The biologics manufacturing patent notice challenge: a comparative examination

In a recent study, we created and analyzed a novel dataset of US biologics manufacturing patents held by nine leading firms that produce originator therapeutic proteins. Here, we expand our data and analysis to encompass not simply US patents but also their family members, with the total set constituting a substantially broader group of patents held internationally. Our wider focus allows us to compare firm strategies in the USA and other jurisdictions. We also contrast the strategies of US-based firms with those headquartered in Europe. Unlike prior comparative studies, which focus primarily on litigated patents, we assess a broader competitive landscape. Our analysis yields several findings. First, all nine firms accumulate many more biologics patents in the USA than in jurisdictions like Europe and Japan. They do so in part by accumulating large numbers of patents with claims of varying scope over a long time period within a given US family. Second, we show distinct patterns of patent accumulation based on firm type. US-based firms with origins in biologics research and development (R&D) that continue to have internally focused R&D efforts dominate patent accumulation not only in the USA but also in Europe and Japan. In contrast, firms that make small molecules in addition to biologics secure fewer patents, regardless of their location. As a detailed illustration of patent practice, we provide a case study of Regeneron's Eylea. Overall, our findings indicate a substantial notice challenge for biosimilar entry and provide support for reform that increases transparency and information flow regarding biologics patents generally, and manufacturing process patents specifically. Our results also support mechanisms for reducing the anti-competitive impact of large patent families, such as limitations on the number of late-filed patents within a family that can be asserted against biosimilar firms.