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HHS/FDA RIN: 0910-AC48 Publication ID: Spring 2003 
Title: Applications for FDA Approval To Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications 
Abstract: The final rule would clarify the types of patents for which information must or must not be submitted to FDA. The final rule would also revise the patent declaration to make it more detailed. The rule would also revise the regulations regarding the approval date for certain abbreviated new drug applications or "505(b)(2) applications" by stating that there is only one opportunity for a 30-month stay in the approval date of an ANDA or 505(b)(2) application. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 314.52(a)(3)    21 CFR 314.53(b)    21 CFR 314.53(c)(1)    21 CFR 314.53(c)(2)    21 CFR 314.95(a)(3)   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 355a    21 USC 356    21 USC 356a    21 USC 356b    21 USC 356c    21 USC 371    21 USC 374    21 USC 379e   
Legal Deadline:  None

Statement of Need: In recent years, FDA has seen new drug application (NDA) applicants submit patent information to FDA shortly before other patents for the drug are to expire. Disputes have arisen whether the later-filed patents are appropriately submitted to FDA. The Federal Trade Commission (FTC) has also asked FDA to clarify whether NDA applicants can or should list various types of patents at FDA. The FTC has also issued a report questioning whether NDA applicants have used later-filed patents to seek unwarranted delays in the approval of generic drugs.

Summary of the Legal Basis: The principal legal authority for this rule is found at sections 505 and 701 of the Federal Food, Drug, and Cosmetic Act (the Act). Section 505(b) of the Act describes the contents of an NDA and 505(b)(2) application, including the patent listing and patent certification requirements. Section 505(j) of the Act describes the contents of an ANDA, including patent certification requirements. Both sections 505(c) and 505(j) of the Act also describe the 30-month stay of approval dates for ANDA's and 505(b)(2) applications if the ANDA or 505(b)(2) application applicant had certified that a patent was invalid or would not be infringed, and a timely suit for patent infringement ensued. Section 701(a) of the Act gives FDA the authority to issue regulations for the efficient enforcement of the Act.

Alternatives: With respect to patent listing, one alternative would be to remain silent and defer to NDA applicants as to the appropriateness of any particular patent. This alternative, however, would not deter the submission of inappropriate patent information and could lead to unnecessary patent disputes between patent owners, NDA holders, and ANDA or 505(b)(2) application applicants. As for the 30-month stay, there are alternative arguments to justify a single 30-month stay, but those alternative theories could also result in no notice to the patent owner or NDA holder and no opportunity for even a single 30-month stay. Such results would be contrary to the Act's desire to balance generic drug approvals against a need to preserve incentives for innovation. Another alternative would be to continue allowing multiple 30-month stays, but this would have the effect of delaying the introduction of generic drugs into the market.

Anticipated Costs and Benefits: The one-year benefits of the regulation will include the increase in revenues to generic firms and the savings to consumers from the earlier availability of less expensive pharmaceuticals. The estimated total one-year benefit is approximately $3.2 billion. Adjusting this benefit to account for the expected increase in baseline pharmaceutical expenditures, the total benefit for the years 2002 through 2011 is expected to be approximately $53.9 billion. Eliminating multiple 30-month stays per ANDA will prevent delays in generic drug competition. Generic drug companies gain through additional sales, and, to the extent that generic prices are lower than innovator prices, consumers benefit from the "price gap." While the quantified benefits do exceed the quantified costs, this rule has the additional important benefit of preserving the balance struck in the Hatch-Waxman amendments.

Risks: The regulation would deter misuse of the patent listing and patent certification process to obtain unwarranted, multiple 30-month delays in the approval of an ANDA or 505(b)(2) application. Court decisions indicate that ANDA applicants and 505(b)(2) applicants have no private right of action to have inappropriate patents removed from FDA's lists, and the FTC report suggests that some patents submitted to FDA have been inappropriately listed.

Action Date FR Cite
NPRM  10/24/2002  67 FR 65448   
NPRM Comment Period End  12/23/2002    
Final Rule  05/00/2003    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Jarilyn Dupont
Director of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
WO Building 32, Room 4245, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-4830
Fax:301 847-3541

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