Biogen Granted U.S. Patent for Gene Product
Biogen, a struggling biotechnology company in Cambridge, Mass., won a landmark U.S. patent Tuesday on a human protein called alpha interferon, which holds promise in the treatment of cancer and viral diseases.
The patent is believed to be the first granted on a genetically engineered duplicate of a product that is made naturally by the human body.
Similar to a patent recently awarded to Biogen in Europe, it ends years of uncertainty in the fledgling biotech industry over whether the U.S. patent office would allow patent protection on substances found in nature. Traditionally, the patent office has not allowed such patents unless the substance in question occurred naturally in unusable or scarce quantities.
Biotechnology is a series of techniques developed in the 1970s to rearrange deoxyribonucleic acid, or DNA, the basic string of genetic material that tells living cells what to do. The object is to create cells that produce large quantities of useful human, animal or plant proteins. Alpha interferon, which is produced naturally by the human immune system to fight disease, is such a protein.
Analysts and industry executives hailed the patent award as a clear demonstration to the biotechnology industry that naturally occurring drugs can win patent protection just as traditional chemically made drugs can. Such protection is essential if companies and investors are to ensure a profit on drugs, which typically take 10 years and $75 million to develop, test and bring to market.
More specifically, the patent award, which was expected, cements the hold that drug giants Schering-Plough and Hoffmann-La Roche have on the alpha interferon market, which could be worth at least $50 million to $100 million within five years.
Schering-Plough holds the license on Biogen’s patents to market drugs developed from it. Hoffmann-La Roche, in conjunction with Genentech of South San Francisco, holds a similar patent.
Hoffman-LaRoche’s patent covers a technique for purifying alpha interferon that has been made naturally in the body whereas Biogen’s covers alpha interferon covered through gene-splicing in the laboratory.
In May, Hoffmann-La Roche and Schering-Plough agreed to cross-license their patents on alpha interferon, a technique used commonly in the drug industry to avoid costly legal battles that would delay products. Under the arrangement, both companies can sell the product without fear of a patent-infringement lawsuit from the other.
Through Schering-Plough, Biogen’s alpha interferon went on sale in April in Ireland and has won approval in three other European markets.
Approval from the U.S. Food and Drug Administration is expected by year-end. Hoffmann-La Roche and Genentech also hope to get FDA approval by year-end on their alpha interferon drug.
