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Patent Listing in FDA's Orange Book
April 25, 2024
For over 40 years, the U.S. Food and Drug Administration
(FDA) has maintained a resource formally titled Approved
Drug Products with Therapeutic Equivalence Evaluations.
This frequently updated publication-now available as a
searchable online database-is more commonly called the
Orange Book after the color of the print version's cover.
The Orange Book
The Orange Book lists all of the nonbiologic (a.k.a. small-
molecule) drugs approved by FDA to be marketed in the
United States. (Biological products, which are drugs
derived from living organisms-such as vaccines, blood
components, and monoclonal antibodies-are listed in a
separate FDA publication known as the Purple Book.)
Along with information about the approved drugs (e.g.,
dosages and forms), the Orange Book includes FDA's
therapeutic equivalence evaluations-that is, the approved
products that are pharmaceutically equivalent and
bioequivalent to another approved product (e.g., a generic
form of a brand-name drug). Finally, the Orange Book
includes information on patents and regulatory exclusivities
that may protect a brand-name drug from generic
competition.
The Orange Book serves as an important resource for health
care providers and the pharmaceutical industry. Health care
providers may use the Orange Book to determine the
regulatory status of a product (e.g., whether a drug has been
approved by FDA or if an approval has been withdrawn).
Pharmacists may use the Orange Book to determine
whether a therapeutically equivalent generic form of a drug
is available to substitute when they fill a prescription
written for a brand-name drug.
For drug manufacturers, the Orange Book's information on
a drug's patents and regulatory exclusivities can be critical
to whether and when generic competition occurs. (For more
information, see CRS Report R46679, The Role of Patents
and Regulatory Exclusivities in Drug Pricing.)
PharmaceutcaI Patents
Patents are a form of intellectual property that protect new
inventions. To obtain a patent, an inventor must file a patent
application with the U.S. Patent and Trademark Office
(USPTO). USPTO reviews the application and grants a
patent only if the claimed invention meets the statutory
requirements. A patent's term lasts for about 20 years.
Like any other invention, pharmaceutical-related
innovations must be new, useful, nonobvious, and
sufficiently described to be patented. For example, if a
person synthesizes a new chemical with potential use for
treating human disease, she may obtain a patent on that
chemical itself (an active-ingredient patent). Pharmaceutical
manufacturers often obtain many other types of drug
patents beyond the active ingredient, including patents on
methods of using a drug, drug formulations, devices to
administer a drug, and methods of making a drug. A single
brand-name drug may thus be protected by multiple patents,
which may expire at different times.
Patent Listng n the Orange Book
Only certain types of pharmaceutical patents are included in
the Orange Book. By statute, a company seeking FDA
approval of a new drug must include in their new drug
application (NDA) any patent that either (1) claims the
drug and is a drug substance (active ingredient) patent or
a drug product (formulation or composition) patent; or
(2) claims a method of using such drug for which approval
is sought. If the drug is later approved by FDA, the patent
information in the NDA (along with any updates) is listed
in the Orange Book with the drug.
FDA regulations provide that [p]rocess patents, patents
claiming packaging, patents claiming metabolites, and
patents claiming intermediates must not be included in an
NDA. As a result, these types of patents should not be listed
in the Orange Book per FDA regulation.
Brand-name and generic drug manufacturers have disputed
in court whether certain patents should be listed in the
Orange Book. In Jazz Pharmaceuticals v. Avadel CNS
Pharmaceuticals, the U.S. Court of Appeals for the Federal
Circuit held that a patent on a computerized risk evaluation
and mitigation strategy (REMS) system for a drug should
not have been listed in the Orange Book. Similarly, in In re
Lantus Direct Purchaser Antitrust Litigation, the U.S.
Court of Appeals for the First Circuit held that a patent on a
device for injecting a drug should not have been listed in
the Orange Book. A 2022 report from FDA and a 2023
report from the Government Accountability Office reveal
varied stakeholder views on these issues, with some calling
for FDA to clarify the rules for listing REMS and device
patents in the Orange Book.
The FDA's M-nIstera Role
FDA does not actively police the patent information in
NDAs to make sure that the listed patents in fact claim the
drug or a method of using the drug. FDA maintains that it
lacks expertise in patent law and that its role with respect to
Orange Book patents is only ministerial. In other words,
FDA merely lists the patent information provided by drug
companies without independently verifying that the patent
should be listed in the Orange Book. This approach has
raised concerns among some commentators that NDA filers
may list inapplicable patents in the Orange Book to deter
generic competition.
FDA does offer an administrative process through which
any person who disputes the accuracy or relevance of](ViewImageLocal?handle=hein.crs/govepam0001&div=1&collection=&method=preview&ext=.png&size=3)