Generic Medicines

New drugs are generally protected by world wide patents. This is perfectly understandable given the significant cost and length of time taken to bring a drug through development, clinical trials and eventually to the market.  See the recent press coverage surrounding the cost of the breast cancer drug Kadcyla® produced by Roche – www.bbc.co.uk/news/health-27122644  Kadcyla® has been found to extend the life of a terminally ill patient suffering from breast cancer by up to six months. Once a patented drug is out of patent protection however, generic drugs become widely available at a lower price. A relatively recent example was when the heartburn and acid indigestion drug, Zantac™, came out of patent. There are now a number of generic versions of the drug on the market.

The Intellectual Property Enterprise Court in London has found two patents related to the breast-cancer treatment drug Herceptin® invalid, paving the way for generic versions of the drug to be marketed in the UK later this year. 

The case before the Intellectual Property Enterprise Court in London involved Hospira UK Limited and Genentech Inc. Hospira sells generic medicines particularly in the cancer field, and wishes to sell a generic form of Herceptin® in the UK. This could only happen after the expiry of a Supplementary Protection Certificate obtained by Genentech in respect of Herceptin®.

Genentech (a Roche company) developed and sold their drug under the Herceptin® trade mark. Herceptin® was a breakthrough in breast cancer treatment due to the way it targets the HER2 receptor, which is overproduced by cancer cells in about 20% of breast cancer patients. Hormones or other proteins can attach to the receptor, stimulating growth of the cancer cells and worsening the patient’s prognosis. 

The last remaining enforceable patent on Herceptin® expires in July this year. Pending any appeal by Genentech, the generic medicines marketed by Hospira should be available later this year.