Trying to patent a human gene is like trying to patent a tree. You can patent a table that you build from a tree, but you cannot patent the tree itself
William Haseltine - President, Human Genome Science

On the previous page a patent was defined as the right to prevent others from making, using, selling, or importing a given invention. This page describes what can be patented.

There are two categories of patents that may be applicable to genetic engineering and biotechnology, utility and plant patents.

Utility patents may be granted to person who invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. There are three basic requirements for utility patents; nonobviousness, novelty, and utility. Nonobviousness is a judged by taking the frame of mind of an average person in a given field with knowledge of all prior art (previous knowledge and inventions). Generally, if something provides new and unexpected results, it may be patentable. Novelty simply means that you cannot patent something that is already known or patented. Utility patents do not apply to theoretical phenomena or ideas, the invention/discovery must be useful.

Patentable biotechnology inventions include:

• A process of genetically altering or otherwise inducing a single or multi-celled organism to:
  • Express an exogenous nucleotide sequence
  • Inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence
  • express a specific physiological characteristic not normally associated with that organism
• Cell fusion procedures yielding a cell line that expresses a specific protein (eg. monoclonal antibody)
  
• A method of using a product produced by the above manipulations

Plant patents may be granted to anyone who has invented or discovered and asexually reproduced any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber-propagated plant or a plant found in an uncultivated state. Asexually propagated plants are those that are reproduced by means other than from seeds, such as by the rooting of cuttings, by layering, budding, grafting, inarching, etc. The purpose of asexual reproduction is to establish the stability of the plant. The term "tuber" is refers to a short, thickened portion of an underground branch. Such plants covered by the term "tuber-propagated" are the Irish potato and the Jerusalem artichoke. Algae and macro fungi are regarded as plants, but bacteria are not. Grant of a patent for a plant precludes others from asexually reproducing or selling or using the patented plant. A plant patent is regarded as limited to one plant, or genome. A sport or mutant of a patented plant would not be considered to be of the same genotype, would not be covered by the plant patent of the parent plant, and would be separately patentable.

The third category of patents, design patents, applies to any new and nonobvious ornamental design for an article of manufacture. The design patent protects only the appearance of an article, but not its structural or functional features. This has little application in biology.

When a utility or plant patent expires, the subject matter of the patent becomes public domain. The next page describes how long one has from the time of invention to apply for a patent and how long a patent lasts.