The court noted that the Supreme Court construed “patented inventions” as used in the Hatch-Waxman Act to mean instrumentalities that are subject to premarket approval. Here, the patentee ...

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 ...

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

Under provisions in the Hatch-Waxman Act, the FDA permits marketing of generics for older indications that no longer have patent protection, even if the brand-name drug develops new, patented uses.

thus providing the company with additional protection under the Hatch-Waxman Act. This comes on top of the market exclusivity granted by Orphan Drug Designation in both the U.S. and Europe.

The company also asserts that, under the Hatch-Waxman Act, Liquidia’s decision to file an amendment instead of a new NDA allowed it to avoid a potential 30-month stay on approval for PH-ILD.