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The term patent cliff refers to the phenomenon of patent expiration dates and an abrupt drop in sales that follows for a group of products capturing a high percentage of a market. Usually, these phenomena are noticed when they affect blockbuster products —a blockbuster product in the pharmaceutical industry, for example, is defined as a ...
Proprietary drug are chemicals used for medicinal purposes which are formulated or manufactured under a name protected from competition through trademark or patent. [ 1 ] The invented drug is usually still considered proprietary even if the patent expired. [ 2 ] When a patent expires, generic drugs may be developed and released legally.
t. e. In the European Economic Area (European Union member countries, Iceland, Liechtenstein and Norway), a supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that extends the duration of certain rights associated with a patent. It enters into force after expiry of a patent upon which it is based.
The term of a patent is the maximum time during which it can be maintained in force. It is usually expressed in a number of years either starting from the filing date of the patent application or from the date of grant of the patent. In most patent laws, annuities or maintenance fees have to be regularly paid in order to keep the patent in force.
The original patent term under the 1790 Patent Act was decided individually for each patent, but "not exceeding fourteen years". The 1836 Patent Act (5 Stat. 117, 119, 5) provided (in addition to the fourteen-year term) an extension "for the term of seven years from and after the expiration of the first term" in certain circumstances, when the inventor hasn't got "a reasonable remuneration for ...
One exception occurred during the 2010 Swine Flu Epidemic when the FDA authorized expired Tamiflu based on SLEP Data. [9]The US FDA is able to extend the shelf life of drugs throughout national, state, local, tribal, and territorial stockpiles through two legal means: by issuing an Emergency Use Authorization on using a drug past its expiration date (which is legally an unapproved use of a ...
In patent law, the research exemption or safe harbor exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs.According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA in the United States, does not constitute infringement for a limited term before the end of patent ...
Generic pharmaceutical price decay is what happens (in the UK) once the originator brand has lost its patent exclusivity (patent expiry) and generic versions of the originator brand have been launched. [1][2][3][4][5][6] The number of license holders entering the market is controlled by the ease of manufacture and the number of companies making ...