USA Law and Practice Contributed by: Steven Lieberman, Joseph A Hynds and Jennifer P Nock, Rothwell, Figg, Ernst & Manbeck PC
1.4 Term of Each Intellectual Property Right Generally, a patent expires 20 years after its filing date, but this term can vary depending on the timing of the patent application and patent pros- ecution. Patents issued and applications filed before 8 June 1995 expire either 20 years from filing or 17 years from issue, whichever is later. Patent applications filed after 8 June 1995 expire 20 years after the earliest effective US filing date. This may be earlier than the filing date of the patent application if it claims priority to an earlier non-provisional or international application. Under limited circumstances, a patent term may be extended to account for administrative delays when acquiring the patent. For example, if the USPTO does not issue a patent within three years after its filing date, the patent holder may obtain an extension of patent term equal to the period in excess of three years. For certain drug products and medical devices, a patent may be extended for up to five years to account for the regulatory review conducted by the US Food and Drug Administration (FDA). 1.5 Rights and Obligations of Owners of Intellectual Property Rights The USPTO website provides general infor- mation about all US patents. Furthermore, the FDA maintains publications identifying patents applicable to certain approved pharmaceutical products. For drug products, the FDA publica- tion is Approved Drug Products with Therapeu- tic Equivalence Evaluations (more commonly known as the “Orange Book”). Similarly, the FDA has the List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (known as the “Purple Book”) with information about approved biological products. The FDA maintains elec-
tronic databases on its website with the infor- mation contained in both the Orange Book and Purple Book. A patent gives its owner the right to exclude oth- ers from making, using, selling and importing the patented invention. To maintain the enforceabil- ity of a utility patent, the USPTO must receive maintenance fees for the patent, due 3.5, 7.5 and 11.5 years after the date of issue. Design and plant patents do not require maintenance fees. The remedies available to the patent holder vary depending on the chosen forum of enforcement. In a district court, a patent holder may seek equi- table remedies in the form of a preliminary or permanent injunction and may seek monetary damages for both past and future infringement. At the US International Trade Commission (ITC), a patent holder may seek cease-and- desist orders and exclusion orders to prevent the importation of patent-infringing goods. The exclusion orders direct US Customs and Border Protection to exclude articles from entry into the USA. A limited exclusion order prevents speci- fied entities from importing the articles and a general exclusion order prevents any entity from importing the articles. The ITC cease-and-desist orders can direct infringers to stop importing infringing articles and to stop sales of infringing articles in US inventory. The ITC cannot award monetary damages. 1.6 Further Protection After Lapse of the Maximum Term The USA allows certain extensions of patent terms for administrative delays. Delays by the USPTO in the issue of patents can lead to pat- ent-term compensating for the time of the delay (commonly referred to as “Patent Term Adjust-
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