Paragraph IV certification

These applications are technically referred to as Abbreviated New Drug Apphcations (ANDAs) containing a paragraph IV certification. 

For ease of discussion purposes, the term generic applicant means those applicants who have filed an ANDA containing a paragraph IV certification. See Appendix A for a glossary of frequently used terms. 

Multiple 30-month stays prevented FDA approval of the generie applicants AND As for 4 to 40 months beyond the initial 30-month period. FDA approval may have occurred more quickly in the absence of the multiple 30-month stays, because the data indicate that FDA approval has occurred, on average, within 25 months and 15 days for generic applicants with paragraph IV certifications that were not sued. 

Thus, the 180-day exclusivity has been granted for 31 out of the 104 drug products for which a first generic applicant filed an ANDA containing a paragraph IV certification from 1992 through 2000. 

By contrast, the absence of such a rule also could dampen the incentive for later generic apphcants to develop ehgihle AND As containing paragraph IV certifications. 

When an applicant makes a paragraph IV certification, two additional provisions of Hatch-Waxman are implicated. These two provisions are at the heart of the FTC s study. 

The first is the automatic 30-month stay protection afforded brand-name companies. An ANDA filer that makes a paragraph IV certification must provide a notice to both the patait holder and the... 

According to the FDA, from the time Hatch-Waxman became effective in 1984 through December 31, 2000, 8,019 ANDAs were filed wifh the FDA." Of these applications, 7,536 (94 percent) raised no patent issues (i.e., the ANDAs did not contain a paragraph IV certification). A substantial portion of the total number of ANDAs, however, relate to the same brand-name product or NDA. Thus, the total number of ANDAs does not represent 8,019 unique brand-name drug products, and it is unclear as to how many unique brand-name drug products the total 8,019 ANDAs related. 

Four hundred eighty-three (483) (or six percent of the total number of ANDAs filed) contained Paragraph IV certifications. The 483 ANDAs relate to 130 unique brand-name drug products as measured by unique NDAs. The share of ANDAs with paragraph... 

In many instances, only one generic applicant had filed an ANDA containing a paragraph IV certification for a particular drug product. In these cases, special orders were served only on the first generic applicant. 

Filing of the lawsuit stays the FDA s approval of the ANDA until the earliest of (1) the date the patents expire (2) a final determination of non-infringement or patent invalidity by a court in the patent litigation or (3) the expiration of 30 months from the receipt of notice of the paragraph IV certification. This chapter reviews the frequency and outcome of these patent infringement lawsuits. 

The supply agreement was for not only the strength of the drug product for which the generic company was the first ANDA IV filer, hut also for two additional strengths of the same drug product for which it had not filed an ANDA with a paragraph IV certification. 

The initial 30-month stay is not dependent upon the number of patents for which a paragraph IV certification is made. Whether a generic applicant makes an initial paragraph IV certification with respect to one patent, or to multiple patents, only one 30-month stay will be invoked. 

To comply with this decision, the FDA has provided a Guidance for Industry that redefines eourt to be a district court. This definition applies, however, only to AND As eontaining paragraph IV eertifieations that were filed with the FDA after Mareh 2000. If a generic applicant filed its ANDA with the paragraph IV certification prior to March 2000, the definition of a court will remain the court that enters final judgment from which no appeal can be or has been taken. ... 

There may be additional drug products that have obtained a second 30-month stay that are not included within this study because the first ANDA with a paragraph IV certification was filed after January 1, 2001. See Chapter 1 for the scope of the study. 

For 2 dmg products, the generic applicant obtained a license to use the patents that were subject to the paragraph IV certification prior to the patent s expiration. The generic applicant then obtained FDA approval and began marketing the generic product that was the subject of its ANDA... 

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

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