TY  - GEN
N2  - There is a widespread perception that drug prices in the U.S. are much higher than they should be, and that the problem is only getting worse. Critics argue that the pharmaceutical industry is improperly gaming the system in a manner that takes advantage of legal loopholes and administrative limitations to the detriment of patients and third-party payers. Both houses of Congress responded in 2019 with a slew of hearings focused on pharmaceutical pricing, and dozens of bills have been introduced that would attempt to bring down the cost of drugs. Much of the discussion, and some of the proposed legislation, is aimed particularly at the oft-stated claim that drug companies are “evergreening” the patent protection on their products, thereby delaying generic market entry and the lowering of prices assumed to flow from generic competition. The present Article examines some recent legislative proposals aimed specifically at the perceived problem of pharmaceutical evergreening. To provide context, the Article begins by reviewing some of the academic literature and other commentary that would lend support to these efforts. The Article also provides this author’s own analysis and commentary of the proposed legislation, which generally concludes that the legislative proposals are largely misguided, and, if enacted, would be likely to cause more harm than good by discouraging innovation in pharmaceuticals without effectively addressing the core concerns. Instead, any legislative measures taken to address evergreening should focus directly on the misuse of patents, rather than impairing the ability of innovators to patent pharmaceutical inventions irrespective of their merit and their potential to improve the human condition.
AB  - There is a widespread perception that drug prices in the U.S. are much higher than they should be, and that the problem is only getting worse. Critics argue that the pharmaceutical industry is improperly gaming the system in a manner that takes advantage of legal loopholes and administrative limitations to the detriment of patients and third-party payers. Both houses of Congress responded in 2019 with a slew of hearings focused on pharmaceutical pricing, and dozens of bills have been introduced that would attempt to bring down the cost of drugs. Much of the discussion, and some of the proposed legislation, is aimed particularly at the oft-stated claim that drug companies are “evergreening” the patent protection on their products, thereby delaying generic market entry and the lowering of prices assumed to flow from generic competition. The present Article examines some recent legislative proposals aimed specifically at the perceived problem of pharmaceutical evergreening. To provide context, the Article begins by reviewing some of the academic literature and other commentary that would lend support to these efforts. The Article also provides this author’s own analysis and commentary of the proposed legislation, which generally concludes that the legislative proposals are largely misguided, and, if enacted, would be likely to cause more harm than good by discouraging innovation in pharmaceuticals without effectively addressing the core concerns. Instead, any legislative measures taken to address evergreening should focus directly on the misuse of patents, rather than impairing the ability of innovators to patent pharmaceutical inventions irrespective of their merit and their potential to improve the human condition.
T1  - Congress Should Decline Ill-Advised Legislative Proposals Aimed at Evergreening of Pharmaceutical Patent Protection
AU  - Holman, Christopher M.
LA  - eng
ID  - 42120
KW  - Patent
KW  - Drugs
KW  - Legislation
KW  - Evergreening
KW  - Patent thicketing
TI  - Congress Should Decline Ill-Advised Legislative Proposals Aimed at Evergreening of Pharmaceutical Patent Protection
LK  - https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3593954
UR  - https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3593954
ER  -