BIOTECH FIRM PATENTS DRINKING OF POPULAR MEDICINAL TEA

Feb. 18, 2005--The United States Patent and Trademark Office (USPTO) earlier this month issued US 6,849,278 to Universal Biotech Co., Ltd., Kaohsiun (Taiwan), a company which researches, develops and sells traditional Chinese medicine. The patent was granted for a "[m]ethod to counter oxidation of LDL, decrease triglyceride or cholesterol and inhibit atherosclerosis using Hibiscus sabdariffa extract". Hibiscus sabdariffa, a flowering plant grown mainly in Sudan, Thailand, China and Mexico, has been used as a traditional medicine in many cultures for the treatment of dozens of conditions, ranging from headache to cancer.

The patent claims, inter alia, a method of treating a patient suffering from atherosclerosis by administering Hibiscus sabdariffa water extract. Startlingly, a literal reading of “water extract” would include making tea by steeping the Hibiscus plant. The literal meaning of a claim carries heavy weight to courts in determining whether patent infringement has occurred.

Such broad patents issue because of the “new use” doctrine. An inventor cannot obtain patent rights on a substance for which his only contribution was discovering a new use. However, courts have generally upheld patent protection for an inventor on the method of using the substance. In this case, “administering” the water extract would simply mean drinking the tea. The case file for this patent indicates that the patenteee convinced the USPTO that although Hibiscus sabdariffa extract has been used to lower cholesterol, it had not previously been known that this process occurred by countering oxidation of LDL (often referred to as “bad cholesterol”). The patent also applies only to patients suffering from atherosclerosis, and not the public in general.

Hain Celestial Group, the largest U.S. importer of hibiscus, is not bothered by the issuance of this patent. Dr. Jim Kinsinger, corporate director of regulatory compliance for the company explained, “The fact that tea is a water extract shouldn't be an issue as tea use far predates the patent application. We are not making any claims about health issues (today).”

FDA rules prohibit a company from making health claims without first conducting clinical trials, which can be prohibitively expensive. The USPTO, however, has no such rules. This suits Dr. Kinsinger just fine. “We and other companies can take advantage of the info.”

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