The Federal Circuit recently issued a split panel decision on induced infringement. The court's decision is important in that it may, if upheld upon further appeal and not distinguished by subsequent courts, limit the ability...more
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more
When a new drug is first approved by the U.S. Food and Drug Administration (FDA), the drug is entitled to a period of market exclusivity. For a subset of these new drugs, the FDA will determine that the product has the...more
Drug Approval and Patent Listing Process -
Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more
On May 28, 2015, the U.S. District Court for the District of Columbia vacated and remanded the U.S. Food and Drug Administration's (FDA) administrative decision denying five years of new chemical entity exclusivity for Amarin...more