While several intellectual property rights battles are being fought over the mRNA platform, a key question that remains unaddressed is whether and to what extent mRNA is patent eligible.
Patent eligible subject matter refers to subject matter that is inherently suited for patent protection. Section 3 of the Patents Act, 1970 is the key section on “patent eligibility” and lists out what are not “inventions”.
For mRNA, sections 3(c), 3(d), 3(i) and 3(j) are of relevance. Section 3(i) broadly excludes products of nature, scientific principles and abstract ideas; Section 3(d) excludes new forms of known substances without the enhancement of known efficacy / new uses of known substances (see e.g. Monsanto IPAB case we reported here); Section 3(i) medical and other treatments; and 3(j) plants and animals in whole or part excluding micro-organisms (Monsanto litigation over patents for selected and modified genetic sequences from a bacteria called Bacillus thuringiensis (bt) here).
However, the legal boundaries of each of these exclusions are far from clear. Except for section 3(d), Indian courts have not provided much clarity on the meaning and scope of these exclusions. Further, patent cases involving biotechnology have been few and far between. Legal uncertainty aside, there appears to be a gap in factual and scientific understanding of the true characteristics of this pathbreaking technology. An essential first step to understanding the true characteristics of this technology and consequently patent eligibility is the need to collect scientific evidence regarding the process of making, composition and other features of mRNA. Such information is not widely known since many of these aspects of the platform are protected as trade secrets. At the same time, initial efforts to reverse engineer the platform have been successful. The mRNA technology transfer hub was able to reverse engineer the mRNA platform for Covid without assistance from patentees. The hub relied on publicly available information and researcher support. It may therefore be possible to gather information regarding the nature and characteristics of mRNA, a first step to examine whether it trips up on any Section 3 exclusions. Such information may be especially relevant to the mRNA component of the platform which mimics essential biological functions.
In this regard, the scientific community can learn from gene patent litigation strategies adopted in the past, in countries like the US (Myriad as discussed below), to help courts and policy makers craft solutions that balance the interests of both the inventing community and public health needs.
This article was originally published on Bill of Health, the blog of Petrie-Flom Center at Harvard Law School.
Is Messenger RNA Patent-Eligible?
Amid ongoing patent disputes over the mRNA platform, a significant scientific question remains unanswered: whether mRNA itself 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.