The case that raised the issue of patent linkage in india was that of bristolmyers squibb co. Patent linkage in asian countries compared to the us. Bayer received an indian patent for nexavar in march 2008, which is one of the potential. A chinese version of the orange book the register will categorise each of the approved drugs as an innovative drug, improved new drug or generic drug that has passed. Pursuant to the korus fta, korea has to fully implement patent drug market approval linkage. Applicant full name the full name of the firm holding legal responsibility for the new drug application.
Under the linkage regime created by hatchwaxman, innovators list patents in the orange book and unless the generic awaits expiry of all listed patents, it must certify that it does not infringe the listed patents or that the patents are invalid. The impact of patent linkage on marketing of generic drugs ravikant bhardwaj, k d raju and m padmavati rajiv gandhi school of intellectual property law, iit kharagpur, kharagpur 721 302, india received 12 march 20, revised may 20 reasonable prices and innovation are two fundamental goals of health policies. Dec 02, 2019 patent linkage disallows the marketing approval of the generic drug until the patent of the originator reference drug is valid. Apr 01, 2019 the nda holder must confirm the correctness of its description of the approved method of use claimed by the patent that has been included as the use code in the orange book, or withdraw or amend the patent information in accordance with paragraph f2 of this section, provide a narrative description no more than 250 words of the nda. The patent linkage system in taiwan intellectual property. The us is the first country to adopt patent linkage as a part of the hatch waxman act 1984. Green list the korean version of orange book when a company of a new drug application nda has obtained a drug market approval ma from kfda, the nda holder must list patent information in the patent list green list of kfda. The patent holder failed to ask the fda to include it in the orange book. For drug patent linkage, there should be a system for filing objections and a patent declaration system.
The patent linkage system originated in the us and was later adopted by other countries. Equivalence evaluations commonly known as the orange book 15, regulatory marketing exclusivities and patent linkage. Taiwan passes patent linkage legislation taiwan business. This paper attempts to look back to the legislation and practice of orange book patent listing in u.
In turn, for the generic drug industry, hatchwaxman introduced an abbreviated. Under the socalled orange book system, branded pharmaceuticals which benefit from patent protections are. Eu unlikely to follow us with patent linkage system. A patent might not be listed for in the orange book because either a its a process patent. Patent linkage is essentially a mechanism that conditions marketing approval of followon medicines to the expiration of the reference products. Us fda requires applicant to list patents that cover the drug as part of nda filing applicant must submit signed declaration fda. When a manufacturer seeking marketing approval for a new chemical entity submits a new drug. Moreover, the cdsco does not maintain any register of patented pharmaceuticals like the orange book in the us. Under the socalled orange book system, branded pharmaceuticals which benefit from patent protections are indexed, with the purportedly relevant patents listed. This puts the public, including the generic companies, on notice as to those u. New cfda draft policy introduces patent linkage and orange book type record print twitter linkedin on 12 may 2017, the chinese food and drug administration cfda issued a policy. Equivalence evaluations commonly known as the orange book15, regulatory marketing exclusivities and patent linkage. This project deals with the concept of patent linkage and the position with respect to this concept in us and india. In the electronic orange book, a reference standard is identified by rs in the rs column.
Patent linkage clearly favours patentees, protecting them from potentially infringing products being approved, and in some countries providing a 30 month stay on marketing approval. Patent linkage patent information can be obtained efficiently. The food and drug administration fda maintains a list of pharmaceutical products and uses currently under patents in approved drug products with therapeutic evaluation equivalents widely known as the orange book. In the united states, patent linkage is statutorily recognized by the drug price competition and patent term restoration act of 1984, otherwise known as the hatch waxman act. Where the applicant seeks to challenge a patent, the applicant should declare noninfringement of the relevant patent and notify the patent owner within 20 days of filing. Such programs are possible due to the patent linkage system which operates in the us. Under the linkage system, the impi issues a special edition of the official gazette known as the gazette for medicaments gm, similar to the orange book published by the food and drug administration fda of the us government. Apr 30, 2012 patent linkage clearly favours patentees, protecting them from potentially infringing products being approved, and in some countries providing a 30 month stay on marketing approval applications.
Patent linkage in asian countries compared to the us lexology. The patent register is an alphabetical listing of medicinal ingredients and their associated patents, the patent expiry dates and other related information established in accordance with the patented. Delhi high court turned down the request of bayer corporation in august 18, 2009 to link patent status of its kidney cancer drug nexavar sorefenib tosylate with the marketing approval of the generic equivalent of the same patented molecule manufactured by cipla, during the patent life of nexavar in india. Pdf moderating the impact of patent linkage on access to. Apr 26, 2012 this article provides a snapshot of the patent linkage position in the us visavis asia and the pacific. About 2 days back, mint ran a story stating that the dcgi, dr surinder singh is now backtracking on his earlier initiative to frame rules to bring. Dec 03, 2019 patent linkage disallows the marketing approval of the generic drug until the patent of the originator reference drug is valid. Since the orange book decision down in 2009, there have been a number of patent infringement cases involving standardessential patents which the defendant invoked the orange book defense at some point to varying degrees of success. Orange book blog is aaron barkoffs personal website and it is intended for other attorneys. Linkage system for pharmaceutical patents moeller ip. New cfda draft policy introduces patent linkage and. Taiwan passes patent linkage legislation taiwan business topics. The distinguishing features of the us patent linkage system are. Nov 16, 2015 patent submissions in orange book patent holder submits patents to be listed in orange book under 21 u.
Overview of data exclusivity and patent registration linkage. Linkage pharmaceutical evergreening in canada and australia. Under the linkage regime created by hatchwaxman, innovators list patents in the orange book and unless the generic awaits expiry of all listed patents, it must certify that it does not infringe. This publication identifies the drug products which have been approved on the basis of safety and effectiveness by the food and drug administration fda. Linkages between generic approval and the patent system in. New cfda draft policy introduces patent linkage and orange. Jun 24, 20 linkage system for pharmaceutical patents. In the us, the publication of approved drug products with therapeutic equivalence evaluations, commonly known as the orange book identifies drugs which have been fda approved based upon their safety and efficacy profiles. The equivalent to the us orange book in mexico is known as the linkage patent system. From offices in atlanta, boston, london, palo alto, reston, seoul, shanghai, taipei, tokyo, and washington, dc, the firm practices all aspects of patent, trademark, and trade secret law, including counseling, prosecution, licensing, and litigation. In turn, for the generic drug industry, hatchwaxman introduced an abbreviated new drug application process for generic drugs that limits the amount of data required by the fda and provides. The starting point for understanding the patent linkage system in the us is arguably the fda orange book. Orange book china ipr intellectual property developments. Bruce pokras conference presentations orange book companion.
Relevant legal databases should also be made available to determine if chinas drug regulators are approving infringing generic drugs and if patent infringement cases are brought to. More specifically, pharmaceutical patents are only permitted if they are composition or method of use patents. Generic applicants must allege no relevant patent, patent expiration, or invaliditynoninfringement. Patent pfizer gets first generics ban under korea patent linkage law in accordance with the koreau. December 28, 2011 the equivalent to the us orange book in mexico is known as the linkage patent system. For generic drug companies, the orange book provides notice that there are patents out there covering fdaapproved drugs. Owners of registered medicines file all applicable patent claims in the fdas orange book. Chinas proposed patent linkage system shares all crucial elements of the u. Nov, 2019 finnegan partners barbara rudolph and amanda murphy will discuss patent listing dispute of new drug application and resolution, addressing orange book patent listing issues at the 2019 symposium for drug patent linkage system. There is no linkage between the patent rights and marketing approval of. Moderating the impact of patent linkage on access to.
When a manufacturer seeking marketing approval for a new chemical entity submits a new drug application nda to the fda, the application must also list the patents that the manufacturer wishes to claim on the drug. Hetero drugs ltd, decided in december 2008 by the delhi high court. Patent linkage and indian laws intellectual property india. The impact of patent linkage on marketing of generic drugs. Jul 25, 2017 several key policies are outlined in the policy document including drug patent linkage, drug trial data exclusivity and the introduction of the chinese version of the orange book. The program will take place at the ntuh international convention center in taipei city, taiwan. Under the new patent linkage mechanism, which will resemble the orange book system that has long been in use in the united states, generic manufacturers will also benefit by having a clearer. In turn, for the generic drug industry, hatchwaxman introduced an abbreviated new drug. Orange book patent listing and patent certifications.
Several key policies are outlined in the policy document including drug patent linkage, drug trial data exclusivity and the introduction of the chinese version of the orange book. The proposed rule contains a wealth of information concerning the manner in which fda has interpreted and proposes to interpret various hatchwaxman issues, including orange book patent listing, patent certifications, amendments and supplements to 505b2 applications and andas, and the 30month stay. Listing drug patents in green list the korean version of orange book. October 2008, american conference institute, maximizing pharmaceutical patent life cycles conference. The fta between korea and usa includes provisions regarding the patent drug market approval ma linkage. Finnegan partners barbara rudolph and amanda murphy will discuss patent listing dispute of new drug application and resolution, addressing orange book patent listing issues at the. The process of patent linkage establishes a desirable communication process between the health ministry and the patent offices to prevent marketing approval of generic drugs before expiration of. The green list is similar to the orange book in the u.
The catalogue of chinas marketed drugs chinas version of the u. Us fda requires applicant to list patents that cover the drug as part of nda filing applicant must submit signed declaration fda relies on innovator drug companys assertion patent information published in orange book. In the united states, patent linkage is statutorily recognised by the drug price competition and patent term restoration act, a major amendment of the federal food, drug and cosmetic act, enacted in 1984. Jul 24, 2017 several key policies are outlined in the policy document including drug patent linkage, drug trial data exclusivity and the introduction of the chinese version of the orange book. China needs to enhance patent protection to achieve. A generic drug company must make one of the following declarations when filing an application for approval of a generic drug equivalent to a new drug. Eu unlikely to follow us with patent linkage system, says. The nda holder must confirm the correctness of its description of the approved method of use claimed by the patent that has been included as the use code in the orange book, or withdraw or. Above all, patent linkage changes the nature of patent law from a private right, where enforcement depends on the rights holder s diligence, to a public right, where enforce.
Under the new patent linkage mechanism, which will resemble the orange book system that has long been in use in the united states, generic manufacturers will also benefit by having a clearer environment in which to operate, minimizing the risk of being caught up in litigation. Patent linkage and indian laws ipr law firms intellectual. In the us, the publication of approved drug products with therapeutic equivalence evaluations, commonly known as the orange book identifies drugs which have been fda. Site search finnegan leading intellectual property law firm. Free trade agreement, korea adopted a patentregulatory approval linkage system, similar to the u. Taiwan fda will publish in a patent linkage registration system, known as orange book, information regarding the patents associated with the new drug for public inspection. This article proposes to analyze the current status of patent linkage in india, in light of the honble delhi high court and supreme courts judgment in the case of bayer corporation and others v cipla, union. New cfda draft policy introduces patent linkage and orange book type record print twitter linkedin on 12 may 2017, the chinese food and drug administration cfda issued a policy document titled policies regarding the promotion and protection of innovators rights in drugs and medical devices consultation draft the policy document for. New cfda draft policy introduces patent linkage and orange book type record on 12 may 2017, the chinese food and drug administration cfda issued a policy document titled policies regarding the promotion and protection of innovators rights in drugs and medical devices consultation draft the policy document for public comment. In order to make the data observable and accessible, china would adopt an orange book to listing relevant patents for approved pharmaceuticals.
Drug patent linkage upon the filing of an application for drug registration, the applicant must submit a statement regarding the relevant patent rights of which the applicant is aware. Orange book type patent linkage system, which has been fully implemented since march 2015. China new cfda draft policy introduces patent linkage. Linkage in us is applied though the publication of approved drug products with therapeutic equivalence evaluations, commonly known as the orange book. Effect on 180day generic exclusivity january 2009, american conference institute, pharmabiotech ip due diligence conference.