Patent Term Calculation

The 20-year patent term has specific rules that differ from common misconceptions: THE BASIC RULE — 35 U.S.C. § 154(a)(2): 'such grant shall be for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under section 120, 121, 365(c), or 386(c), from the date on which the earliest such application was filed'; WHAT THIS MEANS: the 20-year term is measured FROM THE EARLIEST EFFECTIVE FILING DATE of the US non-provisional application; the term ENDS 20 years from that date; the patent is ENFORCEABLE only from its ISSUE DATE to its EXPIRATION DATE; IF A CONTINUATION IS FILED: a continuation patent shares the filing date of the original application; if an original application is filed on January 1, 2024, and a continuation is filed on January 1, 2030, and the continuation issues in 2031 — it expires on January 1, 2044 (20 years from the original filing date — only 13 years of enforceability); CONTINUATIONS BURN REMAINING PATENT LIFE: the longer you delay filing continuations, the less patent term remains when the continuation issues; THIS IS WHY CONTINUATION STRATEGY MATTERS: file continuations while sufficient term remains; DON'T COUNT FROM ISSUE DATE: a common error is to think the patent term is 20 years from issuance; it is 20 years from the EARLIEST US FILING DATE; PROVISIONAL APPLICATIONS: provisional applications do NOT count as the start of the 20-year term; however, the 12 months a provisional is pending IS subtracted from available patent life because the non-provisional must be filed within 12 months; EFFECTIVE START: the 20-year clock starts with the FIRST non-provisional application in the family; for a continuation or CIP: it starts with the PARENT non-provisional application; for a divisional: same rule — earliest parent non-provisional; EXAMPLE: provisional filed January 2020; non-provisional filed January 2021; patent issued March 2025; expiration: January 2041 (20 years from January 2021 non-provisional).

Patent Term Adjustment compensates patent owners for USPTO delays during prosecution: STATUTORY BASIS — 35 U.S.C. § 154(b): Congress created PTA in 1999 (AIPA) to compensate patent owners for USPTO delays that reduce available patent term; PTA ADDS DAYS TO THE EXPIRATION DATE: PTA days are added to the end of the 20-year term; the actual expiration date of the patent = [filing date + 20 years] + [PTA days]; THREE CATEGORIES OF USPTO DELAY: A-DELAY (§ 154(b)(1)(A)): delay in the USPTO failing to provide timely responses; 14 months from filing to first office action; 4 months to respond after applicant files a reply; 4 months after allowance to issue; each day the USPTO exceeds these benchmarks is A-delay; B-DELAY (§ 154(b)(1)(B)): delay when total prosecution from filing to issue exceeds 3 years (36 months); B-delay = days beyond 36 months not caused by applicant; if total prosecution time = 48 months and applicant caused 6 months delay, B-delay = 48 - 36 - 6 = 6 months; C-DELAY (§ 154(b)(1)(C)): delays caused by interference; derivation proceedings; secrecy orders; or a successful appeal at the Board or Federal Circuit; SUBTRACTION FOR APPLICANT DELAYS: if the applicant causes delays (e.g., late responses; RCE filing; extensions of time), those days are subtracted from the PTA; EXAMPLE: the USPTO was late in sending a first office action = 45 A-delay days; total prosecution = 48 months (12 B-delay days); applicant filed one RCE (≈ 3 months subtracted); PTA = 45 + 12 - 90 = negative, so PTA = 0; PTA CANNOT BE NEGATIVE: PTA is never less than zero; OVERLAP — NO DOUBLE COUNTING: if days qualify under both A-delay and B-delay, they are counted only once; CHALLENGING INCORRECT PTA: the USPTO calculates PTA in the Notice of Allowance; the patent owner can submit a request for reconsideration of PTA within 2 months of issue; if the USPTO disagrees, the patent owner can challenge PTA in district court (within 180 days of issue); STRATEGIC IMPLICATIONS: PTA rewards patent owners for USPTO slowness; in practice, PTA of 300-500 days is common; some biotech/pharma patents have PTA of 1,000+ days; each additional day of PTA = one more day of exclusivity.

Patent Term Extension compensates patent owners for time lost during FDA regulatory review: STATUTORY BASIS — 35 U.S.C. § 156: created by the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) of 1984; PTE APPLIES TO: human drugs (new drug applications — NDA, biologics — BLA); animal drugs; medical devices (requiring PMA); food additives; color additives; veterinary biological products; WHO QUALIFIES: the patented product must require FDA approval before it can be commercially marketed; the patent must be in force during the regulatory review period; the patent must be the FIRST USE of the patented item; PTE — KEY LIMITS: ONE PATENT PER PRODUCT: only ONE patent per approved product can receive PTE; the patent owner must choose which patent gets the extension; TYPES OF PATENT ELIGIBLE: a patent claiming the approved PRODUCT; a patent claiming a METHOD OF USING the approved product; a patent claiming a METHOD OF MANUFACTURING the approved product; MAXIMUM EXTENSION: 5 years (1,825 days); the total remaining patent term after FDA approval cannot exceed 14 years; PTE CALCULATION: PTE = one-half of the Investigational New Drug (IND) clinical testing period + the full NDA regulatory review period; in practice: pharmaceutical drugs that take 10 years in clinical trials and 2 years of FDA review can recover up to 6 years but are capped at 5 years; APPLICATION TIMING: the PTE application must be filed with the USPTO within 60 days of FDA approval; late filings are denied; REDUCED SCOPE DURING EXTENSION: during the PTE extension period, the patent claims are narrowed to cover only the approved product and the FDA-approved use; the patent cannot be enforced beyond its approved product during the extension; BIOSIMILAR IMPLICATIONS: the Biologics Price Competition and Innovation Act (BPCIA, 2010) provides 12 years of data exclusivity for biologics; this interacts with PTE; biologics patents are still eligible for PTE; PEDIATRIC EXCLUSIVITY: an additional 6-month pediatric exclusivity can be added to the end of PTE if the sponsor conducts FDA-requested pediatric studies; this 6-month exclusivity is valuable (applies to all patents for the drug).

Terminal disclaimers can shorten patent term to resolve double patenting rejections: WHAT IS A TERMINAL DISCLAIMER: a terminal disclaimer (TD) is a statement filed by the patent applicant during prosecution that disclaims the portion of the patent term that would extend beyond the expiration date of a related patent; WHY TDs ARE REQUIRED: the USPTO issues an obviousness-type double patenting (ODP) rejection when the claims of a continuation are considered obvious variants of the parent claims; to overcome the ODP rejection, the applicant files a TD; THE EFFECT OF A TD: the TD-burdened patent will expire on the SAME DATE as the patent it references; if the parent expires January 1, 2040, and the continuation would expire January 1, 2043, the TD makes the continuation expire on January 1, 2040 (losing 3 years of term); COMMON OWNERSHIP REQUIREMENT: TDs also require that the TD-burdened patent and the referenced patent are commonly owned throughout their remaining lives; if they are ever separately owned, the TD-burdened patent becomes unenforceable; TERMINAL DISCLAIMER AND PTA INTERACTION: the Merck v. Hi-Tech Pharmacal (Fed. Cir. 2012) line of cases and subsequent USPTO rules address how PTA interacts with TDs; generally, PTA can still increase the expiration date of a TD-burdened patent up to the date of the patent it is disclaimed over; STRATEGIC IMPLICATIONS OF TDS: TDs reduce the value of continuation patents when the continuation's expiration would extend significantly beyond the parent; in portfolio management, it matters which patent in a family gets the TD and which is the TD reference; TDs are NOT required for STATUTORY double patenting (same claims in two patents) — statutory double patenting cannot be overcome by TD (the claim must be canceled); RECENT CONTROVERSY — ODP AT THE PTAB: the IP Innovation v. Red Hat line has generated attention around whether unrelated ODP rejections in IPR can shorten patent life; the current USPTO rules allow ODP rejections in reexamination; ODP is a validity ground that can be raised in litigation (even though it cannot be raised in IPR); TERMINAL DISCLAIMER LINKING BETWEEN PATENTS: if patent A has a TD over patent B, and patent B has a TD over patent C, the entire chain is linked; this chain analysis is critical in pharmaceutical portfolios where multiple patents cover a drug product.

Maintenance fees must be paid to keep a US utility patent in force after issuance: MAINTENANCE FEE SCHEDULE: maintenance fees are due at 3.5 years; 7.5 years; and 11.5 years after issuance; GRACE PERIOD: there is a 6-month grace period after each due date (surcharge applies during grace period); FEES (2025 — APPROXIMATE LARGE ENTITY FEES): 3.5-year maintenance fee: $2,000; 7.5-year maintenance fee: $3,760; 11.5-year maintenance fee: $7,700; small entity (50% reduction); micro-entity (80% reduction); FAILURE TO PAY — EXPIRATION: if a maintenance fee is not paid by the end of the grace period, the patent EXPIRES; once expired, the patent becomes unenforceable and the public is free to use the patented invention; REVIVAL AFTER EXPIRATION: a patent that has expired for failure to pay a maintenance fee may be revived; UNINTENTIONAL DELAY: petition to revive under 37 C.F.R. § 1.137(a); the patent owner must certify the delay was unintentional; no time limit on revival for unintentional delay; revival fee required; DELAYED PAYMENT WITH SURCHARGE: paying after the anniversary date but before the end of the grace period requires a surcharge; DESIGN AND PLANT PATENTS — NO MAINTENANCE FEES: design patents (15-year term) and plant patents (20-year term) do NOT require maintenance fees; utility patents are the only patent type that requires ongoing maintenance fees; MAINTENANCE FEE STRATEGY: large patent portfolios should be reviewed at each maintenance fee interval to determine which patents are still commercially relevant; abandoning low-value patents at the 3.5-year maintenance fee due date frees capital; expensive-to-maintain patents with near-zero licensing or enforcement value should be reviewed carefully; ANNUITIES IN FOREIGN COUNTRIES: foreign patents require ANNUAL annuity (maintenance fee) payments; these fees start from the filing date; foreign annuities are a significant cost driver for international patent portfolios; DOCKETING: maintenance fees are tracked by docketing software; missed maintenance fees in large portfolios are a serious malpractice risk; careful docketing with multiple reminders is essential.