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:
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:
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.