Science is expensive. It costs a lot of money, and it takes a substantial amount of time. Clinical trials, in particular, can be a heavy financial burden. In academia, these costs can be offset by funding through the form of grants. But academic institutions aren’t typically responsible for transforming research into products for the market. You won’t see MIT competing with Apple with a new smartphone, and you won’t see UCSF producing and marketing a cancer drug. The job of getting products to the consumer has traditionally been left to industry. But for various reasons, businesses aren’t supported in entirety by the NIH and NSF grants that academic institutions rely on. So how can businesses offset the costs it takes to bring a product to market? Lawmakers recognized this dilemma in 1790, and established the U.S. patent system to address it. The patent system is a legal mechanism that exists to incentivize innovation by rewarding innovators, who endure research and development costs, with a temporary monopoly on their innovations (see 1).
Under U.S. patent law, a breadth of innovations can seek patent protection–from components of virtual reality headsets, to pharmaceuticals to technology that allows cars to identify and respond to potential collisions. But what about patents and stem cells? What can be patented in regenerative medicine? The truth of the matter is that much of the law and legal precedent is ambiguous and will remain so until more of regenerative medicine transgresses into patient-ready therapies whose inventors seek patent protection. That said, some case law has already established parameters for patent eligibility that may be applicable to regenerative medicine.
In 1996, Ian Wilmut and Keith Campbell from Roslin Institute drove what was once thought of as science fiction into the realm of reality: successfully cloning Dolly the sheep through somatic cell nuclear transfer (SCNT). From a scientific perspective, mammalian cloning is undoubtedly a hallmark biotechnological innovation, an innovation whose development incurred research and development costs. As such, one might assume that Dolly would be considered as legally innovative and as such, rewarded with patent protection. However, when Campbell and Wilmut applied for patents related on their innovation, the applications were rejected in part, calling into question if from a legal perspective, the advent of somatic cell nuclear transfer is recognized and rewarded as innovative.
The case In Re Roslin Institute refers to the 2014 U.S. Court of Appeals of the Federal Circuit’s decision regarding the patentability of Campbell’s and Wilmut’s clones. Roslin Institute applied for patents on both the method of cloning as well as on the clones themselves. The patent examiner, however, rejected the latter patent claims on the grounds that 1) the claims did not cover patentable subject matter under Title 35 of U.S. Code Section 101 (see 2), and 2) the innovation at hand was anticipated and obvious by Sections 102 (see 3) and 103 (see 4). This case was then appealed to the Patent Trial and Appeals Board (PTAB) which affirmed the patent examiner’s decision. The PTAB decision was appealed again to the Federal Circuit. The Federal Circuit affirmed both the PTAB and patent examiner decisions. The institute was not granted the patent on mammalian clones; though from a scientific perspective Dolly is the result of research and ingenuity, from a legal perspective, it is a patent ineligible clone.
In its opinion, the Federal Circuit reasoned that unlike patent applicants in previous life science patents cases, Roslin Institute “did not create or alter any of the genetic information” because the cloned animal is genetically identical to one existing in nature. Therefore, according to the Federal Circuit’s opinion,
Dolly herself is an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature… Dolly’s genetic identity to her donor parent renders her unpatentable.
If in accordance with the U.S. Constitution, Article 1, Section 8, Clause 8, patent law indeed recognizes and incentivizes scientific advances and innovation, this case reveals an interesting conflict with respect to the life sciences: one between what is perceived as scientifically innovative as opposed to what qualifies as legally innovative and awarded patent protection.
Further, this case sets an especially challenging precedent for the scope of patentability of products in regenerative medicine. If, at least in part, regenerative medicine and stem cell research intend to treat and cure disease by mimicking biology and nature, then innovators in the field will have to consider what aspects of their products are patent protectable in light of Sections 101-103 standards of patentable subject matter and obviousness. Alternatively, those in the field may be forced to rely on alternative economic incentives and funding to take their products to the market, and provide patients with novel, disruptive therapeutics.
(1) Article 1, Section 8, Clause 8 of the U.S Constitution expresses that patent law recognizes and incentivizes scientific advances and innovation
(2) Section 101 is the codified law that sets the standard for what is patent eligible subject matter, or more simply put, what can be protected by patent rights.
(3) Section 102 is the codified law that further qualifies what is necessary of innovations to be patent eligible, namely establishing a standard of novelty for innovations that seek patent protection.
(4) Like section 102, section 103 sets an additional qualifier of patent law: obviousness, whereas to be patent eligible, innovations need to be non-obvious with respect to the prior art (or prior research/patents/disclosed work) that has been done in the field of interest.
Umeet has been an SSSCR member since 2012, previously serving as the Conference Chair and President of SSSCR-Berkeley, and presently sitting on the SSSCR International Executive Committee. Passionate about the intersections of science, law, and technology, Umeet graduated from UC Berkeley with BAs in Molecular and Cell Biology and Legal Studies. In the past, Umeet has conducted research both in the lab and in empirical legal studies. Currently, Umeet is working as a Litigation Paralegal at Computerlaw Group LLP before heading off to law school. In her free time, Umeet likes to dabble in programming and data science over a cappuccino.