Patent Litigation and the MRD Testing Market: Strategic IP Management as a Catalyst for Innovation

The molecular residual disease (MRD) testing market has emerged as a critical battleground for innovation in oncology, with patent litigation shaping both competitive dynamics and technological progress. Over the past three years, high-stakes legal disputes involving firms like Natera, CureVac, and Arbutus Biopharma have underscored the strategic importance of intellectual property (IP) in this rapidly growing sector. As the market expands—projected to grow from $2 billion in 2025 to $7 billion by 2033 at a 15% compound annual growth rate (CAGR)—companies are increasingly leveraging litigation and IP management to secure market share and drive R&D investment [1].

Litigation as a Double-Edged Sword

Patent litigation outcomes in the MRD space have had mixed effects on innovation. For smaller firms, winning a lawsuit can provide a short-term boost to R&D spending, as seen in a study of 1,062 Chinese firms where plaintiff micro and small-sized enterprises (MSEs) experienced increased breakthrough innovation post-victory [1]. However, larger firms often adopt a "patent defense strategy," using litigation to reinforce their dominance. Natera’s 2023 victory against NeoGenomics, which halted the commercialization of a competing MRD test, exemplifies this approach. The court’s decision emphasized the need to protect innovators from "irreparable harm," effectively granting Natera a de facto monopoly in a niche segment of the market [3].

Conversely, losing a patent case can paradoxically spur innovation. A 2025 study found that medium and large-sized enterprises (MLEs) often respond to litigation defeats by pivoting to incremental improvements or diversifying their IP portfolios [1]. For instance, after the U.S. Patent and Trademark Office (USPTO) invalidated three of Moderna’s mRNA-related patents in March 2025, the company reportedly accelerated its investment in alternative delivery systems, including lipid nanoparticle (LNP) modifications [2].

Strategic IP Management: Beyond Litigation

Companies in the MRD testing market are increasingly adopting nuanced IP strategies to navigate litigation risks. Natera, a leader in ctDNA-based MRD testing, has expanded its patent portfolio to include proprietary algorithms for analyzing single nucleotide variants, creating a "thicket" of overlapping protections that deter competitors [4]. This approach mirrors tactics used in the pharmaceutical industry, where firms like AbbVie employ layered patent strategies to extend market exclusivity [2].

Collaboration is another emerging trend. In 2025, Myriad Genetics and Personalis entered a cross-licensing agreement to share foundational MRD IP, reducing litigation risks while broadening access to testing. This move reflects a broader industry shift toward balancing IP rights with public health needs, particularly as MRD testing becomes a standard tool in personalized medicine [3].

Market Dynamics and Future Outlook

The MRD testing market’s growth is being fueled by technological advancements such as next-generation sequencing (NGS), digital PCR (dPCR), and AI-driven data analysis. These innovations are not only improving diagnostic accuracy but also reducing costs, making MRD testing more accessible for patients with hematological malignancies and solid tumors [1]. However, regulatory and reimbursement challenges remain significant hurdles. Companies that successfully navigate these issues while maintaining robust IP portfolios—like Natera, which recently secured a U.S. patent for ctDNA testing—are likely to dominate the market [4].

Investors should also monitor the impact of international litigation outcomes. For example, the UK’s invalidation of CureVac’s mRNA patents in October 2024 and Germany’s March 2025 ruling in favor of Moderna highlight the fragmented nature of global IP enforcement. Firms with diversified patent strategies, such as Arbutus Biopharma’s simultaneous lawsuits in Delaware and New Jersey, may gain a competitive edge in this uncertain landscape [2].

Conclusion

Patent litigation in the MRD testing market is a high-stakes game of innovation and strategy. While legal victories can provide temporary monopolies, the long-term winners will be those that balance aggressive IP management with collaborative approaches to drive broader adoption of MRD testing. As the market matures, companies that prioritize both technological advancement and strategic IP protection—while navigating regulatory and reimbursement challenges—will be best positioned to capitalize on the sector’s explosive growth.

**Source:[1] The impact of patent infringement litigation decisions on ... [https://pmc.ncbi.nlm.nih.gov/articles/PMC11464761/][2] mRNA/LNP Patent Litigation Update (Q1 2025) [https://www.jdsupra.com/legalnews/mrna-lnp-patent-litigation-update-q1-5560565/][3] Middle District of North Carolina Finds Public Interest ... [https://www.fr.com/insights/thought-leadership/blogs/middle-district-of-north-carolina-finds-public-interest-favors-granting-preliminary-injunction][4] Natera’s Intellectual Property A Strategic Advantage in the ... [https://csimarket.com/news/natera-s-intellectual-property-a-strategic-advantage-in-the-growing-genetic-testing-market-br2025-06-14180428]