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IP Explained: How does the U.S. patent process work?

Megan Van Etten   |     June 24, 2021   |   SHARE THIS

Have you ever used a Teflon-coated pan or hit a golf ball down the fairway? Had a friend or family member receive treatment with a new medication? All these products were developed because patents encouraged the R&D that led to these innovations. Patents are a form of intellectual property protection that give inventors the exclusive right to make, use, sell, offer for sale or import their inventions for a set period of time. This alleviates some of the risk inventors take on when developing new products. Patients are well-served by having more inventions protected by intellectual property – it means more competition so more access to medicines in the long run – and these protections are an investment in the system that fosters innovation. Patents are not just handed out. The process for obtaining a patent is no small feat. It often takes about two years for an applicant to be granted a patent because the process requires an extensive and robust review by expert patent examiners at the United States Patent and Trademark Office (USPTO). 

From idea to application

Whether it’s a golf ball or a COVID-19 vaccine, innovation begins as an idea that can become an invention. An invention can then be the subject of a patent application formally filed with the USPTO. The patent application must describe the invention clearly enough for someone knowledgeable in the field to understand, make and use it. The patent application also breaks an invention down into discrete claims which become the legal description of the aspects of the invention that are protected by law. Typically, in the biopharmaceutical industry, a long period of research and development is carried out before companies even file for a patent. 

From application to evaluation

The application is then evaluated by a USPTO patent examiner – typically a skilled scientist or engineer – who thoroughly reviews the application to ensure the application meets the long-established legal requirements, including being novel, useful and nonobvious. More than 85% of patent applications are rejected at least once. If that happens, the applicant can try to address the examiner’s concerns by amending the written application, and in some cases, also through an on-the-record discussion with the examiner. Ultimately, the examiner must be satisfied before a patent will be allowed. Applicants can also appeal an examiner’s rejections if the applicant is unable to overcome the examiner’s rejections but does not believe the rejections have merit.

From application to issuance

The process from patent application to issuance takes about two years on average. Once a patent is granted, the inventor has the right to prevent others from making, using, selling, offering to sell or importing the patented invention for a basic period of 20 years from the application’s filing date. In the case of innovative medicines, a patent does not constitute authorization to sell a product made with the invention; that is determined by the U.S. Food and Drug Administration (FDA). Even after an innovator begins applying for patent protection for each innovation incorporated into a medicine, it still often must spend years in clinical trials proving the medicine’s safety and efficacy before it can bring the medicine to market. This means that the innovator does not typically enjoy the entire 20-year patent term for each innovation that makes a medicine possible.

Obtaining a patent is a rigorous and thorough process. Patents are an essential incentive to innovation and encourage companies to make the needed investments to develop new treatments and potential cures that are vitally important to patients. Patents are particularly important to the biopharmaceutical industry, as only 12% of new treatments that make it to clinical trials are ultimately approved by FDA for use. 

Learn more about the process for obtaining a patent here. 

Megan Van Etten

Megan Van Etten Megan Van Etten is senior director of public affairs at PhRMA. She is responsible for leading the association’s public affairs efforts on international issues, including trade, intellectual property and access to medicines. Prior to joining PhRMA, Megan was director of media and external communications at the U.S. Chamber of Commerce and communications director at the Beer Institute. She has also worked as a communications consultant for global public relations firms. When not at the office, Megan enjoys exploring new Washington, D.C. restaurants and traveling with her husband and friends.

Topics: Research and Development, Patents, IP Explained

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