Lawsuit Alleges Infringement of Gabapentin Rapid Test Patent

On Wednesday a case was filed in the United States District Court for the Central District of California Eastern Division by Ark Diagnostics, Inc. against Acro Biotech, Hangzhou Alltest Biotech Co. and their employees. The case alleged patent infringement of a patent held by Ark Diagnostics regarding rapid testing for the presence of gabapentin, commonly called Neurontin, in blood or urine.

Gabapentin was released as a prescription medication with anti-seizure, neuropathy, and anti-convulsant indications. However, not every patient metabolizes gabapentin at the same rate, which has required the development of testing as to the concentration of gabapentin metabolites or analogs in the patient’s system to know if additional gabapentin is required to achieve additional therapeutic concentration. 

Additionally, the medication has been used illegally as an enhancer or booster for illegal narcotic use. This combination of medications can unfortunately lead to respiratory issues and increased risk of fatal overdose. This second issue has escalated the need for rapid and inexpensive concentration testing.

Ark obtained patent number 10,203,345 for a two stage rapid test for presence and concentration of gabapentin in either blood or urine. This test involves a first stage where the sample is mixed with a commercially produced anti-body. If gabapentin is present, the antibody is consumed at this time and there is no anti-body remaining for the second stage, where a different gabapentin reagent is added to the sample. The presence of un-neutralized gabapentin in the second stage is used to create a visible line on the test marker which can be interpreted by the test technician. 

The complaint alleged, citing to the packaging and actual testing product being offered by Acro Biotech, that Acro Biotech is directly infringing on both the testing methodology and the chemical combinations that are used in the test.

The complaint asked for an accounting and payment of damages from the violation of the patent as well as injunction against further sales of the infringing product. The Plaintiff is represented by Asheesh Paul Puri of Maynard Cooper and Gale