FDA Proposed Rule to Revise Hatch-Waxman Regulations

On October 24th the FDA published proposed regulations that affect implementation of the Hatch-Waxman law. These changes in part respond to recommendations in a July 2002 Federal Trade Commission (FTC) report and a Citizen Petition filed with the FDA by the FTC in May 2001. Of course, recent Congressional activity in response to high profile use of Hatch-Waxman provisions to delay market entry of some generics undoubtedly impacted the decision to propose the new rule - announced by the President in a Rose Garden ceremony.


The 1984 Hatch-Waxman Act struck a balance between the pioneers who conduct research leading to approval of new drug applications (NDAs) and the generics who make products equivalent to the pioneers' and market them at reduced prices after approval of abbreviated new drug applications (ANDAs). One of the Act's most important features is establishment of a legal structure intended to limit the uncertainty associated with patent litigation relative to when generic products could enter the marketplace. The applicable elements of the Hatch-Waxman law are:

  • Orange Book. Each NDA holder is required to identify, or "list," any patent that claims the drug or a method of using the drug and for which an action of infringement can reasonably be asserted. Listing is required when the NDA is filed or when a patent is subsequently issued. All such patent information is compiled in a collection entitled Approved Drug Products with Therapeutic Equivalence Evaluations, known as the "Orange Book."
  • Paragraph IV Certifications. As part of an ANDA, the generic applicant must certify the status of the drug for which it seeks approval in relation to patents listed in the Orange Book. The ANDA applicant may certify that no patents are listed, that the patents have expired, or that approval is sought only after their expiration. Alternatively, the ANDA applicant may certify that a listed patent is invalid or will not be infringed by the manufacture, use, or sale of the generic product. The latter is known as a "Paragraph IV" certification. An ANDA applicant is required to notify an NDA holder of any Paragraph IV certification.
  • 30-Month Stays. If a patent owner files an action for infringement against an ANDA applicant within 45 days of receiving notice of a Paragraph IV certification involving the patent, approval of the ANDA is stayed for 30 months (or such other period as the court may order). The 30-month stay protects the patent owner from the harm that could otherwise ensue from the FDA granting marketing approval to a potentially infringing product.


July 2002 FTC Report

In July 2002, the FTC released a report entitled "Generic Drug Entry Prior to Patent Expiration." The report reviewed the eight instances between 1992 and 2000 in which brand-name companies listed patents in the Orange Book after an ANDA was filed. The FTC's findings included:

  • 30-Month Stay for Litigation. The report asserted that circumstances in which a brand-name company lists a patent after the NDA has been approved (but before ANDA approval) has led to delays in generic drug entry into the market through the use of a second automatic stay. The FTC concluded that FDA approval of ANDAs has at times been extended beyond the original 30-month stay as a result of late "improperly" listed patents (some of the patents were held to be invalid or not to cover the pioneer drug). It recommends limiting innovator companies to only one automatic 30-month stay per ANDA.
  • Listability. As noted above, the 1984 law requires that patents be "listed" in the Orange Book. The FTC report analyzes three types of patents that raise "listability" questions and recommends that FDA clarify whether they meet the two-pronged statutory test for listing: (1) the listed patent claims the approved drug product or the method of using the approved drug product and (2) the listed patent is of the type with respect to which a claim of patent infringement could reasonably be made. The type of patents that the FTC asserts raise "listability" questions are:
    1. Patents that do not claim the approved drug substance, drug formulation or use e.g. metabolite patents, polymorph patents and drug intermediate patents.
    2. Product-by-process patents.
    3. Double patenting patents.
FDA Proposed Rule

The proposed rule would interpret the Hatch Waxman law to limit an NDA holder to a single 30-month stay per ANDA. The rule's rationale for this limitation is the law's requirement that an NDA holder may only be notified of a Paragraph IV certification if an ANDA is amended to "include" the certification. The proposal concludes that an ANDA that already has made Paragraph IV certification cannot be amended to "include" a Paragraph IV certification since one already exists. Thus, there would be no notification to the NDA holder and no subsequent 30-month stay would be available.

The proposed regulations also address the issue of proper patent listings and institute new patent certification statements that NDA applicants must submit. The proposed rules clarify that patents claiming active ingredients, drug formulations, methods of use and product-by-process must be listed by an NDA holder.¹ Patents that must not be listed are patents that claim packaging, metabolites and intermediates.²

The proposal also revises the declaration that must be submitted in conjunction with an NDA application. The proposed declaration is more detailed than the one required under current regulations and is designed to prevent NDA applicants and NDA holders from attempting to list inappropriate patents. As part of the requirement for submitting this declaration, the NDA holder must confirm that an ANDA application containing the same active ingredient that is claimed by the listed patent is the "same" for ANDA approval purposes.

¹ The proposal further defines "active ingredients" to include compounds that are considered "the same as" the active ingredient based on, for example, solubility, stability, and bioavailability. According to the proposed regulations "active ingredients" include different forms of a drug substance, i.e. anhydrates, hemihydrates, dehydrates and different polymorphs (different crystalline forms of the same substance).

² The FDA's proposed regulations do not address "double patenting" patents.