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United States patent law
United States patent law
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Patent law
Overviews
Procedural concepts
Patentability requirements and related concepts
Other legal requirements
By region / country
By specific subject matter
See also
United States patent law
Legislation
Types of patent claims
Procedures
Other topics

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 (usually, 20 years) from profiting from 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.[1]

History

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  • 1623 – England adopts Statute of Monopolies, which has been acknowledged as a legal predecessor of the US patent law.
  • 1789 – U.S. Constitution in Article I, Section 8, Clause 8 authorizes Congress "to promote the Progress of . . . useful Arts, by securing for limited Times to . . . Inventors the exclusive Right to their . . . Discoveries." It is believed that, unlike most parts of the US Constitution, which were derived from the British legal tradition, the IP clause was based on the French practice.[2]
  • 1790 – First Patent Act empowered the Secretary of State, the Secretary of War, and the Attorney General to examine patents for inventions deemed "sufficiently useful and important."
  • 1793 – Second Patent Act eliminated examination of patent applications, emphasized enablement requirement. This Act did not have a requirement for claims, but it mandated a distinction "from...other things...and from other inventions" in the description:

description shall "distinguish the same from all other things before known," and in "the case of any machine" shall, explain the "principle... by which it may be distinguished from other inventions."[3]

Legislation

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The issues of patent validity and patent infringement fall under exclusive jurisdiction of the Federal government. On the other hand, questions of patent ownership (like other questions of private property) are contested in state courts, although federal courts can make decisions about patent ownership by applying the relevant state law, when appropriate.[8]

Most of the US patent law is codified in Title 35 of the United States Code, as authorized by Article One, section 8, clause 8, which states:

The Congress shall have power ... To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries;

. The "patentability" of inventions (defining the types things that qualify for patent protection) is defined under Sections 100–105. Most notably, section 101[9] sets out "subject matter" that can be patented; section 102[10] defines "novelty" and "statutory bars" to patent protection; section 103[11] requires that an invention to be "non-obvious".

Although this statement is superficially similar to intellectual property clauses in the constitutions of other countries, the US patent system has several peculiarities:

  • This clause is interpreted as giving the primary IP rights only to individuals (i.e. "inventors") rather than to organizations (see Stanford University v. Roche Molecular Systems, Inc.),
  • Until 16 March 2013 the US gave priority to first inventors to invent, although the US adopted first inventor to file system since (see First to file and first to invent).
  • The US has provisional patent applications, which can be filed one year before filing regular patent application, thus delaying the start on the nominal 20 year patent term by one year.
  • Unlike most other countries, the US allows extension of patent monopoly beyond 20 years from the filing date via patent term adjustment[12] due to the patent prosecution delays by the USPTO or due to product approval delays by Food and Drug Administration.
  • The US does not have utility models.
  • There is no criminal liability for patent infringement in the US, only civil liability.
  • Although lawsuits for declaratory judgement are prohibited in the US in general, they are allowed in cases of potential patent infringement.[13][14]
  • A research exemption and fair use is allowed for using patented product or process for research and educational purposes, albeit their scopes have seen reductions in recent years.[15]
  • The large size of the US economy, the strong pro-patentee legal regime and over 200 years of case law make US patents more valuable and more litigated than patents of any other country. The long history of patents and strong protection of patent holders contributes to abuse of the system by patent trolls, which are largely absent in other countries.[citation needed]

The US also has an extensive body of case law comprising federal court precedents that have accumulated over more than 200 years. US Federal District courts have primary jurisdiction in patent infringement cases. Patent validity can be challenged in the same US Federal District courts, as a declarative judgement or counter-claim of non-infringement. Alternatively, patent validity (or examiners' refusals to grant patents) can be challenged at Patent Trial and Appeal Board (PTAB). The US Court of Appeals for the Federal Circuit (CAFC) reviews the decisions of the Federal District Courts and of the PTAB. The rulings of the CAFC can be reviewed by the SCOTUS, but only on a discretionary basis (i.e. there is no right to appeal the CAFC's decisions).

Patentable subject matter (§101)

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Main article: Patentable subject matter in the United States

One author of the US Patent Act of 1952 stated that patentable subject matter should encompass "anything under the sun that is made by man."[16] At that time, the USPTO and US courts interpreted both "anything" and "made by man" quite broadly. However, the meaning of these terms has been narrowed substantially over the years.

There are four types of "anything" (i.e. of statutory categories of inventions): a process, a machine (usually implies moving parts), (an article of) manufacture (usually implies no moving parts, e.g. textile fabric or a chair), a composition of matter (chemicals, materials), as well as improvements thereof.[17] Not every object falls into a statutory category: for example, electromagnetic waves,[18] and rules for playing games[19] are not patentable (but a new and non-obvious type of dice for playing games may be patentable as a "manufacture"). The most significant restrictions occurred over time with respect to patentability of "processes" (methods). For example, patenting of business methods in US (in contrast to other countries) was quite common between c. 1990 and 2014,[20] but courts gradually curtailed patentability of business methods to the point of almost complete exclusion in Alice Corp. v. CLS Bank International (2014).[21][22]

Also, US courts have been struggling with the meaning of "made by man". Since at least 1948 in Funk Bros. Seed Co. v. Kalo Inoculant Co. the Supreme Court made clear, that trivial implementations of a newly discovered natural phenomenon or natural product are not eligible for a patent. However, in 1991 in Amgen v. Chugai Pharmaceutical the CAFC concluded that genes isolated from their natural environment were patentable.[23] This practice came to an end in 2013 when the Supreme Court decided in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013) that "mere isolation of genes does not qualify for patent protection". At the same time the Court allowed patenting of complementary DNA without introns, since "it does not exist" in nature.[24] Similarly, inventions based on routine applications of discoveries (such as that different people metabolize the same drug at different rates as in Mayo Collaborative Services v. Prometheus Laboratories, Inc., or that pregnant woman's blood contains DNA of fetus' father as in Ariosa v. Sequenom) is not patent-ineligible in the US, since the new elements in such inventions are not "made" but rather "discovered" by man. Although the presence of such "discoveries" helps patentees to meet the non-obviousness requirement, an additional man-made contribution (called "inventive concepts" in Alice Corp. v. CLS Bank International) is required to limit this discovery to a patentable invention.

Patent subject matter eligibility is discussed in the details in section 2106 of Manual of Patent Examining Procedure.[25] Additional examples can be found here.[clarification needed][26]

Novelty (§102)

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Section 102 of the patent act defines the "novelty" requirement. The novelty requirement prohibits patenting a technology that is already available to the public. Specifically, 35 U.S.C. 102 states:

(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless— (1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention ...

For a technology to be "anticipated" (and therefore patent-ineligible) under 35 U.S.C. 102, the prior art reference must teach every aspect of the claimed invention either explicitly or impliedly. "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference."[27]

The issue of novelty often arises during patent examination, because of inadvertent and/or partial disclosures by inventors themselves prior to filing a patent application.[citation needed] Unlike the laws of most countries, the US patent law provides for a one-year grace period in cases of inventor's own prior disclosure.[28] Another unique feature of the US patent practice is a provisional patent application, which allows an inventor to establish a priority and gives them a year to improve on their invention before filing a complete (i.e. non-provisional) patent application.

Obviousness (§103)

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Main article: Non-obviousness in United States patent law

To be patentable, a technology must not only be "new" but also "non-obvious." The US requirement for non-obviousness corresponds to the inventive step requirement in other countries. An "invention" is obvious (and therefore ineligible for a patent) if a person of "ordinary skill" in the relevant field of technology would have thought the technology was obvious, on the filing date of the patent application. Legislatively the requirement for non-obviousness was established in the Patent Act of 1952. Specifically, 35 U.S.C. 103 states:

35 U.S.C. 103 Conditions for patentability; non-obvious subject matter. A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.

The non-obviousness requirement does not demand that the prior art be identical to the claimed invention. It is enough that the prior art can somehow be modified (or combined) in order to teach the claimed technology. So long as the modification of the prior art (or combination of several prior art references) would have been obvious to a person having ordinary skill in the art (PHOSITA) at the time the application was filed, the applied-for technology will be considered obvious and therefore patent-ineligible under 35 U.S.C. §103.

As the practice of the USPTO and US Federal Courts showed later, the PHOSITA criterion turned out to be too ambiguous in practice. The practical approach was developed later by the US Supreme Court in Graham v. John Deere Co. in 1966 and in KSR v. Teleflex in 2006.

Application procedure

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U.S. patent (1985-2018)
U.S. patent (2018-present)

Patent applications can be filed at the United States Patent and Trademark Office (USPTO). Prior to June 7, 1995, the duration of a US utility patent was 17 years from patent issuance. Since that date, the duration of the US utility patent is 20 years from the earliest effective filing date. However, patent term adjustment or extension are possible if the USPTO fails to issue a patent within 3 years after filing the full application, subject to various conditions on the applicant.[29][circular reference] The rules for drafting and filing a patent application are set out in the Manual of Patent Examining Procedure (MPEP).

Pre-grant publication (PG Pub)

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Since the American Inventors Protection Act, the USPTO publishes patent applications 18 months after the earliest priority application (which often is a provisional application) is filed. This time limit can be extended under certain circumstances, for an additional fee.[30] The applications may be published before a patent has been granted on them if the patent is not granted within the 18-month time frame. Applicants can opt out of publication if the applications will not be prosecuted internationally.[31]

Infringement and enforcement

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Following the grant of a patent, possible post-grant proceedings include reissue, ex parte reexamination, inter partes reexamination, inter partes review, post-grant review, supplemental examination, and post-grant validity review of business method patents.[32]

U.S. Federal District Courts (FDCs)

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Litigation in the Federal District Courts remains the main remedy for patent infringement. 5000-6000 patent cases are filed each year in the United States. The two most popular districts for patent cases are E.D. Texas and D. Delaware.[33]

U.S. International Trade Commission (ITC)

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In cases involving importation of a patented product into the US, the patent holder may wish to pursue a cause of action in the United States International Trade Commission (ITC) instead of, or in addition to, the court system. The ITC is an agency of the U.S. federal government empowered to enforce patent holders' rights under Section 337 of the Tariff Act of 1930. In contrast to courts, which have a wide range of remedies at their disposal, including monetary damages, the ITC can grant only two forms of remedy: exclusion orders barring infringing products from being imported into the United States, and cease-and-desist orders preventing the defendants (known as respondents) in the ITC action from importing infringing products into the United States. In addition, the ITC can grant temporary relief, similar to a preliminary injunction in U.S. federal court, which prevents importation of allegedly infringing products for the duration of the ITC proceeding.[34] In some cases, this may provide a quicker resolution to a patent owner's problems.[citation needed]

Court of Appeals for the Federal Circuit (CAFC)

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The Court of Appeals for the Federal Circuit hears appeals from US Federal District Courts and from the International Trade Commission. The decisions of the CAFC can be appealed to the US Supreme Court, but only on discretionary basis via a petition for a writ of certiorari.

Utilization and importance

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A survey of 12 industries from 1981 to 1983 shows that patent utilization is strong across all industries in the United States, with 50 percent or more patentable inventions being patented.[35]

However, this is not to say that all industries believe their inventions have relied on the patent system or believe it is a necessity to introduce and develop inventions. Another survey for the same time period show that, of those 12 same industries, only two—pharmaceuticals and chemicals—believe thirty percent or more of their patentable inventions would not have been introduced or developed without having patent protection. All others—petroleum, machinery, fabricated metal products, primary metals, electrical equipment, instruments, office equipment, motor vehicles, rubber, and textiles—have a percentage of twenty-five or lower, with the last four of those industries believing none of their inventions relied on the patent system to be introduced or developed.[35]

Industry Percent That Would Not Have Been Introduced Percent That Would Not Have Been Developed
Pharmaceuticals 65 60
Chemicals 30 38
Petroleum 18 25
Machinery 15 17
Fabricated Metal Products 12 12
Primary Metals 8 1
Electrical Equipment 4 11
Instruments 1 1
Office Equipment 0 0
Motor Vehicles 0 0
Rubber 0 0
Textiles 0 0

See also

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Concepts

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Legislation

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Other

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References

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[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

United States patent law

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patent law comprises the statutes, administrative regulations, and judicial precedents that govern the grant and enforcement of for inventions, primarily codified in Title 35 of the and administered by the United States Patent and Trademark Office (USPTO). Rooted in Article I, Section 8, Clause 8 of the U.S. Constitution, which empowers "to promote the Progress of Science and useful Arts, by securing for limited Times to... Inventors the exclusive Right to their... Discoveries," the system grants qualified inventors temporary monopolies in exchange for public disclosure of their inventions, thereby incentivizing innovation while eventually enriching the public domain. must satisfy statutory criteria including patentable subject matter under 35 U.S.C. § 101 (excluding laws of nature, natural phenomena, and abstract ideas), novelty under § 102, non-obviousness under § 103, and sufficient description under § 112. The framework originated with the Patent Act of 1790, the first federal statute signed by President George Washington, establishing a system of examination by a board including , and has evolved through key revisions such as the 1836 Act creating the independent , the 1952 Patent Act codifying modern requirements like non-obviousness, and the 2011 Leahy-Smith America Invents Act (AIA), which shifted to a first-inventor-to-file priority, introduced post-grant review procedures, and aimed to curb abusive litigation. Since 1790, the USPTO has issued millions of patents, with annual grants exceeding 300,000 in recent years amid exponential application growth, reflecting the system's role in fostering technological advancement. Econometric analyses link robust protections to higher rates and , as evidenced by correlations between patent intensity and across U.S. metropolitan areas and over time, though the causal mechanisms involve balancing ex ante incentives for against potential ex post restrictions on cumulative . patents, the most common type, endure for 20 years from filing, covering processes, machines, manufactures, and compositions of matter, while patents protect ornamental appearances for 15 years and patents safeguard asexually reproduced varieties. occurs via federal courts, where patentees may seek injunctions or damages, contributing to the U.S. position as a global leader in filings and high-value inventions. Notable controversies include the proliferation of non-practicing entities (NPEs), often termed patent trolls, which acquire broad or low-quality patents primarily for litigation extortion rather than , imposing billions in direct and on productive firms through aggressive suits enabled by fee-shifting limitations and vague claiming. Reforms like the AIA's inter partes review and subsequent judicial doctrines, such as heightened standards in Twombly and Iqbal and restrictions on injunctions in eBay v. MercExchange, have mitigated some abuses, yet indicates persistent inefficiencies from over-enforcement of software and business method patents, which academic sources—potentially influenced by institutional incentives favoring expansionist interpretations—have debated amid concerns over deterrence. These dynamics underscore the tension between rewarding genuine inventive contributions and avoiding deadweight losses from , with first-principles evaluation emphasizing patents' utility in verifiable disclosure over speculative social planning.

Historical Foundations

Constitutional Origins and Early Implementation

The authority for United States patent law derives from Article I, Section 8, Clause 8 of the , which empowers "To promote the Progress of and useful , by securing for limited Times to Authors and Inventors the to their respective Writings and Discoveries." This clause reflects the framers' intent to incentivize innovation through temporary monopolies, drawing from English common law precedents like the of 1624 while limiting grants to useful inventions to avoid abusive privileges. Congress enacted the first federal patent statute, the Patent Act of 1790, on April 10, 1790, signed into law by President George Washington. The Act established a registration system requiring applicants to submit a petition, specification of the invention, and optionally a model, with examination by a board comprising the Secretary of State, Secretary of War, and Attorney General to assess novelty, utility, and importance. Patents granted under this Act lasted 14 years, were signed by the President and board members, and applied equally to citizens and aliens without residency requirements. Implementation began immediately, with the Patent Board—led by Secretary of State Thomas Jefferson, alongside Secretary of War Henry Knox and Attorney General Edmund Randolph—personally reviewing applications in a quasi-judicial process emphasizing empirical utility and originality. Jefferson, who denied his own swivel chair patent due to prior art, conducted detailed examinations, such as for the first patent issued to Samuel Hopkins on July 31, 1790, for a potash production process, prioritizing inventions with clear causal benefits to agriculture and manufacturing. Over its brief tenure until early 1793, the board issued approximately 57 patents, revealing the system's administrative burdens: applications required unanimous board approval, models were often impractical, and the lack of a dedicated office led to ad hoc reviews in Philadelphia. These challenges, including low volume and enforcement difficulties without a centralized bureau, prompted revisions in the Patent Act of 1793, which shifted to a registration model without substantive examination.

Major Legislative Evolutions

The Patent Act of 1790, enacted on April 10, 1790, established the first federal patent system in the United States, authorizing a board consisting of the Secretary of State, Secretary of War, and to examine applications and grant patents for inventions deemed "sufficiently useful and important," with terms limited to 14 years. This act required inventors to submit specifications and models where practicable, but its rigorous pre-grant review process, involving figures like , resulted in only about 57 patents being issued before its repeal. The Patent Act of 1793, signed into law on February 21, 1793, replaced the examination-based system with a registration approach, empowering the Secretary of State to issue patents upon the applicant's oath of novelty and originality, without substantive prior review. It expanded to include "any new and useful art, machine, manufacture or ," but initially restricted eligibility to U.S. citizens and residents, reflecting early protectionist policies amid international tensions. The Patent Act of 1836, effective July 4, 1836, reintroduced mandatory examination by creating the independent with professional examiners, required detailed specifications and claims to define scope, and implemented sequential patent numbering starting with No. 1. This reform addressed abuses under the 1793 registration model, such as frivolous grants, by enforcing novelty assessments; it set 14-year terms with optional 7-year extensions for meritorious cases and reduced nationality-based fees over time to encourage broader participation. The Patent Act of 1952 codified U.S. patent law in Title 35 of the United States Code, explicitly requiring inventions to demonstrate utility, novelty, and non-obviousness to a person of ordinary skill in the art, thereby formalizing judicial doctrines into statutory criteria under sections 101, 102, and 103. It shifted patent terms to 17 years from the date of issuance rather than filing, introduced provisions for functional claiming and joint inventorship, and aimed to simplify procedures while clarifying infringement remedies, responding to post-World War II innovation demands without altering core eligibility standards. The Bayh-Dole Act of 1980, enacted December 12, 1980, permitted universities, nonprofit organizations, and small businesses to retain title to patents arising from federally funded research, reversing prior policies where the government claimed ownership and often failed to commercialize inventions. This shift facilitated , leading to over 15,000 startup companies and licensing revenues exceeding $1 trillion cumulatively by enabling private sector development of taxpayer-supported innovations. The of 1994 implemented changes effective June 8, 1995, aligning U.S. law with TRIPS by extending terms to 20 years from the earliest filing date for applications filed on or after that date, replacing the prior 17 years from issuance to better harmonize with international norms and account for prosecution delays. It also introduced options and adjustments for regulatory review delays, increasing effective protection periods for pharmaceuticals and other products subject to approval processes. The Leahy-Smith America Invents Act of 2011, signed September 16, 2011, marked the most substantial overhaul since 1836 by transitioning to a first-inventor-to-file priority , effective for applications filed after March 16, 2013, to reduce uncertainty in determining inventorship amid global first-to-file standards. Key provisions included new post-grant review proceedings for invalidity challenges, inventor oath reforms to streamline filings, and USPTO fee-setting authority, aimed at curbing abusive litigation while enhancing examination efficiency, though implementation faced debates over definitions and derivation proceedings.

Statutory Requirements for Patentability

Eligible Subject Matter

35 U.S.C. § 101 defines patent-eligible subject matter as any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. These four categories broadly encompass human-made inventions, as affirmed by the Supreme Court in Diamond v. Chakrabarty (1980), which held that a genetically engineered bacterium qualified as a manufacture or composition of matter because it was a product of human ingenuity rather than a naturally occurring phenomenon. The statute imposes no explicit exclusions, but eligibility under § 101 serves as a threshold requirement distinct from novelty (§ 102), non-obviousness (§ 103), and adequate disclosure (§ 112). Judicial precedent has carved out three implicit exceptions: laws of nature, natural phenomena, and abstract ideas, which cannot be patented because they represent fundamental building blocks of innovation rather than inventive applications. In Mayo Collaborative Services v. Prometheus Laboratories (2012), the Supreme Court invalidated claims to a medical diagnostic process correlating metabolite levels with optimal dosages, ruling that the claims preempted a without transforming it through inventive steps beyond routine activity. Similarly, Association for Molecular Pathology v. Myriad Genetics (2013) determined that isolated human DNA sequences, even if extracted from the body, remained ineligible as products of nature lacking human alteration sufficient to confer novelty. For abstract ideas, Bilski v. Kappos (2010) rejected the Federal Circuit's rigid "machine-or-transformation" test as the exclusive criterion for process patents but confirmed that certain business methods embodying fundamental economic practices are ineligible. The Court in Alice Corp. v. CLS Bank International (2014) articulated a two-step framework still applied today: first, determine if the claim is directed to a judicial exception; second, assess whether additional elements integrate the exception into a practical application or provide an inventive concept amounting to "significantly more" than the exception itself. Under this test, claims reciting abstract ideas—such as mathematical algorithms or generic computer implementations of financial intermediation—fail eligibility absent concrete technological improvements, as mere automation of mental processes on generic hardware does not suffice. The U.S. Patent and Trademark Office (USPTO) implements these principles through examiner guidance, evaluating claims for integration into a practical application (e.g., improving computer functionality or solving a technical problem) rather than mere field-of-use limitations or insignificant post-solution activity. Recent updates, including the 2024 guidance on artificial intelligence inventions, clarify that AI-related claims reciting mathematical models or mental processes are ineligible unless they demonstrate a specific technological improvement, such as enhanced precision in data processing beyond conventional methods. This framework balances promoting innovation by protecting applied inventions while preventing monopolization of basic knowledge, though post-Alice litigation has invalidated thousands of software and biotech patents deemed overly abstract.

Novelty and Prior Art

In United States patent law, novelty requires that a claimed must not have been previously known or used in a manner that anticipates its elements, ensuring that patents reward genuine innovation rather than preexisting knowledge. This requirement, codified in 35 U.S.C. § 102 as amended by the Leahy-Smith America Invents Act (AIA) of 2011 and effective for applications filed on or after March 16, 2013, bars patentability if the invention lacks novelty relative to . encompasses disclosures that render the claim anticipated, meaning a single reference discloses every limitation of the claim either explicitly or inherently, with the reference interpreted as it would be understood by a person of ordinary skill in the art at the time. Under AIA 35 U.S.C. § 102(a)(1), a claimed is not novel if, before its effective filing date—defined as the earliest filing date of the application or a claimed priority application to which benefit is properly accorded—it was ed, described in a printed , in use, on sale, or otherwise available to the anywhere in the world. Additionally, § 102(a)(2) treats as any U.S. , U.S. , or granted on an application with an earlier effective filing date, even if published after the claimed 's filing date, provided it names another inventor. This framework shifted the U.S. from a first-to-invent system to a first-inventor-to-file system, prioritizing the filing date while harmonizing with international standards, though retaining a one-year absent in jurisdictions requiring absolute novelty. use or sale includes commercial exploitation or non-secret uses observable by the , without requiring actual observation if the use was accessible. Exceptions to under 35 U.S.C. § 102(b) preserve novelty for certain pre-filing disclosures, providing a one-year . Specifically, § 102(b)(1) excludes from § 102(a)(1) any disclosure made one year or less before the effective filing date if it originated from the inventor, joint inventor, or someone obtaining the subject matter from them, or if the inventor's prior public disclosure precedes a third party's intervening disclosure of the same subject matter. For § 102(a)(2) , § 102(b)(2) similarly excepts references where the subject matter was obtained from the inventor or where the inventor's earlier application supports the claim and discloses the subject matter. These exceptions apply only if the disclosure's inventor origin is evident from its content or context, and they do not extend to independent third-party disclosures outside the . During examination, the United States Patent and Trademark Office (USPTO) searches for and applies to reject claims lacking novelty under 35 U.S.C. § 102, with applicants able to antedate references via affidavits or declarations showing derivation or earlier invention dates where applicable within the . In litigation, courts assess de novo for but defer to USPTO fact findings on inherent disclosures, requiring clear and convincing evidence to invalidate issued patents. This rigorous standard underscores novelty's role in preventing overbroad monopolies on incremental or preexisting technologies.

Non-Obviousness and Inventive Step

Non-obviousness under United States patent law, as set forth in 35 U.S.C. § 103, prohibits patenting a claimed if the differences between the subject matter sought to be patented and the are such that the as a whole would have been obvious to a person having ordinary skill in the art (PHOSITA) to which the claimed pertains, at the time the was made (pre-AIA) or before the effective filing date (post-AIA). This requirement, enacted in the Patent Act of 1952, aims to ensure patents reward genuine inventive contributions rather than mere incremental or predictable advances. The PHOSITA is an objective, hypothetical individual possessing ordinary skill level, knowledge, and creativity in the relevant field, without requiring extraordinary genius or undue experimentation. The in Graham v. Co., 383 U.S. 1 (1966), established the foundational framework for assessing obviousness, comprising four factual inquiries: (1) the scope and content of the ; (2) the differences between the and the claims at issue; (3) the level of ordinary skill in the pertinent art; and (4) objective indicia of non-obviousness, such as commercial success, long-felt but unresolved needs, failure of others, and unexpected results. These Graham factors guide courts and the United States Patent and Trademark Office (USPTO) in evaluating whether renders a claim obvious, often through combinations of references where a PHOSITA would predictably substitute or modify elements. Secondary considerations serve as rebuttal evidence, demonstrating that market or technical realities reflect non-obviousness despite apparent prima facie obviousness. Subsequent jurisprudence refined this approach, notably in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), where the Court rejected rigid adherence to the teaching-suggestion-motivation (TSM) test—requiring explicit teachings in for combinations—as overly narrow and inconsistent with § 103's statutory language. Instead, KSR endorsed a flexible, expansive inquiry incorporating , the interrelated teachings of multiple references, and obviousness in predictable arts where familiar elements are combined without . The decision clarified that obviousness arises not only from explicit motivations but also from market pressures, design incentives, or the absence of unexpected results in known technologies. In USPTO examination, a prima facie case of obviousness is established by mapping claim limitations to prior art combinations, after which applicants may traverse rejections via arguments on Graham factors, claim amendments, or evidence of secondary indicia. Updated USPTO guidance in 2024 reinforces KSR's flexible framework, directing examiners to avoid rigid TSM applications and to weigh all record evidence holistically, including whether a claimed invention addresses a recognized problem using known solutions in a non-trivial manner. This aligns non-obviousness with the international "inventive step" concept under agreements like the TRIPS Agreement, though U.S. law emphasizes the PHOSITA's perspective over subjective inventor insights.

Disclosure and Enablement

Under 35 U.S.C. § 112(a), a patent specification must satisfy three distinct disclosure obligations: providing a written description of the invention, enabling a person skilled in the art to make and use it without undue experimentation, and setting forth the best mode contemplated by the inventor for carrying out the invention. These requirements ensure the patent bargain—public disclosure in exchange for temporary exclusivity—is fulfilled by conveying sufficient technical detail to advance knowledge while preventing overbroad claims unsupported by the inventor's actual conception. The written description requirement mandates that the specification demonstrate the inventor's possession of the full scope of the claimed as of the filing date, such that a skilled could recognize the inventors as having invented what is claimed. This is assessed case-by-case, focusing on whether the disclosure conveys structural or functional features defining the 's boundaries, rather than mere generalizations. In Ariad Pharmaceuticals, Inc. v. & Co. (2010), the Federal Circuit, sitting , affirmed this as a separate from enablement, invalidating claims to methods of reducing NF-κB activity for lacking of specific species supporting the broad genus. Enablement requires the specification to teach a person of ordinary skill in the art (POSITA) how to make and use the invention's full scope without undue experimentation, applying the same standard to the claimed embodiments regardless of technological field. Courts evaluate this using the factors from In re Wands (Fed. Cir. 1988): (1) the breadth of the claims relative to the disclosure; (2) the nature of the invention; (3) the state of the ; (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary to satisfy the claim scope. In Amgen Inc. v. Sanofi (2023), the unanimously held that Amgen's patents claiming broad genera of antibodies by functional characteristics (e.g., PCSK9-binding without undue experimentation to identify structures) failed enablement, as disclosing only 26 representative antibodies did not suffice for the vast undisclosed variants, requiring cell-based screening akin to undue experimentation across the full claim breadth. The best mode requirement obligates disclosure of the inventor's preferred embodiment known at filing, evaluated subjectively based on the inventor's knowledge and objectively on whether the mode is concealed such that it impedes enablement. Unlike written description and enablement, failure to satisfy best mode cannot invalidate a patent in post-grant infringement litigation following the America Invents Act of 2011, though it remains grounds for rejection during examination. This provision guards against inventors withholding optimal implementations to retain competitive advantages post-patent.

Patent Application and Examination

Filing and Prosecution Process

A patent application in the United States is filed with the United States Patent and Trademark Office (USPTO) under the requirements of 35 U.S.C. § 111. Nonprovisional applications, which seek examination on the merits, must include a written specification disclosing the invention in full, clear, concise, and exact terms; at least one claim particularly pointing out and distinctly claiming the subject matter regarded as the invention; any drawings necessary to understand the invention; and an oath or declaration executed by the inventor or joint inventors affirming originality. The specification must commence with a title, provide a background, describe the invention's structure and operation, and include the best mode contemplated by the inventor for carrying it out, enabling a person skilled in the art to make and use it without undue experimentation. Applications are typically filed electronically via Patent Center, with filing fees starting at $320 for small entities as of 2024, subject to entity size reductions or micro-entity status. The effective filing date is the date on which the USPTO receives the specification and any required drawings, provided the application identifies the inventor by name and includes a cover sheet or application data sheet with address and residency information. Provisional applications, authorized under 35 U.S.C. § 111(b), offer a lower-threshold entry point, requiring only a written description and necessary drawings without formal claims, , or . These establish an early filing date for priority purposes but expire after 12 months, during which a corresponding nonprovisional application must be filed claiming benefit under 35 U.S.C. § 119(e) to avoid loss of the provisional date. Provisional filings, with fees around $150 for small entities, do not undergo substantive examination but serve to secure a priority date against intervening disclosures. Upon filing, the USPTO conducts a formal review for completeness, assigns an application number and , and forwards it to an examiner in the relevant . Prosecution commences with the examiner's substantive examination, involving a search for and assessment of under 35 U.S.C. §§ 101 (subject matter eligibility), (novelty), 103 (non-obviousness), and 112 (disclosure s). The examiner may issue a restriction if multiple inventions are claimed, requiring election of a single group for examination. Typically, the first Office Action on the Merits (FAOM) issues 14 to 24 months after filing, communicating rejections (e.g., under §§ or 103 based on cited references) or objections to the specification or claims. Applicants respond to non-final Office Actions within three months, extendable to six months with fees up to $2,200 for large entities, by submitting amendments to the claims or specification, arguments distinguishing the invention from prior art, or evidence such as affidavits under 37 C.F.R. § 1.132. Responses must be in writing, fully address each rejection, and maintain support in the original disclosure to avoid new matter issues under 35 U.S.C. § 132. Applicants may request an interview with the examiner, conducted by phone or video, to discuss claim amendments or prior art interpretations, potentially accelerating resolution. An Information Disclosure Statement (IDS) may be filed to submit known prior art, with requirements for duty of candor under 37 C.F.R. § 1.56. Prosecution continues iteratively until the examiner issues a Notice of Allowance, typically after 2-3 years on average for patents, or a final rejection. Against final rejection, options include filing a Request for Continued Examination (RCE) with additional fees to reopen prosecution, appealing to the Patent Trial and Appeal Board (PTAB) under 35 U.S.C. § 134, or abandoning the application. Upon allowance, the applicant pays the issue fee (around $1,200 for large entities) within , leading to publication and grant of the , printed with a 20-year term from the earliest nonprovisional filing date, subject to maintenance fees at 3.5, 7.5, and 11.5 years. Abandonment occurs automatically for failure to respond or pay fees, though revival is possible upon showing unintentional delay under 37 C.F.R. § 1.137.

Examination Standards and Rejections

The United States Patent and Trademark Office (USPTO) conducts substantive examination of patent applications to assess compliance with the patentability criteria outlined in 35 U.S.C. §§ 101, 102, 103, and 112, among others. Upon assignment to an examiner in a relevant technology center, the process involves reviewing the specification, claims, and drawings; performing a prior art search using databases such as USPTO records, scientific literature, and foreign patents; and determining whether the claimed invention meets statutory thresholds. Examiners apply a preponderance of the evidence standard, bearing the initial burden to establish a prima facie case of unpatentability before shifting the burden to the applicant to rebut. The examination aims to ensure only inventions demonstrating utility, novelty, non-obviousness, and adequate disclosure receive protection, with the first Office Action typically issued within 14 to 24 months of filing, often containing rejections. Rejections occur when claims fail to satisfy statutory requirements, requiring examiners to articulate specific reasons, cite supporting evidence such as references, and explain how the claims are rendered unpatentable. Common grounds include ineligibility under 35 U.S.C. § 101 for claims directed to abstract ideas, laws of nature, or natural phenomena without significantly more inventive application, as interpreted in cases like Alice Corp. v. CLS Bank International (2014); under § 102 if a single reference discloses all claim elements arranged as in the claim; obviousness under § 103 if the differences between the claimed invention and would have been obvious to a person of ordinary skill; and deficiencies under § 112 for inadequate written description, lack of enablement, omission of best mode, or indefinite claims. Other rejections may address double patenting, improper dependency, or non-statutory subject matter like human organisms.
Rejection GroundStatutory BasisKey Criteria
Subject Matter Eligibility35 U.S.C. § 101 must be a process, machine, manufacture, or ; excludes abstract ideas unless integrated into practical application with significantly more.
Novelty/35 U.S.C. § 102All elements must not be identically disclosed in a single reference or activity before the effective filing date.
Obviousness35 U.S.C. § 103Claimed not obvious over combination, considering Graham factors: scope/content of , differences, level of ordinary skill, and secondary indicia like commercial success.
Specification Requirements35 U.S.C. § 112Must enable skilled artisan to make/use without undue experimentation, provide written of claimed scope, disclose best mode known to inventor, and define claims with reasonable certainty.
Applicants respond to non-final rejections within three months (extendable to six) by amending claims, submitting evidence, or arguing against the examiner's findings, prompting further review. Final rejections, permissible after the second or subsequent examination, limit further prosecution unless the applicant files a request for continued examination (RCE), appeals to the Patent Trial and Appeal Board (PTAB), or abandons the application. In fiscal year 2023, the USPTO allowance rate hovered around 55%, reflecting rigorous scrutiny amid increasing application volumes exceeding 600,000 annually. Persistent rejections underscore the adversarial nature of prosecution, where examiners prioritize compact prosecution to resolve issues early.

Publication and Provisional Applications

A provisional patent application provides inventors with a mechanism to establish an early effective filing date for an without the full formalities of a nonprovisional application. It requires a written of the , any necessary drawings, a cover sheet identifying the and applicants, and payment of the filing , but omits formal claims, an inventor's oath or declaration, and an information disclosure statement. This filing secures "" status, allowing the applicant 12 months to further develop the or prepare a nonprovisional application that can claim priority to the provisional's date under 35 U.S.C. § 119(e). Provisional applications undergo no substantive examination by the United States Patent and Trademark Office (USPTO) and automatically expire after 12 months if not followed by a timely nonprovisional filing; they do not mature into issued patents. The provisional format, introduced under the of 1994 effective January 1, 1995, aims to lower initial costs and barriers for inventors while preserving novelty against intervening . To support priority claims, the provisional's disclosure must adequately describe the as later claimed in the nonprovisional, enabling a person skilled in the art to make and use it without undue experimentation. Failure to file a nonprovisional within the 12-month period forfeits the priority date, potentially barring due to subsequent disclosures or third-party activity. Nonprovisional patent applications are generally published by the USPTO 18 months after their earliest claimed filing date, including any provisional priority date, to promote public access to pending inventions as and provide notice of potential future patents. This practice stems from the American Inventors Protection Act of 1999 (AIPA), enacted November 29, 1999, with publication provisions effective November 29, 2000, amending 35 U.S.C. § 122(b). Publications include the specification, claims (if present), drawings, and an application data sheet, formatted similarly to issued patents but prefixed with "US" followed by the application number and publication year. Exceptions to mandatory publication apply if the applicant certifies at filing that the invention has not and will not be patented outside the or under international treaties, and submits a non- request; revocation of this request triggers . Applications abandoned before 18 months or those solely for patents (which are not published pre-issuance) also avoid . Post-, the document enters the as effective from the date for third parties, though the applicant's defensive use of the filing date precedes it under certain conditions. Provisional applications themselves are not published independently.

Scope, Duration, and Maintenance of Patents

Claims and Infringement Analysis

In United States patent law, claims delineate the precise boundaries of the patentee's exclusive rights, serving as the of the invention as required by 35 U.S.C. § 112(b), which mandates that claims "particularly point[] out and distinctly claim[] the subject matter which the applicant regards as his ." This provision imposes two core requirements: the claims must set forth the subject matter regarded as the , and they must do so with sufficient to inform skilled artisans of the scope while providing notice to potential infringers. Claims are typically drafted in independent form, standing alone to define the , or in dependent form, incorporating and narrowing the scope of an independent claim by adding further limitations. The construction of patent claims is a question of law exclusively for the court to resolve, as established by the Supreme Court in Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), which held that interpreting terms of art within claims falls within the judiciary's province to ensure uniformity and predictability. Courts conduct claim construction by examining the intrinsic evidence—primarily the claim language, specification, and prosecution history—supplemented by extrinsic evidence such as expert testimony or dictionaries when ambiguities persist, often through specialized proceedings known as Markman hearings. This process determines the ordinary meaning of claim terms to a person of ordinary skill in the art at the time of the invention, avoiding undue importation of limitations from the specification unless clearly required. Infringement analysis begins with comparing the accused product or to the properly construed claims; liability arises if every limitation of at least one claim is met, pursuant to 35 U.S.C. § 271(a), which prohibits unauthorized making, using, offering to sell, selling, or importing the patented . Direct infringement requires literal correspondence or equivalence under the , while indirect forms include inducement under § 271(b)—actively encouraging another to infringe with knowledge of the —and contributory infringement under § 271(c), involving sale or import of a component especially made for the and not a staple article suitable for noninfringing use. Literal infringement occurs when the accused embodiment embodies each claim element exactly as construed, whereas the extends protection to insubstantial variations that perform substantially the same function in substantially the same way to achieve substantially the same result, preventing accused infringers from practicing known equivalents to evade liability, as articulated in judicial precedents. Courts apply function-way-result or insubstantial differences tests to assess equivalence, tempered by limitations like prosecution history , which bars claiming equivalents surrendered during , and the all-elements rule, ensuring no claim limitation is entirely vitiated. This dual framework balances the patentee's right to exclude against fair notice, with fact-finders (typically juries) resolving factual issues of equivalence post-construction.

Term Limits and Extensions

The term of a utility in the United States is twenty years from the date on which the earliest application was filed that claims priority to the , provided the application was filed on or after June 8, 1995. This duration applies to plant as well, while design have a term of fifteen years from the date of grant. The term commences upon issuance of the and requires payment of maintenance fees at 3.5, 7.5, and 11.5 years after issuance to avoid expiration due to nonpayment. Provisional applications do not count toward the term calculation, as the clock starts with the filing of the non-provisional application. Patent Term Adjustment (PTA) extends the term to compensate for delays caused by the United States Patent and Trademark Office (USPTO) during prosecution. Under 35 U.S.C. § 154(b), PTA is calculated based on three periods: failure to notify of USPTO delays within fourteen months of filing (A delay), failure to issue a first substantive examination or notice of allowance within specified times (B delay), and appellate delays (C delay), reduced by any applicant delays such as failures to respond within three months or overlaps exceeding three months. The USPTO determines PTA at issuance, but applicants may request reconsideration or appeal to the Patent Trial and Appeal Board or federal courts if disputed. PTA ensures the effective term aligns with the twenty-year statutory limit despite administrative delays, with the Supreme Court upholding its constitutionality in Wyeth v. Abbott Laboratories (2013) as a restoration rather than extension of rights. Patent Term Extension (PTE) under 35 U.S.C. § 156 restores patent term lost due to regulatory review by agencies like the (FDA) for products such as drugs, medical devices, or food additives. Enacted via the Hatch-Waxman Act of 1984, PTE is available only for the first permitted commercial marketing or use, up to five years, but capped so that the patent's remaining term plus the extension does not exceed fourteen years from the approval date. The extension period equals the regulatory review time minus safe harbor deductions for premarket activities, with applications filed post-approval within sixty days. PTE applies to one patent per product and excludes time before the product's regulatory submission date. The FDA determines eligibility, with the USPTO issuing the certificate upon approval.

Fees and Abandonment

Patent applicants must pay various fees to the Patent and Trademark Office (USPTO) during filing, examination, issuance, and maintenance, with non-payment or untimely responses leading to abandonment of applications or expiration of granted patents. The fee structure, updated effective January 19, 2025, includes entity-size reductions: small entities (e.g., individuals or businesses with fewer than 500 employees) receive approximately 50-60% discounts on most fees, while micro entities (e.g., independent inventors meeting income and patent limits) qualify for up to 75% reductions. Initial fees for a patent application consist of a basic filing fee of $350 (large entity), plus search and examination fees totaling $744, payable upon filing or within specified deadlines to avoid incomplete submission and potential abandonment. During prosecution, response fees for office actions (e.g., $1,360 for a first request for continued examination) and extension fees (e.g., $220 for the first month) are required; failure to pay or respond within (extendable up to three additional months for 440−440-1,100 per month, large entity) results in implicit abandonment. Upon allowance, an issue fee of $1,200 (large entity) must be paid within to grant the ; non-payment leads to abandonment of the allowed application. Applications may also be expressly abandoned via a written declaration under 37 CFR 1.138, often to avoid pre-grant (18 months after filing) or strategically withdraw without . The USPTO issues a Notice of Abandonment to the applicant or attorney of record, confirming the status. Abandoned applications can be revived via under 37 CFR 1.137 if abandonment was unintentional, requiring a $2,100 (large ) and of due care, with revival possible within two years or longer under certain conditions. For issued patents (excluding and patents), fees are mandatory under 35 U.S.C. § 41(b) to prevent expiration, due at 3.5 years (2,150large[entity](/page/Entity)),7.5years(2,150 large [entity](/page/Entity)), 7.5 years (4,040), and 11.5 years ($7,940) after issuance as of January 19, 2025. Payments may be made up to six months early or within a six-month post-deadline with a $2,200 surcharge (large ); failure to pay timely, even with surcharge, causes the to expire at the end of the , rendering it unenforceable and entering the . Expired patents cannot be revived, though for of delayed is possible if submitted within specified limits and fees paid. These fees fund USPTO operations and incentivize by allowing patentees to assess ongoing value.
Maintenance Fee StageDue Date (Years After Issuance)Large Entity Fee (Undiscounted, as of Jan. 19, 2025)Small Entity DiscountMicro Entity Discount
First3.5$2,150~50% ($1,075)75% ($538)
Second7.5$4,040~50% ($2,020)75% ($1,010)
Third11.5$7,940~50% ($3,970)75% ($1,985)
Fees reflect aggregate increases of about 7.5% for FY 2025 to cover operational costs exceeding $3.97 billion. Surcharges apply for late payments or excess claims (e.g., $200 per claim over 20).

Enforcement Mechanisms

Direct and Indirect Infringement

Direct infringement under United States patent law is defined in 35 U.S.C. § 271(a) as occurring when a party, except as otherwise provided, without authority makes, uses, offers to sell, or sells any patented invention within the United States, or imports such invention into the United States during the term of the patent. This liability applies to literal infringement, where the accused product or process meets every limitation of a valid, enforceable claim in the patent, as determined through claim construction and comparison by courts. The doctrine of equivalents may extend direct infringement liability to equivalents that perform substantially the same function in substantially the same way to achieve the same result, provided they do not vitiate claim limitations or ensnare prior art, though this judicial expansion is not codified in § 271(a). For process patents, direct infringement also arises under 35 U.S.C. § 271(g) when a party imports, sells, or uses products made abroad by a , unless the process is materially changed or insignificant, or the product is trivially different; this provision, enacted in , closed a territorial allowing foreign production to evade U.S. rights. Direct infringement requires no intent or knowledge of the ; attaches upon performance of the proscribed acts, enabling patentees to enforce exclusivity over the invention's commercial exploitation. Indirect infringement encompasses induced and contributory forms, both requiring an underlying act of direct infringement by another party, as affirmed by the in Limelight Networks, Inc. v. Akamai Technologies, Inc. (2014), which held that liability under § 271(b) or (c) cannot exist absent direct infringement, even if divided among multiple actors unless the inducer or contributor directs or controls the performance or forms a enterprise. Induced infringement under 35 U.S.C. § 271(b) occurs when a party actively induces another to infringe, defined as purposeful encouragement with knowledge that the induced acts infringe the patent, including willful blindness to such knowledge as established in Global-Tech Appliances, Inc. v. SEB S.A. (2011). Active inducement involves more than mere provision of instructions or products; it demands affirmative acts like or distributing materials promoting infringing use, with evidence of specific intent often inferred from circumstantial facts rather than direct proof. Contributory infringement under 35 U.S.C. § 271(c) applies when a party offers to sell, sells, or imports a component of a patented or material for a patented process that constitutes a material part, knowing it to be especially made or adapted for infringing use and not a staple article or suitable for substantial noninfringing use. This doctrine targets non-staple components whose primary value lies in enabling infringement, excluding everyday items with significant legitimate applications, as distinguished in pre-1952 precedents codified to limit overbroad liability. Unlike inducement, contributory infringement focuses on the product's inherent and at the time of sale, without requiring active encouragement, but courts scrutinize whether noninfringing uses are "substantial" based on evidence of market demand and technical feasibility. Both indirect doctrines necessitate proof of the defendant's of the , diverging from direct infringement's , a requirement reinforced by the in Global-Tech to align with statutory text and prevent unintended expansion of secondary liability. Post-AIA (America Invents Act of ), these standards apply uniformly, though safe harbors under § 271(e)(1) exempt certain research on patented inventions for FDA approval or off-label uses from liability. Enforcement typically proceeds in courts, where patentees must prove infringement by a preponderance of , with indirect claims often hinging on of and amid challenges in attributing divided acts.

Federal Courts and Specialized Forums

Patent infringement lawsuits in the United States are adjudicated exclusively in federal district courts, which hold original jurisdiction over civil actions arising under federal patent laws pursuant to 28 U.S.C. § 1338(a). Venue for such actions is proper where the defendant resides or where the defendant has committed acts of infringement and maintains a regular and established place of business, as specified in 28 U.S.C. § 1400(b). These courts handle claims for damages, injunctive relief, and determinations of validity, with trials often involving jury assessments of factual issues such as infringement and willful conduct. Appeals from district court decisions in patent cases are directed exclusively to the Court of Appeals for the Federal Circuit (CAFC), which was established by the Federal Courts Improvement Act of 1982 to provide national uniformity in patent law interpretation. The CAFC exercises appellate jurisdiction over patent matters from all federal district courts, the Patent Trial and Appeal Board, and certain agency decisions, issuing precedential opinions that bind lower courts nationwide. Further review may be sought in the . A specialized administrative forum for patent enforcement involving imports is the (ITC), which investigates unfair trade practices under Section 337 of the Tariff Act of 1930, including by imported articles. ITC proceedings, initiated by complaint, can result in general exclusion orders barring infringing goods from U.S. entry, limited exclusion orders, or cease-and-desist orders, with remedies focused on import restrictions rather than monetary damages. These investigations typically conclude within 12 to 16 months and are appealable to the CAFC. Approximately 90% of Section 337 cases involve patent issues, making the ITC a key venue for addressing extraterritorial infringement threats.

Remedies, Defenses, and Willful Infringement

A patentee proving infringement under 35 U.S.C. § 271 may seek remedies through civil action in federal court, as provided by 35 U.S.C. § 281. Primary monetary remedies include adequate to compensate for the infringement, with courts awarding either the patentee's lost profits—demonstrated by showing consumer demand, absence of acceptable noninfringing substitutes, manufacturing capability, and causation—or a reasonable royalty representing the minimum infringer would have paid in a hypothetical , but no less than this royalty in any event. Pre-suit damages are limited to six years prior to filing under 35 U.S.C. § 286, and recovery requires notice of infringement under 35 U.S.C. § 287 unless the patented article is marked. Equitable relief, such as permanent injunctions under 35 U.S.C. § 283, is not automatic but requires satisfying the four-factor test established by the in eBay Inc. v. MercExchange, L.L.C. (2006): (1) irreparable injury to the patentee, (2) inadequacy of legal remedies, (3) balance of hardships favoring the patentee, and (4) no disservice to the . Courts may also award prejudgment interest, costs, and, in exceptional cases under 35 U.S.C. § 285, reasonable attorney fees to the prevailing party, where the case stands out due to factors like unreasonable litigation conduct or improper patent procurement. Accused infringers may assert defenses under 35 U.S.C. § 282, which presumes patent validity subject to clear and convincing evidence of invalidity, including by , obviousness to a person of ordinary skill, lack of enablement or in specification, or failure to claim . Non-infringement arguments focus on whether the accused product or process meets every limitation of the asserted claims under the or literal infringement standards. Other defenses include patent exhaustion after authorized sale, permissible repair rather than reconstruction of patented articles, equitable from misleading conduct inducing reliance, laches barring claims after unreasonable delay causing prejudice, and prior user rights for pre-filing commercial use under 35 U.S.C. § 273. Patent misuse, requiring proof of and tying arrangements, can unclean hands the patentee's . Willful infringement, enabling courts to enhance damages up to three times under 35 U.S.C. § 284, requires evidence of deliberate or intentional disregard of known rights, as clarified by the in Halo Electronics, Inc. v. Pulse Electronics, Inc. (2016), which rejected rigid objective recklessness tests in favor of a flexible totality-of-circumstances inquiry focused on the infringer's subjective . Post-Halo, willfulness assessments consider factors like knowledge of the patent, copying, pre-suit notifications, opinion-of-counsel reliance, and litigation conduct, but enhancements remain discretionary and rare, awarded only for egregious cases to deter culpable behavior without punishing reasonable infringement risks. Juries typically determine underlying infringement and willfulness facts, with judges exercising discretion on enhancement amounts.

Post-Grant Challenges and Proceedings

Reexamination and Supplemental Examination

Ex parte reexamination allows any person to request that the United States Patent and Trademark Office (USPTO) reexamine the validity of one or more claims in an issued patent based solely on prior art consisting of patents or printed publications. Enacted in 1980 under 35 U.S.C. §§ 301-307, the process requires the requester to submit prior art that raises a substantial new question of patentability (SNQ) affecting any claim of the patent. The USPTO examines the request and, if an SNQ is found, orders reexamination, conducting proceedings akin to original patent examination under 35 U.S.C. §§ 132 and 133, including opportunities for the patent owner to respond and amend claims without broadening their scope. Reexamination certificates issue upon conclusion, confirming, canceling, or amending claims as appropriate, with files publicly accessible via Patent Center. Inter partes reexamination, which permitted third-party participation throughout the process, was available from 1999 until its phase-out under the Leahy-Smith America Invents Act (AIA) of 2011, with final proceedings transitioning to inter partes review by September 16, 2013. Today, reexamination remains the primary form, handled by the USPTO's Central Reexamination Unit, which oversees all such post-grant proceedings. Requests must detail the and explain its relevance to , with fees set by USPTO rule, and no discovery or occurs, limiting it to a non-adversarial review. Supplemental examination, introduced by the AIA and effective September 16, 2012, enables owners to request USPTO consideration of any believed relevant to the , including but not limited to , such as evidence of inequitable conduct during prosecution. Governed by 35 U.S.C. § 257, the process requires submission of at least one item of per request, with the USPTO determining within three months whether it raises an SNQ; if not, a certificate issues immunizing the against invalidity or unenforceability challenges based on that in subsequent proceedings, except for fraud on the USPTO. If an SNQ is identified, the USPTO initiates reexamination under 35 U.S.C. § 257, merging the supplemental filing into that proceeding without further third-party involvement. Unlike reexamination, supplemental examination is owner-initiated and non-public until a reexamination order, serving primarily to preempt defenses like inequitable conduct by placing potentially overlooked material before the USPTO proactively. Requests must be filed separately, identified clearly, and may be submitted electronically or on paper, with fees reflecting the broader scope of reviewable information. A supplemental examination certificate publishes upon determination, and if reexamination follows, a separate reexamination certificate issues upon its conclusion, potentially strengthening the patent against litigation risks.

Inter Partes Review and Patent Trial and Appeal Board

The Patent Trial and Appeal Board (PTAB) is an administrative tribunal within the United States Patent and Trademark Office (USPTO) established by the Leahy-Smith America Invents Act (AIA), enacted on September 16, 2011, and effective September 16, 2012, replacing the prior Board of Patent Appeals and Interferences. The PTAB conducts trials for post-grant proceedings, including inter partes review (IPR), and hears appeals from patent examiner rejections. Inter partes review, governed by 35 U.S.C. §§ 311–319, allows any third party, except the patent owner, to petition the PTAB to challenge the validity of one or more claims in an issued patent on grounds of anticipation (35 U.S.C. § 102) or obviousness (35 U.S.C. § 103), using only prior art consisting of patents or printed publications. IPR proceedings became available for patents issued before, on, or after September 16, 2012, supplanting the earlier inter partes reexamination process to provide a more streamlined, adversarial review. IPR begins with a filed by the challenger, detailing specific and grounds for unpatentability, accompanied by expert declarations and evidence establishing a reasonable likelihood of prevailing on at least one claim for . The patent owner may file a preliminary response, after which the PTAB has up to to decide on ; if instituted, the proceeding advances to a trial phase involving limited discovery, patent owner responses, petitioner replies, motions (including for or judgment on the pleadings), oral hearings, and a final written decision within one year, extendable by six months for good cause. Key limitations include a one-year time bar from service of an infringement complaint on the petitioner (35 U.S.C. § 315(b)), preventing the petitioner from reasserting the same grounds or claims in district court or International Trade Commission proceedings (35 U.S.C. § 315(e)), and no appeal of the institution decision. Proceedings may be joined with others involving the same , and district court infringement suits are typically stayed pending IPR outcome. Empirical data from USPTO fiscal year 2023 (FY23) trials show that IPRs resulted in 30% of all challenged claims being found unpatentable and 51% of instituted claims invalidated, with 12% of patents in terminated proceedings fully invalidated (133 out of 1,117). Institution rates hovered around 68% by petition in FY24, reflecting PTAB to deny petitions lacking sufficient merit. These outcomes indicate IPR's role in efficiently culling potentially weak , though critics note higher invalidation rates compared to district courts—where Federal Circuit reversal rates on validity are 12.1% versus lower for PTAB decisions—suggesting PTAB applies a preponderance standard more rigorously or with outcome patterns favoring challengers, potentially impacting patent holder incentives. The observes that while IPR provides a cost-effective alternative to litigation, its effects and parallel stay provisions influence strategic filing decisions in patent disputes.

Economic Rationale and Empirical Impacts

Theoretical Foundations as Property Rights

The constitutional authority for United States patent law derives from Article I, Section 8, Clause 8 of the , which empowers "to promote the Progress of and useful , by securing for limited Times to... Inventors the to their... Discoveries." This clause establishes patents as a mechanism to grant inventors temporary monopoly rights over their creations, conceptualized as a form of property to reward the labor and ingenuity invested in invention, thereby encouraging disclosure and public benefit after the term expires. The Framers drew on Enlightenment principles, including John Locke's , which posits that individuals acquire rightful ownership by mixing their labor with unowned resources, provided it leaves "enough and as good" for others—a framework applied to inventions as extensions of the inventor's mental and physical efforts. Statutory codification reinforces this property characterization in 35 U.S.C. § 261, which declares that "patents shall have the attributes of ," enabling assignment, licensing, and akin to tangible assets, subject to federal limitations. This treatment aligns patents with constitutional protections, such as the Fifth Amendment's Takings Clause, where courts have upheld patents as compensable property interests, as affirmed in precedents recognizing their alienability and exclusionary power for over a century. Unlike mere regulatory privileges, these rights vest upon issuance, granting the patentee the ability to exclude others from making, using, selling, or importing the claimed , mirroring core attributes of ownership in real or chattel property. The property rights foundation underscores a natural rights rationale, distinct from purely utilitarian justifications, by viewing inventions as moral entitlements arising from the creator's desert, which incentivizes risk-taking in without relying solely on post-hoc societal welfare calculations. This perspective influenced early patent statutes, such as the 1790 Patent Act, and persists in judicial interpretations emphasizing the inventor's pre-legal claim to exclusivity as a safeguard against free-riding, ensuring that the costs of —often substantial and uncertain—are recouped through market control during the limited term, typically 20 years from filing. Empirical alignment with this theory appears in historical data showing patent systems correlating with technological advancement, as the security of property-like rights reduces underinvestment in high-risk fields like machinery and chemicals during the .

Evidence of Innovation and Growth Effects

Intellectual property-intensive industries, which rely extensively on s for protection, generated more than $8 trillion in annual economic activity as of , underscoring the patent system's contribution to national output. These sectors employed approximately 47 million workers in 2022, accounting for about 29% of total U.S. , while paying wages 62% higher than the national average and supporting equivalent to 41% of GDP. Empirical surveys of patent effects reveal that stronger patent rights incentivize (R&D) investments, particularly in industries with high imitation risks, leading to measurable increases in outputs such as subsequent patents and product . For example, cross-country regressions from 1960 to 1990 show that enhancements in patent protection levels correlate with higher growth, with coefficients indicating a statistically significant positive relationship after controlling for factors like and openness. In the U.S. context, econometric analyses of patent reforms, such as the strengthening of , link improved validity and scope to accelerated R&D spending, with private R&D as a share of GDP rising from 1.9% in 1980 to 2.8% by 2000 alongside a surge in utility grants from 30,000 to over 100,000 annually. Sectoral evidence further demonstrates that patent-dependent fields like pharmaceuticals exhibit innovation rates tied to exclusivity periods, where extended protection under the Hatch-Waxman Act (1984) boosted new drug approvals by facilitating recovery of upfront R&D costs exceeding $1 billion per successful compound. Foreign entry into U.S. markets via rights filings has empirically driven technology diffusion and domestic firm productivity gains, with grants to foreign applicants from 2000 to 2020 associated with a 1-2% increase in U.S. citation-weighted metrics in affected technologies. Overall, from developed economies, including the U.S., affirm that robust regimes support sustained growth by aligning private incentives with social returns on , though effects vary by institutional enforcement quality.

Sector-Specific Contributions

In the pharmaceutical sector, patents have been empirically linked to heightened incentives, particularly given the high upfront R&D costs averaging $2.6 billion per new as of estimates and development timelines exceeding a decade. Surveys of innovators indicate that are among the top mechanisms for appropriating returns on in this field, enabling firms to recoup investments through exclusive marketing periods that typically yield revenues far exceeding non-patented alternatives. For instance, strengthening protection correlates with increased approvals and private-sector patenting spurred by public funding, such as NIH grants leading to a net increase of 2.3 per $10 million invested. This sector's reliance on contrasts with others, as evidenced by cross-industry analyses showing pharma's effectiveness surpassing or machinery. Biotechnology exhibits similar dynamics, where patents facilitate the commercialization of complex inventions like therapies and biologics, attracting and essential for scaling from lab to market. U.S. patent protections have underpinned the sector's growth, with biotech patent applications under the peaking at over 11,500 in 2000 before stabilizing amid global IP harmonization, correlating with market projections reaching $30-50 billion annually by the early 2000s. Empirical studies highlight patents' role in shielding high-risk innovations, though challenges arise in areas like patenting, where overly broad claims can impede follow-on research without demonstrably reducing overall inventive output. Reforms post-2013, such as those clarifying natural phenomena eligibility, have aimed to balance exclusivity with cumulative progress in this R&D-intensive field. In contrast, the software and sectors show more ambiguous empirical impacts from s, with evidence of rapid patent propensity growth since the —outpacing R&D increases—yet associating with lower R&D intensity at the firm level, suggesting substitution rather than complementarity. While s support licensing markets valued in billions, they can encumber sequential in fast-evolving fields, as broad software claims often overlap and trigger litigation that diverts resources from development. Post-2014 Alice Corp. v. CLS Bank rulings, which invalidated many abstract idea s, have empirically spurred patent value and firm activities by curbing low-quality grants, though startups still leverage s for fundraising and exits, with effects varying by firm size and competition intensity. Cross-sector comparisons confirm s' weaker role here relative to pharma, with and lead-time advantages often preferred for appropriation. Manufacturing historically benefited from U.S. patents during industrialization, where they incentivized and process improvements, contributing to over two-thirds of corporate R&D and patents despite comprising less than 10% of private employment by the . Foreign competition, such as from since the , has pressured domestic patenting, reducing in exposed firms but prompting shifts toward higher-value s. Empirical matching of patents to owners reveals that while patents bolster cumulative technological progress in capital goods subsectors, their marginal impact diminishes with accumulated stocks, underscoring path-dependent effects over time. Overall, sector-specific data from USPTO analyses affirm patents' disproportionate contributions in knowledge-intensive areas like pharma and biotech, with manufacturing's gains more tied to against imports than domestic exclusivity alone.

Controversies and Debates

Non-Practicing Entities and Litigation Costs

Non-practicing entities (NPEs), also termed assertion entities or trolls, acquire s primarily to generate revenue through licensing demands or infringement lawsuits rather than commercializing the inventions themselves. These entities do not manufacture or sell products embodying the patented technology, focusing instead on extracting settlements from alleged infringers, often by leveraging the high costs of patent litigation to pressure defendants into out-of-court resolutions. Empirical analyses indicate that NPE-initiated suits frequently involve patents of questionable validity or narrow scope, with settlements driven more by avoidance of legal expenses than by merit-based . U.S. patent litigation statistics reveal NPEs as prolific filers, accounting for a substantial share of cases despite overall declines in total filings. In 2024, patent disputes reached 2,594 filings, with NPEs driving much of the volume, including over 70% of AI-related assertions. NPE campaigns targeted 508 defendants in recent periods, disproportionately affecting smaller firms, where more than 52% of victims from 2017 to 2022 had annual revenues under $25 million. Direct litigation costs imposed on defendants by NPEs totaled approximately $29 billion annually, equivalent to about 19% of affected firms' average expenditures. Median damages awards in NPE cases averaged $14.8 million from 2013 to 2017, often exceeding those secured by practicing entities by a factor of three, though most disputes resolve via settlements to evade protracted trials. The economic burdens of NPE litigation extend beyond direct fees, yielding broader disincentives to . Firms defeated in NPE suits reduced R&D investments by up to 20%, with peer firms experiencing average market value losses of $9.2 million upon announcement of related actions. These "chilling effects" propagate through industry networks, as potential infringers factor in litigation risks when pursuing technological development, potentially suppressing overall inventive activity. While some analyses posit NPEs as enforcers aiding small inventors by monetizing underutilized patents, underscores net costs, including distorted resource allocation toward defensive patenting rather than productive R&D. Debates over NPEs center on their systemic role, with critics highlighting how asymmetric information and venue shopping amplify abusive assertions, while defenders argue they fill gaps in against large incumbents. Studies consistently find NPE patents underperform in licensing markets absent litigation threats, suggesting limited positive contributions to . Legislative responses, such as fee-shifting provisions in the 2011 America Invents Act, have curbed some excesses but failed to eliminate the incentive for low-merit suits, as prevailing defendants recover costs infrequently. Recent data affirm persistent vulnerabilities, particularly in district courts, underscoring ongoing tensions between patent and litigation .

Eligibility of Abstract Ideas and Software

Section 101 of the , Title 35, permits patents for any new and useful , , manufacture, or , but judicially recognized exceptions exclude laws of nature, natural phenomena, and abstract ideas from eligibility, even if novel or non-obvious. Abstract ideas, often encompassing mathematical algorithms, methods of organizing human activity, and mental processes, frequently arise in software-related inventions, where claims involving , of business practices, or generic computer implementation risk ineligibility. The has emphasized that merely applying an abstract idea using conventional technology, such as a general-purpose computer, does not confer eligibility, as this preempts basic building blocks of innovation without adding significantly more. In Alice Corp. v. CLS Bank International (2014), the unanimously invalidated patents on a computer-implemented scheme for mitigating in financial transactions, establishing a two-step framework for evaluating eligibility under § 101. Step one determines whether the claim is directed to an abstract idea; step two assesses whether additional elements transform the claim into a patent-eligible application by providing an inventive concept amounting to significantly more than the idea itself. The Court held that the claims at issue abstracted the concept of intermediated settlement—using a third party to mitigate risk—into a generic computer environment without improving computer functionality or solving a technological problem, thus failing both steps. This built on prior rulings like Bilski v. Kappos (2010), which rejected a rigid "machine-or-transformation" test but affirmed abstract ideas' exclusion, and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), which applied similar scrutiny to natural laws in diagnostic methods. Post-Alice, the U.S. Patent and Trademark Office (USPTO) saw a sharp rise in § 101 rejections, particularly for software and business method applications, with first-action rejection rates climbing from under 10% pre-2014 to over 50% by 2015, stabilizing around 40-50% in technology centers handling software inventions. Empirical analyses indicate Alice reduced favorable eligibility outcomes by approximately 31% during examination and heightened uncertainty, leading to longer prosecution times and higher abandonment rates for borderline claims. In litigation, Federal Circuit decisions invalidated over 65% of challenged software and information technology patents on § 101 grounds through 2023, often deeming generic automation of abstract concepts—like risk hedging or data classification—insufficient for eligibility absent specific technological improvements, such as enhanced computer efficiency or novel hardware integration. To address application inconsistencies, the USPTO issued updated guidance post-Alice, including the 2019 Revised Patent Subject Matter Eligibility Guidance, which refined abstract idea exemplars and emphasized claims integrating exceptions into practical applications, and the 2024 Guidance Update incorporating artificial intelligence examples to distinguish eligible AI-assisted inventions (e.g., those improving model training via specific techniques) from ineligible ones reciting mere mathematical models. A 2025 USPTO memorandum further directed examiners to limit § 101 rejections for AI and software claims, requiring clearer evidence of abstractness and focusing scrutiny on whether claims recite well-understood routines rather than overbroadly assuming computer implementation alone suffices for ineligibility. Despite these clarifications, Federal Circuit precedents like In re Incentive (2025) continue to reject claims relying on off-the-shelf machine learning models for abstract optimizations, reinforcing that post hoc explanations of "technical improvements" must be claim-supported, not attorney argument. Debates persist over Alice's effects on software innovation, with proponents arguing it curtails low-quality patents that previously enabled non-practicing entities to extract rents via litigation without contributing tangible advancements, evidenced by a post-2014 decline in software patent filings and suits without corresponding drops in broader R&D investment. Critics contend the framework's vagueness—lacking bright-line rules for what constitutes an "inventive concept" in software's iterative domain—deters investment, as one study linked Alice to reduced venture funding in patent-heavy software sectors, though aggregate innovation metrics like productivity growth show no clear causation. Legislative responses, such as the Patent Eligibility Restoration Act reintroduced in 2025, seek to codify eligibility by deeming practical applications of ideas patentable unless purely mental or mathematical, aiming to align U.S. standards closer to Europe's while preserving exceptions for pure abstractions. These efforts reflect ongoing tension between preventing over-patenting of ideas and fostering certainty for technology-driven inventions.

Extensions in Pharmaceuticals and Biotech

Patent term extensions (PTE) under 35 U.S.C. § 156 compensate patent holders for regulatory delays imposed by the (FDA) before commercial marketing of pharmaceutical products, including human drugs, antibiotics, and biological products. Enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, this provision allows extensions of up to five years for eligible patents claiming such products, provided the delay stems from premarket review requirements. The extension applies only once per patent and is limited so that the total remaining patent term from the approval date does not exceed 14 years. Eligibility requires that the patent claim a product, method of use, or method of manufacture subject to FDA regulatory review, with the application filed within 60 days of approval. The regulatory review period consists of a testing phase—typically from the application date—and an approval phase from the submission to approval. The PTE duration is calculated as half the testing phase plus the full approval phase, minus any preexisting patent term used during testing and other deductions for overlapping periods, capped at five years. For instance, if a drug's testing phase spans eight years and approval takes two years with minimal deductions, the extension could approach five years, effectively restoring lost exclusivity. In biotechnology, PTE similarly applies to patents covering biologics approved via the Biologics License Application (BLA) pathway, compensating for FDA review delays akin to small-molecule drugs. The Biologics Price Competition and Innovation Act (BPCIA) of , which created an abbreviated approval pathway for biosimilars, does not alter PTE eligibility but provides reference biologics with 12 years of market exclusivity separate from patent terms. Biological products, such as recombinant proteins or monoclonal antibodies, qualify if the patent directly claims the biologic and regulatory hurdles delayed market entry, though courts have clarified that extensions attach to the original patent rather than reissues without new claims. Empirical analyses indicate that PTE has bolstered pharmaceutical by extending effective life—averaging an increase from 9.2 to 12.8 years for sampled drugs—and stimulating investment, with estimates of an additional $4.4 billion in real R&D spending from 1988 to 2002. These extensions incentivize costly clinical trials and in high-risk sectors like biotech, where development timelines often consume over half the standard 20-year term from filing. Critics argue extensions prolong monopolies and elevate prices, potentially hindering access, but evidence links them to higher R&D labor and technological progress without disproportionate when secondary patents are discounted. USPTO oversight ensures applications are scrutinized for eligibility, with decisions appealable to federal courts.

Recent Developments and Reforms

Legislative Initiatives Post-2023

In 2024, several bipartisan patent reform bills were introduced or advanced in but failed to progress beyond committee stages amid ongoing debates over balancing innovation incentives with litigation concerns. The Judiciary Subcommittee on Intellectual Property held hearings and advanced measures like the IDEA Act in December 2024, which aimed to address patent misuse in deceptive practices, though broader reforms stalled. Legislative efforts largely carried over into 2025 without enactment, reflecting persistent divisions on issues such as eligibility standards and post-grant review procedures. The Patent Eligibility Restoration Act (PERA) of 2025, reintroduced on May 1, 2025, by Senators (R-NC) and (D-DE) as S. 1546, alongside a companion House bill H.R. 3152 by Representatives (R-CA) and Scott Peters (D-CA), seeks to amend 35 U.S.C. § 101 by eliminating judicial exceptions for abstract ideas, laws of nature, and natural phenomena while providing explicit eligibility for practical applications in fields like diagnostics, software, and biotech. The bill responds to post-Alice Corp. v. CLS Bank uncertainties, which have invalidated patents in key sectors, by shifting eligibility determinations away from § 101 toward novelty and non-obviousness tests under §§ 102 and 103, with safeguards against superficial computer implementations or unmodified genes. A Senate Subcommittee hearing on October 9, 2025, debated its implications for business methods and medical diagnostics, highlighting support from innovation advocates but opposition from those fearing over-patenting of routine processes. As of October 2025, PERA remains referred to the Committee without further advancement. Complementing eligibility reforms, the PREVAIL Act, reintroduced in 2025 with bipartisan sponsorship, proposes changes to inter partes review (IPR) proceedings under the Leahy-Smith America Invents Act by prioritizing district court claim constructions, limiting PTAB expansions of invalidity grounds, and restoring patent owners' automatic rights to preliminary injunctions and stays of litigation during IPR. Sponsors argue it counters perceived PTAB biases favoring challengers, which have led to high invalidation rates—over 80% in some tech sectors—potentially deterring investment. The bill's status mirrors prior iterations, pending in committees as of mid-2025 without markup. The RESTORE Patent Rights Act of 2025, introduced February 25, 2025, as S. 708 by Senator and H.R. 1574 in the House, establishes a rebuttable presumption for permanent injunctions in infringement cases under 35 U.S.C. § 283, reversing Inc. v. MercExchange's case-by-case approach that critics say weakened enforcement against willful infringers. Proponents, including manufacturing and tech coalitions, contend it bolsters property rights by enabling patentees to exclude competitors, fostering licensing and R&D investment, while the presumption can be overcome by showing irreparable harm lacks. Like PERA, it awaits committee action in 2025. On October 24, 2025, Representative Thomas Massie (R-KY) introduced H.R. 5811, the Restoring America's Leadership in Innovation Act (RALIA), aiming to revert aspects of the 2011 America Invents Act by reinstating a "first-to-invent" priority system over first-to-file, expanding inventor oaths, and curbing fee diversion from USPTO operations. Massie described it as aligning with constitutional intent under Article I, Section 8, to promote domestic progress by prioritizing actual invention dates, potentially aiding individual inventors against corporate filers. The bill, referred to the Judiciary Committee, represents a narrower, conservative push amid broader reform gridlock. Overall, these initiatives underscore unresolved tensions in patent policy, with no major laws passed by late 2025, leaving reliance on judicial and USPTO adjustments.

Judicial and USPTO Policy Shifts

The U.S. has continued to limit its intervention in patent law during the 2023-2025 period, denying multiple petitions for and thereby preserving Federal Circuit precedents on issues such as obviousness, enablement, and . This restraint has allowed the Court of Appeals for the Federal Circuit to shape policy through decisions like the en banc ruling in EcoFactor, Inc. v. LLC (2025), where the court overturned a $20 million jury award by clarifying the role of in assessments and secondary indicia of non-obviousness. In another significant case, the Federal Circuit's en banc decision addressed royalty calculations, holding that lump-sum settlement licenses alone do not suffice to establish a reasonable royalty rate without additional evidence of . Federal Circuit rulings have maintained a stringent approach to patent eligibility under 35 U.S.C. § 101, particularly for software and abstract ideas, with ongoing invalidations of claims reciting generic computer implementations of mental processes or data manipulations absent technical improvements. Post-Amgen v. Sanofi (2023), the court has applied heightened enablement requirements, rejecting broad functional claims in biotechnology where specifications fail to disclose sufficient working examples or common structural features. The U.S. Patent and Trademark Office (USPTO) has introduced policy adjustments aimed at refining examination practices and funding operations. In August 2025, an internal USPTO memorandum instructed examiners to more rigorously assess whether AI-assisted inventions integrate into practical applications before deeming them abstract ideas under § 101, signaling a potential easing of rejections for software-related claims by refocusing on pre-Alice precedents and claim-specific improvements. This guidance, while not altering statutory law, encourages examiners to avoid categorically excluding AI implementations, potentially broadening patentability in computational fields. To address rising operational costs, the USPTO finalized fee adjustments effective , 2025, increasing rates for filing, examination, and maintenance of patents by an average of 7%, with larger hikes for excess claims and appeals to incentivize concise applications and fund backlog reduction. These changes, authorized under the America Invents Act as amended, aim to align fees with aggregate processing expenses without introducing new substantive eligibility criteria. Additionally, in September 2025, the USPTO updated its Legal Framework for the Patent Electronic System, clarifying policies on electronic submissions to enhance efficiency and reduce errors in prosecution.

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