Nature’s Indelible Marker

Naturally abundant, stable isotopes have already protected the identity and origin of $1.5 billion in pharmaceutical materials against Intellectual property infringers

By Anthony D. Sabatelli, Ph.D., J.D.

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The pharmaceutical industry is an important segment of the world economy. In 2013, worldwide sales of prescription drugs were over $830 billion. If one adds in over-the-counter medicines and other health-related products such as vitamins and nutritional supplements, that market approaches nearly $1 trillion dollars annually. With such huge markets at stake, there is the continuous threat of unauthorized sales of competing counterfeit and patent-infringing pharmaceutical products.

In an effort to find a simple, accurate way to unequivocally identify and secure the origins of drugs and other compounds, a Niantic, Connecticut-area scientist developed an alternative, finding a way to use the naturally occurring molecular fingerprint of drug products, active pharmaceutical ingredients and their synthetic pathways to help biotech and pharmaceutical companies enforce their hard-won patent rights against counterfeiters and other bad actors looking to profit by stealing intellectual property.

According to Dr. John Jasper, chief scientific officer for Nature’s Fingerprint, a division of Molecular Isotope Technologies LLC (MIT LLC), this fingerprinting technology has real, practical, application potential. “What we are doing is measuring chemical tracers, also known as stable isotopes, to determine the origins of drug products and pathways to help pharmaceutical companies and law enforcement authorities combat Intellectual property infringement,” says Jasper. “The distribution of natural-abundance stable isotopes in a drug product is analogous to the highly specific pattern of a human fingerprint. It is this ‘fingerprint’ of nature that can be used to highly specifically identify the source or process for a given drug product.”

Jasper explains that large-scale scientific research involving both radioactive and non-radioactive (i.e., stable) isotopes goes back to the time of the Manhattan Project, which produced the first atomic bombs during World War II. Isotopes — whether stable or radioactive — are forms of the same chemical element having different atomic masses. For example, uranium has an isotopic form with a mass of 235 and also an isotopic form with a mass of 238. By 1942, isotopes had only been known for about 30 years. Most of the research involving isotopes had been theoretical, relating to determining atomic structures and studying the then-mysterious properties of radioactivity. The Manhattan Project changed all that. The dire urgency of the war effort led to the development of sophisticated techniques for separating and identifying isotopes. One of these techniques, Isotope Ratio Mass Spectrometry (or IRMS for short), which is used to measure the relative abundance of isotopes in a sample, is now an important methodology in the field of those studying and using isotopes.

In 1999, Jasper began developing the technology around the premise that naturally abundant, stable isotopes might be used to identify individual batches of pharmaceutical materials. According to Jasper, “we had shown that every batch of pharmaceutical products had its own highly specific ‘isotopic fingerprint.’ We subsequently realized the potential applications of our technology to provide evidentiary support for patent infringement and enforcement efforts had just opened up immensely.”

The technology is sufficiently unique that it was awarded two U.S. patents, the most recent being issued in 2013. The latest patent relates to methods and systems to correlate a product such as a pharmaceutical to the synthetic process by which it was made. In other words, the method is a means of finding the “smoking gun” of the patent infringer. Even the FBI has recognized the value of this unique technology, calling upon Jasper for advice during the anthrax scare post 9/11.

It is well recognized that pharmaceutical research is a high-risk and expensive undertaking. It takes many years and huge investments to bring a new drug product to the marketplace. This is not surprising considering that a single human Phase III clinical trial can easily top $50 million dollars to run. Phase III is the last stage of clinical testing before a pharmaceutical developer submits an application for drug approval to the FDA. The FDA typically requires two such “well-controlled” studies for drug approval. According to the Tufts Center for the Study of Drug Development, which has been tracking the cost of prescription drug development for over 30 years, the cost of developing a single new drug today is estimated to cost as much as $1.2 billion. On top of this immense cost, the average time for bringing a new drug to market from its original inception in the lab is now over 10 years. Finally, the success rate for prescription drug development is quite low — by some estimates, only about one in 20 drugs make it all the way from initial Phase I human clinical trials to the marketplace. Going back even further to inception at the lab bench, the success rate might be just one in several thousand.

The main way to secure protection for new pharmaceutical products is through sound patent protection. However, the cost of patent protection is high and time consuming. The “gold standard” in patent protection for a new, small organic molecule drug product is a composition of matter patent. Such patents specifically describe or “claim” the drug compound, and preferably a broader genus of chemical structures surrounding that compound. Furthermore, the cost for filing, obtaining and maintaining a single patent across a broad range of countries can cost tens of thousands of dollars, and in many instances can easily top a half a million dollars.

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