WASHINGTON — The Association for Accessible Medicines and the Biosimilars Council has released a white paper, Serial Patent Litigation Problems and Solutions, which analyzes the increasingly common practices used by brand drug manufacturers to stymie lower-cost generic and biosimilar versions of their medicines from entering the market, denying patients options as well as significant savings.
“Serial patent litigation delays patient access to more affordable medicines,” said John Murphy III, president and CEO of AAM. “Congress should take action now to streamline patent litigation and ensure that it does not serve as a barrier to generic entry.”
The white paper outlines ten case studies of specific medications hindered by serial litigation. Serial patent litigation is a problem plaguing the pharmaceutical industry, delaying generic competition and inflating drug prices. Brand pharmaceutical companies leverage held-back or later-issued patents to file multiple successive actions against generic companies, giving them multiple opportunities to block competition. This greatly benefits brand companies, as they can readily obtain and assert a large number of related patents at a relatively low cost. Serial patent litigation significantly harms generic manufacturers, as well as patients and payors, as the availability of lower-cost, lifesaving generic medications is significantly delayed.
Serial patent litigation allows brand pharmaceutical companies to undermine the Hatch-Waxman law and one of Congress’ key goals to speed up the introduction of low-cost generic drugs to market. Legislative solutions are urgently needed to address the substantial harm that has impacted—and will continue to impact—both generic pharmaceutical companies and American patients.
