FDA Confirms Its View On Generic Drug Label Carve-Outs

The Camptosar® decision clarifies questions

surrounding whether and to what extent a generic drug applicant

must match each of the pioneer drug's labeled uses or

whether certain uses of the pioneer drug can be carved out by

the generic applicant as a result of patent or statutory

exclusivity bars.

The U.S. Food and Drug Administration's (FDA's)

approach to generic drug applications that seek approval for

one or more, but not all, of the uses of a brand name

"pioneer" drug has been evolving over time.

Generic drug makers sometimes seek "carve-outs"

because of concerns about patent or statutory exclusivity

rights that protect the carved-out uses but not the uses for

which the generic applicant seeks approval. FDA's recent

Camptosar® decision has apparently

resolved—perhaps conclusively—important questions

surrounding whether and to what extent a generic drug applicant

must match each of the pioneer drug's labeled uses or

whether certain uses of the pioneer drug can be carved out by

the generic applicant as a result of patent or statutory

exclusivity bars. For more information see FDA July 28, 2008,

Decision Letter, Docket No. FDA-2008-P-0069 (denying Citizen

Petition, available

here .)

Moreover, as FDA's interpretation of the law has

evolved, the law of patent infringement in these circumstances

has likewise been developing in parallel.

Background

The Drug Price Competition and Patent Term Restoration Act

of 1984, commonly called the Hatch-Waxman Act, Pub. L. No.

98-417, amended the Federal Food, Drug, and Cosmetic Act (FDC

Act), to provide for, among other things, an abbreviated

pathway for approval of generic versions of brand name drugs.

The statute permits the filing of an abbreviated new drug

application (ANDA) for a generic version that is the

"same" as the approved brand name drug, the so-called

"listed" drug, in terms of active ingredient, dosage

form, strength, route of administration and, in general,

labeling, and that is demonstrably "bioequivalent" to

the listed drug.

The Hatch-Waxman Act also provides a mechanism intended to

protect the patent rights of the holder of the approved

application for the listed brand name drug by requiring that

the ANDA applicant "certify" as to the status of

patents "claiming" the drug or a "method of

using such drug;" by establishing a system for resolving

patent challenges in federal district court in a timely manner;

and by providing a 30-month stay of FDA approval of the generic

(that can be shortened or lengthened by the court) once patent

litigation is initiated on certified

patents—categorically prohibiting FDA approval of the

generic drug even if the ANDA otherwise meets the criteria for

approval established by the statute and the agency's

implementing regulations.

However, an ANDA applicant may elect not to certify with

respect to each and every method of use patent, and instead may

elect to submit a so-called "section viii" statement

stating that the applicant is not seeking approval to market

the product for one or more patented methods of use covering

the listed drug. Where the listed drug is marketed and labeled

for a patented method of use for which a section viii statement

has been filed by the ANDA applicant, there exists a divergence

between the labeling for the listed drug and the labeling for

the proposed generic drug subject to the ANDA. This divergence

of labeling arguably undercuts the sameness requirement that is

the conceptual predicate for generic drug approvals. In other

words, in this context, the proposed labeling for the generic

drug may well be substantially different from the labeling for

the listed drug because it might omit one or more methods of

use for which the listed drug is labeled and approved. The

question raised is whether this lack of sameness in the

labeling precludes approval of ANDAs with method of use

labeling carve-outs.

FDA's Camptosar Label Carve-Out"

Decision

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