Exclusivity

Patents

Orange Book Frequently Asked Questions

1. What is the difference between patents and exclusivity?

Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes. Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims. Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met. See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, and 505(j)(5)(B)(iv) of the FD&C Act. Periods of exclusivity and patent terms may or may not run concurrently. Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition.

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2. How long is a patent term?

Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent.

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3. How long does an exclusivity period last?

It depends on what type of exclusivity is at issue.

Orphan Drug Exclusivity (ODE) – 7 years

New Chemical Entity Exclusivity (NCE) – 5 years

Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities

New Clinical Investigation Exclusivity – 3 years

Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity

Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)

Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)

See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, 505(j)(5)(B)(iv), and Section 505(j)(5)(B)(v) of the FD&C Act.

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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 and exclusivity apply to drugs in different ways. Patents can be issued or expire at any time regardless of the drug’s approval status. 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.

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5. 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. Related information can be found on the web page Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act: Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric "Rule," and their Interaction

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6. Where can I find patent and exclusivity regulations in the Code of Federal Regulations (C.F.R.)?

See 21 C.F.R. 314.50 Content and format of an NDA

See 21 C.F.R. 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent

See 21 C.F.R. 314.53 Submission of patent information

See 21 C.F.R. 314.54 Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug

See 21 C.F.R. 314.60 Amendments to an unapproved NDA, supplement, or resubmission

See 21 C.F.R. 314.70 Supplements and other changes to an approved NDA

See 21 C.F.R. 314.94 Content and format of an ANDA

See 21 C.F.R. 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent

See 21 C.F.R. 314.96 Amendments to an unapproved ANDA

See 21 C.F.R. 314.97 Supplements and other changes to an ANDA

See 21 C.F.R. 314.101 Filing an NDA and receiving an ANDA

See 21 C.F.R. 314.107 Date of approval of a 505(b)(2) application or ANDA

See 21 C.F.R. 314.108 New drug product exclusivity

See 21 C.F.R. 316.31 Scope of orphan-drug exclusive approval

See 21 C.F.R. 316.34 FDA recognition of exclusive approval

Code of Federal Regulations on the Government Publishing Office web site.

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7. 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. The posting of exclusivity information in the Orange Book is the official vehicle for dissemination of this information.

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8. When should an NDA holder submit patent information?

Patent information is required to be submitted with all new drug applications (NDAs) and certain supplemental applications (sNDAs) on Form FDA 3542a at the time of submission of the NDA or sNDA. Patent information for listing in the Orange Book must be submitted on Form FDA 3542 within 30 days following approval of an NDA or supplemental application. For patents issued after approval of the NDA or supplement, the NDA holder must submit the required patent information within 30 days of the issuance of the patent for it to be considered timely filed. If the NDA holder timely submits the required patent information, but FDA notifies the NDA holder that its Form FDA 3542 is incomplete or shows that the patent is not eligible for listing, the NDA holder must submit an acceptable Form FDA 3542 within 15 days of FDA’s notification to be considered timely filed as of the date of the original submission of patent information. New patent information may still be submitted after 30 days of the issuance of the patent, but such information is not considered timely filed.

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A patent submission date is the date on which the FDA receives patent information from the new drug application (NDA) holder. See 21 C.F.R. 314.53(d)(5).

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The FDA began patent submission date data collection in 2013. The October 2016 final rule “Abbreviated New Drug Applications and 505(b)(2) Applications” states, “FDA intends to list the date of submission of patents and patent information in the Orange Book on a prospective basis beginning as soon as is practicable after the effective date of this rule.” The Orange Book will now publish patent submission dates for all new records going forward.

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NDA holders should email error correction requests, including justification for the request to:

orangebook@fda.hhs.gov.

Requests will be considered on a case by case basis and, if accurate, will be updated in the Orange Book as soon as is practicable.

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12. How should an NDA holder correct or request removal of patent information?

An NDA holder must submit a correction or change to previously submitted patent information on a new Form FDA 3542. For changes to descriptions of approved methods of use, see question 14.

If an NDA holder determines that a patent or patent claim no longer meets the requirements for listing, the NDA holder must promptly notify FDA to amend the patent information or withdraw the patent or patent information and request that the patent or patent information be removed from the list. The NDA holder seeking to withdraw a patent must submit to its NDA a statement containing the NDA number to which the request applies, each product(s) approved in the NDA to which the request applies, and the patent number, and identify the submission as “Time Sensitive Patent Information.” If the NDA holder is required by court order to amend patent information or withdraw a patent from the list, it must submit an amendment to its NDA that includes a copy of the order, within 14 days of the date the order was entered. In addition, the NDA holder must submit a correction to the expiration date of the patent on Form FDA 3542 within 30 days after the grant of patent term extension.

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13. Should an NDA holder submit patent information when seeking approval of a supplement?

An NDA holder must submit patent information when it seeks approval of a supplement to add or change the dosage form or route of administration, to add or change the strength or to change the drug product from prescription use to over-the-counter use.

For supplements that seek approval for other changes (for example, to change the formulation, to add a new indication or other condition of use, or to make any other patented change regarding the drug substance, drug product, or any method of use), the requirements for submitting patent information depend on whether the existing patent information in the Orange Book for the original NDA continues to claim the changed product:

If one or more patents, for which information was properly submitted for the product approved in the original NDA, claim the changed product, then the applicant is not required to resubmit this patent information, and FDA will continue to list the patent information.

If one or more patents, for which information was properly submitted for the product approved in the original NDA, no longer claim the changed product, the applicant must submit a request to remove the listed patent information at the time of the approval of the supplement.

If one or more patents, for which information was not previously submitted, claim the changed product, the applicant must submit the patent information required under 314.53(c).The NDA holder also must submit patent information for any supplement if the description of the patented method of use in the Orange Book would change upon approval of the supplement.

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14. When may an NDA holder amend the description of the approved method(s) of use claimed by the patent?

An amendment to the description of approved method(s) of use claimed by the patent will be considered timely if it is submitted within 30 days of: (1) patent issuance, (2) approval of a corresponding change to product labeling, or (3) a decision by the U.S. Patent and Trademark Office or a Federal court that is specific to the patent and alters the construction of a method-of-use claim(s) of the patent (and the amendment contains a copy of the decision). Outside of these circumstances and except as provided in the patent listing dispute regulation (21 CFR 314.53(f)(1)), an amendment to the description of the approved method(s) of use claimed by the patent will not be considered timely filed.

If the amendment to the description of the approved method(s) of use claimed by the patent is filed within an acceptable time frame but is incomplete or shows that the patent is not eligible for listing, the NDA holder must submit an acceptable Form FDA 3542 within 15 days of FDA’s notification to be considered timely filed as of the date of the submission of amended patent information.

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15. What actions must a pending ANDA or 505(b)(2) applicant take if patent information is untimely filed?

If patent information is untimely filed, generally a previously submitted ANDA or 505(b)(2) applicant is not required to submit a patent certification or statement to address the patent or patent information that is late-listed with respect to the pending ANDA or 505(b)(2) application.

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16. Is there a specific format in which patent information needs to be submitted to the agency?

If the NDA applicant is submitting patent information with an original NDA, an amendment, or a supplement prior to approval, use Form FDA 3542a. If the NDA holder is submitting information on a patent that claims an approved drug or an approved method of using the drug after approval of an NDA or supplement, use Form FDA 3542. The agency will not list or publish patent information in the Orange Book if it is not provided on Form FDA 3542.

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17. To which submissions does the final rule apply?

The effective date of the final rule on “Abbreviated New Drug Applications and 505(b)(2) Applications” applies to any submission received by FDA on or made after December 5, 2016, the effective date of the rule, including any changes to previously submitted patent information.

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18. Does previously submitted patent information have to be re-submitted on the new Forms FDA 3542 and 3542a?

No. While any patent information submitted after the effective date of the final rule must be submitted in a manner consistent with the final rule, including use of the new forms, NDA holders and applicants are not required to re-submit patent information previously submitted on a prior version of the form.

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FDA’s patent listing role is ministerial. Generally, we will not respond to specific questions regarding the eligibility of patents for listing.

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