Reimagining Drug Development: Moving Beyond Patents
By Max Morgan
The pharmaceutical industry has faced a crisis of declining productivity in recent years. The number of new drugs coming to market has decreased, even as research and development costs soar. As a result, pharmaceutical companies have increasingly shifted their focus away from truly novel innovation for critical health needs, in favour of developing lower-risk "me-too" drugs for validated biological targets and existing disease indications.
In our article, my co-author Richard Gold and I argue that a major reason for this decline in productivity is the conflict between the current intellectual property system and the increasing need for collaboration in drug discovery. Patents and trade secrets, the primary tools used by drug firms to protect their innovations, create silos that hinder collaboration and information sharing. This not only impedes the formation and management of collaborative efforts but also leads to negative spill-over consequences for society, such as increased research duplication, delays in progress, and a lack of access to crucial information and data.
We believe there's a better way. We advocate for a shift away from patents and trade secrets towards regulatory exclusivities as the primary commercial incentive for drug development. Regulatory exclusivities like ‘new chemical entity’ exclusivity (NCE) and orphan drug exclusivity (ODE), granted by bodies like the FDA and EMA, offer a range of advantages. Like patents, they protect innovative new products from generic competition, but they are also less costly to obtain, maintain, and enforce, and they offer a certain period of market protection regardless of the development timeline for a new drug. Most crucially, regulatory exclusivities are not invalidated by prior sharing or public disclosure of research data and outcomes. This enables the initiation and governance of open collaborations that better promote research efficiency and better align with social justice goals by encouraging knowledge sharing while preserving a commercial incentive mechanism.
To make the transition away from patents and secrecy a reality, we propose a two-pronged policy approach. First, governments should actively support and fund public-private partnerships focused on discovering and developing drugs for unmet health needs that are ignored by private investors and poorly served by proprietary development incentives. These needs include for example treatments for rare, pediatric, and tropical diseases, antimicrobial-resistant pathogens, and emerging viruses of pandemic potential. These partnerships should be mandated to adopt open science practices that enhance social welfare while prioritizing regulatory exclusivities over patents and secrecy as assets for commercial translation.
Second, to incentivize broader adoption of this model on a voluntary basis, governments should offer stronger and longer regulatory exclusivities to sponsors who forgo patents and trade secrets and openly disclose data and outcomes during development. FDA and other national bodies should offer strong regulator-enforced exclusivity rights over data during the pre-approval period for sponsors who make their preclinical and clinical data available for third-party research use within a reasonable time after study completion. Sponsors who have done so should also enjoy a longer period of exclusivity following product marketing authorization, designed to roughly align with typical patent monopolies. As policy levers, governments could choose to further lengthen a sponsor’s exclusivity period in areas of significant unmet therapeutic need or in exchange for commitments on pricing and access to promote early widespread adoption of new treatments.
We believe these policy changes have the potential to revolutionize drug development, making it more efficient and equitable. By strategically combining approaches that target both unmet health needs and improve general drug development, we can create a pharmaceutical ecosystem that prioritizes both true innovation and the public good.
Read the full article here.