LEGAL AND REGULATORY CONSIDERATIONS IN THE SELECTION OF A
PHARMACEUTICAL PROPRIETARY NAME
OVERVIEW
In an era of increasing
globalization, the desire for pharmaceutical branding that is both protectable
and acceptable within the United States as well as in Europe is often
frustrated by differing and seemingly conflicting systems of pharmaceutical
naming laws and pharmaceutical branding regulations. Today the challenge of
pharma branding is even greater due to the recently heightened scrutiny of
pharmaceutical brand development by the FDA's Office of Post-Marketing Risk
Assessment (OPDRA). Targeted by the recent IOM Report, "To Err is
Human," as a significant factor in the incidence of medication errors,
confusingly similar pharmaceutical brand names are under attack by
pharmaceutical regulatory agencies, brand safety groups and consumers. This new
emphasis on the safety of a proprietary brand name as opposed to the
protectability of a pharmaceutical brand name can wreak havoc on the
unsuspecting company that fails to properly prepare for the regulatory
submission of a new pharmaceutical brand name. This article will provide an
overview of the unique goals, processes and procedures that drive the
regulatory interactions between the various regulatory agencies involved in the
pharmaceutical branding approval process and those sponsors seeking marketing
approval for their new pharmaceutical brand names. The healthcare branding
regulatory processes to be discussed in this article are the U.S. Patent and
Trademark Office’s (PTO) trademark registration process, the FDA's proprietary
name review process, and the European Union's Committee for Proprietary
Medicinal Products (CPMP) trade name review process.
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BENEFITS OF A STRATEGIC PHARMACEUTICAL BRANDING
"The proprietary name is an unsleeping salesman that ceaselessly promotes the product and, therefore, should pack as much recognition and recall value as possible."
A well-chosen pharmaceutical branding strategy promotes pharma brand name awareness and is easily recalled by prescribers, pharmacists, and consumers. Aside from the obvious marketing implications of choosing a pharmaceutical brand name with high recognition and memorability, there are significant regulatory benefits in choosing a pharmaceutical brand name that is not easily confused with other healthcare brand name products. Much of today's pharmaceutical naming regulatory and legal scrutiny revolves around the problem of confusingly similar pharmaceutical proprietary names and their effect on medication errors. It is well established that concern regarding a pharmaceutical brand name's likelihood of confusion is the most frequent reason for the rejection of a pharmaceutical proprietary name during the approval process. Particularly during the first few months of a pharma brand name’s introduction into the marketplace, when initial prescriber and pharmacist awareness and recognition of the new pharmaceutical brand name is low, a well-chosen pharmaceutical branding strategy can raise public awareness of the new drug product entrant and decrease the risk of medication errors caused by confusion with existing pharmaceutical name brands. How does the sponsor begin the process of pharmaceutical branding? The first step in acquiring a pharmaceutical brand name normally begins with a trademark registration in the U.S. Patent and Trademark Office (PTO).
PTO TRADEMARK REGISRATION
Brand Names
A trademark identifies and distinguishes the source of the goods or services of one party from those of others. Trademark rights are established from either actual use of the mark or from the filing an application to register the mark in the Patent and Trademark Office (PTO) by stating that the applicant has a bona fide intention to use the mark in commerce regulated by the U.S. Congress. Most proprietary brand names for pharmaceutical brands are registered as trademarks under "intent to use" rather than "actual use" filings, since the proprietary pharmaceutical naming is typically finished prior to approval of the drug's New Drug Application (NDA).
Although it is not necessary to register a trademark at the PTO, there are several advantages in doing so and virtually all proprietary names for prescription drugs are registered with the PTO. A federal (PTO) trademark registration is designated by the symbol ® following the drug name, while an unregistered mark is designated by the symbol ™ following the proprietary name. The federal (PTO) registration provides trademark protection only in the United States and its territories. If a federal trademark owner wishes to protect his trademark in other countries, it must be done separately.
Major advantages of federal trademark registration over an unregistered mark are that it:
· gives notice nationwide
of the trademark owner's claim
· can be filed prior to use by filing an affidavit of a serious intent to use
the mark
· represents evidence of ownership of the mark, and
· can be used to invoke the Federal court jurisdiction.
A distinct disadvantage of the federal (PTO) trademark registration system is that its term is limited to 10 years, with 10-year renewal terms. The federal registration must also be continuously "maintained" at 5-year intervals by the filing of an affidavit of continued use or the trademark registration is cancelled. Alternatively, an owner's rights in an unregistered trademark, once established, can last indefinitely if the owner continues to use the mark to identify its goods. The costs of filing and maintaining a federal registration, however, must be counterbalanced against an owner's relative lack of ability to protect an unregistered mark on a national basis and the attendant expense of investigating, defending and protecting the use the trademark in numerous state courts as conflicting marks appear.
PTO TRADEMARK PROCESS
An applicant for a federal trademark begins the PTO registration process by conducting a preliminary search of the Trademark registry and other records such as phone directories and state trademark directories to determine if the desired trademark is available prior to filing an application to the PTO. The applicant also examines the PTO registries for conflicting trademarks particularly in Class 5 (Pharmaceuticals) and Class 10 (Medical Apparatus). Once the applicant has searched all the records for conflicts with the proposed trademark, he submits the trademark application to the PTO for federal registration. The PTO then conducts its own official search of registered and pending marks to determine whether the mark applied for can be registered. Then the PTO publishes the prospective mark and awaits opposition from other trademark holders. The PTO screening and opposition process eventually culminates in the acceptance or rejection of the federal registration of the mark. PTO acceptance of the trademark completes the first step in obtaining marketing approval for a proposed proprietary name.
After the PTO trademark
registration has been completed, the second step in the process of proprietary
name adoption is the FDA's independent regulatory review of the proposed
proprietary name. The focus of the FDA review is not to determine confusion
relating to source of origin for a product, but rather to determine whether the
proposed pharmaceutical name presents a public health risk due to confusion
between itself and other pharmaceutical brand names already in the marketplace
or those pharmaceutical brand names recently approved for marketing. The FDA
regulatory review focus differs substantially from the PTO trademark
registration process and may even conflict with the applicant's ability to use
his previously approved trademark registration to identify his pharmaceutical
brand name product in the marketplace.
Brand Name
|
TRADEMARKS |
PROPRIETARY NAMES |
|
PTO |
FDA |
|
Does not
evaluate health |
Evaluates
health/safety |
|
Does not
have |
Has all
confidential information |
|
Handwriting
not |
Considers
physician handwriting and |
|
Speech
similarity with |
Speech
similarity with common |
|
PTO does
not consider promotional |
FDA
considers hyperbole, fanciful |
FDA's REGULATORY AUTHORITY
The Food and Drug Administration (FDA) exercises authority over the regulation of proprietary names through 21 USC 352, Section 502(a) of the Federal Food, Drug, and Cosmetic Act whereby a pharmaceutical brand name drug is misbranded if its labeling is false or misleading in any particular. The labeling of a pharmaceutical brand name drug may be misleading if it includes a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient. 21 CFR 201.10(c)(5). A drug whose proprietary name is confusingly similar to other proprietary or established pharmaceutical brand names would be considered to be misleading and misbranded. (e.g."Losec" vs. "Lasix" or "Tobraflex" vs." Tobradex.").
A second regulation often used in the consideration of a proposed proprietary name is found in 21 CFR 201.10(c)(3). The labeling of a pharmaceutical brand drug may be misleading by reason (among other reasons of) (c)(3): The employment of a fanciful proprietary name for a pharmaceutical brand or ingredient in such a manner as to imply that the pharmaceutical brand name drug or ingredient has some unique effectiveness or composition when, in fact, the pharmaceutical brand name drug or ingredient is a common substance, the limitations of which are readily recognized when the pharmaceutical brand name drug or ingredient is listed by its established name. An example of a "fanciful" proprietary name could be a pharma name such as "Magnacef" where the pharmaceutical brand would be recognized as a magnificent cephalosporin. Another example of a fanciful pharmaceutical brand name might be the pharmaceutical brand "Perfest" for an estrogen product where the implication is that this common product is uniquely effective in relieving symptoms of estrogen deficiency.
FDA's REGULATORY PROCESS
The Office of Post-Marketing Drug Risk Assessment (OPDRA) in the FDA's Center for Drug Evaluation and Research (CDER) conducts a Proprietary Name Review for new prescription brand name drugs as early as the end of Phase II of clinical development and again 90 days prior to anticipated approval of the pharmaceutical brand name drug's NDA. The primary purpose of the Proprietary Name Review is to determine whether or not the proposed pharmaceutical brand name may be confusingly similar to other proprietary pharmaceutical brands and generic pharmaceutical names that have been recently approved or are already on the market. Particular attention is paid to other look-alike or sound-alike pharma brand names.
Brand Names
The process begins when a pharmaceutical sponsor submits the proposed proprietary name for its new drug to the Consumer Safety Officer (CSO) or Project Manager of the appropriate therapeutic Medical Review Division. The Medical Review Division then requests an internal safety consult from OPDRA and utilizes the OPDRA consult to assist it in making the final decision as to the approval or rejection of a proposed proprietary name. OPDRA's initial review of the proposed pharmaceutical brand name evaluates the proprietary name's potential for confusion as compared with all other proprietary and generic drug names on the market in the United States. OPDRA's secondary review of the tentatively approved proprietary name, held 90 days prior to anticipated pharmaceutical name approval, evaluates potential pharma name confusion only with those other proprietary and generic pharma names that have been approved subsequent to the initial review of the proposed proprietary name. OPDRA's proprietary name consult is then sent to the Medical Review Division for that drug. Overall, the Medical Review Divisions have adopted OPDRA's recommendations approximately 95% of the time.
After the Medical Review Division has reviewed the OPDRA consult, it corresponds directly with the sponsor to inform it of the Division's decision to approve or reject the proposed proprietary name. In the event that the sponsor disagrees with the proprietary name rejection, he or she may request a meeting with the Medical Review Division (with OPDRA representation) to address the Agency's concerns with potential name confusion. Evidence that can be useful to a sponsor in this informal appeal process is market research data that shows a lack of confusion among health care providers. During the appeal, the sponsor can also submit additional risk management strategies that are tailored to the specific issues of potential name confusion. If the Medical Review Division continues to reject the proprietary pharmaceutical name, then the sponsor may contact the Office level for further review, it may choose to rebrand the product, or it may allow the NDA to be approved under the generic (unprotectable) name. Generic Drug sponsors (ANDA holders) and their distributors, are not required to submit their proprietary healthcare names ("branded generics") to the FDA for approval prior to marketing the healthcare name, but the ANDA holders are required to furnish these pharmaceutical brand names to the FDA in their annual reports. Many conflicts arise due to this loophole in the law, however where there is evidence that a "branded generic" has already caused harm [and that harm has been associated with pharmaceutical brand name confusion] then the FDA can take immediate action to force the sponsor to change the proprietary pharma name or remove the healthcare brand product from the market.
REGULATION OF PROPRIETARY NAME SELECTION IN EUROPE
The European Agency for the
Evaluation of Medicinal Products (EMEA) governs the marketing of medicinal
products throughout the European Community. The Committee for Proprietary
Medicinal Products (CPMP) is specifically charged with the determination of
whether or not a proposed trade name of a medicinal product could create public
health concerns and risks to public safety. A trade name of the medicinal
product is defined by the CPMP as the invented pharmaceutical brand name of the
medicinal product without identification of the pharmaceutical form and
strength. The CPMP makes the determination of trade name approval in liaison
with a subcommittee known as the Trade name Review Ad Hoc Group, which was
created by the CPMP in October of 1999. The Trade name Review Ad Hoc group is
chaired by an EMEA representative and meets prior to each CPMP meeting where
its conclusions are presented for endorsement at a subsequent plenary CPMP
meeting.
Brand Names
EUROPEAN (CPMP) REVIEW PROCESS
The European (CPMP) trade name review process begins when the applicant notifies the EMEA of an intention to submit an application (at the latest 4-6 months prior to the planned submission date). EMEA members (the National Competent Authorities) are contacted by the EMEA and asked to consider the proposed trade name(s) and to notify the EMEA of any objections to the proposed trade names on grounds of confusion or public health risk within 30 days of receipt of such notification. One of the most significant EMEA criteria is the "three letter rule" which states that there must be a minimum of 3 distinguishing letters between the proposed trade name and any existing pharmaceutical brand name.
The most recurrent basis for EMEA objection is when a trade name conveys misleading therapeutic or pharmaceutical connotations, misportrays the product composition, or is liable to cause confusion (in print, handwriting or speech) with the trade name of an existing medicinal product. The proposed trade name and any objections are then discussed at the next CPMP Trade name Review Ad Hoc Group meeting and the outcome is presented at the subsequent plenary CPMP for endorsement. If there are objections to the proposed trade name(s) the applicant is invited to justify retention of the trade name and to rebut the identified public health risk or propose an alternative trade name. The alternative trade name should be resubmitted at least one month prior to adoption of the Opinion (pharma brand name drug approval). It is equally important for applicants to abide with similar policy guidelines recommended by the World Health Organization (WHO) and Member States, such as their request that trade names not be derived from international non-proprietary names (INNs) and that INN stems not be used in trade names.
If the trade name issue cannot be resolved at time of the adoption of the opinion (approval of the drug), the drug can be approved using the International Nonproprietary Name (INN) name (common name) together with the name of the manufacturer. The pharma name of a medicinal product may later be changed through a variance. The European proprietary name selection process, although streamlined, occurs much later in the drug approval process when compared the United States. The disparity in timing, and the differing criteria used by the European Union to assess the confusion potential of a proposed proprietary name, can result in disparate outcomes for the sponsor. The proprietary name may be approved or rejected in the United States on the basis of healthcare brand name confusion while the opposite result can occur in the European Union countries, resulting in two different proprietary names for the same drug product.
CONCLUSION
Brand Names
A well-chosen proprietary
name for a new drug product can benefit the sponsor as well as the public by
providing the new drug product with high recognition, high memorability, and a
decreased risk of medication errors due to pharmaceutical brand name confusion
with other existing pharmaceutical brand name drug products. While the focus of
the PTO trademark registration process is to identify and distinguish the
source of the goods of one party from those of the others, the focus of the FDA
review is to safeguard public health by preventing medication errors due to
confusingly similar proprietary names. The European CPMP trade name review also
focuses on whether the proposed trade name of a medicinal product could create
public health concerns and more particularly risks to public safety. Neither
the FDA nor the CPMP process, however, allows for consideration of whether a
particular proprietary name will or may constitute an infringement of another
entity's intellectual property rights. Significant differences also exist in
the time frames and criteria used by the FDA and the CPMP to evaluate the
impact of a new proprietary name on public health. Therefore, it is increasingly
important to understand the limitations of U.S. trademark protection for
proprietary drug names, the need to research potential pharmaceutical name
confusion and other public safety concerns prior to submitting a proprietary
pharma name to U.S. or European regulatory authorities, and to recognize that a
brand name's registration with the PTO, or review by the FDA, or CPMP may lead
to different outcomes. Understanding the differences in focus, function and
process between these regulatory agencies, therefore, should help a sponsor
anticipate how those differences might impact its ability to ultimately obtain
international marketing approval for its proposed pharmaceutical proprietary
name.
Brand Names
James L. Dettore, President
& Chief Executive Officer
Patricia Kuker Staub, Esq., RPh
September 28, 2001
__ABBREVIATED BIO________________
James L. Dettore, President
and Chief Executive Officer,
is senior strategist and founder of Brand Institute.
Brand Institute is the leader in healthcare brand name identity,
with eight U.S. offices and recently opening internationally
in London. Mr. Dettore graduated from the Harvard University
Graduate School of Business Administration (OPM) and currently
serves on the Executive Committee, Harvard University
New York Chapter (OPM).
Patricia Kuker Staub, Esq,
RPh, is a managing
Director of Brand Institute Inc., and formerly
was employed by the FDA. She received her
law degree from the University of Pittsburgh
School of Law and is admitted to the Pennsyl-
vania and New York Bars. She is also registered
as a U.S. Patent and Trademark Office attorney.
Copyright 2001 by the Regulatory Affairs
Professionals Society (RAPS). Posted with permission on
Brandinstitute.com. Reprinted from the December 2001 issue of Regulatory
Affairs Focus. This article may not be published, reposted or redistributed
without express permission from RAPS obtain such permission, send a message to jschomisch@raps.org.
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