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Similar to Hatch- waxman act (The drug price competition and patent term restoration act) (1984) -> by Mohit kumar (20)
Hatch- waxman act (The drug price competition and patent term restoration act) (1984) -> by Mohit kumar
- 1. PRESENTED BY: MOHIT KUMAR M.PHARMACY (P (PHARMACEUTICS) 3rd SEMESTER SETH G. L. BIHANI S. D. COLLEGE OF TECHNICAL EDUCATION GAGAN PATH, SRI GANGANAGAR (RAJ.) 335001, INDIA.
- 2. INTRODUCTION WHAT IS HATCH-WAXMAN ACT KEY COMPONENTS COMPARISON ENACTMENT OFTHE HATCH-WAXMAN ACT THE STATUTORY EXPERIMENTAL USE EXCEPTION ABBREVIATED NEW DRUG APPLICATIONS(ANDA) CERTIFICATIONS FOR ORANGE BOOK-LISTED PATENTS SECTION VIII STATEMENT OR A PATENT CERTIFICATION. PATENT INFRINGEMENT PROCEEDINGS PATENTTERM EXTENSION REGULATORY EXCLUSIVITIES PEDIATRIC EXCLUSIVITY
- 3. The Hatch-Waxman Act established the legal and economic foundation for today’s generic pharmaceutical industry.
- 4. • INNOVATION, by providing incentives for biopharmaceutical companies to research and develop new, innovative pharmaceuticals; and • AFFORDABILITY, by creating an abbreviated path for generic manufacturers to bring lower-cost versions of pharmaceuticals to market.
- 5. Creating a patent litigation framework with a clear process and predictable timetable where a generic manufacturer can challenge a brand manufacturer’s patents in federal court without risking liability for patent infringement damages. Allowing generic manufacturers to reference the brand manufacturer’s safety and efficacy data in their U.S. Food and Drug Administration (FDA) approval applications, rather than fund their own costly and lengthy clinical studies. Establishing a “safe harbor” provision that exempts generic manufacturers from patent infringement liability for development work, before the patent expires, for their own pharmaceutical approval application with the FDA. Incentivizing generic manufacturers to challenge patents for brand name pharmaceuticals and speeding patient access to generic pharmaceuticals by providinga 180-day market exclusivity period for the first marketed generic. Providing brand manufacturers with incentives to develop new pharmaceuticals through a 5- year exclusivity period during which generic manufacturers cannot submit FDA applications for new generic versions of the pharmaceutical and restoring some of the patent term lost due to the lengthy FDA regulatory approval process. Establishing a 3-year exclusivity period for improved versions of brand pharmaceuticals that required additional clinical studies for FDA approval during which generic manufacturers cannot gain FDA approval of their applications for generic versions of the improved pharmaceuticals. Since Hatch-Waxman’s enactment, the generic pharmaceutical industry has seen enormous growth and biopharmaceutical companies have continued to discover and develop innovative new treatments for costly, complex diseases.
- 6. • A mere 19% of prescriptions in the United States were filled with generics. • Only 35% of top-selling pharmaceuticals hadgeneric competitors after their patents expired. • It took 3 to 5 years for generics to enter the market after the patents on brand-name pharmaceuticals expired. • Nearly 90% of prescriptions in the United States are filled with generics • More than 80% of approved pharmaceuticals have generic versions available. • Generics often enter the market immediately upon patent expiration and are often adopted rapidly; some capture as much as 90% of the market within three months of becoming available.
- 7. The Roche v. Bolar decision was widely seen as the impetus for congressional enactment of the Drug Price Competition and Patent Term Restoration Act of 1984. Signed into law on September 24, 1984, that law has come to be known as the Hatch- Waxman Act. The new law was subsequently codified in Titles 15, 21, 28, and 35 of the U.S. Code.
- 8. The Hatch-Waxman Act created a statutory exemption from certain claims of patent infringement. As codified in 35 U.S.C. §271(e)(1), this provision mandates: “It shall not be an infringement to make, use, offer to sell, or sell within the United States a patented invention; solely for uses reasonably related to the development and submission of information under a Federal Law which regulates the manufacture, use or sale of drugs or veterinary biological products.” This provision effectively overturned the Roche v. Bolar decision.
- 9. The Hatch-Waxman Act created a new type of application for market approval of a pharmaceutical. This application, termed an “Abbreviated New Drug Application” (ANDA), may be filed at the FDA. An ANDA may be filed if the active ingredient of the generic drug is the bioequivalent of the approved drug. An ANDA allows a generic drug manufacturer to rely upon the safety and efficacy data developed by the original manufacturer. The Hatch-Waxman Act also continued the FDA’s earlier “paper NDA” practice by establishing what has come to be known as a Section 505(b)(2) application. Such an application relies, at least in part, upon safety and efficacy data that the applicant did not itself develop, but rather is available in the published literature. ANDAs and Section 505(b)(2) applications may allow a generic manufacturer to avoid the costs and delays associated with filing a full- fledged NDA. These two expedited marketing approval pathways also allow a generic manufacturer, in many cases, to place its FDA-approved bioequivalent drug on the market as soon as any relevant patents expire.
- 10. All approved drug products, both brand name and generic, are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. This publication is commonly known as the “Orange Book” due to the color of its cover. Although today most individuals likely view its contents through use of the Internet or the smartphone “Orange Book Express” app. The Orange Book uses a coded lettering system to identify those approved drugs the FDA considers therapeutically equivalent. The FDA considers those drugs with an “A” code to be therapeutically equivalent, while those with a “B” code have a documented bioequivalence problem. The Orange Book provides physicians, pharmacists, and patients with information to help them decide when therapeutically equivalent generic drugs can be substituted for brand-name products. The Orange Book also plays a role in the resolution of patent disputes. The Hatch-Waxman Act requires each holder of an approved NDA to list pertinent patents it believes would be infringed if a generic drug were marketed before the expiration of these patents. Would-be manufacturers of generic drugs must then engage in a specialized certification procedure with respect to Orange Book-listed patents. An ANDA applicant must state its views with respect to each Orange Book-listed patent associated with the drug it seeks to market.
- 11. The generic applicant must either file a so-called section viii statement or a patent certification. Section viii statements are appropriate when the applicant is seeking approval for a method-of-use that is not claimed in a patent listed in the Orange Book. Alternatively, the generic applicant must provide one of four certifications- 1. the brand-name firm has not filed any patent information with respect to that drug; 2. the patent has already expired; 3. the date on which the patent will expire; or 4. the patent is invalid or will not be infringed by the manufacture, use, or sale of the drug for which the ANDA is submitted. These certifications are respectively termed paragraph I, II, III, and IV certifications.
- 12. An ANDA certified under paragraphs I or II is approved immediately after meeting all applicable regulatory and scientific requirements. A generic firm that files an ANDA including a paragraph III certification must, even after meeting pertinent regulatory and scientific requirements, wait for approval until the drug’s listed patent expires. A paragraph IV certification leads to additional possibilities.
- 13. Under 35 U.S.C. §271(e)(2), the filing of an ANDA with a paragraph IV certification constitutes a “somewhat artificial” act of patent infringement. The Hatch-Waxman Act requires the ANDA applicant to notify the proprietor of the patents that are the subject of a paragraph IV certification. The patent owner may then commence patent infringement litigation against the ANDA applicant in federal district court. This charge of infringement under 35 U.S.C. §271(e)(2) is technical in nature. At this stage the generic manufacturer has done nothing more than request FDA approval to market a drug. If the patentee’s charge of infringement is successful, however, it may prevent the marketing of that generic equivalent until the date the patent expires. If the patent owner brings a patent infringement charge against the ANDA applicant within 45 days of receiving notice from the ANDA applicant, then the Hatch-Waxman Act provides the patentee with a significant benefit.
- 14. The Hatch-Waxman Act also provides for the extension of patent term. Ordinarily, patents may last as long as 20 years from the date the patent application is filed. The Hatch-Waxman Act provides that for pharmaceutical patents, the term of one patent may be extended for a portion of the time lost during clinical testing. If, as is often the case, the patent proprietor owns more than one patent covering a drug, it must choose one to be eligible for term extension. In particular, the patent holder is entitled to have restored to the patent term one-half of the time between the IND application and the submission of an NDA, plus the entire period spent by the FDA approving the NDA.
- 15. The statute sets some caps on the length of the term restoration. The entire patent term restored may not exceed five years. Further, the remaining term of the restored patent following FDA approval of the NDA may not exceed 14 years. The Hatch-Waxman Act also provides that the patentee must exercise due diligence to seek patent term restoration from the USPTO, or the period of lack of diligence will be offset from the augmented patent term. As a simplified example, suppose that four years passed between the filing of the IND and NDA, and another two years passed between the filing of the NDA and its approval. The period of extension would be (4÷2) + 2 = 4 years. Patent term extension under the Hatch-Waxman Act does not occur automatically. The patent owner must file an application with the USPTO requesting term extension within 60 days of obtaining FDA marketing approval.
- 16. The Hatch-Waxman Act includes provisions that create regulatory exclusivity for certain FDA-approved drugs. The FDA administers these provisions by issuing approval to market a pharmaceutical to only a single entity. Stated differently, during the statutorily stipulated period of time, the FDA protects an approved drug from competing applications. A grant of regulatory exclusivity does not depend on the existence of patent protection. Indeed, it is possible that two completely different entities may own USPTO-granted patent rights, on one hand, and FDA-issued regulatory exclusivity, on the other. The Hatch-Waxman Act was not the first legislation to provide for a regulatory exclusivity.
- 17. Two years earlier, Congress had approved the Orphan Drug Act in order to encourage firms to develop pharmaceuticals to treat rare medical conditions. Such drugs are called “orphan” drugs because firms may lack the financial incentives to “adopt,” or sponsor, products to treat small patient populations. The Orphan Drug Act established a seven-year term of market exclusivity for drugs determined to treat rare disease and conditions. Orphan drug exclusivity prevents the FDA from approving another marketing approval application for the same drug and same orphan indication. Expanding upon this concept, the Hatch-Waxman Act established a five-year exclusivity that is available to drugs that qualify as a new chemical entity (NCE). A drug is judged to be an NCE if the FDA has not previously approved that drug’s active ingredient. During that five-year period of NCE exclusivity, the FDA may accept neither a Section 505(b)(2) application nor an ANDA for a drug product containing the same active moiety protected under the NCE exclusivity. The term of NCE exclusivity may be reduced to as little as four years if a generic firm files a paragraph IV ANDA.
- 18. The Hatch-Waxman Act also provided for a three-year new clinical study exclusivity period. New clinical study exclusivity may be awarded with respect to either an NDA or a supplemental NDA that contains reports of new clinical studies conducted by the sponsor that are essential to FDA approval of that application. In contrast to NCE exclusivity, new clinical study exclusivity applies only to the use of the product that was supported by the new clinical study. The Hatch-Waxman Act further provided prospective manufacturers of generic pharmaceuticals with a reward for challenging the patent associated with an approved pharmaceutical. The reward consists of a 180-day generic drug exclusivity period awarded to the first generic applicant to file a paragraph IV certification. Congress hoped that this entitlement would encourage generic applicants to challenge a listed patent for an approved drug product.
- 19. granted by FDA. unique as the only exclusivity that also attaches to listed patents. study resulting in 6 months of PED exclusivity may also result in 3 year Hatch Waxman exclusivity. results in 6 months if sponsor “fairly responds” to Written Request. attaches to all drug products that contain the same active moeity provided they are held by the same sponsor.
- 20. an extension of a patent. subject to challenge via PIV certification. 6 month ped exclusivity can not be “carved- out” of labeling in traditional sense.
- 21. Ohly D.C.(2010) The Hatch-Waxman Act: Prescriptions for Innovative and Inexpensive Medicines. Schiff Hardin Visiting Scholar (2016 ) The Hatch-Waxman Act: A Primer. Congressional Research Service Toufanian J.D.,Shimer M., (2015) Hatch-Waxman 101. Regulatory Education for Industry (redi): generic drugs forum Rose P.(2009) The Changing Landscape Of U.S. Anticompetition Laws For The Pharmaceutical Industry. Colin A Underwood Reddy L., Hatch Waxman Act. Krishna Teja Pharmacy College Barons L., Gregory D et al.(2013) Hatch-Waxman Act: Overview. Practical Law Company