35 U.S. Code § 271 - Infringement of Patent

Understanding the patent infringement statute of the United States can be challenging. This statute outlines the protection for patent holders against infringement. It states that anyone without authority who manufactures, uses, sells, or makes an offer to sell an invention that is protected under a patent is infringing on that patent. This applies to any sale or production of the invention within the United States as well as outside and being imported into the United States. In order for this statute to apply, the patent term must not have expired.

Anyone who is actively participating in an activity that goes against the terms of the patent is liable for their actions and will be considered to be a patent infringer. 

If anyone sells or makes an offer to sell a component of any machine, composition, material, apparatus, or combination that is protected under a patent, they are liable as contributing to patent infringement. This applies to anyone who is selling or offering to sell any part of the process, as long as it constitutes a material part of the patented invention. The exception is if the article or commodity can be proven for other use, which indicates substantial non-infringing use.

Additionally, a patent owner who is entitled to relief for patent infringement cannot be determined to be guilty of misuse, denied assistance, or be guilty of extending the patent terms illegally, based on doing at least one of the following:

  • Receiving revenue for doing things that would be considered contributory patent infringement if done by another person
  • Authorizing or licensing someone else to do things that would infringe on the patent if done by another person
  • Trying to enforce the rights of a patent against contributory infringement or infringement of the terms
  • Refusing to use or license the patent rights
  • Changing the license of the patent rights or selling the patent product without providing market power for the product on conditional terms.

It is not considered infringement to offer to sell, make, or use an invention that is mainly manufactured with hybridoma technology, recombinant DNA or RNA, or any other process that relates to site-specific techniques for genetic manipulation. In order for this to apply, the use for this invention must be related to the submission of information and development under federal laws that regulate the sale, use, and manufacture of veterinary biological products and drugs. The terms that relate to this clause are used in the Act of March 4, 1913 and the Federal Food, Drug, and Cosmetic Act.

It is considered an act of infringement if you submit any of the following:

  • An application for any type of drug claimed and protected under a patent, or a drug for which the use is claimed and protected under a patent (Under the Federal Food, Drug, and Cosmetic Act, section 505(j) or 505(b)(2), the infringement rules are outlined)
  • An application for a veterinary biological product or drug that is not mainly manufactured with hybridoma technology, recombinant RNA or DNA, or any other process relating to site-specific techniques for genetic manipulation (Under the act of March 4, 1912 (21 U.S..C. 151-158) or section 505(j) of the Federal Food, Drug, and Cosmetic Act, the infringement rules are outlined)

When referring to any patent included in the list of the Public Health Service Act, section 351(I)(3) or section 351(I)(7), which includes patents that need the approval of production of a biological product, the application must include all required information under the mentioned Act. If the purpose of submitting a patent application is to participate in the commercial sale, use, or manufacture of a biological product, veterinary biological product, or drug, it will not be approved if another patent already protects the product or drug.

If action is being taken for infringement of a patent under this rule, no injunctive or other type of relief can be granted if it prohibits the sale, offer of sale, production, or use of the invention within the United States or from being imported into the United States, based on the description of a patented invention in the first paragraph.

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