A dispute over a pharmaceutical patent required a specialized expert in liquid injectable drug formulations.
The Case Challenge
Our client represented the defendant in a patent case involving an injectable drug solution and sought a pharmaceutical formulation expert to consult on the use of acids and solvents in drug formulations. They were looking for an industry expert with a doctorate, experience with the Food and Drug Administration (FDA), and previous work testifying as an expert witness. The client preferred candidates located on the US East Coast.
The Expert Solution
Intellectual property disputes in the pharmaceutical industry often call for formulation experts, but each case requires unique knowledge. In this matter, we needed to find someone with experience working specifically on injectable formulations and the chemicals required to stabilize liquid pharmaceuticals and prevent them from degrading. Our expert services team performed a custom search to identify and present the right candidates.
An IMS researcher found six well-qualified experts within a day of beginning the search. Our recruiting team reached out to each of them, vetted four, and presented three candidates to our client by the end of the week. After interviewing two of the formulators, the client selected an expert with strong expertise in sterile injectable formulations and issues related to stability and degradation.
The chosen expert has a PhD in physical-organic chemistry as well as 25 years of experience in formulation development and 15 years in pharmaceutical manufacturing. He is a seasoned expert witness who has consulted and testified in several intellectual property disputes involving pharmaceutical patents and formulations.
The Outcome
The case was dismissed with prejudice.
Legal and Regulatory Trends in Pharmaceutical IP
The pharmaceutical field faces several new and interesting challenges in the already busy world of patent litigation and drug regulation. In 2023, the US Supreme Court issued an important ruling affecting the patentability of antibodies while the first drug candidate created using artificial intelligence progressed through the research and regulation pipeline. The level of expertise required to effectively consult and testify in pharmaceutical matters will only increase along with the pace of the industry.
How IMS Can Help
IMS has decades of experience finding the best pharmaceutical industry experts, including formulators, medicinal chemists, biochemists, engineers, and drug manufacturing professionals. Contact our team to start your custom expert witness search today: contactus@imslegal.com
