A potent mix of bureaucratic red tape and adverse court rulings is deterring U.S. startups and small businesses from ...

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, ...

The Patent Eligibility Restoration Act (PERA) proposes a solution to a complex debate: What can be patented, and when do ...

With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent ...

The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...

Known as the Hatch–Waxman Act, the changes had two main aspects 1. The first was restoration of a period of patent protection for new drugs to compensate for the time taken for their clinical ...

The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed ...

Quince Therapeutics, Inc. , a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, announced that the U.S. Patent and ...

In 1984, the US Congress went a step further and approved the Drug Price Competition and Patent Term Restoration Act, otherwise known as the Hatch-Waxman act. The act streamlined the process of ...

She has experience in both inter partes disputes and patent prosecution in a variety of technological areas, including Hatch-Waxman filings ... the America Invents Act, representing both ...

The proposal is part of a long list of measures aimed at reducing the cost of medicines in the US in the budget, along with limits to the three-year exclusivity of the Hatch-Waxman Act ...

SOUTH SAN FRANCISCO, Calif. - Quince Therapeutics, Inc. (NASDAQ: QNCX), a biotech firm focusing on rare diseases with a current market capitalization of $67.76 million, has received a Notice of ...