Patent pool: an agreement between two or more patent owners to
license one or more of their patents to one another or third parties.
Prior art: public knowledge that exists in a field; all
previously issued patents, publications, public announcements, or
knowledge that bear on the invention claimed in a patent application.
Prosecution: the process by which an inventor engages with the
patent office to obtain a patent and determine the scope of its claims.
Provisional patent application: a preliminary patent
application filed without a formal patent claim, oath or declaration, or
any prior art statement. It provides the means to establish an early
effective filing date in a subsequent non-provisional patent application
and allows the term ‘Patent Pending’ to be applied.
Submarine patent: a patent that emerges after it has
unknowingly been infringed upon.
Trade secret: knowledge and information that is not generally
known to the industry. Examples include customer lists, business plans,
and manufacturing methods.
Trademark: a registered name, word, symbol, or device
identifying a company’s products or services.
Abbreviated New Drug Application (ANDA): a simplified
submission permitted for a generic version of an approved drug.
Accelerated development and review: a process designed to
speed the development of drugs that promise significant benefits over
existing therapies or treat serious illnesses for which no therapy
Action letter: An official FDA communication that informs the
sponsor of an NDA or BLA of a decision by the agency. An approval letter
allows commercial marketing of the product.
Bayh-Dole Act: provides the statutory basis and framework for
federal technology transfer activities, including patenting and
licensing federally funded inventions to commercial ventures.
Bioequivalence: demonstration that a generic drug has the same
chemical and biological properties as its pioneer counterpart.