Question

What is not correct about patents and marketing exclusivity?

-Orphan drug designation adds 7 years of market exclusivity from generic competition
-Patents are granted by the USPTO and expire 20 years from date of filing
-Marketing exclusivity can be concurrent with a patent
-Marketing exclusivity is granted by the FDA upon drug approval to protect it from generic competition
-Marketing exclusivity does not extend protection from generic competition beyond the patent life.

Answer 1

The incorrect statement related to patents and marketing exclusivity is the claim that marketing exclusivity does not extend protection from generic competition beyond the patent life. While related, marketing exclusivity can extend beyond the patent life under certain circumstances.

Step-by-step explanation:

Regarding patents and marketing exclusivity, here are the corrections to the statements provided:

• Orphan drug designation does indeed add 7 years of market exclusivity from generic competition, separate from patent protection.
• It's correct that patents are granted by the USPTO (United States Patent and Trademark Office) and typically expire 20 years from the date of filing.
• Marketing exclusivity can indeed be concurrent with a patent.
• The FDA grants marketing exclusivity upon drug approval to protect the drug from generic competition, which is correct.
• However, the statement that marketing exclusivity does not extend protection from generic competition beyond the patent life is not entirely accurate. While marketing exclusivity and patents are distinct forms of intellectual property rights, in some instances, marketing exclusivity can extend beyond the patent life, depending on the type of exclusivity granted.

The 20-year time period for a patent is acknowledged as somewhat arbitrary, primarily aiming to balance the time to earn a good return on the innovation while not allowing the inventor to maintain a permanent monopoly.