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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 ...
In the United States, for utility patents filed on or after June 8, 1995, the term of the patent is 20 years from the earliest filing date of the application on which the patent was granted and any prior U.S. or Patent Cooperation Treaty (PCT) applications from which the patent claims priority (excluding provisional applications). For patents ...
With time the law became successful in promoting the introduction of generics; in 1983 only 35% of top-selling branded drugs with expired patents had generic competition, and only 13% of prescriptions were for generics but in 2012, 84% of prescriptions in the US were filled with generic drugs. [3]
With patents on many blockbuster drugs about to expire, an estimated $250 billion in sales are at risk between now and 2015, according to data from EvaluatePharma.
Investors were reacting to news that ArQule's lead drug, ARQ 197, improved by 66% the median progression-free survival (PFS) of patients with advanced non-small-cell lung cancer. This cancer has ...
Over the past decade, drug companies have become increasingly dependent on blockbuster drugs -- patented specialty drugs that generate more than $1 billion in sales annually. However, when a major ...
In order to start selling a drug promptly after the patent on innovator drug expires, a generic company has to file its ANDA well before the patent expires. This puts the generic company at risk of being sued for patent infringement, since the act of filing the ANDA is considered "constructive infringement" of the patent. [41]
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. Some international and national governmental organizations have set up laws to enforce intellectual property to protect proprietary drugs, but some also highlight the importance of ...