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Subject:  AIDS Virus Receptor Patent and HGSI Date:  2/16/2000  9:20 PM
Author:  ElricSeven Number:  2485 of 25011

In case you didn't hear, Human Genome Sciences was awarded a patent to a receptor possible crucial to the treatment of HIV. Here is the news article:

Are you back? Well, good. With all the hoopla today on the new patent, I decided to take a gander. The patent number is 6,025,154 and can be found on the US Patent and Trademark Office web site:

Lets start with a little primer. A U.S. Patent gives the holder a right to exclude others from making, using or selling what is “claimed” in the patent. What is “claimed” is defined precisely by a set of consecutively numbered sentences that appear at the end of the patent. Appropriately enough, these sentences are called “claims.” Like a deed to land, the claims describe the “metes and bounds” of the patent owner's right to exclude. If all the elements (or subparts) of a claim describe something that is made, used or sold, that thing is infringing on the patent holder's rights.

Gene patents have been allowed since a landmark case in 1979 called Diamond v. Chakrabarty. Against the protest of many religious and other groups, the Supreme Court deemed genes to be patentable as long as they are “made by man.” In other words, one cannot patent a naturally occurring gene.

Gene patents are still hotly disputed, however, due to the fact that people are uncomfortable with the idea that the blueprint of living things can be patented. Recently, the President has publicly expressed concern that recent high volume patenting of human genes may be overly broad. The concern about overly broad protection pertains to patents that include claims to genes as a composition of matter. Once a claim to a gene as a composition of matter is awarded, anyone who makes, uses or sells that gene is an infringer. Contrast this to claims to the gene in a method, such as a method of treating cancer. A claim to the method of using a gene to treat cancer would only be infringed if someone were to make, use or sell the method using the gene to treat cancer. However, ALL methods of using the gene as a treatment (cancer, heart disease, ischemia, etc.) will infringe the gene as a composition of matter.

How can a human gene, which is natural, be patentable if it has to be “made by man?” Well, the USPTO currently considers a gene to be made by man if it has been purified. Purified is defined as separated from its natural surroundings. The rationale is that it doesn't exist in nature in this purified state and it got there through the hand of a person and is therefore “made by man.”

Where does all this lead? Well, much of HGSI's (and many othe biotech companys) value is tied up in gene patents. The pressure from the President and others to narrow claims to genes as a composition of matter can adversely affect these patents. It appears that there are two safety valves for controlling the recent mass patenting of genes. One way to cut down on the number and breadth of the patents is to mandate (legislatively or through the courts) that purification is insufficient to meet the “made by man” standard. Another, is to limit the patents to genes based on a showing of utility.

To meet the utility standard an invention must be useful. It can be useful in any way shape or form. Only one utility needs to be proved. For instance, in a patent directed to a chair one might assert that the use is as a place to sit. Someone who comes along and makes the chair, but uses it to stand on, will still be infringing. The utility standard is not too hard to meet, by the way. Usually, only throw-away or junk utilities are considered insufficient. For instance, an invention claiming a tube with a few magnets on the outside was found to lack utility despite an assertion that the taste of liquids were improved when passing through the tube. The inventor needed more solid scientific support for this utility. They didn't have it and the court declared the patent invalid, making it useless.

Apparently, many recent gene patents are submitted so quickly after finding the gene that the applicants have not carefully determined a use for the gene. Many of the applications rely on homology, or similarity, to known genes as evidence of utility. Others speculated on the future use of the gene based on this homology. Basically, it appears that not much biological experimentation is done to determine what treatme