Composition of matter

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In United States patent law, a composition of matter is one of the four principal categories of things that may be patented. The other three are a process (also termed a method), a machine, and an article of manufacture. In United States patent law, that same terminology has been in use since the first patent act in 1790 (with the exception that processes were formerly termed "arts"). [1]

Contents

The United States Supreme Court has defined "composition of matter" to mean "all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids." [2] That definition is problematic, however, because composite articles can be articles of manufacture—as in the case of a piece of plywood, a concrete sidewalk, a road, a fibreglass bathtub, a (kitchen) countertop, or a flitch beam. [3]

Robinson on Patents has defined "composition of matter" in these terms:

A composition of matter is an instrument formed by the intermixture of two or more ingredients, and possessing properties which belong to none of these ingredients in their separate state. ...The intermixture of ingredients in a composition of matter may be produced by mechanical or chemical operations, and its result may be a compound substance resolvable into its constituent elements by mechanical processes, or a new substance which can be destroyed only by chemical analysis. [4]

A newly synthesized chemical compound or molecule may be patented as a composition of matter. [5] Patents have been allowed on transitory products, such as short-lived chemical intermediates. [6]

Living things as compositions of matter

In Diamond v. Chakrabarty , [7] the United States Supreme Court held that a genetically-altered living microorganism was patent-eligible subject matter. The Chakrabarty Court said that "we must determine whether respondent's micro-organism constitutes a 'manufacture' or 'composition of matter' within the meaning of the statute. [8] The Court's answer to its question was yes----"respondent's micro-organism plainly qualifies as patentable subject matter." [9] But the Court never said which one it was.

The oncomouse

In 1988, the United States Patent and Trademark Office (USPTO) granted U.S. Patent 4,736,866 (filed Jun 22, 1984, issued Apr 12, 1988, expired April 12, 2005) to Harvard College claiming a mouse (the "oncomouse") as “a transgenic non-human mammal whose germ cells and somatic cells contain a re-combinant activated oncogene sequence introduced into said mammal…” [10]

The European Patent Office (EPO) concluded that the usefulness of the oncomouse in furthering cancer research satisfied the likelihood of substantial medical benefit, and outweighed moral concerns about suffering caused to the animal. [11] In the original application, the claims referred to animals in general, but in the course of the proceedings, the patent was amended and finally maintained with claims limited to mice. [12]

The oncomouse has been patented in Australia, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, The Netherlands, New Zealand, Portugal, Spain, Sweden, and the United Kingdom. [13]

After extended litigation, in 2000, a Canadian court permitted issuance of a patent on a mouse as a "composition of matter." [14] However, in 2002, the Canadian Supreme Court reversed that ruling and held (5-4) that the mouse itself could not be patented, but the biochemical process used to modify it could be. [15]

See also

Related Research Articles

The OncoMouse or Harvard mouse is a type of laboratory mouse that has been genetically modified using modifications designed by Philip Leder and Timothy A Stewart of Harvard University to carry a specific gene called an activated oncogene. The activated oncogene significantly increases the mouse's susceptibility to cancer, and thus makes the mouse a suitable model for cancer research.

As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.

Diamond v. Chakrabarty, 447 U.S. 303 (1980), was a United States Supreme Court case dealing with whether living organisms can be patented. Writing for a five-justice majority, Chief Justice Warren E. Burger held that human-made bacteria could be patented under the patent laws of the United States because such an invention constituted a "manufacture" or "composition of matter". Justice William J. Brennan Jr., along with Justices Byron White, Thurgood Marshall, and Lewis F. Powell Jr., dissented from the Court's ruling, arguing that because Congress had not expressly authorized the patenting of biological organisms, the Court should not extend patent law to cover them.

<i>Harvard College v Canada (Commissioner of Patents)</i> Supreme Court of Canada case

Harvard College v Canada (Commissioner of Patents) is a leading Supreme Court of Canada case concerning the patentability of higher life forms within the context of the Patent Act. At issue was the patentability of the Harvard oncomouse, a mouse that had its genome genetically altered by a cancer-promoting gene (oncogene). In a 5-4 split, the Supreme Court held that the oncomouse and higher life forms in general are not patentable subject matter in Canada.

The United States is considered to have the most favorable legal regime for inventors and patent owners in the world. Under United States law, a patent is a right granted to the inventor of a (1) process, machine, article of manufacture, or composition of matter, (2) that is new, useful, and non-obvious. A patent is the right to exclude others, for a limited time from profiting of a patented technology without the consent of the patent-holder. Specifically, it is the right to exclude others from: making, using, selling, offering for sale, importing, inducing others to infringe, applying for an FDA approval, and/or offering a product specially adapted for practice of the patent.

Parker v. Flook, 437 U.S. 584 (1978), was a 1978 United States Supreme Court decision that ruled that an invention that departs from the prior art only in its use of a mathematical algorithm is patent eligible only if there is some other "inventive concept in its application." The algorithm itself must be considered as if it were part of the prior art, and the claim must be considered as a whole. The exact quotation from the majority opinion is: "Respondent’s process is unpatentable under §101, not because it contains a mathematical algorithm as one component, but because once that algorithm is assumed to be within the prior art, the application, considered as a whole, contains no patentable invention." "The fact that the algorithm may not have actually been known previously and that, when taken in combination with other claim elements, it might produce an invention that is novel and nonobvious, plays no part in the analysis."

LabCorp v. Metabolite, Inc., 548 U.S. 124 (2006), is the first case since Diamond v. Chakrabarty in which the U.S. Supreme Court indicated a renewed interest in examining the limits of patentable subject matter for advances in life sciences. Although the Court initially agreed to hear the case, it was later dismissed in 2006 with three Justices dissenting. The defendant's petition to the Supreme Court raised an issue not addressed in opinions from the lower courts: the claim at issue was directed to patent ineligible subject matter and therefore invalid.

Gottschalk v. Benson, 409 U.S. 63 (1972), was a United States Supreme Court case in which the Court ruled that a process claim directed to a numerical algorithm, as such, was not patentable because "the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself." That would be tantamount to allowing a patent on an abstract idea, contrary to precedent dating back to the middle of the 19th century. The ruling stated "Direct attempts to patent programs have been rejected [and] indirect attempts to obtain patents and avoid the rejection ... have confused the issue further and should not be permitted." The case was argued on October 16, 1972, and was decided November 20, 1972.

<span class="mw-page-title-main">Ananda Mohan Chakrabarty</span> Bengali-American microbiologist (1938–2020)

Ananda Mohan Chakrabarty, PhD was an Indian American microbiologist, scientist, and researcher, most notable for his work in directed evolution and his role in developing a genetically engineered organism using plasmid transfer while working at GE, the patent for which led to landmark Supreme Court case, Diamond v. Chakrabarty.

The history of United States patent law started even before the U.S. Constitution was adopted, with some state-specific patent laws. The history spans over more than three centuries.

In United States patent law, the machine-or-transformation test is a test of patent eligibility under which a claim to a process qualifies for consideration if (1) the process is implemented by a particular machine in a non-conventional and non-trivial manner or (2) the process transforms an article from one state to another.

In United States patent law, a machine is one of the four principal categories of things that may be patented. The other three are a process, an article of manufacture, and a composition of matter. In United States patent law, that same terminology has been in use since the first patent act in 1790.

In United States patent law, an article of manufacture is one of the four principal categories of things that may be patented. The other three are a process, a machine, and a composition of matter. In United States patent law, that same terminology has been in use since the first patent act in 1790.

The United States is the largest grower of commercial crops that have been genetically engineered in the world, but not without domestic and international opposition.

<span class="mw-page-title-main">Defences and remedies in Canadian patent law</span>

A patent holder in Canada has the exclusive right, privilege and liberty to making, constructing, using and selling the invention for the term of the patent, from the time the patent is granted. Any person who does any of these acts in relation to an invention without permission of the patent owner is liable for patent infringement.

<span class="mw-page-title-main">Subject matter in Canadian patent law</span>

In Canadian patent law, only “inventions” are patentable. Under the Patent Act, only certain categories of things may be considered and defined as inventions. Therefore, if a patent discloses an item that fulfills the requirements of novelty, non-obviousness and utility, it may nonetheless be found invalid on the grounds that it does not fall within one of the statutory categories of “invention”. Since the Patent Act, the categories of patentable subject matter have been defined and interpreted by Canadian courts.

A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.

J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001), was a decision of the United States Supreme Court holding for the first time that utility patents may be issued for crops and other flowering plants under 35 U.S.C. § 101. The Supreme Court rejected the argument that the exclusive ways to protect these plants are under the Plant Variety Protection Act (PVPA), 7 U.S.C. § 2321, and the Plant Patent Act of 1930 (PPA), 35 U.S.C. §§ 161-164.

Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), was a Supreme Court case, which decided, that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” However, as a "bizarre conciliatory prize" the Court allowed patenting of complementary DNA, which contains exactly the same protein-coding base pair sequence as the natural DNA, albeit with introns removed.

<span class="mw-page-title-main">Patentable subject matter in the United States</span>

Patentable subject matter in the United States is governed by 35 U.S.C. 101. The current patentable subject matter practice in the U.S. is very different from the corresponding practices by WIPO/Patent Cooperation Treaty, and it is considered to be broader in general. Since the enactment of the subject matter requirement ca. 1970, the interpretation of the statute changed multiple times. Although Section 101 of Title 35 U.S.C. reads:

Whoever 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 therefor, subject to the conditions and requirements of this title.

References

  1. ↑ The first patent statute permitted a patent on "any art, manufacture, engine, machine or device." Patent Act of 1790 § 4, 1 Stat. 109, 111 (1790). In 1793, Congress amended the patent laws, changing the language to allow a patent for "any new and useful art, machine, manufacture or composition of matter." Patent Act of 1793 § 1, 1 Stat. 318, 319 (1793).
  2. ↑ Diamond v. Chakrabarty, 447 U.S. at 308.
  3. ↑ A steel plate sandwiched between two wood beams, the three layers being held together with bolts.
  4. ↑ 1 W. Robinson, The Law of Patents for Useful Inventions 278–79 (1890).
  5. ↑ Schering Corp. v. Gilbert, 153 F.2d 428 (2d Cir. 1946).
  6. ↑ See In re Breslow, 616 F.2d 516 (CCPA 1980).
  7. ↑ 447 U.S. 303 (1980).
  8. ↑ 447 U.S. at 308.
  9. ↑ 'Id'. at 309.
  10. ↑ See Oncomouse.
  11. ↑ Article 6 of the EC's Directive 98/44/EC (the "E.U. Biotechnology Directive") excludes from patentability inventions that are contrary to ordre public or morality. These inventions include processes for modifying the genetic identity of animals that are “likely to cause them suffering without any substantial medical benefit to man or animal.”
  12. ↑ WIPO Magazine, "Bioethics and Patent Law: The Case of the Oncomouse" (June 2006).
  13. ↑ CASRIP, "Patentable Subject Matter in Biotechnology: Transgencic Animals and Higher Life Forms" (2007).
  14. ↑ "Patenting life: genetically altered mice an invention, court declares," CMAJ, Oct. 3, 2000, 163(7).
  15. ↑ CBC News, "Supreme Court rejects patent on genetically-modified mouse," Dec. 5, 2002.
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