The U.S. Patent and Trademark Office has agreed to issue Amgen Inc. two additional broad patents on the anti-anemia drug Epogen.
The decision will further solidify the Thousand Oaks-based company's domination of the marketing of biotechnology's best-selling drug that it gained when it won an earlier patent dispute with Genetics Institute.
Epogen is a biotechnology-made copy of erythropoietin (EPO), a human protein that triggers production of red blood cells. In 1987, Amgen was issued a patent that covered some of the cell process needed to produce EPO in a lab.
However, the two new patents Amgen will soon receive are much broader and will cover both the biotechnology process of making EPO and the final product itself. Those patents, valid for 17 years, are expected to deter rivals from making the biotechnology drug overseas and importing it for sale in the United States.
Amgen, now with $400 million in annual sales of EPO, has been the only manufacturer in the United States of the drug since it was approved in June, 1989. The drug is widely hailed for combating anemia in patients suffering from kidney disease and those undergoing chemotherapy.
Earlier this year, a federal appeals court upheld Amgen's first EPO patent and invalidated Cambridge, Mass.-based Genetics Institute's patent on its own version of EPO.
But Genetics Institute had licensed EPO to a U.S. joint venture between Japan's Chugai Pharmaceutical Ltd. and Upjohn Co. The Chugai-Upjohn group hoped to sell the drug here, and as a result it and Amgen had asked the patent office to consider additional patent applications on various EPO claims.
"Chugai could have made this product in Japan and shipped it into this country. But the new patent on the product will stop them," Gordon Binder, Amgen's chief executive, said Thursday.
However, Binder said that Chugai-Upjohn could ask a federal appeals court to overturn the patent office's ruling.
The new, broader patents would also seem to ensure Amgen's control over the lucrative EPO market to treat kidney dialysis patients.
Amgen already holds a seven-year monopoly on that market thanks to the Orphan Drug Act, a federal law that encourages the development of drugs to fight rare diseases.
Amgen's stock, which has nearly tripled in price this year, closed Thursday at $59.875 per share, up 87.5 cents.