Citizens’ petitions

To clarify some of these issues (but not all), the FTC staff has submitted a Citizen Petition to the FDA that seeks guidance concerning the criteria that a patent... 

Appendix F contains a copy of the FTC Staff Citizen Petition, available at... 

Chapter 6 FDA Citizen Petitions and Generic Drug Applications... 

This chapter reviews FDA regulations concerning the use of citizen petitions. It also examines the citizen petitions that brand-name companies have filed about drug products in this study, and discusses their effect on the development of generic drug competition for these drug products. 

The FDA has generally resolved the issues raised by the citizen petitions that brand-name companies file about drug products in this study in a timely manner, and in most instances prior to a distriet eourt ruling on the merits of the patent infringement litigation. Thus, for drug products in the study, eitizen petitions that have been answered by the FDA have not delayed generic competition. 

No general conelusions about the use of citizen petitions can be drawn from this study, however, because it did not examine citizen petitions filed in eonnection with AND As that contained paragraph I, II, or III certifications. Citizen petitions may have a greater potential to delay generic competition in those cireumstances, in which no 30-month stay would be applicable. 

Improper petitioning may be appealing in part because it can be used against any size firm, regardless of relative resources of the parties. The cost of filing an improper citizen petition maybe trivial compared to the value of securing a delay in a rival s entry into a lucrative market. ... 

Comment of the Staff of the Bureau of Competition and the Office of Policy Planning of the Federal Trade Commission, Citizen Petitions Actions That Can be Requested by Petition Denials, Withdrawals, and Referrals for Other Administrative Action, FDA Docket No. 99N-2497 (Mar. 2, 2000) (FTC Staff Comment on Citizen Petitions). 

One of the recommendations in the FTC Staff Comment on Citizen Petitions was that the FDA consider requiring notification of whether the citizen petitioner has received, or will receive, consideration for filing the citizen petition and identification of the party furnishing the consideration. This information may be important in evaluating the competitive effect of the petition. 

The Use of Citizen Petitions About Drug Products for Which an ANDA Containing a Paragraph IV Certification Was Filed... 

For 11 of the 12 drug products covered by citizen petitions, the brand-name company that had filed the citizen petition also had either settled the patent infringement litigation with an agreement that contained a brand payment see Chapter 3), filed a late-issued patent to obtain a second 30-month stay see Chapter 4), or has patent litigation pending in which the brand company has claimed the ANDA infringes more than one patent see Chapter 4). 

Table 6-1 Brand-Name Company Use of Citizen Petitions...

Almost 50 percent of the citizen petitions requested that the FDA require additional bioequivalence studies before approving the generic applicant s ANDA. 

In the 5 cases in which the FDA ruled on the merits of the bioequivalence issues raised by the petition, it did so prior to a district court ruling on the merits of the infringement litigation and prior to the expiration of the 30-month stay. Thus, the filing of the citizen petition in these cases did not affect the generic product s entry. 

In the second category of citizen petitions described in Table 6-1, brand-name companies requested the FDA refrain from approving a generic version of the drug product unless the generic company certified... 

The FDA denied both of these petitions. In each case, the brand-name company had sued the generic applicant for patent infringement, and the citizen petition was resolved by the FDA within the 30-month stay period. Thus, the petition had no effect on the timing of generic drug approval. 

The last 4 citizen petitions dedt with issues unique to the underlying drug product. In one case, the petition was withdrawn, in another the FDA responded to the petition in an informal manner that satisfied the parties involved, in the third instance, the petition was denied, and in the fourth case, the petition was pending as of June 1, 2002. In the first 3 cases, the... 

The citizen petitions related to drug produets in the study that have been resolved did not affect the timing of generie entry. 

FTC Staffs Citizen Petition on the Listability of Certain Patents in the Orange Book... 

The Bureau of Competition and Policy Planning Staff of the Federal Trade Commission ( FTC ) submit this Citizen Petition to the Commissioner of Food and Drugs pursuant to 21 C.F.R. 10.25(a) and 10.30 concerning certain issues relating to patent listings in the FDA s Approved Dmg Produets with Therapeutic Equivalence Evaluations (the Orange Book ). We request that the FDA clarify these issues, on an expedited basis, via industry guidanee or other means that the FDA considers appropriate. 

Whether a brand-name company may appropriately list polymorph patents, or those claiming a use or formulation containing a polymorph, could be clarified through FDA regulation or guidance. This is the subjeet of the FTC Staff s Citizen Petition. 

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