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Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
Patents & market exclusivity
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Patents & market exclusivity

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This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.

This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.

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  • 1. Presentation compiled by “ DrugRegulations” a not for profit organization from publicly available material on the world wide web. www.drugregulations.org 1
  • 2.  Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. §301 et seq, governs manufacture and marketing of pharmaceuticals FDA is the primary regulatory agency for pharmaceuticals Marketing of a new drug requires filing a “New Drug Application” (NDA) with the FDA, along with clinical tests showing that the drug is both safe and effective for the intended use Approved drugs, and certain underlying patents, are listed in the “Orange Book” www.drugregulations.org 2
  • 3. Drug Application Types Types Drug Application  A New Drug Application (NDA) contains full reports of safety and efficacy studies conducted by or for applicant or as to which it has right of reference  An Abbreviated New Drug Application (ANDA) is for a generic duplicate of an approved NDA product:  Borrows safety and efficacy studies from NDA  Must have identical active ingredient, route of administration, dosage form, strength, labeling and intended use  Must demonstrate bioequivalence 3 www.drugregulations.org 3
  • 4. Drug Application Types A “505(b)(2)” application is an NDA for a modification to an approved drug (e.g., different active ingredient, dosage form, strength, etc.) relies upon one or more studies not conducted by or for applicant and for which applicant has no right of reference (e.g., published studies or FDA finding of safety/efficacy of approved drug) application must contain sufficient data to support the safety/efficacy of the modification 4 www.drugregulations.org 4
  • 5. www.drugregulations.org 5
  • 6.  Patents are fully protected under 505(b)(2), because applicants must certify to listed patents on the reference drug, and patentees have at least 30 months to vindicate their patent(s) through litigation without competition. Unlike generics, 505(b)(2) products do not get “AB” ratings, so are not automatically substituted for original products. The safety/efficacy of approved products is a matter of public record, as reflected in the approved labeling. Forcing applicants to re-invent the wheel would be a costly and unnecessary policy choice. Indeed, it would be unethical to subject patients to clinical studies just to prove what everybody already knows about a drug. www.drugregulations.org 6
  • 7.  New Chemical Entity (rarely) New dosage form New dosing regimen New strength New route of administration New indication www.drugregulations.org 7
  • 8.  New active ingredient (different salt, ester, complex, chelate, clathrate, racemate, or enantiomer of active moiety) New inactive ingredient that requires more than limited confirmatory studies Rx OTC switch New Combination Products www.drugregulations.org 8
  • 9.  NDA applicant (including 505(b)(2)) must inform FDA of patents covering drug or method of using it Under 2003 FDA Final Regulations:  Method patent must cover approved method  Product-by-process patent should be listed only where novel product  Metabolite and intermediate patents should not be listed  Patent on different polymorphic form should be listed where testing shows bioequivalence FDA publishes information in “Orange Book” 9 www.drugregulations.org 9
  • 10.  A Drug will have two forms of market protection. The first comes in the form of “exclusivity” which is a creation of law. Exclusivity enables the drug product to have exclusive, or monopoly, status in the market for a certain number of years (five years for a new chemical entity and other periods of time for different situations.) Exclusivity means that the FDA cannot legally approve a generic drug application for that product until the exclusivity period expires. www.drugregulations.org 10
  • 11.  Exclusivity should not be confused with patent protection, which is the second form of market protection for a marketed branded drug. Included in the NDA is information regarding any patents on the drug product. The manufacturer applies for these patents with the US Patent and Trademark Office which, of course, works independently from the FDA. The FDA lists the patents in the Approved Drug Products with Therapeutic Equivalence Evaluations , also known as the Orange Book. www.drugregulations.org 11
  • 12.  Consider a product with one patent. A provisional application was filed, the utility (regular) application was filed within a year, and the patent was issued within three years. The patent term is 20 years from the date of filing. Note that the IND became effective – a requirement for the start of clinical trials – after the patent issued and many years after the patent filing. This scenario is often the case because companies file patent applications before knowing that a product will be suitable for clinical trials. The NDA is filed four years after the IND became effective, and the NDA is approved one year after the NDA filing. www.drugregulations.org 12
  • 13. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 yearsYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 13
  • 14.  If the product is a “new chemical entity,” it will be eligible for 5 years of new product exclusivity. For five years after NDA approval, FDA cannot accept for filing a generic application (ANDA or 505(b)(2)). However, FDA may accept for filing a generic application that contains a patent certification that the patent is invalid, not infringed, or not enforceable – a Paragraph IV certification. 5-year exclusivity is independent of any patent protection that might be available. www.drugregulations.org 14
  • 15. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 yearsYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 15
  • 16. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 years Data Exclusivity, NCEYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 16
  • 17.  If the product is not a “new chemical entity,” it will be eligible for 3 years of new product exclusivity. For three years, FDA may not approve a generic application for the same indication or condition of approval as the approved product. 3-year exclusivity is independent of any patent protection that might be available. A product may be eligible for either 5-year or 3-year exclusivity – but not both. www.drugregulations.org 17
  • 18. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 years Data Exclusivity, NCEYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 18
  • 19. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 years Data Exclusivity, NCE Data Exclusivity, Non-NCEYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 19
  • 20.  If the product also qualifies for Orphan Drug Exclusivity – generally, a product for treating fewer than 200,000 patients in the United States per year – then, the example product is eligible for 7 years of market exclusivity following product approval. During the 7-year period, FDA cannot approve the same drug for the same indication – even if the second applicant generates completely independent data. www.drugregulations.org 20
  • 21. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 years Data Exclusivity, NCE Data Exclusivity, Non-NCEYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 21
  • 22. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 years Data Exclusivity, NCE Data Exclusivity, Non-NCE Orphan Drug Market ExclusivityYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 22
  • 23.  Patent term restoration is designed to restore to the patent term some of the time that was lost in the process of satisfying the requirements for regulatory approval. If the patent and the product meet the requirements for patent term restoration, the duration of the restored is calculated as one-half the period in clinical trials – from the IND effective date to the filing of the NDA -- plus the entire period of FDA review. The restored period cannot exceed 5 years, and the patent life following product approval cannot exceed 14 years. For the product in this example, the restored term is 3 years -- 2 years (one-half of the 4-year clinical trials period), plus one year of regulatory review. www.drugregulations.org 23
  • 24. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 years Data Exclusivity, NCE Data Exclusivity, Non-NCE Orphan Drug Market ExclusivityYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 24
  • 25. Patents & Market Exclusivity Paradigm NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Patent Original Patent Term - 20 years Term Restoration Data Exclusivity, NCE Data Exclusivity, Non-NCE Orphan Drug Market Exclusivitywww.drugregulations.orgYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 25
  • 26.  If the product is eligible for Pediatric Exclusivity – because the drug sponsor completed studies in accordance with a Written Request from FDA – then, the product is eligible for an additional six-months of exclusivity added on to any other exclusivity that has not expired. For example, 5-year exclusivity becomes 5 years and 6 months; 3-year exclusivity becomes 3-years and six-months; and 7-year Orphan Drug exclusivity becomes 7 years and 6 months. With respect to patent protection, the generic applicant must certify that the expiration date of any patent is six months later than the actual expiration date. Accordingly, any generic applicant that is waiting for patent expiration before marketing its product will need to delay marketing for an additional six months. www.drugregulations.org 26
  • 27. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Filed Patent Issued IND Effective Approved Original Patent Term - 20 years PTR Data Exclusivity, NCE Data Exclusivity, Non-NCE Orphan Drug Market ExclusivityYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26www.drugregulations.org 27
  • 28. Patents & Market Exclusivity NDAProvisional FiledApplication PatentFiled Application NDA Pediatric Drug Filed Patent Issued IND Effective Approved Patent Certification Original Patent Term - 20 years PTR Data Exclusivity, NCE Data Exclusivity, Non-NCE Orphan Drug Market Exclusivitywww.drugregulations.orgYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 28
  • 29. Patents & Market ExclusivityProvisionalApplication Patent NDA FiledFiled Application NDA Pediatric Drug Filed Patent Issued IND Effective Approved Patent Certification Original Patent Term - 20 years PTR Pediatric Drug Data Exclusivity, Exclusivity, NCE NCE Data Exclusivity, Non-NCE Orphan Drug Market Exclusivitywww.drugregulations.orgYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 29
  • 30. Patents & Market ExclusivityProvisionalApplication Patent NDA FiledFiled Application NDA Pediatric Drug Filed Patent Issued IND Effective Approved Patent Certification Original Patent Term - 20 years PTR Pediatric Drug Data Exclusivity, Exclusivity, NCE NCE Pediatric Drug Data Exclusivity, Exclusivity, Non-NCE Non-NCE Orphan Drug Market Exclusivitywww.drugregulations.orgYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 30
  • 31. Patents & Market ExclusivityProvisionalApplication Patent NDA FiledFiled Application NDA Pediatric Drug Filed Patent Issued IND Effective Approved Patent Certification Original Patent Term - 20 years PTR Pediatric Drug Data Exclusivity, Exclusivity, NCE NCE Pediatric Drug Data Exclusivity, Exclusivity, Non-NCE Non-NCE Pediatric Drug Orphan Drug Exclusivity Market Exclusivitywww.drugregulations.orgYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 31
  • 32.  The Effective Patent Life is the period of patent protection following product approval – after taking into consideration any applicable Patent Term Restoration and Pediatric Exclusivity. The Effective Patent Life is substantially shorter than the original 20-year patent term. www.drugregulations.org 32
  • 33. Patents & Market ExclusivityProvisionalApplication Patent NDA FiledFiled Application NDA Filed Patent Issued IND Effective Approved Pediatric Exclusivity Original Patent Term - 20 years PTR Effective Patent Lifewww.drugregulations.orgYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 33
  • 34. www.drugregulations.org 34
  • 35.  Prior to 1962, as per Federal Food, Drug and Cosmetic Act, all application for registration were examined on the basis of the safety profile. But for manufacturing of generic, there were also the requirement of the clinical data to prove efficacy. Kefauver- Harris amendment was done in FDC Act in the year of 1962. As per this amendment, proof of efficacy was also required along with the safety profile. www.drugregulations.org 35
  • 36.  To overcome the drawback of Kefauver- Harris amendment, in year of 1984, Drug Price Competition and Patent Term Restoration act was implemented in FDC act, also known as Hatch-Waxman act. "The Hatch-Waxman Act is an act dealing with the approval of generic drugs and associated conditions for getting their approval from the Food and Drug Administration (FDA), market exclusivity, rights of exclusivity, patent term extension and Orange Book Listing." www.drugregulations.org 36
  • 37.  There were no generic drugs in market for 150 off patent drugs. Manufacturers were not interested to manufacture cheaper generic versions because of stringent regulatory procedures. Drug companies were not interested to waste time and money on clinical trials of generic drugs, because of fewer profits from those cheaper generics and more stringent regulations. The Hatch-Waxman Act focused these issues and proposed many changes and started the generic drugs approval procedure as Abbreviated New Drug Application (ANDA), for the purpose of market authorization. www.drugregulations.org 37
  • 38.  Each holder of an approved new drug application (NDA) must list pertinent patents it believes would be infringed if a generic drug were marketed before expiration of these patents. The FDA maintains a list of such patents in its publication, Approved Drug Products with Therapeutic Equivalence Evaluations commonly known as Orange Book. Purpose: To make generic pharmaceutical firms aware of patents protecting brand-name drugs All patents that claim a new drug, or some method of using this drug are listed in the Orange Book. www.drugregulations.org 38
  • 39.  Electronic Orange Book (EOB) is updated daily providing product information for new generic drug approvals. Daily generic updates provide the consumer with the current list of approved generic products which is important for substitution purposes. The EOB content includes: ◦ New Drug Application (NDA) approvals. NDA application numbers are preceded with “N” ◦ Abbreviated New Drug Application approvals (ANDA or Generic). Generic application numbers are preceded with “A”. www.drugregulations.org 39
  • 40.  A generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation. Generics are considered (by the Food and Drug Administration (FDA)) identical in dose, strength, route of administration, safety, efficacy, and intended use. www.drugregulations.org 40
  • 41.  FDA requirements can overlap with patent requirements ANDA “sameness” requirements (FDCA §505(j)(2)(A) ◦ Same active ingredient ◦ Same conditions of use (labeling) ◦ Same dosage form ◦ Same strength ◦ Same route of admin ◦ Bioequivalent ◦ Patent Certification www.drugregulations.org 41
  • 42. NDA ANDA1. Chemistry 1. Chemistry2. Manufacturing 2. Manufacturing3. Controls 3. Controls4. Labeling5. Testing 4. Labeling6. Animal Studies 5. Testing7. Clinical Studies 6. Bioequivalence8. Bioavailability www.drugregulations.org 42
  • 43.  Streamlined generic approval process “Safe Harbor” for pre-approval activities Patent term restoration to offset lengthy regulatory approval process Non-patent exclusivity for innovators and generics Framework for patent notification and litigation www.drugregulations.org 43
  • 44.  Before the Act, a generic manufacturer who used a patented drug during the patent term for the purpose of conducting tests to submit information to the FDA committed patent infringementRoche Products v. Bolar, 733 F.2d 858 (Fed. Cir. 1984) www.drugregulations.org 44
  • 45.  35 U.S.C. § 271 (e)(1): It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into 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. www.drugregulations.org 45
  • 46.  The generic approval process is called Abbreviated New drug Application (ANDA). While filing an ANDA, the generic company has to choose one of the following four options (referred to as paras) A Para I filing is made when the innovator has not made the required patent information in the Orange Book. A Para II filing for the launch of a generic drug is made when the drug is already off patent. www.drugregulations.org 46
  • 47.  A Para III filing is made when the patent for the product exists but the generic company wants to enter the markets after the date of patent expiry passes. A Para IV filing is made when the ANDA applicant believes its product or the use of its product does not infringe on the innovators patents listed in the Orange Book or where the applicant believes such patents are not valid or enforceable. Method of use patent does not claim a use for which applicant is seeking approval. www.drugregulations.org 47
  • 48.  Para IV filer must notify NDA holder/patent owner and provide detailed statement of basis for challenge Under Medicare Prescription Drug, Improvement, And Modernization Act 2003 (for Para IV certifications on or after Aug. 18, 2003), ANDA and 505(b)(2) applicants must give notice  within 20 days of confirmation of generic filing; and  at same time as any amendment or supplement regardless of whether already given notice of another Para IV ◦ Filing generic application (ANDA or 505(b)(2)) with a Para IV is an act of patent infringement 48 www.drugregulations.org 48
  • 49. Patent Information/Certification  NDA holder/patent owner has 45 days from receipt of Para IV notice to sue for infringement.  If timely suit is brought, 30-month stay of FDA approval of generic application unless earlier court decision of invalidity, non-infringement or unenforceability.  Under Medicare Act (for patents listed on or after Aug. 18, 2003), opportunity of one 30-month stay per generic application, limited to patents listed prior to generic application  Generic applicant still has to send notice re later listed patents but, if patent holder sues, no extra 30 month stay 49 www.drugregulations.org 49
  • 50.  Under Hatch-Waxman: First ANDA Para IV filer (not 505(b)(2)) obtains 180- day exclusivity against other ANDA filers (not 505(b)(2)s) Exclusivity triggered by earlier of first commercial marketing or “court decision” Several issues arising under Hatch-Waxman have been addressed by the Medicare Act 50 www.drugregulations.org 50
  • 51.  Under Medicare Act, for ANDAs where no Para IV was made before Dec. 8, 2003: an applicant that submits a “substantially complete” ANDA for a drug that contains and “lawfully maintains” a Para IV certification “for the drug” on the first day that any applicant does so is a “first applicant” and Obtains 180-days exclusivity (unless forfeited) 51 www.drugregulations.org 51
  • 52. Generics & Market ExclusivityProvisionalApplication Patent NDA Filed ANDA filed, NoticeFiled Application NDA Filed Patent Issued IND Effective Approved Patent Infringement Suit Pediatric Exclusivity Original Patent Term - 20 years PTR Effective Patent Lifewww.drugregulations.orgYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 52
  • 53. Market Exclusivity ParadigmProvisionalApplication Patent NDA Filed ANDA filed, NoticeFiled Application NDA Filed Patent Issued IND Effective Approved Patent Infringement Suit Pediatric Exclusivity Original Patent Term - 20 years PTR Effective Patent Life 30-month Staywww.drugregulations.orgYears 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 53
  • 54.  Once FDA authorizes the marketing of the generic drug, the first-filed Paragraph IV ANDA applicant becomes entitled to 180 days of marketing exclusivity. This exclusivity protects the first FDA-approved Paragraph IV ANDA applicant from competition against other ANDA marketers during the 180-day period, This provides an incentive for ANDA applicants to challenge patents on brand-name drugs and to seek generic entry prior to patent expiration. www.drugregulations.org 54
  • 55.  The Generic Pharmaceutical Association (“GPhA”), a trade association comprised of generic drug companies, attributes much of the health of generic marketing to Hatch-Waxman exclusivity, The vast majority of potential profits for a generic drug manufacturer materialize during the 180-day exclusivity period. The 180-day marketing exclusivity does not, however, preclude competition from an Authorized Generic (AG). www.drugregulations.org 55
  • 56.  The courts have determined that a brand-name company can market an AG during that exclusivity period. This is because the brand-name company does not need the FDA to approve an ANDA. Instead, the brand-name company can rely on its already-approved NDA. This practice has become increasingly common. AG‟s have generated increasing controversy. Generic companies contend that AGs deprive generic companies of the “true” exclusivity that was contemplated by the Hatch-Waxman Amendments. However brand-name companies defend AGs as procompetitive and consistent with the Amendments. www.drugregulations.org 56
  • 57.  In order to protect their patents, brand-name manufacturers and initial ANDA filers often agree to a settlement that delays the entry of the generic drug into the market -- namely, pay-for-delay settlements. However, as any other ANDA files are prohibited from selling their own generic versions of the drug in question under the 180-day exclusivity period generated under Paragraph IV, pay-for-delay settlements can also effectively delay the market entry of any generic version of the drug, thereby driving the FTC‟s aforementioned concerns about illegal restraint of trade. www.drugregulations.org 57
  • 58.  A study was undertaken by the Federal Trade Commission on the effects of AGs on competition in the prescription drug marketplace. The Commission undertook this study at the request of Senators Grassley, Leahy, and Rockefeller, They asked the Commission to examine “the short term and long term effects on competition of the practice of „authorized generics, Waxman, one of the co-authors of the Hatch-Waxman Amendments, requested the FTC to study “the impact of so-called „authorized generics‟ on competition in the prescription drug marketplace. www.drugregulations.org 58
  • 59.  According to the report of the FTC number of potentially anticompetitive patent dispute settlements between branded and generic drug companies increased significantly compared with FY 2011, jumping from 28 to 40. Overall, the agreements reached in the latest fiscal year involved 31 different brand-name pharmaceutical products with combined annual U.S. sales of more than $8.3 billion. Of the 40 final settlements that potentially involve pay-for-delay, 19 involved agreement by the branded firm not to market an AG product that would compete with the generic company‟s product. Such “no-AG” promises are valuable to generic firms, as they significantly reduce the level of competition the new generic entrant will face, allowing the generic firm to secure greater market share and extract higher prices from consumers. www.drugregulations.org 59
  • 60.  More and more brand and generic drug companies are engaging in these sweetheart deals, and consumers continue to pay the price. The FTC has challenged a number of these patent settlement agreements in court, contending that they are anticompetitive and violate U.S. antitrust laws. One case, involving the generic testoterone- replecement drug AndroGel is currently pending before the U.S. Supreme Court. The agency also has supported legislation in Congress that would restrict pay-for-delay settlements. Despite the record number of potential pay-for delay settlements in FY 2012, the vast majority of patent settlements (greater than 70%) continued to be resolved without compensation to the generic manufacturer. www.drugregulations.org 60
  • 61.  FDA shall not delay approval of a pending ANDA or 505(b)(2) application “because of any request to take any form of action relating to the application, either before or during consideration of the request, unless”  The request is in writing and is a petition submitted to FDA pursuant to 21 C.F.R. § 10.30 or § 10.35; and  FDA determines, upon reviewing the petition, that a delay is necessary to protect the public health. www.drugregulations.org 61
  • 62.  Consideration of the petition shall be separate and apart from review and approval of any application.  Added by the Animal Drug User Fee Amendments of 2008.  FDA has been criticized for its implementation of FDC Act § 505(q), and, in particular for not decoupling ANDA approval from responding to an applicable petition that could delay generic competition. www.drugregulations.org 62
  • 63.  Delay notification requirement. If FDA determines that a delay is necessary with respect to an application, not later than 30 days after making such determination, FDA shall provide to the applicant –  A determination notification;  Any clarification or additional data that the applicant should submit to the docket on the petition to allow [FDA] to review the petition promptly , and  A brief summary of the specific substantive issues raised in the petition which form the basis of the determination. www.drugregulations.org 63
  • 64.  Denial based on intent to delay.  If FDA determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, FDA may deny the petition at any point based on such determination. www.drugregulations.org 64
  • 65.  Final agency action. ◦ FDA shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.” ◦ FDA may not extend the 180-day period “for any reason,” including consent of the petitioner. www.drugregulations.org 65
  • 66.  Extension of 30-month 180-day exclusivity forfeiture period. ◦ If the filing of an ANDA resulted in first-applicant status and ANDA approval was delayed because of a petition, the 30-month period under FDC Act § 505(j)(5)(D)(i)(IV) (failure to obtain tentative approval within 30 months)  is deemed to be extended by a period of time equal to the period beginning on the date on which [FDA] received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether [FDA] grants, in whole or in part, or denies, in whole or in part, the petition. www.drugregulations.org 66
  • 67.  Exhaustion of administrative remedies. Final agency action  FDA shall be considered to have taken final agency action on a petition if –  (i) during the 180-day period . . . the [Agency] makes a final decision within the meaning of [21 C.F.R. § 10.45(d)]; or  (ii) such period expires without [FDA] having made such a final decision. www.drugregulations.org 67
  • 68. Presentation compiled by “ DrugRegulations” a not for profit organization from publicly available material on the world wide web. www.drugregulations.org 68

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