HP&C’s Mike Heim featured in Law360 article analyzing the role of patent law in the drug-pricing debate
Law 360 recently interviewed Heim, Payne & Chorush co-founder and managing partner Mike Heim for an analysis examining the role of patent law and regulation in the escalating debate over drug-pricing.
The analysis by Law360 senior reporter Ryan Davis explores a number of recent legislative proposals, noting that bipartisan scrutiny is likely to increase after the elections.
Writes Law360: Members of Congress on Wednesday took a panel of pharmaceutical executives to task about their prices at a heated hearing that underscored the strong feelings on the issue. Several lawmakers have been particularly focused on the practice of so-called evergreening, where a single drug is covered by more and more patents over time, which can cause long delays in the entry of lower-priced generic versions.
A number of bills introduced last year have sought to curb that practice or make other changes to patent law that proponents say could reduce drug prices. Given the pharmaceutical industry’s political clout and the far-reaching ramifications of altering patent rules, those efforts will face major obstacles but still bear watching by drug companies and attorneys.
The concept of evergreening has frequently been a talking point among lawmakers who doubt the propriety of pharmaceutical companies getting one patent covering the compound for a drug, but then obtaining many more years of protection by getting new patents focusing on things like new dosages or methods of use… Those proposals did not advance in Congress amid questions from experts about how they would work and what impact they would actually have — yet they are unlikely to be the last word.
While direct governmental control of drug prices could pose a risk of undermining research and development, Mr. Heim noted that focused measures could improve transparency of how pharmaceutical patents are listed with regulators.
Writes Law360: [Heim] suggested that Congress could require drug companies to provide additional detail about the patents they list in the Food and Drug Administration’s Orange Book and why it covers their drug. That type of policing mechanism would make it easier to tell when a newly obtained patent is not meritorious and provide more ammunition for generics makers, Heim said.
“If there was just a more detailed certification so that people could attack it, I think that would be in itself beneficial,” he said.
Click here to read the full article (subscription required).