An East Lyme scientist has developed a method to "fingerprint" drug pathways to determine the origins, which he says will help lawyers in patent-infringement cases and law enforcement authorities tracing pharmaceutical counterfeiting.
John Jasper, chief scientific officer of Molecular Isotope Technologies LLC, has been working for more than a decade on the technique, a process that measures chemical tracers known as isotopes. The isotopic patterns of drugs are similar to fingerprints in that they can be matched to show whether the same highly specific process was used to create them.
If a process is too similar, the likelihood increases that a patent infringement is involved.
"This is pretty big in terms of how it can affect litigation," said Albert C. Lee, senior scientist at the Missouri-based independent laboratory Chemir, who has worked with Jasper in patent-infringement cases. "It's good, very sound science."
The newly patented technology used by Jasper and his company, which is known under the trademark name Nature's Fingerprint Authentication, came originally from geochemistry, Lee said. Jasper, a former scientist at Pfizer Inc. in Groton, whom the FBI called upon for expertise during the anthrax scare that followed 9/11, recognized that it could have pioneering potential in a pharmaceutical setting as well, Lee said.
"He is a really smart guy," Lee said in a phone interview. "John has a really big passion for the science."
So far, according to Jasper, the technology has led to three cases being decided in favor of plaintiffs claiming some kind of chicanery. One other firm accused of patent infringement was cleared of wrongdoing, he said, based on isotopic analysis.
Jasper said one case involved a company claiming that it had used a component of green tea in its product, while his analysis clearly indicated that was not the case. The defendant in the false-advertising case eventually settled out of court.
The technique, which uses light, non-radioactive isotopes, may help in anti-counterfeiting efforts as well, said Jasper, since it can identify not only the type of chemical processes used in creating a drug but also hallmarks of specific manufacturing sites as well. It may have applications in drug-tampering investigations, Jasper said, though the technique has yet to be used in such cases.
"If we want to find the source of one bottle of tablets, we can do it," he said. "We just need one-tenth of a milligram of material."
Jasper, who received his patent last month for determining the origins of pharmaceuticals through the use of so-called ambient chemical tracers, said he participated in a November webinar hosted by the American Intellectual Property Law Association to discuss the importance of his discovery. He believes the use of isotopic fingerprints will improve significantly the way process-patent lawsuits are decided, saving companies millions of dollars in complicated legal cases.
The same process could help identify counterfeit drugs, a growing worldwide problem that costs pharmaceutical companies at least $70 billion a year, according to one industry estimate. Some of these counterfeits have no active pharmaceutical ingredients.
"In underdeveloped countries such as Argentina, Colombia, and Mexico, up to 40 percent of manufactured pharmaceuticals are believed to be counterfeit," according to a report by the U.S. Food and Drug Administration - an agency with which Jasper has worked closely in developing his new process. "Counterfeit drugs pose potentially serious public health and safety concerns."
A method to screen counterfeit drugs has the potential to help law enforcement officers and pharmaceutical companies that often collaborate in trying to shut down illegal manufacturing sites. Jasper said several companies have expressed interest in his fingerprinting methods to identify the sources of counterfeits.
The fingerprinting technology can cost thousands of dollars but is relatively cheap compared with the overall cost of developing a new drug, Jasper said. And it's well worth it, he added, in cases that potentially can mean tens of millions or hundreds of millions of dollars for victims of false advertising or patent infringements.
"They wouldn't do it if they weren't saving money," Jasper said. "It's a good return on investment."