The Complaint: Biopharmaceutical Manufacturer Sues Over Patent Infringement in Generic Drug ANDA Filing
A biopharmaceutical manufacturer alleged patent infringement against a pharmaceutical company that filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to commercially market a generic version of the branded drug before the expiration of the plaintiff’s patents.
The Ask: Two Testifying Experts with Knowledge of Drug Composition, Binding, and Delivery
The defendant approached DOAR to provide two pharmaceutical experts with extensive experience with pharmacological agents and methods of delivery. The matter required a chemical specialist with specific knowledge of drug composition and the binding effects of albumin and paclitaxel. The client also requested a formulations specialist with expertise in nanoparticle delivery of cancer drugs. The formulations expert would have comprehensive knowledge in the creation, formation, and delivery of nanoparticles, along with extensive experience in pharmaceutical composition. Prior experience as an expert witness was also preferred for both expert types.
How DOAR Was Able to Meet the Expert Need
DOAR anticipates demands for pharmaceutical experts and proactively recruits a diverse group of world-class academics, industry executives, and former government regulators to support our clients in ANDA litigation. For this case, DOAR recommended two highly qualified pharmaceutical experts to meet the need. The first expert is a professor of pharmaceutics and pharmacology and a leading academic in the research of drug delivery systems for cancer treatments. He specializes in drug development and oncology, focusing on improving nanoparticle composition. He is recognized for his patented nanoparticle technologies, which have been licensed to leading pharmaceutical companies. The second expert is a trained pharmaceutical scientist with over 20 years of expertise in researching experimental therapeutics and nanomedicine. He specializes in pharmaceutical oncology and formulations and has extensive knowledge of albumin and paclitaxel derivatives.
How DOAR’s Experts Can Assist in ANDA Litigation
Innovation in life sciences is advancing rapidly, and intellectual property litigation in the pharmaceutical industry has grown increasingly complex. DOAR closely monitors the needs and challenges of its clients to identify the industry, regulatory, and technical experts needed. Our testifying experts have extensive experience working on matters in state courts, district courts, the International Trade Commission (ITC), and before the Patent Trials & Appeal Board (PTAB). These professionals are prepared to use their in-depth knowledge of scientific and regulatory principles to address the critical issues in our clients’ cases.
Contact us for more information about how DOAR’s pharmaceutical experts can help inform your litigation strategy and to learn more about our expert teams in other areas of focus with increased risk of litigation.
