Sickle-cell anaemia is particularly common in western Africa and people of western African ancestry. Sickle-cell anaemia is also common in people from Mediterranean countries, the Middle East, and India, or people whose ancestors came from these regions. it is a genetic disorder which in particular shows its clinical manifestations in the black race and Nigeria been the most populous black nation in the world has the highest incidence of this disorder.
Before the first known case of Sickle-cell anaemia in the advanced world in 1910, Nigerians were already battling with this disease. In fact archaeological research in Nigeria has unearthed 700 years old human bones showing evidence of sickle-cell infarcts. So you are in order if you say Sickle-cell anaemia is a Nigerian problem. After man years of this disease in Nigeria traditional healers and medicine men were able to produce medicine that minimize painful episodes which are the most common complication of Sickle-cell anaemia.
One of the medicine was later developed by a team of 8 Nigerian scientists and researchers (Charles Wambebe, P. O. Ogunyale, K. S. Gamaniel, R. N. Nasipuri, J. I. Okogun, Babatunde Samuel, Akin Olusola and Abayomi Orisadipe) at the National Institute for Pharmaceutical Research and Development (NIPRD), Abuja, Nigeria, and Nigeria’s foremost anti-sickle cell disease medication – NIPRISAN™, was born. A patent for the formulation was filed on the 21st of January 1997 with the Office of the Commissioner of Patents and Trademarks, United States of America. The patent was approved in September 1998.
NIPRISAN, as claimed in the patent is a herbal mixture extract, formulated from parts of four different indigenous plants (Piper guineenses seeds, Pterocarpus osun stem, Eugenia caryophylum fruit and Sorghum bicolor leaves) and an inorganic material mixed at specific ratios which has been shown to be safe and effective in the management of sickle-cell disease during a phase 1 and subsequent Phase 2 clinical trials.
The patent document lists eight individuals as the inventors and the National Institute for Pharmaceutical Research and Development as the assignee. NIPRD had earlier licensed the product to Xechem PLC under the chairmanship of Dr. Ramesh Pandey and it was then sold under the tradename, NICOSAN™ in United States of America and in Nigeria. The product successfully got an orphan drug designation from both USFDA and EUFDA under the management of Xechem Plc.
In 2007, despite growing local and international demands for the Nigerian product, the parent company in America went bankrupt and Xechem Pharma Nigeria Ltd gradually was brought to a halt by crippling debts. With these developments and the failure of Xechem Pharma Nigeria Ltd to continue with drug production, the drug became scarce despite the huge local and international demand. NIPRD decided to implement the clause in the NIPRD-Xechem Agreement which stipulates that should Xechem change ownership or be insolvent, NIPRD reserves the right to withdraw the license.
The decision was challenged in a U.S. court and, after a grueling and expensive court case, NIPRD won the court case and withdrew the license from Xechem. Efforts to license the commercialisation to another firm has not been successful as all previous attempts have been hindered by court cases initiated by Xechem creditors and shareholders.
Efforts are underway by some actors to launch a generic brand once the patent expires as the tradename – Nicosan™ is held by Dr. Ramesh Pandey and not Xechem Plc. There are multiple opinions on the expiry date of the Niprisan patent ranging from:
- 1st September, 2015 (17 years from approval)
- 25th January, 2016 (20 years from first filing in Nigeria)
- 21st January 2017 (20 years from USA first filing)
The rule is that patent expiry date is the latter of 17 years from USA approval date or 20 years from the date of filing in USA or Internationally provided it qualifies under the 35 U.S.C 120, 121 or 365 conditions. In the event of patent expiry, the court cases would lose their potency and any player with enough technical and marketing capacity can produce and market the product under a new or existing brand.