For instance, orphan drugs treatments for rare diseases affecting fewer than , people in the US get seven years of exclusivity, while new chemical entities NCEs get five years. And when pediatric exclusivity is granted to a drug, FDA says a period of 6 months of exclusivity is added to all existing patents and exclusivity on all applications held by the sponsor for that active moiety.
Another major difference: Patents can be expired before drug approval, issued after drug approval and anywhere in between, according to FDA, while exclusivity is granted upon approval.
Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims. Patent before exclusivity? Why does a particular drug product only have patents? Only have exclusivity? Have neither? Patents and exclusivity apply to drugs in different ways. Exclusivity attaches upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or neither. Patents and exclusivity may or may not run concurrently and may or may not cover the same aspects of the drug product.
Patents and exclusivities that have expired are removed from the Orange Book. What information related to pediatric exclusivity is listed in the Orange Book? When pediatric exclusivity is obtained, a 6-month period of exclusivity is added to all existing patents and exclusivity on all applications held by the sponsor for that active moiety.
Pediatric exclusivity does not stand alone, but attaches to existing exclusivity. When pediatric exclusivity attaches, in the patent column of the Orange Book, the patent is shown twice—once with the original patent expiration date and a second time reflecting the six month period of pediatric exclusivity linked to that particular patent.
How is an NDA holder notified if their application has received a period of exclusivity? No letters are sent to the application holder to indicate that a period of exclusivity has attached to their application. These additional patents and the complexities surrounding the timing of generic availability create challenges for managed care stakeholders attempting to gauge when generics may enter the market. An understanding of pharmaceutical patents and how intellectual property protection may be extended would benefit managed care stakeholders and help inform decisions regarding benefit management.
This article is based on discussions from a recent roundtable meeting that focused on how drug life-cycle management patent strategies affect the decision-making process regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products transition from single-source to generic status in the United States.
The roundtable participants also explored several strategies manufacturers employ to extend marketing exclusivity. Speeding access to generic medications is a pillar of pharmacy benefit management, as well as a key systematic way of managing pharmaceutical cost trends. This wave has increased competition and yielded significant cost savings for a number of stakeholders. Several important small-molecule drugs have US patent expirations slated for , including Benicar olmesartan medoxomil , Benicar HCT olmesartan medoxomil and hydrochlorothiazide , Crestor rosuvastatin calcium , Cubicin daptomycin , Zetia ezetimibe , 1 and perhaps, although unlikely, Zytiga abiraterone acetate , as will be discussed later in this article.
Health plans, insurers, and pharmacy benefit managers PBMs add generics to their drug formularies as quickly as possible to benefit from savings versus comparator branded medications. This investment results in precious intellectual property that can bring in revenue for a drug maker for years to come.
Without protection of this intellectual property, the pharmaceutical industry would be reluctant to invest the capital needed to develop innovative new products to improve health for individual patients and populations. In recent years, an increased amount of attention has been paid to pharmaceutical patents and litigation in the press and with payers. These factors affect pharmaceutical life-cycle management, the transition of products from single-source to multisource status, as well as formulary decision making and pharmacy budget planning.
Pharmaceutical intellectual property is protected primarily through the US patent system. All patents on branded pharmaceutical products are registered and listed in an addendum to the FDA-published Orange Book. According to statute, the granting of a pharmaceutical patent includes protection on that patent for a period of 20 years from time of patent filing.
Patent protection may be extended beyond 20 years, depending on whether the processing and review of the patent application was delayed at the patent office or delays were incurred during product review by the FDA. During the year life of the patent, other drug manufacturers may not sell generic alternatives of the product without the risk of lawsuit and substantial court-approved penalties.
In practice, much of the initial 20 years of exclusivity may be spent in product development and regulatory review. The results of a survey by the Pharmaceutical Research and Manufacturers of America indicated that member companies spent Patents and exclusivity work in a similar fashion, but are different from one another.
Marketing exclusivity interacts to some extent with patent laws. Exclusive marketing rights are granted by the FDA upon approval of a drug, and this period of marketing exclusivity may or may not run concurrently with the period of patent protection. In its essence, regulatory exclusivity is a congressionally mandated monopoly under the law.
It allows a brand name manufacturer a certain guaranteed period of protection, regardless of what patents they may or may not have. The protection provided by patents, however, is not guaranteed, as discussed later. Marketing exclusivity was granted to the patent holder, but a finite period after which marketing exclusivity would expire was not defined.
Manufacturers who were. For manufacturers of branded drugs, one problem with the system before was that the patents could be found to be invalid or unenforceable.
Marketing or regulatory exclusivity may be a stronger shield to protect intellectual property. However, legislative and regulatory efforts have not been used solely to protect intellectual property; generally, the intention of these statutes has been to balance patent protection with beneficial access to high-quality, affordable medicines ie, generics , with the additional result being a period of market exclusivity.
The Hatch-Waxman Act of sought to speed access to generic medications by providing generic manufacturers with incentives and a pathway for approval. Hatch-Waxman also provided innovators with meaningful patent protection and an opportunity to recoup their investment, and also provided incentives to generic manufacturers to promote the rapid availability of generic alternatives.
The Act established regulatory exclusivity periods for branded and first generic agents. Exclusivity periods were included in the Act as a lever to promote a balance between new drug innovation and generic drug competition. For example, the first generic manufacturer to challenge a patent for a branded product listed in the Orange Book is awarded a day exclusivity period, beginning at FDA approval.
One of the main objectives of the Hatch-Waxman legislation was to promulgate a formal pathway for the introduction of generic drugs, in an effort to bring generics to the market sooner. To achieve this, the Act introduced the abbreviated new drug application ANDA process, and detailed the studies and data required by the FDA to evaluate a generic drug for approval. Under Hatch-Waxman, upon approval of a new chemical entity, the FDA grants a regulatory exclusivity period of 5 years regardless of patent life remaining.
Importantly, as some agents take a longer time to obtain FDA approval, the Hatch-Waxman Act provides patent-term extensions for those products where a longer time is required by the FDA to review the drug application. Some patent approvals may indirectly extend market exclusivity of a product.
It lists prescription drug products and over-the-counter agents that are approved by the FDA as safe and effective. Manufacturers of branded products must identify USPTO-approved relevant patents and provide information on them, including patent expiration dates, to the FDA, which then publishes this information in the Orange Book. The latter usually occurs through the litigation process. The process for challenging a patent listed in the Orange Book generally occurs in the following steps:.
A notice letter is sent to the patent holder. When a generic manufacturer files an ANDA, the patent holder may consider this as an act of infringement, and can file suit for patent infringement. If the patent holder sues the generic manufacturer within 45 days of the receipt of the notice letter, the FDA may not grant final approval of the generic application for 30 months from the time of loss of regulatory exclusivity, unless a district court rules for the generic drug manufacturer before then, allowing time for the patent challenge to be decided in court.
In this case, the appeals process takes an average of roughly 14 months. Edward II gave the foreign workers letters that protected them and provided them with a monopoly on their trade. A patent is an exclusive right granted by the government such as the US Patent and Trademark Office, USPTO for an invention that is new, involves an inventive step, and is capable of industrial application. Patent protection is limited to the country or region that it was issued in and limited to a certain amount of time, typically 20 years from the date of patent application filing.
A patentable invention must be novel, useful, and non-obvious. An invention is defined as a new and inventive solution to a technical problem. In order to be patentable, an invention must have never been publicly disclosed, meaning it was never discussed in a seminar, oral presentation, poster, abstract, paper, or even with your friends or colleagues over a beer.
Once an inventor is granted a patent and therefore a temporary monopoly over their invention , they must fully disclose enough detail about the invention so that others can understand it. This is the trade-off: patents provide government-backed protection over the monopoly of an invention, but the inventor must fully explain the invention publicly. On the other hand, the inventor could not disclose their invention, but runs the risk of it being unprotected and has a monopoly over it only until the competition figures out how to make it themselves.
The process of filing for and being granted a patent can take years. Filing a patent starts with writing a provisional application , which is like a placeholder for the full application that clearly states what the invention is and its limits.
The priority date can be thought of as the defining line between old information prior art and new information invention in the patent application. The claims clearly lay out the boundaries of the invention. Once the full application is filed, the administrative details are reviewed during a formal examination period.
The patent office also writes a non-binding written opinion on patentability and sends the ISR and opinion letter to the inventor, who can address any objections made and modify the patent application as needed. This iterative process widdles down the scope of the claims to ensure the invention and patent fulfills all patentable criteria.
The PCT application is published 18 months after the priority date. This is economical because it can give the inventor a better idea of a patents chances before proceeding with the trouble and costs of regional and national examination. This phase is the most expensive because it involves multiple local patent attorneys and business in multiple languages.
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