Chapter 7 | Drug Patents

Question 1

What is a patent?

Answer 1

a patent is a form of personal property that provides the owner with the right to exclude others from making, using, selling, offering for sale, or importing into the United States the invention described in the patent granted

Question 2

Unlike other types of intellectual property, patents are only granted to inventions that fulfill exacting standards

Answer 2

True

Question 3

To be worthy of patent protection, the invention must have qualities that are novel, useful, and not obvious

Answer 3

True

Question 4

Patents typically expire 20 years from the date of filing

Answer 4

True

the general rule of thumb, the expiration date is usually no later than 21 years from priority

Question 5

Patents are granted by the Patent and Trademark Office at any time during the development lifeline of a drug, and can encompass a wide range of claims

Answer 5

True

Question 6

Exclusivity is

Answer 6

exclusive marketing rights granted by the FDA upon approval of a drug, which may or may not run concurrently with a patent

Question 7

Different types of exclusivity have different durations:

Answer 7

-Orphan drug (ODE): 7 years

-New chemical entity (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)

Question 8

Patents can expire before drug approval, issued after drug approval, or anywhere in between.

Answer 8

True

Question 9

Exclusivity is granted upon FDA approval of a drug if the statutory requirements are met

Answer 9

True

Question 10

Exclusivity is not added to the patent life

Answer 10

True

Question 11

A generic drug is

Answer 11

a drug that is identical, or bioequivalent to the originator brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

(these generically equivalent drug formulations have identical composition with respect to the active ingredient)

Question 12

Generic drugs are strictly regulated by the FDA

Answer 12

True

Question 13

Generic manufacturers must demonstrate to the FDA that a generic drug has the same medical effect as its brand name equivalent by measuring the rate and extent of drug absorption

Answer 13

True

Question 14

FDA’S Criteria for equivalency of generic name vs brand name:

Answer 14

-Drugs are approved as both safe and effective

-They are pharmaceutical equivalents, meaning they 1. contain identical amounts of the same active ingredients in the same dosage form and route of administration, and 2. meet applicable standards of strength, quality, purity, and identity.

-They are bioequivalent meaning they either meet acceptable in vitro standards or meet appropriate in vivo bioequivalence standards

-They are adequately labeled
They are manufactured in compliance with FDAs CGMP regulations

Question 15

FDA’s The Orange Book is

Answer 15

a list of “Approved Drug Products with Therapeutic Equivalence” ; it is generally considered the most reliable information source for determining therapeutically equivalent drug products.

Question 16

The Orange Book Ratings:

Answer 16

A: products for which there are no known or suspected bioequivalence problems

AA: products in conventional dosage forms with no bioequivalence problems

AN: Solutions and powders

AO: Injectable oil solutions

AP: Injectable Aqueous solutions

AT: topical products

B: drug products requiring further FDA investigation and review to determine equivalence.

Question 17

ANDA stands for:

Answer 17

abbreviated new drug application

Question 18

generic drug first-to-file exclusivity:

Answer 18

the first generic drug manufacturer to file an ANDA with the FDA on a new off patent drug received a six month marketing exclusivity

Question 19

single-source drug products:

Answer 19

there is only one approved product available for that active ingredient and dosage form

Question 20

multi-source drug products:

Answer 20

pharmaceutically equivalent products are available from more than one manufacturer

Question 21

It is considered the most significant drug-related legislation affecting the pharmaceutical and healthcare industries since 1962

Answer 21

the hatch-waxman act

also known as the drug price competition and paten term restoration act of 1984

Question 22

The Hatch-Waxman Act made it easier to bring generic drugs to the market by requiring the FDA to only look at bioavailability studies in order to approve an ANDA.

Answer 22

True

It also gave protection to the research-based manufacturers by providing a 30 month automatic cooling off period once the innovator company decides to challenge an ANDA for patent infringement

Question 23

Exclusivity gives exclusive ___________, is granted by the FDA, and can run concurrently with a patent or not.

Answer 23

marketing rights

Question 24

What differentiates exclusivity from a patent?

Answer 24

Exclusivity is only granted upon the drug’s FDA approval.

Question 25

A generic drug is ________ to the originator brand-name drug in dosage, strength, safety, and equality.

Answer 25

bioequivalent

Question 26

The FDA’s Criteria for Equivalency requires the drugs contain identical amounts of the same inactive ingredients.

Answer 26

False

Question 27

A generic drug is __________ to the originator brand-name drug in dosage, strength, safety, and quality.

Answer 27

bioequivalent

Question 28

What list is generally considered the most reliable source of information on therapeutically equivalent drug products?

Answer 28

“Approved Drug Products with Therapeutic Equivalence”

Question 29

Which of the following is an Orange Book rating - a) AZ
b) B
c) BZ
d) CZ

Answer 29

b

Question 30

What is the term for chemical equivalents which, when administered in the same amounts, will provide the same biological or physiological availability as measured by blood and urine levels?

Answer 30

Biologic equivalents.

Question 31

What term denotes a drug that is identical or bioequivalent to the originator brand-name drug in dosage form, safety, strength, route, quality, performance?

Answer 31

generic

Question 32

What term denotes the dispensing of an unbranded generic product for the product prescribed?

Answer 32

generic substitution

Question 33

What is the duration of a patent challenge?

Answer 33

180 days (6 months)