Recently, Philip Brooks sent me a note from one of the readers of his excellent Patent Infringement Updates site. The note was regarding the generic challenge where a brand-name drug has recently gone generic and the drug manufacturer wishes to launch the product in a new indication. The reader asked if the manufacturer would be eligible for the three year market exclusivity extension for a new indication of a known drug. Philip asked if I could post a response summarizing some of the particulars about the new indication extension.

The short answer is that yes, they could get market exclusivity for a new indication and even longer if they are able to obtain a patent on the new indication. However, the drug company would generally need a new dosing strength or formulation to make this commercially reasonable since doctors could, and would, write prescriptions for the old version for the new indication (assuming the drugs are the same.

Patent term exclusivity and FDA market exclusivity are inexorably intertwined. Beyond the normal 20 year patent term, there are generally two mechanisms for gaining additional time added to the exclusivity.

Currently, there exist five ways to extend patent term: (1) patent term adjustments under 35 U.S.C. 154 to remedy U.S. Patent and Trademark Office (“USPTO”) delay during patent prosecution; (2) patent extensions under 35 U.S.C. 156 to remedy delays due to regulatory approval; (3) interim term extensions; (4) extensions under the General Agreement on Tariffs and Trade (“GATT”) Act; and (5) private extensions via Congressional legislation.

But market exclusivity can be gained separate from patent term extension. The FDA rules currently provide qualified drug products competition-free periods by preventing FDA or USDA approval of identical generic products. Market exclusivities enforced by either the FDA or the USDA include: (a) Five-year New Chemical Entity Exclusivity; (b) Three-year New Use/New Clinical Studies Exclusivity; (c) Seven-year Orphan Drug Exclusivity; (d) Six-month Pediatric Exclusivity; (e) 180-day and 30-month stays of FDA Approval; and (f) Animal Product Exclusivity.

(a) Five-year New Chemical Entity Exclusivity. New chemical entity exclusivity is granted to a drug that does not contain an active moiety previously approved in a FDA new drug application (“NDA”). The term of exclusivity is 5 years if the abbreviated new drug application (“ANDA”) does not contain a Paragraph IV certification to a listed patent, and 4 years if it contains the certification. This market exclusivity can be coupled with a six-month pediatric exclusivity.

New chemical entity exclusivity precludes approval and can delay submission of certain Section 505(b)(2) applications (that is, an application with clinical data produced by a third party without permission from the third party to use the data) or certain ANDAs.

(b) Three-year New Use/New Clinical Studies Exclusivity. New indications or dosage forms of previously approved drugs can receive new use or new clinical study exclusivity. The application must contain reports of new clinical investigations conducted by the applicant. The exclusivity term runs for three years from NDA approval and it bars the FDA from approving any ANDA or 505(b)(2) application by another party that relies on the same clinical studies. This exclusivity can be coupled with a six-month pediatric exclusivity.

(c) Seven-year Orphan Drug Exclusivity. For orphan drugs or biologics (those intended to treat rare diseases or conditions with less than 200,000 patients), orphan drug exclusivity bars the FDA from approving any other application (i.e., ANDA, 505(b)(2), NDA or BLA) for that drug used to treat the same orphan disease for seven years. Thus, if two companies are pursuing the same drug for the same orphan indication, whichever wins approval first will obtain exclusivity over its competitor. However, this exclusivity does not block approval of the same drug for a different indication, nor does it block approval of another version of the same drug if the new version offers clinical advantages over the prior product (e.g., greater safety, tolerability, or convenience of administration). This market exclusivity can be coupled with a six-month pediatric exclusivity.

(d) Six-month Pediatric Exclusivity. Pediatric exclusivity may be granted after submission of pediatric studies on the drug at the FDA’s request. The FDA may issue a request for pediatric studies at the drug sponsor’s request or on its own initiative. Pediatric exclusivity grants an additional six months of market protection at the end of listed patent(s) and/or other exclusivity terms for all drug products containing the active moiety. Frequently, a second pediatric study is sought via a supplemental NDA for a drug already granted pediatric exclusivity; thus, a pharmaceutical can potentially receive two pediatric exclusivity terms subject to certain limitations.

(e) 180-Day and 30-Month Stays of FDA Approval. ANDA approval and timing depends partially on a drug’s patent(s). Innovator drug applicants must identify in their NDA any patent(s) that covers the drug, which are then listed in the FDA’s Orange Book. Subsequently, any ANDA applicant must submit a certification for each patent listed in the Orange Book for the subject drug. This certification corresponds to one of four statutory paragraphs, the most important for exclusivity extension being a Paragraph IV certification.

Paragraph IV certification starts the legal process of determining whether the listed patent is valid or will be infringed by the proposed generic product. The ANDA applicant with a Paragraph IV certification must notify the patent owner and the NDA holder for the listed drug that an ANDA containing a patent challenge has been filed. The patent owner may then sue the ANDA applicant for patent infringement. If the patent owner files suit, the FDA will stay approval of the ANDA for 30 months from the date of the notice. This 30-month stay (and associated exclusivity period) remains effective until the court reaches a decision in the suit or otherwise alters the stay period.

The first ANDA applicant to make a Paragraph IV certification receives the benefit of a 180-day market exclusivity period during which no other ANDA can be approved for that drug. ANDA applicants with certifications other than Paragraph IV are not eligible for the 180-day exclusivity. The 180-day exclusivity begins the earlier of the first date of the generic drug’s commercial marketing or a court decision on the patent.

Under the Federal Food, Drug, and Cosmetic Act (FDCA), patents that claim an approved drug, or that claim an approved method of using a drug, are required to be submitted for inclusion in FDA’s publication Approved Drug Products and Therapeutic Equivalence Evaluations (the Orange Book). The effect of an Orange Book listing is to require advance notice to the patent holder and New Drug Application (NDA) sponsor whenever a generic applicant seeks approval to begin marketing a competing version of a drug prior to the expiration of any Orange Book listed patent. Upon such notice, the patent holder may bring an action for patent infringement within 45 days of the notice, and thereby impose an automatic 30-month stay of approval of the generic product (which stay is terminated upon a judicial determination that the patent is invalid, unenforceable, or would not be infringed by the commercial marketing of the proposed generic product).

(f) Exclusivity for Animal Drugs. Veterinary drugs can also receive market exclusivity under the Generic Animal Drug and Patent Term Restoration Act (“GADPTRA”). Exclusivity is for either 3 or 5 years, during which time no other generic copy may be approved (in the case of 3-year exclusivity) or no other generic application may be submitted (in the case of 5-year exclusivity).

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