Evergreening: A common practice to protect new drugs

Nature Biotechnology

Volumn 29, Issue 10, 2011, Pages 876-878

  Gaudry, Kate S ^a  

^a HARVARD LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FLUTICASONE PROPIONATE; NEW DRUG;

AEROSOL; ARTICLE; COST; DRUG APPROVAL; DRUG FORMULATION; DRUG INDUSTRY; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HUMAN; PATENT; PRIORITY JOURNAL; UNITED STATES;

DRUG APPROVAL; DRUG INDUSTRY; PATENTS AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80054730840     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.1993     Document Type: Article

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3. 35 USC §§ 102-103.
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5. S ee 35 USC §§ 102-103.
6. United States Patent and Trademark Office. US Dept. of Commerce, Manual of Patent Examining Procedure § 800 (8th ed., 8th rev. 2010) (hereinafter MPEP
7. MPEP § 2701.
8. 21 USC § 355(j)(5)(F)(ii
9. 21 USC § 355(j)(5)(F)(iii
10. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Exclusivity Codes (FDA, 2011). http:// www.accessdata.fda.gov/scripts/cder/ob/docs/excltermsall.cfm
11. 21 CFR § 355(c)(3)(E)(iv
12. 21 USC § 360(aa)-(cc
13. 21 USC § 355a.
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16. Department of Health and Human Services, Letter to Katherine Gaudry. (Freedom of Information Act Request No. 2010-6543), Jan. 17, 2011.