Annotation for Article 1 of the United States Constitution prepared by the Congressional Research Service. The analysis and commentary for Article 1, Section 8 Clause 8, starts at page 329. The discussion of what constitutes patentable discoveries includes references to many seminal cases that are highly relevant to the patentability of genes. Other patent-related topics include: Origins and scope of power, Patentable discoveries, Procedure in issuing patents, and State power affecting patents.
35 U.S.C. Chapter 10 - Patentability of Inventions
Section 101 - Inventions Patentable
This is the most relevant section of the patent law for determining whether genes are eligible subject matter for patentability. According to Diamond v. Chakrabarty, anything under the sun that is made by man is patentable, with the exception of laws of nature, physical phenomena and abstract ideas. 447 U.S. 303, 309 (1980).
Section 102 - Conditions for patentability; novelty and loss of right to patent.
Section 103 - Conditions for patentability; non-obvious subject matter.
"A patent is an intellectual property right granted by the Government of the United States of America to an inventor to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United states for a limited time in exchange for public disclosure of the invention when the patent is granted." USPTO website.
The Patent Trial and Appeal Board (PTAB) is a board within the PTO that reviews appeals by applicants when a patent examiner has rejected an inventor's patent application. The PTAB also reviews patent interferences, which occur when two or more applicants apply for a patent on the same invention. Patent interferences should be reduced with the new rule which grants patents to the first inventor to file an application (as of March 2013). Previously, the US rule was that the patent was granted to the first to invent, which is more difficult to ascertain in a dispute.
An appeal from a decision of the PTAB is heard in the United States Court of Appeals for the Federal Circuit (abbreviated CAFC - often shortened to Federal Circuit).
Federal Circuit Act of 1982 established the United States Court of Appeals for the Federal Circuit. This court was established mainly to provide more uniformity in the patent system, by eliminating forum shopping in patent suits, settling differences in patent law doctrine among the circuit courts, and allowing a single forum to develop the expertise needed to rule on complex technological questions that arise in patent suits. Black's Law Dictionary, 1674 (9th ed. 2009).
Appeals to decisions made by the Patent Trial and Appeal Board are taken to the Federal Circuit. Appeals from the Federal Circuit are heard by the United States Supreme Court, if certiorari is granted.