The Problem
One of the world’s top pharmaceutical companies was having a problem with generic manufacturers who were thought to be infringing a valuable patent on a top-selling drug. The company in question had patented a particular crystalline form of the drug and was looking to prove that the generic manufacturer was selling this form illegally. A successful challenge might increase the patent life of the product by a number of years, with a consequent substantial increase in income.
The Challenge
Many drug formulations only include a small amount of active ingredient, making the detection of which crystalline form is present difficult using conventional laboratory X-ray sources. The challenge in this case was to see if any of the patented crystalline form was present in the competitor’s formulation - and the resulting analysis had to be rigorous enough to stand up
in court.
The Solution
The intense X-rays used by STFC Innovations Ltd allow the detection limit for crystalline materials to be lowered. The detection of three small, broad diffraction peaks, which could not have been detected with a conventional diffractometer, was enough to show that the patented form of the drug was present in the generic offering.
In this case, the X-ray powder diffraction experiments carried out by STFC Innovations Ltd showed that the generic manufacturer was infringing the patent and led to the successful defence of the court case. This one experiment saved the company millions of dollars in
lost revenue.
The Benefits
The drug manufacturer successfully retained the rights to exclusively market their patented drug for a further six years
Income was increased by several million dollars
The company demonstrated its willingness to use cutting-edge facilities to protect its intellectual property.