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.

REGULATORY

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 exists.

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.


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