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Obtaining Patents in the Biotechnology Field

In order to be deemed patentable, the USPTO requires that an invention must be useful, novel and nonobvious. This summary highlights some of the trends and also discusses how the usefulness requirement presents a unique problem for patents in the biotechnology field.

Biotechnology is any technique that modifies the products of living organisms or improves existing organisms. This field has developed from simple processes of making certain foods such as cheese to manipulation of organisms on a cellular level. While, biotechnology can be used to improve the quality of our lives, the research needed to develop this technology is expensive. Patents are one of the few ways for research companies to recover that cost.

However, the USPTO does not provide guidelines on how to apply the usefulness requirement for biological inventions. Before 1980, the courts denied many biological inventions because such inventions were considered “products of nature.” However, in 1980, the U.S. Supreme Court rejected that view and held that man-made life forms were patentable. This decision created tremendous commercial interests in biotechnology, and companies rushed to patent their creations. In that same year, two scientists were granted patents for techniques that resulted in the first cloning of the mammalian hormone insulin. Today, patents have been granted for biological inventions ranging from hybrid seeds to sequences of human DNA.

In reaction to the explosion of applications, the USPTO, in 1995 and 2001, revised its rules so that makes it harder for biological inventions to pass the usefulness requirements. The patent office now requires an applicant to assert how a specific utility is related to the subject matter, rather than just a general assertion of utility. Critics argue that this requirement will hinder innovation in biotechnology field because certain compounds such as the cloned human genes have uses separate from their biological function. For instance, such clones can be used to signaling component in an analytical device and be studied in conjunction with other genes. In fact such clones are often sold in commerce and have “practical” or “economical” utility. Yet, these clones cannot be patented because their specific benefit or utility in their currently available form are not known. Meanwhile, the usefulness requirement has a lower threshold for patents in other field. For instance, the federal Circuit held, “To violate section 101 the claimed device must be totally incapable of achieving a useful result.” As a result, patents have been granted for inventions that seem to have little or no utility, such as a hat that looks like a fried egg or a method of exercising a cat. This disparity between patents for a biological invention and one in any other field is great and may lower the level of innovation in that field. Consequently, the USPTO needs to better define the term usefulness and may need to set specific guidelines for the biotechnology field.




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