35 U.S.C. § 156 — Extension of patent term

(a) Basic eligibility. The term of a patent that claims a product, a method of using a product, or a method of making a product can be extended. The extension is measured from the patent's original expiration date, which includes any patent term adjustment already granted. To qualify, all of the following must be true: the patent has not already expired when someone applies for the extension; the patent has never been extended under subsection (e)(1) before; the patent's owner (or an agent) applies, following the rules in subsection (d)(1) through (4); and the product went through a "regulatory review period" before it could be sold or used commercially. On top of that, the permission to sell or use the product after that review must generally be the very first time that product was allowed on the market under the law that required the review. There are two special situations: if the patent covers a manufacturing method that mainly uses recombinant DNA technology, "first" means the first time a product made by that patented process was allowed on the market; and for a patent on a new animal drug or veterinary biological product that already covers non-food animals and later gets approved for food-producing animals, "first" means the first approval for food-producing animals — as long as the patent was not already extended based on the non-food-animal approval. The approved product involved is called the "approved product" for the rest of the section. (b) What the extension covers. Except as provided in subsection (d)(5)(F), during the extended period the patent owner's rights are limited. If the patent covers a product, the rights only cover uses of that product approved before the patent's original expiration (under the review law, or under related reviews described in subsection (g)) and also approved on or after the date the regulatory review period ended. If the patent covers a method of using a product, the rights only cover the specific approved use the patent claims, under the same before-and-after timing rule. If the patent covers a method of manufacturing, the rights are limited to the manufacturing method as actually used to make the approved product, or a product that went through a related regulatory review described in subsection (g). "Product," in this subsection, includes the approved product. (c) How the extra time is calculated. The extension equals the part of the regulatory review period that happened after the patent was issued, with adjustments. First, subtract any time the applicant did not act with "due diligence" during the review period. Second, after that subtraction, count only half of the time remaining in certain early, pre-application portions of the review period listed in subsection (g). Third, add the time left in the patent term after approval to this adjusted extension; if the total is more than fourteen years, shorten the extension so the combined total does not exceed fourteen years. Fourth, no product can have more than one patent extended under subsection (e)(1) for the same regulatory review period. (d) Applying for an extension. The patent owner or agent applies to the Director. The application generally must be filed within 60 days after the product gets permission for commercial marketing or use, with a special rule in subsection (i) for certain drug products and exceptions in paragraph (5) for interim extensions. The application must include the approved product's identity and which federal law triggered the review; which patent and which specific claims are involved; information the Director needs to decide eligibility and what rights the extension will cover, plus information regulators need to calculate the length of review; a description of what the applicant did during the review period and the key dates; and any other information the Director requires. If permission to market is granted after 4:30 p.m. Eastern time, or on a non-business day, it counts as received the next business day (Monday through Friday, excluding legal holidays). Within 60 days of an application, the Director notifies the Secretary of Agriculture, if the review involves the Virus-Serum-Toxin Act, or the Secretary of Health and Human Services for other drugs, devices, or additives under the Food, Drug, and Cosmetic Act, and sends that Secretary a copy. Within 30 days of getting the application, that Secretary reviews the dates, determines the length of the regulatory review period, tells the Director, and publishes the determination in the Federal Register. If someone petitions within 180 days of that published determination, claiming the applicant did not act with due diligence, the Secretary must decide the question within 90 days of the petition, following that Secretary's own regulations. For certain drug reviews this decision-making power cannot be delegated below the Office of the Director of Food and Drugs; for Virus-Serum-Toxin Act products it cannot go below the Office of the Assistant Secretary for Marketing and Inspection Services. The Secretary publishes this due-diligence decision too, with the reasoning. Anyone interested can ask, within 60 days of publication, for an informal hearing; if requested, the hearing happens within 30 days, or 60 days if the requester asks for more time, with notice to the patent owner and other interested people. Within 30 days after the hearing, the Secretary affirms or revises the determination and publishes any change. "Due diligence" means the level of attention, steady effort, and promptness that people normally show during a regulatory review period. Every extension application must follow disclosure rules the Director sets. Interim extensions: if the owner reasonably expects the regulatory review to run past the current patent's expiration, the owner can apply for a temporary "interim" extension between 6 months and 15 days before the patent expires. This application needs similar information: what is under review and under what law; which patent and claims; eligibility information; what has been done so far and the key dates; and anything else the Director requires. If the Director finds the patent would qualify for a full extension except that marketing permission has not been granted yet, the Director publishes that finding and issues an interim extension certificate lasting up to one year. The owner can apply for up to four more interim extensions this way, only one more if a special rule in subsection (g)(6)(C) applies, each application filed between 60 and 30 days before the current interim extension expires. Each interim certificate becomes part of the official patent record. An interim extension ends 60 days after the product finally gets marketing permission, unless within those 60 days the applicant tells the Director and submits the rest of the required information — in which case the patent gets the full extension described elsewhere in this section, for up to 5 years past the original expiration, or, in the special case under subsection (g)(6)(C), measured from the approval date. During an interim extension, the owner's rights are limited to whatever is currently under regulatory review: the product itself, the specific claimed use, or the manufacturing method, depending on the kind of patent. (e) Deciding and certifying extensions. The Director can decide a patent is eligible based only on what the application says. If the Director finds the patent eligible and finds the requirements in subsection (d)(1) through (4) satisfied, the Director issues a certificate of extension for the period figured out under subsection (c). This certificate becomes part of the official patent record. If a patent's term would run out before the Director decides on the extension application, the Director can extend the term, for up to a year at a time, until the decision is made — but only if the Director believes the patent is eligible. (f) Key definitions. "Product" means a drug product, or a medical device, food additive, or color additive regulated under the Federal Food, Drug, and Cosmetic Act. "Drug product" means the active ingredient in a new drug, antibiotic, or human biological product, or in a new animal drug or veterinary biological product not mainly made using recombinant DNA or RNA, hybridoma, or similar genetic-engineering methods, including any salt or ester form, alone or combined with another active ingredient. A "major health or environmental effects test" is a test that reasonably evaluates a product's health or environmental effects, takes at least six months to run, not counting time spent analyzing results afterward, and whose data gets submitted for marketing permission. References to "section 351" mean that section of the Public Health Service Act; references to sections 503, 505, 512, or 515 mean those sections of the Food, Drug, and Cosmetic Act; and "Virus-Serum-Toxin Act" means the 1913 law found at 21 U.S.C. 151–158. "Informal hearing" has the meaning given in section 201(y) of the Food, Drug, and Cosmetic Act. "Patent" means one issued by the U.S. Patent and Trademark Office. "Date of enactment" means September 24, 1984, for human drugs, devices, or additives, and the enactment date of the Generic Animal Drug and Patent Term Restoration Act for animal drugs or veterinary biological products. (g) What counts as the "regulatory review period." This depends on the product type. For a new drug, antibiotic, or human biological product: the time from when a testing exemption took effect until the marketing application was first submitted, plus the time from that submission until the application was approved. For a food or color additive: the time from starting a major health or environmental test until a petition was first filed requesting approval to use the additive, plus the time from that petition until the rule allowing the additive took effect, or, if there were objections, until they were resolved and marketing was allowed. For a medical device: the time from starting a human clinical investigation until an application was first submitted, plus the time until that application was approved, or, for devices reviewed under a product development protocol, the time from submitting a completion notice until the protocol was declared complete. For a new animal drug: the time from starting a major health or environmental test, or an exemption taking effect, whichever is earlier, until the application was first submitted, plus the time until the application was approved. For a veterinary biological product: the time from when authority to prepare an experimental version took effect until a license application was submitted, plus the time until the license was issued. Each of these periods is capped. If the patent was issued after this section's enactment date, the extension based on the review period cannot exceed five years. If the patent was issued before enactment and none of the early review steps — testing, exemption requests, petitions — had started yet as of enactment, the cap is also five years. But if the patent was issued before enactment and an early review step had already started before enactment, while marketing approval still had not happened, the cap drops to two years, or three years for new animal drugs or veterinary biological products. (h) Fees. The Director may set fees to cover the Patent Office's cost of handling applications under this section. (i) Special rule for controlled substances. If the Secretary of Health and Human Services tells an applicant that a drug's approval, conditional approval, or indexing will lead to a recommendation to control it under the Controlled Substances Act, then starting on the "covered date," the drug is treated as approved or indexed under the relevant law and as having permission for commercial marketing. The "covered date" is whichever of these happens last: the date an application is approved under specific Public Health Service Act or Food, Drug, and Cosmetic Act provisions; the date an application is conditionally approved; the date a request for indexing is granted; or the date the interim final rule controlling the drug is issued under the Controlled Substances Act.