Intellectual Property Newsletter

Patent Protection for Biotechnology

In a landmark 1980 case, the U.S. Supreme Court established the foundation for biotechnology patent protection by holding that a genetically-engineered bacterium was patentable subject matter. In an oft-cited quote, the Court stated that Congress had intended to allow inventors to patent “anything under the sun that is made by man” that also meets the other patentability requirements.

Biotechnology Defined

“Biotechnology” has been defined broadly as “any technique that uses living organisms (or parts of living organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses.” Researchers generally use the following techniques to modify living organisms:

  • Tissue and cell culture; i.e., the propagation of cell lines in the laboratory
  • Hybridoma technology; i.e., the fusion of an antibody-producing cell with a cancer cell to create a hybrid cell
  • Recombinant DNA technology; i.e., expressing a particular gene in a fast-growing type of cell to obtain mass production of the material encoded by the gene

Patent Law Basics

In order to patent a biotechnological invention in the United States, the invention must satisfy the same criteria as any other invention. In general, the inventor must establish that the invention is of patentable subject matter and is useful, novel, non-obvious, and sufficiently described and enabled in a patent application. If granted, a patent generally allows the inventor to exclude others from developing the invention for a limited period of time.

In the United States, two categories of patents are applicable to biotechnology: (1) utility patents and (2) plant patents.

Utility Patents

Two basic types of utility patents are instrumental for the protection of biotechnological inventions: “process patents” and “product patents.”

A “process,” in general, is a means to an end; e.g., methods, procedures and techniques. For example, in the biotechnology industry, a process patent might be issued for:

  • A method for cloning or sequencing DNA or RNA
  • A technique for purifying or isolating a protein or antibody
  • A procedure for genetically altering a single or multi-celled organism to express a physiological characteristic not normally associated with that organism
  • A cell fusion procedure that yields an antibody-expressing cell line
  • A method for using organisms to degrade oil
  • A biochemical process which produces a compound through a series of steps

“Products,” on the other hand, are physical entities or materials; specifically, machines, manufactures, or compositions of matter. A product patent might be issued for the following examples of biotechnological inventions:

  • Monocolonal antibodies and other biological materials
  • Human cell lines that express DNA sequences of biological importance
  • Genetically-engineered bacteria and other microorganisms
  • Bio-engineered tissues and artificial body parts
  • Transgenic animals; e.g., a mouse that, due to its genetic make-up, is particularly prone to cancer (the “onco-mouse”)

Plant Patents

In addition to utility patents, U.S. patent law provides for plant patents. The elements of plant patentability are not the same as for utility patents. Instead of novelty, utility and non-obviousness, plant patentablity requires novelty, distinctiveness, and non-obviousness. Distinctiveness is measured by examining the characteristics that make the plant clearly distinguishable from other existing plants, e.g., health, color, flavor or productivity, among others.

Plant patents offer the inventor the exclusive right to reproduce the plant and may issue to anyone who has asexually reproduced any distinct and new variety of plant. (Asexual production is reproduction that does not involve the use of seeds). Patentable plants must be developed in a cultivated state, and not merely found in the wild.

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