Under U.S. law, inventors may obtain a patent for "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof[.]" Since the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (447 U.S. 303), the U.S. Patent and Trademark Office (USPTO) has expanded the types of patentable subject matter to include biological materials such as nucleic acids and proteins, as well as methods of using these materials.

However, while the scope of patent-eligible subject matter is generally broad, the Supreme Court has also recognized that not everything is a patentable invention under the law. Notable exceptions to patentable subject matter include inventions that cover: (1) laws of nature; (2) physical phenomena; and (3) abstract ideas. These inventions have been deemed ineligible for patent protection. Unfortunately, the Supreme Court has done little to provide insight into the scope of these exceptions, much less articulate clear tests for patent-eligible subject matter.

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