1. CRYPTIC PATENT REFORM THROUGH THE INFLATION REDUCTION ACT
- Author
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Rai, Arti K., Sachs, Rachel E., and Price, W. Nicholson, II
- Subjects
Pharmaceutical laws -- Evaluation -- Research ,Patent law -- Evaluation -- Research ,Medicare -- Laws, regulations and rules -- Research ,Biological products -- Laws, regulations and rules -- Intellectual property ,Patentability -- Laws, regulations and rules -- Research ,Price control -- Evaluation -- Research ,Trade secrets -- Laws, regulations and rules -- Research ,Government regulation ,High technology industry ,Law ,Inflation Reduction Act of 2022 - Abstract
If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes--and it's not a hypothetical question. The Inflation Reduction Act ('IRA') does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry's ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as 'evergreening,' but legislators have not been receptive to calls for reform. The IRA may just succeed in changing that pattern, at least to some extent, by imposing drug pricing reforms that alter the incentives for evergreening in the first place. In this Article, we lay out the case that the IRA contains implicit reforms to the pharmaceutical patent system. Its details are not straightforward, nor is its implementation, but its effects could nevertheless be major. Drug patent reform, a longtime priority for activists and scholars, may in fact have already happened., TABLE OF CONTENTS I. INTRODUCTION 58 II. THE INFLATION REDUCTION ACT'S CHANGES 65 A. The IRA's Three Reforms 65 B. Impacts Outside Medicare 68 III. IMPACTS ON PATENT ASSERTION 72 [...]
- Published
- 2023