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Student Project: Patentability of Genes: Patent Law

This research guide will facilitate a legal analysis about whether genes should be patented by providing primary, secondary and other source materials.

United States Constitution

Article I, Section 8, Clause 8

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.

Relevant Statutes

35 U.S.C. Chapter 10 - Patentability of Inventions

Section 100 - Definitions

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.

US Patent & Trademark Office

     "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.

Patent Trial and Appeal Board

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).

US Court of Appeals for the 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.

Patent Overview

The Patent Overview provided at WEX is an excellent introduction to patent law.  WEX is sponsored and hosted by the LII.  The information is compiled in a collaborative manner by legal experts.

Legislative History

Legislative History for Patent Law compiled in the Intellectual Property (IP) Mall at the University of New Hampshire School of Law.

Recent Gene Patent Legislative History

  • June 21, 2011, HOUSE REPORT NO. 112–111.  Section 27.  Study on Genetic Testing.  Consideration of HR. 1249 to amend Title 35 U.S.C. for patent reform.
  • January 3, 2009, HOUSE REPORT NO. 110–941.  Hearing Serial No. 66. Stifling or Stimulating–The Role of Gene Patents in Research and Genetic Testing. Subcommittee on Courts, the Internet, and Intellectual Property. October 30, 2007.July 13, 2000.
  • Hearing of the House of Representatives Judiciary Subcommittee for Courts and Intellectual Property, GENE PATENTS AND OTHER GENOMIC INVENTIONSJuly 13, 2000.  Expert witnesses in genetic research testified before this committee regarding whether gene patents encourage or impede medical research.  Some asked that the PTO raise the bar for patentability in its new guidelines.
  • House Report 104-178 - Biotechnological Process Patents is passed in 1995- amends 35 U.S.C §103 - biotechnological process do not have to undergo a separate review of nonobviousness under certain conditions. If the process uses or produces a patentable composition of matter, the process will be determined nonobvious for the purpose of examination of biotechnological process claims. 
  •  March 26, 1993, SENATE REPORT NO. 103–30, Serial No. J–102–83–The Genome Project: The Ethical Issues of Gene Patenting.  June 12, 1991, S. 654–Biotechnology Patent Protection Act of 1991.  September 22, 1992 (Patents, Copyrights and Trademarks)–Oversight hearing on, among other things, the ethical implications of gene patenting.* Requires a subscription to Westlaw.