As we kick off a year expected to focus heavily on drug pricing, the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) held a joint listening session yesterday on the patent system for drugs—and BIO weighed in.
What’s happening: “In order to execute on the President’s drug pricing agenda, the USPTO has issued multiple federal register notices seeking comments on a great diversity of proposals to change the way patents would be examined, reviewed, and enforced,” said Hans Sauer, BIO’s Deputy General Counsel for IP.
“But while it is clear that these proposals are responsive to political narratives, the scope and contours of the underlying problems are subject to debate and poorly substantiated,” he continued.
Why patents matter: “Most of BIO’s members are small, development-stage companies that do not yet have a product on the market and that rely on robust IP rights in order to access capital, engage in partnering and licensing...” he said. “The chances of successfully developing a new therapy are less than 10%, at a cost exceeding $1B over an almost 10-year development process. Robust and reliable patent rights are crucially important if private investment in healthcare innovation is to be sustained in the face of such costs and risk.”
Correcting the record: “[N]ormalized to R&D spend biopharmaceutical companies procure fewer patents than comparable businesses in other technologies,” and biopharmaceutical patents “are invalidated less often in litigation, about 25% of the time, compared to 40-45% across all industries.”
The path forward: Dr. Sauer urged the agencies to focus their work on the realities of the patent system and obtain accurate data—read the full statement here.
More Health News:
Washington Post (Opinion): Congress should not wait around for the end of the antibiotic era
“With recent studies showing that antibiotic-resistant infections are on the rise and more lethal than previously thought, the new Congress should take on the issue, learning from the shortcomings of previous attempts to jump-start antibiotic development,” writes the Washington Post Editorial Board.
