Spring Newsletter 2011
Groundbreaking Technique Supports
Process Patent Protection and Anti-counterfeiting
Process patent protection and counterfeit drugs are among the critical legal issues facing the pharmaceutical industry today. In addition to potential harm to consumers, billions of dollars are lost each year to lost sales and lengthy litigation battles. In recent years, new analytical techniques have been developed to precisely identify patent infringement and counterfeit products. One such technique known as isotopic characterization was pioneered by Molecular Isotope Technologies, LLC (Nature’s Fingerprint®) for use in the pharmaceutical industry.
Isotopic characterization takes advantage of the highly-specific isotopic ratios in raw materials, synthetic intermediates, and final products and how the isotopic ratios systematically vary during chemical synthesis (their Isotopic Pedigree®). While the ratio of stable isotopes in raw materials varies from source to source, they give a highly-distinctive fingerprint to the origin and identity of the material. Additionally, controlled syntheses and manufacturing process will yield products with predictable isotopic differences (Pharmaceutical Technology, March 2007). A suspect product with isotopic ratios differing from patented synthetic pathways indicates the likelihood of patent infringement.
To demonstrate the strength of this technique, Nature’s Fingerprint® in conjunction with the FDA performed a blind study to determine the source of 26 batches of Naproxen. The identity of each sample was carefully concealed and analyzed by EA/IRMS (elemental analyzer / isotope ratio mass spectrometer). Samples were analyzed for the isotopes 18O and 13C and the data plotted on a graph (Figure 1). The results showed that each of the batches originated from one of six different sites around the world (FDA Anticounterfeiting Mtg., Oct 15, 2003). These findings demonstrated the accuracy and repeatability of this technique and how the technology can identify if a suspect product has been produced outside an authorized manufacturer.
Figure 1
Nature’s Fingerprint® and Chemir work together to help pharmaceutical and chemical companies protect their intellectual property. Nature’s Fingerprint owns patented and patent pending technologies for the identification of stable isotopes ratios for APIs (active pharmaceutical ingredient) and final products. Chemir provides custom synthesis services to explore synthetic processes to support or refute legal claims. Together Chemir and Nature’s Fingerprint® provide expert witness and litigation support for patent infringement claims.
