Chemistry Reference
In-Depth Information
CHAPTER 4
Patents
A patent is a contract with the government where, in exchange for disclosing
your invention, you are given an exclusive right to the invention for a period
of time. The inventor has the right to exclude others from making, using,
offering for sale, selling, or importing the invention. Patents do not give
the patent owner a right to do or sell anything, but the ability to prevent
others from making, using, or selling a product or process that falls within
the claimed invention [1]. Unlike copyrights, trademarks, and trade secrets,
patent rights do not exist without an issued patent. The rules vary somewhat
for different countries. This discussion will cover the United States, but many
of the principles are true for other parts of the world. The U.S. Patent and
Trademark Office (USPTO) administers the patent law and issues patents on
behalf of the government. The Patent Office dates back to 1802. Patent law is
established in U.S. Code Title 35. This established the USPTO. Patent rules
are published in Title 37, Code of Federal Regulations.
Patent rights are generally granted for twenty years from the date of filing
the patent application with the USPTO, an agency of the U.S. Department of
Commerce. The patent right excludes others from “making, using, offering for
sale, or selling” the invention in the United States or “importing” the invention
into the United States.
One notable exception to the 20-year term arises from the Hatch - Waxman
Act, also known as the “Drug Price Competition and Patent Term Restoration
Act of 1984” [2]. The statute enables the owners of patents on certain human
drugs, food or color additives, medical devices, animal drugs, and veterinary
biological products to add to the 20-year term some of the time lost while
awaiting premarket government approval from a regulatory agency. This
also provides that it shall not be an act of infringement, for example, to make
and test a patented drug solely for the purpose of developing and submitting
information for an Abbreviated New Drug Application (ANDA) [3]. This
second provision enables generic drug companies to obtain bioequivalency
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