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Professor and Associate Dean Erika Lietzan spoke at a conference hosted by the EIRA Initiative and the Berkeley Policy Institute.
At the conference, entitled “Bringing Medicines to Life: How IP Impacts Innovation in the Life Sciences,” Professor Lietzan presented a new book chapter entitled “Evergreening’s Empirical Chasm.” For more than two decades, policymakers have been told that pharmaceutical innovators companies engage in a practice that is called, disparagingly, “evergreening.” The basic idea is that companies introduce new versions of their drugs that have later expiring patents or regulatory exclusivity. This way, the claim goes, the companies effectively block generic entry for years or decades longer than Congress intended and than is socially desirable.
Professor Lietzan’s book chapter builds off several prior papers that engage with the scholars and advocacy organizations that allege evergreening. It explains why these allegations cannot be squared with the regulatory framework governing new drug approval, or the way patents and exclusivities work and intersect with that framework. It also describes the gap between allegations of evergreening and the data offered to support those allegations.
Initially, this chapter argues, these claims were supported by poorly researched anecdotes. In the last decade, some scholars and advocacy organizations have published papers that purport to provide empirical support for the evergreening accusation. But these empirical studies do not bridge the gap from proof of innovation to proof that generic drugs are blocked from the market. Indeed, studies consistently show generic drug approval and launch 12 to 14 years after the FDA first approves a new molecular entity, even while innovators continue to innovate with their molecules. Adding to her prior work, which has focused on supposed evergreening with small molecule drugs, this new chapter illustrates that evergreening allegations about biological drugs similarly miss the mark.
The EIRA Initiative seeks to inform innovation policy in the biopharmaceutical ecosystem by building an intellectual community committed to evidence-based approaches grounded in a “common sense” appreciation of the practical realities of real-world business environments and the unique technological and regulatory characteristics of the biopharmaceutical market.