What is the difference between patents and exclusivity?

[oswaldosalcedo]

Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. exclusivity is a statuatory provision and is granted to an NDA applicant if statuatory requirements are met. See 21 C.F.R. 314.108. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.


Code of Federal Regulations]
[Title 21, Volume 5, Parts 300 to 499]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.108]

[Page 146-148]

TITLE 21--FOOD AND DRUGS

DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents

Subpart D--FDA Action on Applications and Abbreviated Applications

Sec. 314.108 New drug product exclusivity.

(a) Definitions. The following definitions of terms apply to this
section:
Active moiety means the molecule or ion, excluding those appended
portions of the molecule that cause the drug to be an ester, salt
(including a salt with hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex, chelate, or clathrate) of the
molecule, responsible for the physiological or pharmacological action of
the drug substance.
Approved under section 505(b) means an application submitted under
section 505(b) and approved on or after October 10, 1962, or an
application that was ``deemed approved'' under section 107(c)(2) of Pub.
L. 87-781.
Clinical investigation means any experiment other than a
bioavailability
---------------------------------------------------
Patents expire 20 years from the date of filing. Many other factors can affect the duration of a patent
---------------------------------------------------
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only).

[oswaldosalcedo]

On June 12, 1986, Eli Lilly received orphan drug status for a variant of
this product and later filed an NDA for commercial marketing.


http://www.fda.gov/bbs/topics/ANSWERS/ANS00319.html