Genetic Patents

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By Rich Stim

[NOTE: In September 2011, the U.S. enacted the America Invents Act that bars the issuance of patent claims directed to or encompassing a human organism.]

Ordinarily, patents will not be issued on “inventions” consisting of items or substances that are found to exist in a natural state. The reason for this is obvious. Something occurring in nature without human intervention cannot have been the product of inventive activity.

There are several categories of patentable inventions that do, however, involve “natural” materials. One category is novel and nonobvious plants created through asexual breeding. Plant patents for new plants involving human inventiveness (breeding skill) are specifically authorized by statute (the patent laws and the Plant Variety Protection Act) in the United States.

Genetic engineering is another field where “natural” materials (that is, bacteria, DNA, RNA) have been manipulated by humans through gene splicing and cloning techniques (such as Polymerase Chain Reaction, or PCR) to produce new organic materials and life forms. These new substances and forms, and the processes used to create them, are also considered to be patentable under authority of the U.S. Supreme Court’s decision in the case of Diamond v. Chakrabarty, 447 U.S. 303 (1980), as long as they meet the basic patent requirements of novelty, nonobviousness, and utility.

Because Congress wants basic research in biotechnology to develop as quickly as possible, federal law permits a company to utilize biotechnical inventions patented by another company if the purpose of the use is strictly for research. This is an exception to the general rule that a patent prohibits the manufacture or use of an invention covered by an in-force patent. If, however, the company doing the research desires to commercially exploit the substance or process being utilized, it must obtain permission from the patent owner (usually accomplished by paying a license fee).

In 2010 a federal district court determined that certain patent claims for BRCA1 and BRCA2 human genes were invalid. The genes are found in the cells of breast and other tissue, where they help repair damaged DNA. The genes are a factor in breast cancer diagnosis. The court held that the subject matter was unpatentable because genes are the physical embodiment of [genetic] information. (In Association for Molecular Pathology v. USPTO, 702 F. Supp. 2d 181 (S.D.N.Y. 2010)).