Project Description

Pharmaceutical Drug Distribution Programs Expert
for Hatch-Waxman Litigation

The need

Attorneys defending a multinational pharmaceutical company specialized in generic drugs against two Hatch-Waxman litigations needed an expert in computerized pharmaceutical drug distribution programs. The actions contested the validity and claimed infringement of both compound patents and method-of-treatment patents. An ideal expert would have experience ranging from risk management distribution systems, to computerized pharmaceutical or hospital records systems and contraindication management systems.

Our approach

From conversations with the clients, we knew the right expert would have experience with systems that use computers to house patient records, contraindications, prescriptions or medical information, and manage the prescription or drug dispensing approval process. It was also apparent that the ideal expert would have experience designing such programs and have more detailed knowledge about how these programs function. Experience simply using such programs would not be enough. These details in mind, we went to work to find the right match.

The expert

We found an expert who was a doctor with over 20 years’ experience in the development and evaluation of new technologies and intellectual property with specific expertise in digital-data management and applied medical informatics. Furthermore, he was a fellow of the American college of Medical Informatics and had authored several software packages as well as written books and articles on the subject matter. He had also founded his own software company that produced several successful healthcare-focused software programs. Finally, he held several advanced degrees from top universities including an MD and advanced classes in computer science and a Postdoctoral Fellowship in Medical Informatics. Our clients were very pleased with the outcome as this matter reached a settlement allowing the defendant to sell a generic version of the drug in question in limited volume.