Development & Approval Process (Drugs) > Frequently Asked Question...
`
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Frequently Asked Questions on
`Patents and Exclusivity
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`What is the difference between patents and exclusivity?
`How long is a patent granted for?
`How long is exclusivity granted for?
`Why does the exclusivity expire before the patent?
`Patent before exclusivity?
`Why does a particular drug product only have patents?
`Have neither?
`Why don’t I see some antibiotic drugs listed in the Patent and Exclusivity
`section of the Orange Book?
`What are the pediatric designations on patents and exclusivity as listed in
`the Orange Book.
`Where can I find patent and exclusivity regulations in the C.F.R.?
`How long does an applicant holder have to submit patent information?
`Is there a specific format in which patent information needs to be submit-
`ted to the agency?
`How is an NDA holder notified if their application is granted exclusivity by
`the FDA?
`
`Orange Book Frequently Asked Questions (/Drugs/InformationOnDrugs
`/ucm114166.htm)
`
`1. What is the difference between patents and exclusivity?
`
`Patents and exclusivity work in a similar fashion but are distinctly different from one
`another. Patents are granted by the patent and trademark office anywhere along the
`development lifeline of a drug and can encompass a wide range of claims. Exclusivity
`is exclusive marketing rights granted by the FDA upon approval of a drug and can run
`concurrently with a patent or not. Exclusivity is a statutory provision and is granted to
`an NDA applicant if statutory requirements are met. See 21 C.F.R. 314.108
`(http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=314&
`SECTION=108&YEAR=1999&TYPE=TEXT). Exclusivity was designed to promote a
`balance between new drug innovation and generic drug competition.
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`2. How long is a patent granted for?
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`Patents expire 20 years from the date of filing. Many other factors can affect the
`duration of a patent.
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`3. How long is exclusivity granted for?
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`It depends on what type of exclusivity is granted.
`Orphan Drug (ODE) - 7 years
`New Chemical (NCE)- 5 years
`"Other" Exclusivity - 3 years for a "change" if criteria are met
`Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
`Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)
`
`See 21 C.F.R. 314.108 (http://frwebgate.access.gpo.gov/cgi-bin
`/get-cfr.cgi?TITLE=21&PART=314&SECTION=108&YEAR=1999&TYPE=TEXT)
`New Drug Product Exclusivity.
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`Development & Approval Process (Drugs) > Frequently Asked Question...
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`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm
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`4. Why does the exclusivity expire before the patent?
`Patent before exclusivity?
`Why does a particular drug product only have patents?
`Only have exclusivity?
`Have neither?
`
`Patents can be expired before drug approval, issued after drug approval, and
`anywhere in between. Exclusivity is granted 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 none. Patents and exclusivity may or may not
`run concurrently and may or may not encompass the same claims. Exclusivity is not
`added to the patent life. Expired patents and exclusivity are not included in the
`published list.
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`5. Why don’t I see some antibiotic drugs products listed in the Patent and Ex-
`clusivity section of the Orange Book?
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`Title I of the 1984 Amendments did not apply to drug products submitted or approved
`under the former Section 507 of the Federal Food, Drug, and Cosmetic Act (antibiotic
`products). Therefore,
`(1) holders of approved applications for antibiotic products did not need to submit the
`patent information required of other NDA application holders,
`(2) these antibiotic products were not eligible for exclusivity protection, and
`(3) applicants submitting abbreviated applications for these antibiotic products were
`not required to provide the patent certification statement that was included in ANDAs.
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`Antibiotics submitted after the effective date of the Food and Drug Administration
`Modernization Act (FDAMA) are covered or subject to the provisions of Title I. See
`Guidance for Industry and Reviewers Repeal of Section 507 of the Federal Food,
`Drug and Cosmetic Act (/downloads/Drugs
`/GuidanceComplianceRegulatoryInformation/Guidances/UCM080566.pdf)for
`more information.
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`6. What are the PED designations on patents and exclusivity as listed in the
`Orange Book?
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`When pediatric exclusivity is granted to a drug product, a period of 6 months
`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. PED is
`annotated in the exclusivity column and is linked to exclusivity formerly granted. In the
`patent column, the patent is shown twice-once with the original patent expiration date
`and a second time reflecting the six month period of EXCLUSIVITY that links to that
`particular patent. Related information can be found on the Pediatric Medicine Page
`(/Drugs/DevelopmentApprovalProcess/DevelopmentResources
`/ucm049867.htm) and Pediatric FAQ page (/Drugs
`/DevelopmentApprovalProcess/DevelopmentResources/ucm077915.htm).
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`7. Where can I find patent and exclusivity regulations in the C.F.R.?
`
`See 21 C.F.R. 314.52 (http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=314&SECTION=52&YEAR=1999&TYPE=TEXT)
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`See 21 C.F.R. 314.53 (http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=314&SECTION=53&YEAR=1999&TYPE=TEXT)
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`Notice of
`certification of
`invalidity or
`noninfringement
`of a patent.
`Submission of
`patent
`information.
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`Development & Approval Process (Drugs) > Frequently Asked Question...
`
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm
`
`See 21 C.F.R. 314.95 (http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=314&SECTION=95&YEAR=1999&TYPE=TEXT)
`
`Notice of
`certification of
`invalidity or
`noninfringement
`of a patent.
`See 21 C .F.R. 314.107 (http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=314&SECTION=107&YEAR=1999&TYPE=TEXT) Effective date of
`approval of a
`505(b)(2)
`application or
`abbreviated
`new drug
`application
`under section
`505(j) of the
`act.
`New drug
`product
`exclusivity.
`Scope of
`orphan-drug
`exclusive
`approval.
`FDA
`recognition of
`exclusive
`approval.
`
`See 21 C.F.R. 314.108 (http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=314&SECTION=108&YEAR=1999&TYPE=TEXT)
`
`See 21 C.F.R. 316.31 (http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=316&SECTION=31&YEAR=1999&TYPE=TEXT)
`
`See 21 C.F.R. 316.34 (http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=316&SECTION=34&YEAR=1999&TYPE=TEXT)
`
`C.F.R (Code of Federal Regulation) (http://www.access.gpo.gov/cgi-bin
`/cfrassemble.cgi?title=199921). An external link to the Code of Federal
`Regulations on the Government Printing Office web site.
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`8. How long does an applicant holder have to submit patent information?
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`Patent information is required to be submitted with all new drug applications at the
`time of submission of the NDA. Patent information is published after approval upon
`receipt of post approval submitted FDA form 3542. For patents issued after approval
`of the NDA, the applicant holder has 30 days in which to file the patent to have it
`considered as a timely filed patent. Patents may still be submitted beyond the 30 day
`timeframe but the patent is not considered a timely filed patent. ANDA holders are not
`required to make a certification to an untimely filed patent if the generic application is
`submitted before the patent.
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`9. Is there a specific format in which patent information needs to be submitted
`to the agency?
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`As of August 18, 2003, patent information is required to be submitted on FDA form
`3542a (/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048352.pdf) or
`FDA form 3542 (/downloads/AboutFDA/ReportsManualsForms/Forms
`/UCM048345.pdf) depending on the approval status of the application. Form FDA
`3542 is the only form that will be used for Orange Book publication
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`10. How is an NDA holder notified if their application is granted exclusivity by
`the FDA?
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`No letters are sent to the sponsor indicating the grant of exclusivity. The Orange
`Book (http://www.fda.gov/cder/ob/default.htm) is the official vehicle for
`dissemination of this information.
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