The pharmaceutical development timeline is littered with regulatory submission considerations, one of which is the review of a proprietary (invented or brand) name. However, deciding on when to begin the naming process can often be contingent upon a variety of clinical and commercial considerations that take precedence over the actual review of the name itself.
For many, the decision on when to begin the pharmaceutical brand naming process is contingent upon clinical and commercial checkpoints that take precedent over the creation and evaluation of the name itself. For example, how long do you plan on being in Phase 2 and Phase 3? What is your estimated date for filing the NDA/BLA, NDS or MAA? What is your regulatory submission filing strategy? Is Phase 3 even required? A manufacturer or sponsor could take advantage of a 505(b)(2) pathway, allowing them to skip Phase 3 trials because the drug is based on an existing reference product.
There are countless questions to answer before deciding on when to begin the naming process, and the goal of this article is to address those specific deadlines and nebulous regulatory submission timing considerations that can make it hard to predict a definitive starting point. A manufacturer must be cognizant of the four major components that constitute the overall timeframe for developing a pharmaceutical brand name when considering a start date: the name creation, validation, legal, and regulatory.
Breaking it Down
First, the sponsor/manufacturer must choose a naming and branding agency partner to initiate the creative process, which can take upwards of 2-4 months. This phase is where the upfront information gathering and creative workshop(s), global creative exercises, naming development, comprehensive trademark prescreening, preliminary regulatory screening, and multiple list presentations take place. These steps are all crucial for sponsor/manufacturer teams, as they are filled with the creative thinking, comparatives, and collaboration that define success in the more rigid steps below.
After the creative phase, the next step is validation, where the names are evaluated across a variety of metrics (e.g., internal expanded team, linguistics, commercial, regulatory) and in parallel with regulatory agency (e.g., FDA, EMA, Health Canada, NMPA, PMDA) guidelines. This process takes 3-4 additional months for an exhaustive and complete review, which is needed to ensure the prioritized names have a high likelihood of viability across every vitally important metric.
Following validation, the sponsor/manufacturer—in collaboration with the branding agency—will analyze all the data points generated to help them make an informed decision on which names to prioritize for the legal trademark registration process, which is the third step in the overall naming process.
Your agency partner should assist in sharing the exhaustive diligence they’ve conducted in the prescreening process. Depending on your commercial filing strategy, a sponsor/manufacturer can file with the United States Patent & Trademark Office (USPTO) or through another specific trademark authority. Additionally, if the choice is to protect and file a global trademark, the subsequent step would be to move into the Madrid Protocol via the World Intellectual Property Organization (WIPO). When filing through the USPTO, the process can take anywhere from 6-12 months to complete, assuming the sponsor/manufacturer’s application goes through the process smoothly. If the sponsor/manufacturer seeks to attain a global trademark, the process can take upwards of 24 months on average.
This part of the pharmaceutical brand naming process is difficult to predict due to several elements. For instance, if the examining attorney approves the trademark after initial review, it is then opened for opposition during what is known as the “Opposition Period,” which is where any party who believes it may damage their own trademark has 30 days to file an opposition to the registration—potentially extending the trademark process for several more months. If no opposition is filed, the application is subsequently registered as a trademark. Generally speaking, it is recommended that sponsors/manufacturers seeking to attain a global trademark factor into their plans a conservative 24 months for the registration of a trademark.
Click to view Part II of this series, which addresses the regulatory submission process.