNA (examples in Moderna’s patent application 10,898,574 at columns 56 to 60). Does this make the resultant mRNA man-made? Are there any categories of mRNA that can be classified as naturally occurring? These and other scientific questions need attention.
Given that mRNA is a biotechnology invention that has links to a natural product and mimics the essential biological functions of naturally occurring mRNA, a significant line of inquiry for innovation and access is to what extent mRNA qualifies as a product of nature, and what evidence supports or refutes this characterization. This question has not been raised in any on-going mRNA patent infringement lawsuit, presumably because the parties involved in these lawsuits are competitors who are not incentivized to challenge patent-eligibility, since adverse decisions may affect their patents as well.
Nevertheless, arriving at the correct scientific understanding of the nature and characteristics of the biotechnology invention in question, i.e., whether and what aspects of it are “products of nature” or “apply a law of nature” are crucial questions that should be answered at the threshold to accelerate scientific progress, access, and public health needs.
Unlike Myriad, where these questions were clarified only once the case was before the Supreme Court, i.e., after years of litigation, we must learn from the past and address these questions sooner rather than later in the mRNA context.
