Compared to other nations, the United States frequently presents greater complexity and difficulty when clearing and registering pharmaceutical trademarks. This is mainly because all pharmaceutical and generic trade names, which trademarks cannot protect, must receive approval from the Food and Drug Administration.
Selection, clearance, and registration
Compared to other nations, the United States frequently presents greater complexity and difficulty when clearing and registering pharmaceutical trademarks. The FDA’s requirement that all pharmaceutical trade names and generic names, the latter of which cannot be protected by trademarks, get FDA approval is primarily to blame for this. FDA clearance of product names is subject to a distinct, drawn-out procedure from trademark registration and is governed by various laws. For pharmaceutical businesses, this poses strategic and navigational difficulties and possibilities. Although the rules still apply to them concerning US trademarks and approvals, non-US pharmaceutical companies have a distinct advantage in that they can register pharmaceutical trademarks in the US while mainly avoiding the competing timetables of the US Patent and Trademark Office (USPTO) and the FDA.
Specificity in the description of goods
It is not feasible to apply for a US trademark registration that encompasses the entirety of Trademark Class 5 (or any other class) or all Class 5 medicines in general. As opposed to this, a pharmaceutical business wishing to register a trademark must define the specific products or services for which protection is sought, such as by mentioning the different disorders a pharmaceutical product is intended to treat.
Likelihood of confusion standard
The USPTO applies the likelihood of confusion test to pharmaceutical trademarks more rigorously than trademarks connected to other products. The guiding principle of this strategy is that consumer uncertainty about pharmaceutical items can have grave, potentially fatal health effects. This criterion also guides how the USPTO assesses whether two goods or services are comparable. For similarity evaluation, pharmaceutical medicines for human and animal use are often regarded as related commodities. In the United States, direct-to-patient consumer advertising for pharmaceutical items is also quite common (it is one of only two countries in the world where it is allowed for prescription-only and over-the-counter medications). As a result, consumer sophistication is considered from the patient’s perspective for many (if not most) pharmaceutical goods.
FDA-approved brand names
The USPTO Register is not considered when the FDA compares proposed product names to names of products it has already authorized. As a result, there are situations when a trademark owner who has a valid registration cannot utilize it because the third party with junior trademark rights previously received FDA permission for the relevant product name. The FDA does not adhere to the probability of confusion test used by the USPTO. Instead, it bases its similarity analysis on how much the product name sounds or looks (i.e., appears in a script) like last authorized names. As an illustration, even if a product name and the last name may coexist in the Federal Trademark Register due to the earlier term’s poor trademark status, it is unlikely that this would affect whether the latter name would receive FDA approval. The orthographic component of the FDA’s examination focuses on how product names may appear on a handwritten prescription. For instance, it is assumed that, because doctors’ handwriting occasionally lags at the ends of sentences, pharmacists would place more emphasis on variations between the initial few letters of product names. This is different from the USPTO’s typical methodology, which compares all trademarks simultaneously.
The FDA also considers whether the name might be misleading and lead to other types of pharmaceutical mistakes. For instance, a name that suggests an authorized indication, active component, dose, or administration method will probably be rejected. The FDA has published guidelines that offer suggestions for choosing an appropriate pharmaceutical product name and describe its approach to product name approval and data sets. Additionally, businesses can utilize advanced clearance search technologies that replicate the FDA’s study using programs like the FDA’s own software for phonetic and orthographic computer analysis. The USPTO does not adopt such a strategy.
FDA clearance happens late in the process, during the examination of a final application, which might make it difficult for pharmaceutical businesses to register a trademark. The United States is one of the few nations that demand evidence of usage in US commerce before a trademark application may move forward to registration, with a significant exemption. Although an application may be submitted to use it, proof that the trademark is being used in US commerce must normally be submitted within three years of the date a notice of authorization is issued. Although traditionally, businesses have used code names in clinical studies to obstruct rival trademark applications, consumer sales are not always necessary to demonstrate the use of a trademark in US commerce, and usage in a clinical study may be sufficient in some cases. However, both of these uses of a product name require FDA clearance; thus, most pharmaceutical trademark applications are submitted to use them.
However, non-US businesses may do so if they intend to utilize the trademark in US commerce and have already registered or applied abroad. Because applications based on foreign registration can proceed to registration without proof of usage in US commerce, this can be a valuable tactic for non-US pharmaceutical businesses waiting for FDA clearance of the equivalent product name. After registering a trademark, the owner is not needed to demonstrate usage until the fifth or sixth anniversary of registration.
Utilizing all deadlines and extensions for pursuing the trademark application is another option for US and non-US businesses. For instance, the applicant has up to six months to react to the office action if the USPTO examiner identifies substantial or procedural flaws with the application. Pharmaceutical firms awaiting FDA product name clearance frequently profit from a purposely delayed pace, in contrast to other businesses whose objective may be to get trademark registration as rapidly as feasible.
Non-traditional trademarks
It is possible to register various non-conventional trademarks in the United States, including moving pictures, sounds, tactile and three-dimensional markings, smells, and (theoretically) flavors. However, because trademarks must be unique and non-functional, attempts to register such trademarks frequently encounter significant obstacles. These obstacles to flavor trademarks are challenging for businesses that offer medicinal items since flavor frequently serves a practical purpose by improving product acceptability and enhancing compliance.
Parallel imports and repackaging
As of 2015, according to the federal Food, Drug, and Cosmetic Act (21 USC 360eee-1, 360eee-4), no prescription drug may be marketed in the United States by anyone other than a licensed and regulated drug manufacturer, wholesale drug distributor, third-party logistics provider, or licensed medical professional. Additionally, per 21 USC 355, no prescription medicine may be delivered in immediate or container packaging or with labeling that hasn’t already received FDA approval.
Anti-counterfeiting and enforcement
In 2015, a significant shift in counterfeit product control, according to the FDA. Any organization delivering prescription medications must now own or create:
- Systems to protect storage and handling, systems from enabling inspection, assessment, governmental notice within 24 hours, quarantine, investigation, and clearance or reporting of drug products that show evidence of tampering or are otherwise suspect or illegal;
- uniform machine-readable marking of packages;
- systems to protect storage and handling;
- distribution solely to trading partners subject to similar legislation;
- Record-keeping of papers that records receipt, storage, shipping, and delivery using a secure electronic database, which must be nationally interoperable by 2023;
- Internal education and training systems to recognize questionable and illegal products;
- sample retention for government testing;
- Confirmation that such systems are functional and receipt and delivery to only trading partners who have access to the same systems and who can share information on the precise location.
If the trademark owner has a robust enforcement program as part of the track-and-trace system, counterfeiting for trademark infringement may be a thing of the past, as the manufacturer has access to the track-and-trace data. The system will ensure that only items with codes coming directly from the manufacturer and via which the producer has real-time information of the product’s whereabouts in the distribution chain are allowed to be dispensed by pharmacists. To ensure that the product is not diverted or that the substance in issue is not supplied from outside the closed system, manufacturers might also put limits on trade partners. Distributors and pharmacists must now make sure their items are authentic and keep track of their findings.
The Food, Drug, and Cosmetic Act does not provide for private enforcement, in contrast to the Lanham Act. However, the FDA uses FDA inspectional observations, warning letters, and civil fines to enforce the laws against the distribution of inferior or fake prescription medicines into commerce. Seizures, restraining orders, and criminal sanctions are further judicial proceedings.
A trademark owner may file a civil lawsuit in federal court against counterfeiters under the Lanham Act. Additionally, it permits a pharmaceutical business to request judicial help to confiscate illegally obtained counterfeit goods without informing the counterfeiter. This is an ex parte application for the seizure of counterfeit goods. The Lanham Act also provides for increased fines and legal expenses for willful trademark infringement.
The trafficking of fake pharmaceuticals is primarily addressed by the federal Trademark Counterfeiting Act, which outlines criminal sanctions. The statute imposes fines of $5 million to $30 million, prison terms of up to 30 years for selling fake medicines, and life sentences for selling pharmaceuticals resulting in death. The US government can only bring these legal actions since they involve criminal law.
Advertising
The FDA has the power to regulate prescription medicine advertising. The trade and generic names of the product, its quantitative makeup, and a summary of the approved labeling, including the indication and balancing information such as side effects, contraindications, and effectiveness, must all be included in print advertisements for prescription drugs.
Direct-to-consumer marketing must also include call-to-action encouraging customers to report any unfavorable side effects, as well as a phone number and other details that make it easy for them to do so. Drugs with potentially harmful side effects are not allowed to be advertised directly to consumers. Instead, such advertisements must provide a brief overview of the potential usage risks and a link to a source with more detailed information. Consumer-friendly terminology should be used to convey this information.
Although they serve distinct objectives, the Food, Drug, and Cosmetic Act and the Lanham Act regulate the marketing of prescription pharmaceuticals. A remedy for unfair competition based on dishonest business practices, such as the use of false or deceptive labeling, is provided under the Lanham Act. Various state consumer protection statutes provide consumer remedies. State governments may also enforce these laws. The Food, Drug, and Cosmetic Act does not grant any private right of action. However, if businesses or people make false, deceptive, or biased promotional claims, the government may fine them. The Lanham Act is not preempted or rendered inoperative by any provisions included in the Food, Drug, and Cosmetic Act or FDA regulations. However, courts have the authority to decide whether a specific government agency action (such as special warning requirements) has preempted a private right of action. Otherwise, the court must apply the Lanham Act’s requirements for unfair business practices separately from the FDA’s interpretations. In deciding whether to apply the Lanham Act claim, a court may also conclude that agency conduct has probative or evidentiary significance.
Generic substitution
The process of coming up with an appropriate or generic name for a biological entity is covered in a guideline paper from the FDA titled “Non-proprietary Naming of Biological Products.” The FDA guideline paper suggests that biologics and biosimilars have non-proprietary or proper names that share a term for the active ingredient and a four-letter FDA-designated suffix specific to each sponsor. The primary name of the FDA-licensed biologic reference product would be used for biosimilar goods, together with a four-letter suffix joined by a hyphen. The four-letter suffix must contain at least three distinct letters, be an original sequence devoid of any connotations, and not be connected to any other drug product or deceive customers. Applicants are asked to suggest up to 10 suffixes, arranged according to preference. As long as it’s essential to protect patients, the FDA may occasionally continue to add prefixes to distinctive proper names in addition to suffixes. For instance, the correct name of the Sandoz biosimilar of Neulasta®, ZarxioTM, is filgrastim-sndz. The prefix for the reference product was created using chemical norms; the suffix “stim” refers to a protein that stimulates cells, “ib” refers to an antibody, and other letters in the name provide extra mechanistic details (such as “gra” for granulocyte stimulation). Although the generic prefix of the reference product is not subject to proprietary protection, the FDA must first approve the name to guarantee that it is not promotional and to reduce medication mistakes.
Online issues
Domain names: A company can use the Uniform Domain Name Dispute Resolution Policy (UDRP) or file a lawsuit in federal court alleging a breach of the Anti-Cybersquatting Piracy Act to protect its trademarks against typosquatters, cybersquatters, and unauthorized entities.
If it is found that a domain name was registered in bad faith, the only options for relief under the UDRP are its revocation or transfer. UDRP complaints are decided based on the complaint itself if a registrant does not reply to a complaint, which is frequently the case. This saves both money and time. An analysis of UDRP rulings involving pharmaceutical, medical, and pharmacy firms indicates that it is possible to have bad faith when domain names are passively held or linked to websites with no active commercial purpose.
The Anti-Cybersquatting Piracy Act forbids the registration of a domain name with the bad faith intention of making money from a mark that is confusingly similar to a registered (or unregistered) mark, or that dilutes a well-known mark. Suppose the court has jurisdiction over the registrar or organization where the domain name is registered. In that case, a trademark owner may submit a claim under the act and demand damages, including fees and expenses. In cases when the registrant is not subject to personal jurisdiction and cannot be identified, the legislation also allows for in rem jurisdiction (over the domain name itself). Damages in money are not available in such cases.
It is essential to consider whether the intention is to take control of the domain name, in which case a UDRP complaint may be appropriate, or whether the trademark infringement is more pervasive and disruptive, in which case federal court litigation may be advised when deciding how to protect one’s domain name from unauthorized registration. The following are additional considerations:
- Timing: UDRP claims are typically resolved more quickly. However, when other considerations suggest that an Anti-cybersquatting Piracy Act claim is in the trademark owner’s interest, a party may seek immediate injunctive relief under the act.
- Cost: Anti-cybersquatting Piracy Act claims are more expensive, implicate federal court procedures, and are typically filed along with other IP claims.
- Remedies: a party cannot claim monetary damages in a UDRP claim. Under the Anti-cybersquatting Piracy Act, a plaintiff can recover monetary relief.
E-pharmacies: A national awareness campaign from the FDA called “BeSafeRx: Know Your Internet Pharmacy” offers materials to warn and educate people about the risks of ordering and buying medicine from dubious online pharmacies. Through BeSafeRx, patients may locate a reliable online pharmacy and get guidance on how to spot a dubious or illegal pharmacy. The only trustworthy internet pharmacies, according to BeSafeRx, are those that:
- require a valid prescription from a doctor or other healthcare professional;
- are within the United States;
- have a licensed pharmacist available for consultation; and
- are licensed by the state board of pharmacy in the state in which the patient resides.
Many internet pharmacies have sold medications with labels from countries other than the United States. When violations were discovered, the FDA took enforcement action. Many of these goods are regarded as inferior or fake by regulatory organizations. Enforcement has trailed behind the market, as with many internet activities.