Orange Book News Today

This week in Other Barks and Bites: the D.C. Court of Appeals finds that the Administrative Procedures Act waives sovereign immunity in the context of copyright rule promulgation; the U.S. Chamber of Commerce calls out Bernie Sanders for abusive subpoenas targeting a pharmaceutical executive at Novo Nordisk; and more.

For those hoping for a quick answer to whether generics will be able to enter the market, it looks like it will take a Federal Circuit decision, probably by the end of 2026 at the earliest.

Two prominent congressional Democrats this week wrote to eight pharmaceutical company CEOs, urging them to remove 130 patents from a government registry.

Obesity takes a staggering toll on patients, public health and our nation's health care system, including the Medicare and Medicaid programs.

Manufacturers of brand-name drugs will try every tack to delay generic entry, experts say

The full Senate Judiciary Committee met today to discuss ways to make U.S. prescription drugs more affordable, with a focus on the role patents play in high drug prices.

The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration's (FDA) publication of "Approved Drug Products with Therapeutic Equivalence Evaluations...

Brand pharma companies invest valuable resources, time, and money in moving drugs from development to FDA approval. The new drug approval may also enjoy some type of FDA exclusivity.

The FTC crackdown comes six months after the regulator challenged drugmakers in a similar fashion.

On April 30, 2024, the FTC issued a press release and warning letters to ten pharmaceutical companies notifying them that the FTC had “availed [themselves] of the FDA’s regulatory...