Project Description

Microbiology expert for

Hatch-Waxman infringement litigation

The need

Attorneys from an Am Law 100 firm representing a global pharmaceutical company in its Hatch-Waxman infringement case against a company specializing in generics needed a bacterial microbiology expert to make their case. The patent in question was on a drug used as a sedative and anesthetic and the infringement was around a specific ingredient used to prevent bacterial growth to allow for longer storage of the drug. It was unlikely that the accused product used an identical ingredient, but likely that it used something similar enough to constitute infringement under the doctrine of equivalents. Therefore, the ideal expert would need to be able to speak with authority on how the specific ingredient worked to stop bacterial growth as well as discuss bacterial cell structures, bacterial cell wall disruption by antimicrobial agents and, as an added plus, antibacterial agents and how they work.

Our approach

From our discussions with the attorneys, we developed an understanding of the complexities of the case as well as the additional desire for the expert to have experience in pharmaceutical formulations and patent litigation. The stakes were high for the plaintiff and the case was on an accelerated schedule, so we quickly went to work to find the best expert.

The expert

We found an expert with a PhD in Biochemistry and over 30 years of experience as a distinguished professor and researcher at several prominent universities. His research and the lab he directed focused on the study of antimicrobials. He had many notable discoveries to his name and was a fellow of the American Academy of Microbiology, a member of the Faculty of 1000 in Pharmacology and Drug Discovery and had received many awards and honors over his career. Finally, he had patent litigation experience.