Patentable, statutory or patent-eligible subject matter is subject matter of an invention that is considered appropriate for

patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an sufficiency of disclosure, enabling discl ...

protection in a given jurisdiction. The laws and practices of many countries stipulate that certain types of inventions should be denied patent protection. Together with criteria such as

novelty Novelty (derived from Latin word ''novus'' for "new") is the quality of being new, or following from that, of being striking, original or unusual. Novelty may be the shared experience of a new cultural phenomenon or the subjective perception of an ...

, inventive step or nonobviousness,

utility In economics, utility is a measure of a certain person's satisfaction from a certain state of the world. Over time, the term has been used with at least two meanings. * In a normative context, utility refers to a goal or objective that we wish ...

(or

industrial applicability In certain jurisdictions' patent law, industrial applicability or industrial application is a patentability requirement according to which a patent can only be granted for an invention which is susceptible of industrial application, i.e. for an in ...

), which differ from country to country, the question of whether a particular subject matter is patentable is one of the substantive requirements for

patentability Within the context of a national or multilateral body of law, an invention is patentable if it meets the relevant legal conditions to be granted a patent. By extension, patentability also refers to the substantive conditions that must be met fo ...

. The problem of patentable subject matter arises usually in cases of biological and software inventions, and much less frequently in other areas of technology.

Legislation

The subject-matter which is regarded as patentable as a matter of policy, and correspondingly the subject-matter which is excluded from patentability as a matter of policy, depends on the national legislation or international treaty.

Canada

According to the

Canadian Intellectual Property Office The Canadian Intellectual Property Office (CIPO; French: ''Office de la propriété intellectuelle du Canada, OPIC'') is responsible for the administration and processing of the greater part of intellectual property (IP) in Canada. CIPO's areas ...

(CIPO) patents may only be granted for physical embodiments of an idea, or a process that results in something that is tangible or can be sold. This excludes theorems and computer programs per se. However, business methods are patentable.

European Patent Convention

The

European Patent Convention The European Patent Convention (EPC), also known as the Convention on the Grant of European Patents of 5 October 1973, is a multilateral treaty instituting the European Patent Organisation and providing an autonomous legal system according to w ...

(EPC) does not provide positive guidance on what ''should'' be considered an invention for the purposes of patent law. However, it provides in a non-exhaustive list of what are not to be regarded as inventions, and therefore ''not'' patentable subject matter: then qualifies Art. 52(2) EPC by stating: (In a previous version of the EPC, some further items were excluded under , as formally being not industrially applicable, notable medical methods as applied by a physician or a veterinarian. Nowadays these methods are excluded directly under Art. 53 EPC, together with other policy exclusions.)

Practice at the European Patent Office (EPO)

Under , "European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application." So, four questions need to be assessed: #Is there an invention? #Is the invention susceptible of industrial application? #Is the invention novel? #Does the invention involve an inventive step? The first question "Is there an invention?" is equivalent to: "Is the claimed subject-matter as a whole within the realm of patentable subject-matter?" The invention question or patentable subject-matter question precedes the three further questions, which cannot, and need not, be assessed if there is no invention. According to the

case law Case law, also used interchangeably with common law, is a law that is based on precedents, that is the judicial decisions from previous cases, rather than law based on constitutions, statutes, or regulations. Case law uses the detailed facts of ...

of the Boards of Appeal of the EPO, the question "Is there an invention?" also implicitly implies the further question: "Does the claimed subject-matter have a technical character?" "Having technical character is an implicit requirement of the EPC to be met by an invention to be an invention within the meaning of ". Patentable subject-matter considerations also intervene again at a secondary level, during the

inventive step The inventive step and non-obviousness reflect a general patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive—i.e., non-obvious—in order to be patented. In other words, " henon ...

assessment. In

T 641/00 T 641/00, also known as ''Two identities/COMVIK'', is a decision of a Technical Board of Appeal of the European Patent Office (EPO), issued on September 26, 2002. It is a landmark decision regarding the patentable subject matter requirement and i ...

(Comvik/Two Identities), the Board held that, "An invention consisting of a mixture of technical and non-technical features and having technical character as a whole is to be assessed with respect to the requirement of inventive step by taking account of all those features which contribute to said technical character whereas features making no such contribution cannot support the presence of inventive step." The non-technical features are the ones that are excluded from the realm of patentable subject-matter as a matter of policy.

T 258/03 T 258/03, also known as ''Auction Method/Hitachi'', is a decision of a Technical Board of Appeal of the European Patent Office (EPO), issued on April 21, 2004. It is a landmark decision for interpreting Article 52(1) and (2) of the European Paten ...

(Hitachi/Auction Method) further developed this test for patentable subject-matter. Under this test, a patent application or patent which does not provide a technical solution to a technical problem would be refused (under ) or revoked (under ) as lacking inventive step. The EPO provides guidelines for evaluating the patent-eligibility of computer-implemented inventions (CII), such as in particular based on Artificial Intelligence (AI). For instance, AI-based image processing programs are considered technical and therefore patent-eligible. Conversely, AI-based text processing programs with a text classification only based on the content of the text are not considered technical. These are excluded from patentability because attaching meaning to words is a cognitive task and not a technical implementation.

Practice in the United Kingdom

Following the 2006

Court of Appeal An appellate court, commonly called a court of appeal(s), appeal court, court of second instance or second instance court, is any court of law that is empowered to Hearing (law), hear a Legal case, case upon appeal from a trial court or other ...

judgment in

Aerotel v Telco and Macrossan's application ''Aerotel v Telco and Macrossan's Application'' is a judgment by the Court of Appeal of England and Wales. The judgment was passed down on 27 October 2006 and relates to two different appeals from decisions of the High Court. The first case inv ...

, which contains a lengthy discussion of case law in the area, the UKPO has adopted the following test:Patents Act 1977: Patentable subject matter
: (1) properly construe the claim : (2) identify the actual contribution : (3) ask whether it falls solely within the excluded subject matter : (4) check whether the actual or alleged contribution is actually technical in nature. The Court decided that the new approach provided a structured and more helpful way of applying the statutory test for assessing patentability which was consistent with previous decisions of the Court. This test is quite different from the test used by the EPO, as expressed in

(Comvik/Two Identities) and

(Hitachi/Auction Method), but it is considered that the end result will be the same in nearly every case.

United States

Patentable subject matter in the United States is governed by 35 U.S.C. 101. The two particularly contentious areas, with numerous reversals of prior legislative and judicial decisions, have been computer-based and biological inventions. The US practice of patentable subject matter is very different from that of the

European Patent Office The European Patent Office (EPO) is one of the two organs of the European Patent Organisation (EPOrg), the other being the Administrative Council. The EPO acts as executive body for the organisation

. Whereas the EPO adopted an exclusionary approach by denying patentability to specific types of inventions (discoveries, scientific theories and mathematical methods; aesthetic creations; schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; presentations of information), the US Supreme Court in its Alice-Mayo framework proposed an inclusionary approach: instead of categorically excluding certain types of invention, an additional "inventive concept" is required to limit the scope of the patent claims to certain applications of a newly discovered algorithm or a law of nature. There is an important relationship between patent eligibility and

non-obviousness The inventive step and non-obviousness reflect a general patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive—i.e., non-obvious—in order to be patented. In other words, " he ...

tests in the US patent law. The non-obviousness criterion can be easily met if a claim is based on a discovery of new natural phenomenon/principle/law. In the patentable subject matter analysis, however, this "discovery" is assumed to be prior art, and an "additional inventive concept" must be present in the claim.Genetic Technologies Ltd. v. Merial LLC: Gene-Based Assays in the Wake of Mayo. 2016. Biotechnol Law Rep. 35/3, 89-92. M. Sanzo. doi: 10.1089/blr.2016.29015.ms. Things (including living organisms and

nucleic acids Nucleic acids are large biomolecules that are crucial in all cells and viruses. They are composed of nucleotides, which are the monomer components: a 5-carbon sugar, a phosphate group and a nitrogenous base. The two main classes of nucleic a ...

) found in nature are not patent-eligible ( Funk Bros. Seed Co. v. Kalo Inoculant Co.) even, when isolated from their natural environment (e.g. a

protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residue (biochemistry), residues. Proteins perform a vast array of functions within organisms, including Enzyme catalysis, catalysing metab ...

-encoding

gene In biology, the word gene has two meanings. The Mendelian gene is a basic unit of heredity. The molecular gene is a sequence of nucleotides in DNA that is transcribed to produce a functional RNA. There are two types of molecular genes: protei ...

from a

chromosome A chromosome is a package of DNA containing part or all of the genetic material of an organism. In most chromosomes, the very long thin DNA fibers are coated with nucleosome-forming packaging proteins; in eukaryotic cells, the most import ...

), but things (even alive) "made by man" may be (

Diamond v. Chakrabarty ''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 coul ...

, Association for Molecular Pathology v. Myriad Genetics, Inc.), provided that they are different in a useful manner from their natural predecessor(s). In the case of computer-implemented methods, the

algorithms In mathematics and computer science, an algorithm () is a finite sequence of mathematically rigorous instructions, typically used to solve a class of specific problems or to perform a computation. Algorithms are used as specifications for per ...

(even new and non-obvious) per se are not patentable (

Gottschalk v. Benson ''Gottschalk v. Benson'', 409 U.S. 63 (1972), was a Supreme Court of the United States, 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 pat ...

, Parker v. Flook), and an additional "inventive concept" is required to limit the algorithm to new and useful application(s) (

Diamond v. Diehr ''Diamond v. Diehr'', 450 U.S. 175 (1981), was a United States Supreme Court decision which held that controlling the execution of a physical process, by running a computer program did not preclude patentability of the invention as a whole. The h ...

).Alice at Six: Patent Eligibility Comes of Age. 2021. Chi-Kent J Intell Prop. 20/64. M.A. Perry, J.S. Chung.

Japan

Legal controversies

The question of what should and should not be patentable subject matter has spawned a number of battlegrounds in recent years, setting against each other those in each area supporting patentability, claiming that patents would cause increased innovation and public good, against opponents with views that patentability is being sought only for private good but would do public harm. Flashpoints have included the patenting of naturally occurring biological material, genetic sequences,

stem cells In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can change into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of cell ...

, "

traditional knowledge Traditional knowledge (TK), indigenous knowledge (IK), folk knowledge, and local knowledge generally refers to knowledge systems embedded in the cultural traditions of regional, indigenous, or local communities. Traditional knowledge includes ...

," programs for computers, and business methods.

References and notes

External links

Typepad.com
''Ex parte Lundgren'' (U.S. Board of Patent Appeals and Interferences, October 2005), especially the dissent of Judge Barrett, which contains a lengthy presentation of statutory subject matter following page 19.
Patent.gov
UK Patent Office Manual of Patent Practice section on patentability. {{DEFAULTSORT:Patentable Subject Matter Patent law