The Doctrinal Growth of the Patent Law & Biotechnology

The aspects of law discussed below are concerned with the processes of propertizing innovations in science, generally, and biotechnology, particularly.
The United States is presently the state within which most scientific and legal activity regarding biotechnology occurs - both in terms of the innovation of new plants and animals varieties and also in developing legal doctrines through case law and other methods to regulate the growth of biotechnology. In particular, biotechnological innovations focusing on genes and ‘gene sequences’ have attracted the most legal interest.

This is evidenced by both the quantity of patents filed on genetic innovations and the number of lawsuits in which the plaintiff party either challenges or attempts to enforce these proprietary claims. This legal interest in biotechnology is due, in part, to the investment placed in and the expected revenue generating capacity assigned to its applications. For example, aggressive attempts have recently been made by both governmental and private for- profit companies to map the whole human genome sequence. It is believed that this knowledge will give many human scientists, such as those working in medical research, key information that will allow them to correct many serious illnesses of the human body. Most biotechnology companies, following contemporary capitalist logics of proprietorship, appear to believe that patenting human genes and gene sequences is an important strategy for controlling the future and rapidly expanding market of biotechnology.

Genes or gene sequences are complicated combinations of proteins within a DNA that contains the coded information about the function that a gene or gene sequence performs in an organism’s body. Among the various problems that discovering genes and gene sequence in an organisms’ body has in the patent law is that it is a “discovery and not an invention”.

Patent law seeks to provide a temporary monopoly to the creator for the use of, what in legal terminology is called, an “invention”.

Three criteria must be met in order for something to qualify as an invention: (1) it must be ‘new’, (2) it must be ‘nonobvious’ or ‘inventive’ and (3) it must be a ‘useful” process, manufacture or combination of substance(s).

The rationale of this temporary monopoly is to provide an incentive to the inventor to both create and disclose novel and useful developments so that the general public may benefit from advancements and the creation of new knowledge.

Biotechnological inventions, like inventions in any other technology, may receive patent protection if they fulfill the three requirements stated under the law. Hence, making a new medicine for cancer by using the technologies of biomedical sciencewould amount to ‘an invention’ and would receive protection under patent law. But the difficulty with human genes and gene sequences as a patentable biotechnological invention is that they are neither new, as they have always existed in our bodies, nor inventive, for they are discoverable due to their prior existence.

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