Hospira Inc.’s U.K. unit won a court ruling overturning two patents for Roche Holding AG’s top-selling breast-cancer drug Herceptin, paving the way for the generic drug-maker to sell a cheaper competitor in the country.
The primary patent on Herceptin expires on July 28 in Europe. Lake Forest, Illinois-based Hospira was seeking to invalidate two additional protections that relate to the dosages and composition of the drug.
Justice Colin Birss ruled both patents, owned by Roche’s Genentech unit, were invalid in a ruling today in London.
The decision erodes Roche’s exclusivity for the treatment in the U.K. and opens the door for Hospira to begin selling its own version. The medicine, the 10th best-selling drug in the world according to research firm Global Data, generated 6.08 billion Swiss francs ($6.93 billion) for Basel, Switzerland-based Roche in 2013 and has helped it become the world’s biggest maker of cancer drugs and diagnostic tests.
Herceptin was first approved in the U.S. in 1998 for breast cancer that has spread to other areas of the body and has been a huge success. Worldwide sales of the drug were 49 billion Swiss francs from 1999 to 2013, including European sales of 8 billion Swiss francs from 2010 to 2013, according to the suit.
Roche will begin to lose its exclusive rights to Herceptin as its first patent for the medicine expires in Europe this year and in the U.S. in 2019. The medicine boosted survival for the 20 percent of women whose breast tumors have a gene mutation that leads to extra proteins known as HER2 being generated from their cancer cells.
A lawyer for Hospira, Simon Cohen, didn’t immediately return a telephone call seeking comment. Trevor Crosse, a lawyer for Roche’s Genentech unit, referred inquiries to the company, which didn’t immediately provide comment.
The case is Hospira U.K. Ltd. v Genentech Inc., in the U.K. High Court of Justice, Chancery Division, Case No. HC12C03487.