Clearing and establishing pharmaceutical brands and trade dress requires thoughtful planning and welltuned project management skills
This article highlights some considerations relating to trademark usage standards, clearance and prosecution that pharmaceutical firms and their advisers should bear in mind during the drug branding process in the United States.
Establishing trademark use in commerce
The path to drug commercialisation is long. On average, the process for bringing a drug from conception to market lasts from 10 to 12 years. There is tension between the general US trademark law principle requiring commercial use of a mark as a threshold requirement for rights enforcement and registration on the one hand, and the lengthy drug commercialisation process on the other.
Commercial use as pre-condition to registration
For both US applicants and non-US applicants which are not in a position to obtain US registration based on home registration, and which thus must prove use before registration, there is tension between the typical registration pre-condition of commercial use and the desire to secure registration for a pharmaceutical mark. Statement of use deadlines for intent-to-use trademark applications can be extended, but typically not for a long enough period of time to enable a US pharmaceutical company to secure registration based on approved marketplace usage. Pharmaceutical companies often run out of available extensions of the statement of use deadline, requiring re-filing and involving loss of the earlier constructive priority date.
Commercial use as pre-condition to registration enforcement
There is a distinction between owning a registration and being able to enforce that registration successfully. Non-US applicants can often secure a US trademark registration based on a registration in their home jurisdictions without the need first to prove use of the mark in the United States, but ownership of a US registration does not automatically enable a registrant to enforce rights in US courts of law. Enforcement of US trademark registration rights, no matter what the basis for securing registration, typically requires actual or closely imminent commercial use of a mark in the United States for the purpose of having standing to bring suit.
Clinical trial use can be the answer
Thankfully, a flexible ‘use in commerce’ standard is available to pharmaceutical companies that makes registration and enforcement of a mark possible before the drug’s commercialisation. Ongoing branded shipments of a drug to clinical investigators in interstate commerce by a company awaiting Food and Drug Administration (FDA) marketing approval qualify as use in commerce for the purposes of both enabling US applicants to obtain registration and enabling registrants to demonstrate that they have standing to bring suit in the United States.
Communicate with colleagues
Pharmaceutical companies that hope to rely on clinical trial use to establish use in commerce should note that the mark must appear on the product itself, or more likely on product packaging containing the drug as transported in interstate commerce (ie, between two US states or into the United States from abroad) to the trial sites. Communication about these standards early in the process is important. If the legal or marketing team does not ensure that the need for proper trademark use on the packaging for the clinical study materials is on the clinical trial task list, the trademark registration process or the ability to enforce registration rights in the mark might be delayed unnecessarily.
Pharmaceutical companies also should keep in mind that use in small print in wording such as “Manufactured for [firm name] by X” is not typically considered a source identifying trademark use. Care should be taken to display the brand name separately from and more prominently relative to such notices.
Trademark clearance considerations Clear carefully – doctrine of greater care
The US courts and the US Patent and Trademark Office (USPTO) require a lesser degree of proof for establishing likelihood of confusion between medicinal product marks. This principle, often referred to as the doctrine of greater care, serves public health interests by increasing the zone of protection around established pharmaceutical marks and thus ostensibly making medical prescription errors less likely.
The doctrine of greater care poses the need for especially careful clearance advice, and the enhanced risk of a finding of conflicts looms large during pharmaceutical trademark and trade dress clearance and application prosecution before the USPTO. The challenge is compounded by two other notable principles that come into play as an applicant attempts to navigate possible relative grounds refusals before the USPTO.
First, the USPTO follows the practice of resolving ‘close to call’ relative grounds examination decisions in favour of the senior filer. Second, the USPTO restricts the nature of evidence that it will consider in determining whether a more recently applied-for mark is likely to be confused with a senior mark to evidence that relates to the goods as precisely worded in both the cited senior registration and the more recent application. Real-world differentiating factors are often ignored. To the extent that the wording of the goods within the cited registration and application does not explicitly restrict the means of administering the drug or the channels of trade, the USPTO will not consider the practical differences. This might be the case, for example, where the product identified by the senior mark is administered orally, where the applied-for mark is administered transdermally, or where the channels of trade for the respective products are entirely different. Given the increased risks of obstacles to both use and registration that the doctrine of greater care imposes, it is imperative that pharmaceutical companies obtain and review a so-called ‘full search’ as part of the clearance process.
Consider several candidates
Roughly 40% of proposed proprietary drug names are refused by the FDA based on prescription error confusion concerns. It is not uncommon for a mark that survives scrutiny on relative grounds examination before the USPTO to be later rejected by the FDA during its regulatory approval process. It is recommended that pharmaceutical companies clear and apply to register multiple trademark candidates for the same product in the interest of having viable alternative names available.
Use all tools at your disposal
A final suggestion concerning clearance is specific to trade dress. Searching the Internet through Google Images using product description keywords is an effective means of identifying potentially conflicting third-party trade dress rights. It is also possible to clear trade dress elements through searching the US federal database online. One can search for relevant federal records by focusing on the ‘design description’ field by using both keywords describing the trade dress and numerical design codes that correspond to categories of visual element (published in the USPTO Design Code Manual).
As with letter string marks, pharmaceutical companies should obtain and review a more comprehensive research report relating to trade dress elements from a reputable trademark research firm. The screening approaches described above are generally effective in identifying obvious conflicts, but it can be difficult to anticipate all appropriate keywords and design codes. The research firm specialists cast a wider net in terms of identifying possible conflicts.
Trademark prosecution strategies Start broad
Special considerations for pharmaceutical marks also extend to trademark application prosecution. When a chemical compound is identified as holding promise for use in a pharmaceutical product, the precise disease or health condition that will be treated generally comes into focus only over time. During the early stages of development, a given compound might present wide-ranging health benefits. There is tension between a brand builder’s resulting need for flexibility as to the scope of an application and the USPTO’s stringent goods specification standards. A mark generally cannot be registered in connection with broad wording such as “a full range of pharmaceutical preparations” without first demonstrating that the mark is in fact used to identify such a broad range of products. However, to the extent that such wording reflects the applicant’s good-faith intentions (which should be documented in case those intentions are ever questioned), an applicant can include “a full range of pharmaceutical preparations” in an application initially, and then narrow the wording as statement of use deadlines approach, perhaps using the divisional approach described below.
The USPTO allows an applicant to divide applications under certain circumstances, including where the applicant has established use of the applied-for mark in relation to some but not all of the goods or services in the application and desires that the application proceed to registration for only goods or services for which use has been established. This can be an effective tactic for pharmaceutical companies. Under this approach, the used goods are assigned to a new ‘child’ application for which the applicant will file a statement of use, and the not-yet-used goods are retained in the ‘parent’ application for which the applicant will file a statement of use deadline extension. This is an effective approach in the interests of preserving breadth of an application during prosecution, but again requires an intention to make use of the mark as broadly as described.
Registering pharmaceutical trade dress
Trade dress elements that are considered to be product configuration elements, as opposed to product packaging elements, are not considered to be inherently distinctive and thus are registrable before the USPTO or enforceable in court only upon a showing that the elements have acquired distinctiveness in the minds of consumers through use. For example, the shape of a tablet shape will almost certainly be considered product configuration trade dress.
Distinctiveness can be deemed acquired based on sales over a period of time, but pharmaceutical brand owners do not have the luxury of time in establishing rights and positioning themselves to confront copiers. They should therefore consider creative ways to draw the public’s attention to drug tablets or capsules in order to condition consumers to view the product aspects as indicating a specific source. This should include the incorporation of non-functional markings and other elements on packaging and tablets or capsules that would not be deemed to be product configuration aspects, and thus that would not require a showing of acquired distinctiveness to enable registration or enforcement. For the purposes of accelerating the acquisition of distinctiveness for product configuration trade dress elements, ‘look for’ advertisements (ie, those that direct consumers’ attention to a colour or other aspect of the appearance of a product) can be powerful evidence in demonstrating that the product aspects have come to have source-identifying significance in the marketplace.