Five Reasons Why Your Company May Wish To Consider Submitting Your Pharmaceutical Trademark Candidate Through The FDA Pilot Program
1. A Pilot submission allows your company to reduce substantially the risk of rejection.
Currently, a trademark submission to the FDA faces various uncertainties. What data will be required to support the proposed mark? What type of data will be acceptable in this case? What additional issues can be anticipated? The FDA Pilot Program provides an opportunity to address these issues prior to submitting the trademark to the FDA and, if managed correctly, can result in a submission package that is better targeted, is more complete, and raises fewer objections from the FDA. As a result, decisions on the submission can become more predictable.
2. A Pilot submission allows your company to influence the future trademark submission process.
The FDA is actively seeking comments and feedback on the Pilot process, opening the door to multiple opportunities to meet and discuss with the FDA all aspects of the submission. The Pilot program therefore provides your company with the opportunity to discuss the advantages and disadvantages of various aspects of the submission and to offer alternatives. In this way, sponsors with well-supported proposals have the opportunity influence the outcome of the pilot and any resulting guidance adopted by the FDA.
3. A Pilot submission helps protect your company against claims that its trademark selection resulted in medication mix-ups.
Unfortunately, claims—including strict liability claims—against pharmaceutical trademark owners arising from medication mix-ups cannot be ruled out. For example, Dennis Quaid and his wife filed claims in a currently pending action against Baxter Laboratories alleging that the packaging of two of its heparin products were too similar and caused a mix-up adversely affecting their newly-born infants. The Pilot process offers a potential defense against such claims. Although FDA review and approval of a trademark prior to its use cannot guarantee immunity from claims, it offers the opportunity to obtain FDA consideration of the risks of any potential drug name using safety review testing methods and standards recommended by the FDA in the Concept Paper for the Pilot. Recent US case law indicates that such consideration by the FDA using approved safety review methodology may provide a defense against, or possibly preempt, strict liability claims like those raised in the Quaid v. Baxter case.
4. A Pilot submission commits the FDA to a well-defined, manageable process.
The FDA’s procedures for the Pilot may appear daunting. You may also have heard from others that the Pilot program will require exorbitant costs and a vast amount of additional testing not previously found necessary. This, however, need not be the case. The Pilot program is an opportunity to commit the FDA up front to the details of a process that could be both workable and productive, which would avoid many of the pitfalls that can arise in a traditional proprietary name/trademark submission. Sponsors can clarify at the early stage of their project what is required and better prepare their submission to meet the FDA’s requirements, thereby eliminating many of the uncertainties that can plague a traditional submission.
5. A Pilot submission is easier and more cost-effective with Troutman Sanders Pilot Submission Support Service.
With our clients in mind, Troutman Sanders set out early to develop and compile resources to support Pilot submissions, which resulted in its new Pilot Submission Support Service. Our team is uniquely qualified to offer this Support Service. Led by a former in-house Vice President and Trademark Counsel of a large, international pharmaceutical company, our team is well experienced with FDA trademark submissions. From trademark creation to regulatory submission to responding to regulatory rejections, our team has experience at each stage. In addition, we worked closely with Thomson CompuMark, a part of Thomson Reuters, over the past several months to develop a searching product that incorporates the additional content recommended by the FDA as part of a Pilot submission. We know that a well-managed, controlled process need not be overwhelming nor need it require uncontrolled costs. Troutman Sanders can help your company establish and manage a cost-effective Pilot submission, providing for your company either turnkey project support for the entire project or targeted support services where needed.