Patents are a form of IP protection referenced in the U.S. Constitution that grant inventors the exclusive right to make, use, or sell their inventions for a set period of time. Patents are an essential incentive to innovation and are particularly important to the biopharmaceutical industry. The process for obtaining a patent requires extensive review by patent examiners and substantive responses by the patent applicant, often taking several years.
A patent starts with an idea that can be described in a patent application, which is thoroughly reviewed at the USPTO*. Typically, in the biopharmaceutical industry, the filing of a patent application is preceded by a long period of research and experimentation.
The patenting process starts with filing a patent application with the USPTO. The patent application must describe the invention clearly enough for someone knowledgeable in the field to understand, make and use it. A patent application breaks an invention down into discrete claims which become the legal description that limits the enforceable scope of the invention.
The patent application is evaluated by a patent examiner, who is a skilled scientist or engineer often with an advanced degree. The examiner thoroughly reviews the patentability of applications with the aid of the USPTO's vast library of references. Frequently, the examiner rejects patent claims that fail to meet statutory requirements that include being novel, useful and nonobvious as well as being adequately described. 18 months after filing, the vast majority of applications will be published and made publicly available. The process from patent application to issuance takes about two years on average.
More than 85% of patent applications are rejected at least once by the examiner.
The applicant may amend the application to address the examiner's concerns, may appeal the examiner's decision, or try to address the examiner's concerns in an on-the-record discussion. Only if the examiner is satisfied, the patent will be allowed.
Once issued, a patent gives the inventor the right to prevent others from making, using, or selling the patented invention described in the claims for a period of 20 years from the application date. In the case of prescription medicines, a patent does not on its own constitute FDA authorization to sell a product made with the invention. Issued patents can also be challenged.
If a patent applicant does not believe that the examiner's objections can be addressed and overcome, the application may be abandoned and the patent will not be issued.
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