East Lyme — John Jasper and his collaborators may have hit on a discovery that will revolutionize the drug industry.

Jasper, founder and chief executive of Niantic-based Nature's Fingerprint, will publish a paper next month in the leading scientific journal Pharmaceutical Technology that opens the possibility of essentially re-patenting existing drugs and extending their lives for up to 20 years through a new process known as molecular isotopic engineering.

"Because MIE designed drug molecules are essentially new chemical entities, MIE has some potentially interesting intellectual property implications," Jasper and colleagues Peter Farina, Ann Person, Peter S. Mezes and Anthony D. Sabatelli said in the journal article, which he released with approval early to The Day.

Jasper said that by using isotopic engineering, pharmaceutical companies may be able to tinker with existing formulations using his patented method to make subtle changes that could be considered by regulators as distinct chemical entities. The result could be companies being able to patent multiple versions of the drug, allowing pharmaceutical firms to essentially extend the lives of their brands — if, Jasper emphasized, U.S. and other regulators approve the new idea.

These new formulations, which would have the same effect on patients as previously approved drugs, could perhaps more easily pass muster with regulators, Jasper said, since they are only slightly different from treatments previously approved — meaning they are likely equally safe. Jasper noted that every lot of common medicinal products is slightly different when analyzed using isotopes, yet they all have the same basic effect on patients.

"It's a novel way to protect products," Jasper said. "I hope it will generate more business."

Jasper added that his isotopic fingerprinting method can also have patent implications for drug companies that over the past few years have been less likely to file process patents detailing the way drugs are formulated because of concerns about their ability to defend their intellectual property. But he said process patents, which can extend patent life by roughly five years on average, are now easier to defend thanks to isotopic fingerprinting methods his company has pioneered.

"We can do that better than anyone else," he said.

Sabatelli, co-author of the journal article and a patent attorney with Dilworth IP, said in a phone interview that the main implication of isotopic fingerprinting is to provide drug companies an accurate and sensitive tool to help protect their products and supply chains as well as to authenticate where products are manufactured.

This is particularly important during litigation, he and Jasper said, in which isotopic analysis already has helped companies protect billions of dollars worth of intellectual property, while also in at least one case proving the suspected drug-patent interloper innocent of the charges. It's also important to consumers, Sabatelli said, because isotopic analysis should enable drug companies to produce better-quality products.

Sabatelli pointed out that the fingerprinting technique is equally effective with traditional and the more complex biologic drugs, which are becoming increasingly prevalent on today's research scene.

"It's really amazing the power of his technique," Sabatelli said of Jasper. "What he's doing is groundbreaking, yet it's so elegantly simple."

Jasper, who also is chief executive officer of Molecular Isotope Technologies LLC, has been working for more than a decade on the isotopic technique that measures chemical tracers to reveal "fingerprints" showing the specific process used to create a drug. A former scientist at Pfizer Inc. in Groton, Jasper was called in by federal authorities to help in a criminal case involving tracing the provenance of packages sent soon after the 9/11 attacks on the World Trade Center and Pentagon.

Jasper said the technique also has implications in anti-counterfeiting efforts, because fingerprinting through isotopes can discover hallmarks of specific manufacturing sites.  

He added that the U.S. Food and Drug Administration is aware of some of his new research, and he expects there will be a lot of questions before it approves new drugs based on isotopic composition rather than chemical composition. The idea is likely to make drug companies happy, he said, because of the possible extended life for their products, though of course their original drugs would still be subject to generic competition.

"It's potentially huge," Jasper said.

l.howard@theday.com