Patent Law

A U.S. patent is a government-granted right to exclude others from making, using, selling, or importing a specific invention for 20 years from the filing date (utility and plant patents; 15 years for design patents). That exclusionary right — the legal foundation for pharmaceutical pricing, licensing deals, and tech transfer — is earned by satisfying four requirements under Title 35 of the U.S. Code: the invention must be novel (not previously known or published, § 102), non-obvious (not obvious to someone skilled in the field, § 103), useful (has a practical utility, § 101), and adequately described in a written specification that enables reproduction (§ 112). The 2011 America Invents Act shifted the U.S. from a "first-to-invent" to a "first-inventor-to-file" system, aligning with international norms and creating strong incentives to file before public disclosure. The USPTO receives approximately 650,000 patent applications and grants roughly 350,000 patents per year. Disputes — whether in federal district courts or through Inter Partes Review (IPR) at the Patent Trial and Appeal Board (PTAB) — are a major commercial weapon, particularly in pharmaceuticals, semiconductors, and software, where a single patent's validity can be worth billions.

Current Law (2026)

Legal Authority

• 35 U.S.C. § 101 — Patentable subject matter (whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter may obtain a patent; excludes laws of nature, natural phenomena, and abstract ideas per Supreme Court precedent)
• 35 U.S.C. § 102 — Novelty (invention must be new — not previously patented, described in a printed publication, in public use, on sale, or otherwise available to the public before the filing date; first-inventor-to-file system under AIA)
• 35 U.S.C. § 103 — Non-obviousness (patent may not be obtained if the differences between the claimed invention and prior art are such that the subject matter would have been obvious to a person having ordinary skill in the art)
• 35 U.S.C. § 112 — Specification requirements (patent application must contain a written description of the invention, enable one skilled in the art to make and use it, and set forth the best mode; claims must particularly point out and distinctly claim the subject matter)
• 35 U.S.C. § 131 — Examination (USPTO examines applications and grants patents if requirements are met)
• 35 U.S.C. § 154 — Patent term and rights (patent grants right to exclude others from making, using, offering for sale, selling, or importing the invention for 20 years from filing date; provisional rights from publication)
• 35 U.S.C. § 261 — Ownership and assignment (patents are personal property; may be assigned, granted, or conveyed; recorded at USPTO)
• 35 U.S.C. § 271 — Infringement (direct infringement: making, using, selling, offering to sell, or importing without authority; induced infringement: actively inducing another to infringe; contributory infringement: selling a component with no substantial non-infringing use)
• 35 U.S.C. § 281-289 — Remedies (civil action for infringement; injunctions; damages adequate to compensate for infringement but not less than a reasonable royalty; enhanced damages up to 3x for willful infringement; attorney's fees in exceptional cases; design patent damages include infringer's total profit)
• 35 U.S.C. § 311-329 — Inter Partes Review and Post-Grant Review (PTAB proceedings to challenge patent validity; IPR based on prior art patents and publications; PGR on any ground of invalidity; must be filed within specified time periods)

Implementing Regulations

• 37 CFR Part 1 — Patent application procedures: filing, prosecution, examination, fees, appeals, and maintenance

• 37 CFR Part 11 — Registration and conduct of patent practitioners (attorneys and agents) before the USPTO

• 37 CFR Part 42 — Patent Trial and Appeal Board trials: Inter Partes Review (IPR), Post-Grant Review (PGR), and Covered Business Method (CBM) proceedings

• 21 CFR Part 60 — FDA Patent Term Restoration (17 sections across 5 subparts — the FDA-side procedures implementing 35 U.S.C. § 156, which authorizes patent term extensions for innovator pharmaceuticals and medical devices to compensate for regulatory review time lost before market approval; authority: 35 U.S.C. § 156, 42 U.S.C. § 262; administered jointly between FDA and the USPTO): Under 35 U.S.C. § 156, the patent owner of a drug, medical device, food additive, or color additive may apply to the USPTO for a patent term extension equal to the time spent in FDA regulatory review — the period from IND filing to NDA/BLA/PMA approval — reduced by 50% of the testing phase, with a cap of 5 years' extension and a maximum total patent term of 14 years after approval. FDA's role under Part 60 is to determine the length of the "regulatory review period" — the verified dates FDA uses to calculate how long the product was under active regulatory review. Key provisions:

  • § 60.2 — Purpose: FDA's procedures are designed to produce a thorough yet efficient determination of the regulatory review period within 30 days of PTO's written request, so that the patent term extension calculation can proceed without delay; FDA establishes record-based standards for what counts as the start and end of each phase of regulatory review
  • § 60.20 — FDA action on regulatory review period determinations: upon receiving a PTO request, FDA consults its records and experts to verify the dates in the extension application and calculate the regulatory review period; FDA publishes its determination in the Federal Register within 30 days; the determination specifies the length of the testing phase (IND effective date through NDA/BLA submission) and the approval phase (NDA/BLA submission through approval) that together form the regulatory review period
  • § 60.22 — Regulatory review period determinations: FDA calculates two sub-periods — (1) the testing phase beginning the day after the IND effective date (30 days after IND submission unless placed on clinical hold) and ending the day the marketing application is submitted; (2) the approval phase beginning on the submission date of the NDA, BLA, PMA, or NDA supplement and ending on the date of approval; FDA determines each date from its official records (IND file, NDA/BLA filing docket, approval action letter)
  • § 60.24 — Revision of regulatory review period determinations: any person (not just the patent owner) may request a revision of FDA's determination within 60 days after publication in the Federal Register; if the patent owner contests FDA's dates, FDA reviews the record and issues a revised determination if warranted
  • § 60.30 — Due diligence petitions: any person — typically a generic drug competitor — may file a petition with FDA no later than 180 days after FDA publishes its regulatory review period determination, arguing that the patent owner did not act with "due diligence" in seeking approval during the regulatory review period; due diligence challenges are the primary mechanism by which competitors contest the validity of a patent term extension that would delay generic entry
  • § 60.36 — Standard of due diligence: FDA evaluates whether the patent owner reasonably pursued marketing approval throughout the regulatory review period given the circumstances; delays attributable to FDA-required studies, clinical trial enrollment difficulty, or manufacturing scale-up may be deemed diligent; unnecessary delays in responding to FDA requests, failure to pursue approval after completing required studies, or deliberate delay tactics may defeat the due diligence standard and reduce or eliminate the extension
  • § 60.40–60.46 — Due diligence hearings: if any party requests a hearing within 60 days after FDA publishes its due diligence determination, FDA holds an informal hearing at which the patent owner and petitioner may present their positions; within 30 days after the hearing, FDA's Commissioner issues a final due diligence redetermination that governs the PTO's extension calculation

  Patent term restoration under § 156 produces a maximum extension capped at 5 additional years, with the combined patent term after approval capped at 14 years. For a blockbuster pharmaceutical with 20-year original patent protection, a 5-year extension at $1+ billion/year in revenue is transformative — the difference between a patent expiring 5 years earlier and generic competition beginning sooner is worth tens of billions of dollars in net present value. Part 60's procedural framework — FDA's determination, the 60-day revision window, and the 180-day due diligence petition period — sets the timeline within which generic manufacturers must mount any challenge to a competitor's patent extension. The due diligence petition process allows generic manufacturers and patient advocacy groups to contest extensions that would unjustifiably delay generic entry; successful petitions have shortened or eliminated patent term extensions for products where the innovator delayed seeking approval after completing required studies.

How It Works

The U.S. patent system grants inventors a time-limited monopoly — the right to exclude others from making, using, or selling their inventions — in exchange for publicly disclosing how the invention works. This bargain between private incentive and public knowledge has driven American innovation since the Constitution authorized Congress to secure "exclusive Rights" to "Inventors."

An inventor files a patent application with the USPTO describing the invention in detail and claiming the specific aspects to be protected. A patent examiner searches prior art (existing patents, publications, and public knowledge) and evaluates the claims against patentability requirements. The examiner may issue office actions rejecting claims; the applicant may amend claims or argue patentability. Average prosecution takes about 2–3 years; rejected applicants can appeal to the Patent Trial and Appeal Board (PTAB) and then to the Federal Circuit Court of Appeals. The America Invents Act (2011) transitioned the U.S. from a "first-to-invent" to a "first-inventor-to-file" system aligned with international practice: when two inventors independently create the same invention, the patent goes to whoever files first, not whoever actually invented first. A one-year grace period protects inventors from their own prior disclosures.

The most actively litigated area of patent law is subject matter eligibility (§ 101). While the statute broadly covers "any new and useful process, machine, manufacture, or composition of matter," the Supreme Court has carved out exceptions for laws of nature, natural phenomena, and abstract ideas. The Alice Corp. v. CLS Bank (2014) two-step framework asks whether a claim is directed to an abstract idea and, if so, whether it contains an "inventive concept" that transforms the idea into a patent-eligible application. This framework has invalidated thousands of software and business method patents and created significant uncertainty about what software innovations can be protected. Patent owners enforce rights through civil lawsuits in federal district court — with the Eastern and Western Districts of Texas as historically popular venues — or through the International Trade Commission to block infringing imports. Remedies include injunctions (discretionary since eBay v. MercExchange, 2006), damages (at least a reasonable royalty, up to 3x for willful infringement), and attorney's fees in exceptional cases. Patent litigation costs a median $3–5 million per side through trial. The AIA also created Inter Partes Review (IPR) — an administrative PTAB proceeding that challenges patent validity based on prior art; about 60% of IPR petitions result in at least some claims invalidated, and proceedings typically conclude within 12–18 months at far lower cost than litigation.

How It Affects You

State Variations

Patent law is exclusively federal — there are no state patent laws. However:

Pending Legislation

• S 1546 (Sen. Tillis, R-NC) — Patent Eligibility Restoration Act of 2025: shifts patent eligibility to utility-focused test, lists exclusions. Status: Introduced.
• S 2658 (Sen. Hassan, D-NH) — Medication Affordability and Patent Integrity Act: forces drug sponsors to certify patentability to FDA and USPTO. Status: Introduced.
• HR 4570 (Rep. Neguse, D-CO) — Interagency Patent Coordination and Improvement Act: creates USPTO-FDA task force. Status: Introduced.

Recent Developments

• Patent eligibility under § 101 remains the most contested area — the Federal Circuit and district courts continue to struggle with applying the Alice framework to AI, software, and diagnostic method patents
• AI-generated inventions raise novel questions — the Federal Circuit held in Thaler v. Vidal (2022) that AI cannot be listed as an inventor, but the use of AI as a tool in the inventive process remains under active consideration
• PTAB reform proposals have addressed concerns about the balance between patent challenger and patent holder rights in IPR proceedings
• USPTO has issued guidance on patenting AI-related inventions and on the use of AI in patent prosecution
• In February 2026, USPTO sought public input on the selection of locations for community outreach offices in the Southeast Region, as part of the agency's expansion of regional presence.