Patent-Eligibility - What is "Patentable?"

Patentable Subject Matter - 35 U.S.C. § 101

The patent law specifies the general field of subject matter that can be patented and the conditions under which a patent may be obtained.

In the language of the statute, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act or method, and primarily includes industrial or technical processes. The term “machine” used in the statute needs no explanation. The term “manufacture” refers to articles that are made, and includes all manufactured articles. The term “composition of matter” relates to chemical compositions and may include mixtures of ingredients as well as new chemical compounds. These classes of subject matter taken together include practically everything that is made by man and the processes for making the products.

The Atomic Energy Act of 1954 excludes the patenting of inventions useful solely in the utilization of special nuclear material or atomic energy in an atomic weapon 42 U.S.C. 2181 (a).

The patent law specifies that the subject matter must be “useful.” The term “useful” in this connection refers to the condition that the subject matter has a useful purpose and also includes operativeness, that is, a machine which will not operate to perform the intended purpose would not be called useful, and therefore would not be granted a patent.

Interpretations of the statute by the courts have defined the limits of the field of subject matter that can be patented, thus it has been held that the laws of nature, physical phenomena, and abstract ideas are not patentable subject matter.

A patent cannot be obtained upon a mere idea or suggestion. The patent is granted upon the new machine, manufacture, etc., as has been said, and not upon the idea or suggestion of the new machine. A complete description of the actual machine or other subject matter for which a patent is sought is required.

  1. Diamond v. Chakrabarty, 447 U.S. 303 (1980)
  2. In re Bilski (Fed. Cir. October 30, 2008)Acrobat
  3. In re Bilski - U.S. Supreme Court Oral Argument Transcript (November 9, 2009)Acrobat

Case Study: Association for Molecular Pathology v. United States Patent and Trademark Office (a.k.a., "The Myriad Case")

Are Isolated Human Genes (DNA molecules) Patent-Eligible?

Yes they are!

  1. ACLU v. USPTO & Myriad - Federal Circuit decision (July 29, 2011)Acrobat
  2. ACLU v. USPTO & Myriad - United States [federal government] Amicus Curiae Brief (October 29, 2010)Acrobat
  3. ACLU v. USPTO & Myriad - Myriad Motion for Summary Judgment (December 24, 2009)Acrobat
  4. ACLU v. USPTO & Myriad - USPTO Motion for Summary Judgment (December 23, 2009)Acrobat
  5. ACLU v. USPTO & Myriad - Complaint (May 12, 2009)Acrobat

Patents in Suit:

  1. U.S. Patent No. 6,033,857 (cl. 1, 2)
  2. U.S. Patent No. 5,837,492 (cl. 1, 6, 7)
  3. U.S. Patent No. 5,753,441 (cl. 1)
  4. U.S. Patent No. 5,747,282 (cl. 1, 2, 5, 6, 7, and 20)
  5. U.S. Patent No. 5,710,001 (cl. 1)
  6. U.S. Patent No. 5,709,999 (cl. 1)
  7. U.S. Patent No. 5,693,473 (cl. 1)

Case Study: Prometheus v. Mayo

Are Diagnostics and Disease Treatment Methods Patent-Eligible?

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. September 16, 2009)Acrobat

Compare:

Classen Immunotherapies Inc. v. Biogen Idec (non-precedential) (Fed. Cir. December 19, 2008)Acrobat

Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. (dismissed certiorari as improvidently granted) 126 S. Ct. 2921 (2006)Acrobat

Patents in Suit:

Prometheus v. Mayo:

U.S. Patent No. 6,355,623 (cl. 1)

U.S. Patent No. 6,680,302 (cl. 1)

Classen v. Biogen:

U.S. Patent No. 5,723,283 (cl. 1)

LabCorp v. Metabolite:

U.S. Patent No. 4,940,658 (cl. 13)


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