Expert response from Hans Sauer
Deputy General Counsel for Intellectual Property for the Biotechnology Industry Organization
Friday, 27/09/2013 17:05
Most people associate patents with mechanical or electronic devices, new chemical substances, intricate machines or other inanimate things. The notion that patents are also available for living things may be puzzling at first. A patent is a form of property right that allows its owner a certain measure of control over how others may make, use or sell the patented invention. Surely the inventor of e.g. a new gyroscope sensor (like those used in Segway scooters) should have good reason to object if a competitor were to copy his new design and start selling it for profit. But should a horticulturist who with similar effort developed a new variety of seedless mandarin be treated the same as an engineer who developed a new gyroscope?
Man has always owned and used plants, animals, and microbes, and has sought to protect them from being commercially exploited by others. The ancient Chinese empire imposed capital punishment on anyone who smuggled silk moth eggs out of the country. In the middle ages, brewers swore their apprentices to secrecy and fiercely guarded “their” special yeast lest it fall into the hands of competitors. And Thomas Jefferson famously smuggled rice out of Italy in defiance of a law prohibiting its exportation “on pain of death.”
In contrast to such secrecy, patents are time-limited and public. Patents are awarded only for new inventions, and must contain a detailed technical description that teaches others how to practice the invention after the patent expires. In many cases involving living materials (e.g. genetically engineered bacteria) the inventor even deposits samples in public cell culture banks where they can be accessed by scientists.
The question of whether the USPTO “should” allow the patenting of living organisms cannot be answered by the USPTO itself. The USPTO is bound by the patent laws, which are mainly concerned with whether an invention is new and original and has technical merit rather than whether it is inanimate or living. For example, the patent laws have long permitted patents on organisms such as bacteria or fungi or other microbes provided they were engineered or changed from their natural state for some useful purpose. Patented engineered microbes are used in many scientific or industrial processes, ranging from the production of antibiotics to the fermentation of organic waste. Going back to the 1930s, there is also a long history of patents for new varieties of plants that are reproduced asexually, e.g. through cuttings or by grafting or division, such as new fruit trees or new ornamental plants. For example, some of the apple varieties on sale in supermarkets, like Fuji, Red Delicious or Honeycrisp apples, were patented by the horticultural companies that developed them.
After the advent of modern biological engineering and breeding techniques, patents were also awarded for new pest- or herbicide-resistant crop varieties, and on vegetables or grains that are more nutritious and stay fresh longer. There are also a number of patents on animals. For example, many hatcheries that supply oyster farmers around the country have long used patented oysters for breeding stock. There are also some patented laboratory animals that were genetically engineered to be useful for e.g. cancer or Alzheimer¹s research.
To be clear, the USPTO does not award patents on living organisms (and other things) that were merely discovered in nature. The Supreme Court has said that if a new plant were discovered in the wild it would not be patentable, even if it had never before been known by man. On the other hand, a bacterium that was engineered by man to do something it cannot naturally do like digest crude oil is patentable under the same conditions that apply to any other kind of invention. And, of course, the USPTO does not award patents on living organisms even if they were engineered by man unless they are really new, unobvious, and practically useful just like any other invention. The patent law also specifically forbids patents that would encompass a human being (not that anyone would seriously want to apply for such a patent but nonetheless, Congress felt it was worth making the point).
Biologically engineered organisms like pest-resistant crops, or modified bacteria for producing antibiotics, can be very expensive and time-consuming to develop. And because they are living and capable of reproduction, they can very easily be copied by competitors without a lot of reverse engineering. For such products, patent protection is often needed to provide assurances that great investments of time and effort ran be recouped down the line. For example, new biotechnology crop varieties can easily require more than a decade of effort and over $100 million in R+D costs before they are approved for commercial use.
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