The Orange Book

CD-R (CD-recordable) is a writable, nonerasable disk, also called CD-WORM or CD-WO (CD-write once). Permanent marks are produced by a focused laser beam. The definition of the CD-R format and of the erasable—rewritable EOD /MO-R format is put down in the Orange Book (Philips/Sony). 

J. Inczedy, T. Lengyel, A. M. Urc, A. Gelencser, and A. Hulanicki. Compendium of Analytical Nomenclature (The Orange Book). 1997. Available at http //www.iupac.org/publications/ analytical compendium/. 

United Nations 1999. Recommendations on the Transport of Dangerous Goods, Test and Criteria (the Orange Book), 3rd Edition. 

Recommendation 1 Permit only one automatic 30-month stay per drug product per ANDA to resolve infringement disputes over patents listed in the Orange Book prior to the filing date of the generic applicant s ANDA. 

Yes. If a brand-name company lists an additional patent in the Orange Book after the generic applicant has filed its AND A, more than one 30-month stay may be generated. The generic applicant is required to re-certify to this later-listed patent, and if, upon notice of the generic s re-certification, the brand-name company sues within 45 days, then FDA approval of the generic s previously filed ANDAis stayed for an additional 30-months from the notice date or until a court decision in the newly instituted patent litigation. 

From 1992 through 2000, brand-name companies have listed patents in the Orange Book after an ANDA has been filed for the drug product in 8 instances 6 of these 8 instances occurred since 1998. For the 8 drug products, the additional delay of FDA approval caused by the additional 30-month stay (beyond the first 30-month stay) ranged from 4 to 40 months. In all 4 of the... 

As a result, there is no mechanism to delist an improperly listed patent from the Orange Book. The laek of such a mechanism may have real world consequences in that the Commission is aware of at least a few instanees in which a 30-month stay was generated solely by a patent that raised legitimate listability questions. 

Thus, the usual patent protections would remain for hrand-name companies whose patents may he listed in the Orange Book after the filing of a generic applicant s ANDA solely hecause it took a long time for the Patent Office to issue the patent. 

Id. at 355(j)(2)(B). Although the patent holder and the NDA filer are often the same person, this is not always the case. The Hatch-Waxman Amendments require that all patents that claim the drug described in an NDA must be fisted in the Orange Book. Occasionally, this requires an NDA filer to list a patent that it does not own. 

Out of 40 drug products in Table 2-4, 11 drug products had at least one patent listed in the Orange Book that was... 

See Chapter 4 for a full discussion of multiple 30-month stays. Both suits on the later-issued patents raised questions whether the patents should be listed in the Orange Book. 

Moreover, most of the later-issued patents in the Orange Book raise questions about whether the FDA s patent listing... 

The FDA has adopted regulations governing the types of patents that can be listed in the Orange Book. The listing regulation is separated into 6 subsections below for ease of reading. Specifically, the brand-name company must list in the Orange Book each patent which ... 

Several generic applicants have attempted to obtain court orders requiring the FDA or brand-name companies to delist certain patents from the Orange Book. 

The FDA has stated that it laeks the resources and the expertise to review patents submitted with NDAs. The ageney does not ensure that a submitted patent elaims the approved drug before listing it in the Orange Book. Moreover, the FDA has deelined to enaet any administrative proeedures for resolving listing disputes. If a party disputes the accuracy of a listed patent, it may notify... 

Box 4-2 Private Parties Have No Right to Seek the Deiisting of a Patent in the Orange Book... 

The issue of whether a generic applicant could seek to delist a patent fiom the Orange Book was recently addressed in a court decision regarding BuSpar. Bristol-Myers Squibb ( BMS ) had listed one patent in the Orange Book relating to buspirone (Patent No. 

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