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FDA's Draft Guidance for Industry on 180-Day Exclusivity

March 1, 2017

FDA's Draft Guidance for Industry on 180-Day Exclusivity

March 1, 2017

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The guidance clarifies how the FDA generally deals with issues regarding 180-day exclusivity for generic drug products.

The Food and Drug Administration (FDA) recently published its draft "Guidance for Industry" in a question and answer (Q&A) format regarding generic drug exclusivity, commonly known as 180-day exclusivity.[1] Following typical government protocol, the two-month period for the industry and general public to submit comments on the draft guidance ends on March 14, 2017. FDA will then address those questions, make any necessary edits and publish the final version of the guidance in due course. The draft guidance consolidates court decisions and application-specific decisions the FDA has taken in citizen petition responses, litigation and other documents. The guidance also clarifies how the FDA generally deals with issues regarding 180-day exclusivity for generic drug products, some of which are outlined below. The FDA will update this guidance as appropriate.

Basic Statutory Scheme

The FDA first details the following statutory scheme and the legal authority for 180-day exclusivity. The Hatch-Waxman Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created the Abbreviated New Drug Application (ANDA) approval pathway. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) further amended certain of those statutory provisions related to 180-day exclusivity for generic applicants. These statutes provide an incentive and a reward in the form of a 180-day period of exclusivity to the first ANDA applicant, vis-à-vis certain other ANDA applicants, that files an ANDA with a paragraph IV certification and sends a notice of such certification to the New Drug Application (NDA) holder and each patent owner (stating that the Orange Book listed patent(s) are invalid, unenforceable or will not be infringed by the manufacture, use or sale of the new drug for which the ANDA application is submitted) and successfully defends the ensuing litigation. An ANDA applicant may forfeit 180-day exclusivity if certain events take place. These events include failure to market, withdrawal of application, amendment of certification, failure to obtain tentative approval, expiration of all patents and entry into agreement with another applicant, NDA owner or a patent owner.      

When Do the Pre-MMA Statutory Provisions Apply?

If any ANDA application referencing a given Reference Listed Drug (RLD), with or without paragraph IV certification, was filed before December 8, 2003, any subsequent ANDA application for the RLD is governed by the pre-MMA statutory provisions. If all ANDAs referencing an RLD are filed after December 8, 2003, the MMA statutory provisions will apply.

Which Applicant Qualifies as the First Applicant?

A substantially complete application is one that contains information required under section 505(j)(2)(A) of the FD&C Act and does not contain a deficiency described in 21 CFR 314.101(d) and (e), which includes some necessary paperwork, environmental assessment and statements of compliance with certain regulation. A "first applicant" is the earliest filer that either files a substantially complete ANDA containing at least one paragraph IV certification to an Orange Book patent or amends its prior substantially complete application to add a paragraph IV certification, as long as the amendment is filed before another applicant has filed a substantially complete ANDA application containing a paragraph IV certification for the same product. Since the statute requires "a" paragraph IV certification, the "first applicant" need not file paragraph IV certification for all patents or even for the latest expiring patent. Filing paragraph IV certifications for multiple patents may be advisable in some cases, however, to prevent forfeiting the 180-day exclusivity when there is a risk of losing 180-day exclusivity when a patent for which paragraph IV certification was filed expires. Further, a split certification for a patent—i.e., filing a paragraph IV certification for drug product or drug substance claims and a section viii statement with respect to method-of-use claims in the same patent—will not affect qualification as a first applicant. Similarly, submitting a paragraph III certification for a patent that expires after the patent for which a paragraph IV certification was submitted, does not affect qualification as a first applicant. Based on the available information, the FDA makes decisions about eligibility for 180-day exclusivity when an ANDA is ready for approval. 

Notice of Paragraph IV Certification

Please note that the first applicant that files a paragraph IV certification along with the original ANDA application, or files a paragraph IV certification after filing its ANDA but before receipt of a paragraph IV acknowledgment letter from the FDA, must provide notice of paragraph IV certification to the NDA owner or a patent owner within 20 days of receiving a paragraph IV acknowledgment letter from FDA. The first applicant that files a paragraph IV certification after receipt of a paragraph IV acknowledgment letter from FDA must provide a paragraph IV certification to the NDA owner or a patent owner at the same time that the amendment or supplement is submitted to the FDA. Providing paragraph IV certification later may have consequences, including losing out on 180-day exclusivity[2].

How Many First Applicants?

There can be multiple "first applicants." If multiple applicants submit ANDAs with paragraph IV certifications on the first possible day for that RLD, all applicants will be considered “first applicants.” Although there can be multiple first applicants for a given product, there is only one 180-day exclusivity period for each drug product, which is triggered by the first commercial marketing of an approved generic by any one of the first applicants. However, there can be separate 180-day exclusivity periods for different strengths of same product, which is considered a distinct drug product by the FDA. 

Effect of 180-Day Exclusivity on Other Applicants

The 180-day exclusivity blocks the approval of subsequent ANDAs that also contain a paragraph IV certification but not those having paragraph III certifications. Likewise, the 180-day exclusivity only blocks approval of applications filed under 505(j) but does not block, for example, the approval or marketing of authorized generics. When the 180-day exclusivity is waived, relinquished or expired, other ANDAs may be approved by the FDA, with the exception of products covered by patents having pediatric exclusivity. If the first applicant is approved prior to the start of pediatric exclusivity, any subsequent applicant's ANDA will need to contain a paragraph II certification and will not be eligible for approval until the pediatric exclusivity expires. 

What Can Shorten the 180-Day Exclusivity?

The first applicant needs to "lawfully maintain" a paragraph IV certification. This is achieved by continually maintaining a paragraph IV certification for a qualifying patent. Amending an application to change from a paragraph IV certification to include a paragraph III certification or a section viii statement for that patent, then amending it back to a paragraph IV certification, results in a finding that the paragraph IV certification was not lawfully maintained. Moreover, although an ANDA applicant does not need to win its patent litigation to be the first applicant, a court’s holding of infringement can lead to a finding that it did not lawfully maintain its paragraph IV certification. Failure to "lawfully maintain" a paragraph IV certification is one of the grounds of forfeiting the 180-day exclusivity.

Other reasons for the forfeiture of a 180-day exclusivity period is detailed by 505(j)(5)(D)(i)(I), having provisions that the first applicant forfeits exclusivity (1) if it fails to market its drug in earlier of 75 days from approval and 30 months from filing ANDA application, or (2) within 75 days of court's final judgment of invalidity or non-infringement for the patent. The FDA interprets these provisions literally, with few exceptions. For example, the FDA does not consider the 180-day exclusivity forfeited when an NDA holder requests to remove the qualifying patent from the Orange Book. However, expiry of a patent for which a paragraph IV certification was filed can shorten the 180-day exclusivity period. 

The 30-month period for gaining approval for an ANDA by the FDA is extendable by the amount of time lost due to a citizen's petition. 

A first applicant may also forfeit its 180-day exclusivity if the FDA has not approved the ANDA application by the 30-month date, unless the delay is because of a change in the requirements for approval.

In summary, the guidance addresses basic questions and more complicated questions. FDA continues to adhere to the Agency's position outlined in Hi-Tech Pharmacal Co., Inc., v. United States Food and Drug Administration and AstraZeneca Pharmaceuticals LP v. Burwell. The FDA intends to update this guidance to include addition Q&A.

For Further Information

If you have any questions about this Alert or would like more information, please contact Frederick (Rick) R. Ball, Carolyn A. Alenci, any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.


[1] 82 Federal Register 4361, published January 13, 2017

[2] See, e.g., Purepac Pharmaceutical Co. v. Thompson, 354 F. 3d 877 (D.C. Cir. 2004)

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.