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 CLIK 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 CLIK 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.
The company
Managing Director and Dentist David James was surfing the net looking for information to solve a patient’s gum alignment problem when he stumbled across a medical technique which is set to revolutionise the treatment of human disease.
David had discovered the research of Dr Shi, a cellular biologist at The National Institute of Health in the US, who had discovered stem cells in the milk tooth of his young daughter. The extraction of stem cells for treatment of many serious diseases has been a highly controversial issue because human embryos have been used. In the past many scientists have refused to be involved in such research for moral and ethical reasons. Dr Shi's discovery was therefore a major medical breakthrough, particularly as the cells in baby teeth are easier to extract and grow better.
The business challenge
David purchased the British and European rights to the technique for $100,000 and with the help of a dozen investors, set up BioEden Ltd, to collect and harvest stem stells from children's teeth. There were also strict European regulations from the Human Tissue Authority for the company to comply with. The result is a system allowing patients to have "insurance policies" for their children's future health.
So how does it work? When a tooth falls out it is kept in a glass of chilled milk which acts as a nutrient to keep the cells alive, and then couriered to the lab, within 48 hours, where the cells are harvested.
From there, medics inject the tooth with a special solution to isolate the cells. The cells are then observed under a microscope and allowed to grow to ensure they are healthy stem cells.
The benefit is that they may be used to help treat any diseases the child develops as they grow older.
How Daresbury helped with the solution
BioEden has attracted clients from all over the world including Italy, Kuwait and India. The need to transport the client child's tooth to the Daresbury Lab within 48 hours means that proximity to the two airports of Liverpool and Manchester (both less than 25 minutes drive) is essential. Between them the airports serve over 250 destinations worldwide, opening up a global market for BioEden. BioEden has also tapped into the many resources provided to businesses on campus and benefits from the scientific critical mass of expertise in the Daresbury Laboratory.
The benefits - now and in the future
Although the scheme is new many parents from the medical profession who understand its value have enrolled their children. Research into stem cells is still in its early days but by the time these children need such treatments advances will have been made.
The venture has been put to MPs who will be discussing the prospect of creating a national scheme with government backing. In addition, the medical faculty at Liverpool University (one of the founder stakeholders in the Daresbury Science & Innovation Campus) is interested in furthering the research.