Intellectual Property Client Alert: FDA Proposes Changes To Clarify Patent Listing Requirements and 30-Month Stays of Approval Following Submission of Abbreviated New Drug Applications
5/21/2003
The United States Food and Drug Administration (FDA) has proposed amendments to its patent listing requirements for new drug applications (NDAs). The proposal, which was published in the Federal Register on October 24, 2002, attempts to clarify the types of patents that must and must not be listed in the FDA's "Orange Book" (formally titled Approved Drug Products with Therapeutic Equivalence Evaluations) and proffers revisions to the declaration that NDA applicants must provide regarding their patents, with the aim of ensuring that NDA applicants list only appropriate patents. The proposal would also revise the regulations regarding the effective date of approval for certain applications submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FFDCA).
If the proposed changes are enacted, the playing field for "Big Pharma" and Generic Drug companies will be substantially altered.
This alert discusses the proposed rules and offers some views on what the future may hold.
