Name of author: Khyati Deshmukh (LLM student at National Law University, Jodhpur)
Name of author: Gauresh Chaudhary (LLM student at National Law University, Jodhpur)
Patent conception doctrine, Biotech patent strategy, IP case analysis, Patent interference law, Innovation policy
Introduction
The billion-dollar question of who owns Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) gene-editing technology remains unresolved following the recent ruling of the US Federal Circuit in the case of Regents of the University of California v. Broad Institute, Inc. where it overturned PTAB’s 2022 decision and remanded the matter back. The dispute involves the University of California (Regents) and the Broad Institute (Broad) as major parties embroiled in a lengthy dispute. At stake is who first conceived the application of the CRISPR Cas9 system, which precisely cuts and edits DNA sequences in living cells. Both parties claim they were the first to conceive the CRISPR technology in eukaryotic cells.
The dispute concerns who first conceived the CRISPR-Cas9 system in eukaryotic cells. The Regents filed their provisional application in May 2012, claiming a broad CRISPR application. The Broad Institute, filing later, was first to demonstrate actual success in eukaryotic cells, leading to competing priority claims. In its 2022 decision, the PTAB misapplied the fundamental concept of conception.
In this high-stakes dispute, the misapplication of patent law concepts shows how patent doctrines struggle with cutting-edge biotechnology. The case reveals procedural errors and raises questions regarding the legal system’s adaptability to govern technologies that can alter the code of life itself.
PTAB’s Problematic Analysis
The Patent Trial and Appeal Board (PTAB) erroneously held that Regents failed to demonstrate the conception of CRISPR technology in the first place. According to them, establishing that an inventor conceived an invention requires demonstrating a clear understanding of how the invention would be implemented in practice. The PTAB essentially combined the concept of conception with reduction to practice. Both parties, on various issues, appealed against the decision of the PTAB. The Federal Circuit held that the PTAB erred by conflating the concept of conception with reduction. Citing various case laws, it was held that PTAB overlooked whether the Regents were using routine methods or skills when they came up with the invention. The Federal Circuit clarified that conception requires a definite idea of invention with knowledge exceeding “general hope” but less than scientific certainty.
The PTAB held that the Board deserves conception priority because Regents’ scientists had doubts and saw experimental failures after their May 2012 filing. According to PTAB, this extensive research by Regents’ scientists meant that complete conception did not exist. However, the Federal Circuit, relying on Sewall v Walters has held that “the existence of research or experimentation does not necessarily indicate, by itself, that complete conception did not exist.” As per the court, without determining if Regents’ scientists employed routine methods during conception, declaring their later experiments as extensive was a legal error. For these reasons, the Federal Circuit remanded the matter to PTAB.
Legal Analysis
Patent conception requires complete mental formulation in the inventor’s mind. As per Burroughs case, the inventor must have a definite, permanent idea such that only ordinary skill is necessary to reduce the invention to practice. Priority derives from the conception date, not from the experimental success. With this distinction, priority goes to the person who was first to conceive. The reason why both parties claim that they were the ones who first came up with the application of CRISPR technology because the party that wins the conception priority gets earlier patent rights, a stronger position in licensing negotiations, control over fundamental CRISPR technology, and the ability to charge royalties or exclude competitors.
According to the PTAB, continued experimentation by the Regents’ scientists showed the lack of complete conception. The Federal Circuit was proper in holding PTAB in error here because PTAB essentially required the conception to be proven by successful reduction to practice. Instead of looking at later doubts, the PTAB should have analysed whether Regents described a routine method to a person skilled in the art at conception. They should have assessed whether the standard techniques were sufficient for a skilled person to carry out the invention and whether the Regents had demonstrated any successful results with the originally described procedures. The Federal Circuit emphasised that conception occurs when an inventor has a complete idea that could be implemented using a routine method. Later experimental difficulties or doubts do not negate earlier conception if the original concept required only a routine method known to a person skilled in art. This prevents patent law from requiring working prototypes. It helps to focus on the novel idea and not the routine implementation.
Priority Rights and Global Market
Both parties subsequently filed Patent Cooperation Treaty (PCT) applications to obtain European patents. In 2020, the European Patent Office revoked patent EP 2771468 filed by Broad Institute for lack of novelty. The reason behind the revocation was intermediate prior art becoming relevant due to a failed priority claim, as there were discrepancies in the names of the applicants. Under the US Provisional application, four people were named as applicants by the Broad. Based on a US provisional application, a PCT application was filed to claim priority date from the US provisional application.
Under the European Law, all the applicants from a priority document must be named in a subsequent application, or if anyone is not mentioned, then a valid transfer of rights must happen. If proper procedure is followed, then intermediate prior art published between the provisional and PCT application remains irrelevant. However, the PCT application filed by Broad did not include a fourth party, which became a fatal flaw resulting in the loss of priority as intermediate prior art became relevant. Without a valid priority, this prior art became earlier than the effective filing date, destroying the novelty of Broad’s claims. While the Broad found fortune in US proceedings but the Regents hold all the first-generation patents on CRISPR Cas9 systems in Europe currently.
While the Federal Circuit’s conception doctrine reflects American principles of patent law, the European Patent Office follows a strict first-to-file system where to claim valid priority, all applicants must be mentioned in subsequent applications. In India, Section 10(4) of the Patents Act requires that specifications must fully and particularly describe the invention. This sets a standard higher than the US’s routine method doctrine. Section 3(d) of the Patents Act requires enhanced efficacy beyond routine adaptations, which can exclude certain CRISPR-related patents entirely. However, India’s pre and post-grant opposition systems work more efficiently and faster than lengthy US interference proceedings.
Policy Implications for Access and Innovation
CRISPR technology is one of the most significant biotechnology inventions of the 21st century. India, under Section 84 of the Patents Act, can grant compulsory licenses for such technologies (as done in Nexavar case); however, in the Seba P.A. decision, the Supreme Court has held that Section 84 must be used cautiously in light of international ramifications under trade-related pushbacks under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. CRISPR’s complex patent thicket can impede access to affordable gene therapies, making the compulsory licensing mechanism increasingly relevant for India’s healthcare policy.
CRISPR disputes show the need to regulate emerging technologies like synthetic biology. Patent laws were initially developed for mechanical inventions, which may require a fundamental overhaul. Patent laws must be developed to adapt to fast-changing biological innovations that blur the discovery-invention boundaries.
Conclusion
Although the revision of PTAB’s analysis by the Federal Circuit safeguards the core of patent law, it also underscores the difficulties in adapting traditional principles to emerging technologies. The results and incentives in global healthcare will be shaped by the integration of rapidly evolving technologies with the doctrine of conception, international filing strategies, and affordable access.
The resolution of this decade-long dispute will impact the commercialisation of CRISPR technologies and the broader frameworks governing transformative biotechnologies. This case highlights how crucial it is for developing countries like India to adapt their patent systems to reward innovation and balance access to affordable healthcare. Legal doctrines must evolve as quickly as the sciences they seek to regulate in this age of transformative biotechnology.