Many people, scientists included, envision genomics research as a group of scientists busily working to locate and identify new genes and then, in the "Eureka!" moment, discovering one and rushing off to publish it in a paper or file it in a patent application. The problem with this picture is that it fails to recognize the IP treasures represented by everything that happens before the "Eureka!" moment.
While no one will deny that researchers put a lot of hard work into identifying genes, many people fail to recognize the inventions that may come of that work. Researchers are faced with a myriad of practical problems every day, each of which must be solved in order to obtain meaningful results. Many of these solutions are simple and do not represent any great innovation, but others are quite clever and may be patentable.
Seeking patent protection for research tool inventions used in genomics discovery is valuable both for offensive and defensive purposes. At a bare minimum, obtaining a patent for a bioinformatics invention should prevent others from obtaining a patent on the same process and using it against you. Although it may be possible to invalidate another's patent by showing you invented the process first, this would involve lengthy and expensive litigation and you just might be barred from using your own invention in the meantime.
Obtaining your own patent may prevent these unfortunate circumstances. (Publishing your invention should serve similar purposes from a defensive standpoint.)
The real value in obtaining a "research tools" patent, however, lies in its offensive uses. The clever solutions that make one lab run better may address a similar problem occurring in other labs. Obtaining a patent for this solution gives a research group two primary paths to interact with these other labs.
First, if the other lab is a competitor, the patent owner may enforce the patent to prevent the competitor from using the patented process, product, or composition. This gives the patent owner a competitive advantage until the competitor can either develop its own solutions to the problem or until the state of the art changes.
On a more congenial note, the patent owner can also license the patented process to anyone who might find it useful. This group of potential licensees may include others in the genomics field as well as organizations in a variety of other fields. If the patent claims are sufficiently broad, they should cover many variations upon the particular process used by the patent owner, all of which may be licensed.
Most people in the genomics industry readily identify research tool inventions that relate to a bench process or contain a unique biological or chemical formulation. However, in genomics research this may be only half the pie.
An unprecedented amount of computational analysis is used for genetics discovery. The entire field of bioinformatics has partially evolved around the genomics industry. This presents a wealth of computational inventions that many people in the genomics industry may not recognize as an invention. These overlooked inventions may represent an even larger treasure than is first apparent because many are based upon algorithms that are more widely adaptable to other industries than are traditional research tools.
To locate overlooked bioinformatics inventions, one should search for any process involving computation biology or that involves storage, retrieval, and analysis of biological data. In particular, processes designed to aid in locating new genes ( e.g., processes with steps designed to aid in gene sequencing and nucleic acid hybridization) and molecular modeling (such as processes to predict protein structure) should be scrutinized.
Patentable bioinformatics inventions may include methods, apparatuses, data structures in computer memory with algorithms, hybrid compositions of matter on computer chips, modification of search algorithms, and new methods of analysis where databases are created and characterized.
For example, U.S. Patent No. 5,795,716 covers a "Computer-Aided Visualization and Analysis System for Sequence Evaluation." The patent claims a computer program product that identifies an unknown base in a nucleic acid sequence by performing computations with signals received from probes that indicate their extent of hybridization with an unknown sequence. The patent also claims a system for identifying the unknown base. Thus, out of a simple signaling and detection system developed from common laboratory protocols, coupled with specifically designed computer code, the patent owner has obtained two reasonably broad patent claims.
By carefully examining their own research methods for similar bioinformatics inventions, genomics researchers may have quite a few "Eureka!" moments that may be even more valuable to them than many gene discoveries.
Rochelle K. Seide is a partner at the law firm of Baker Botts, where she specializes in biotechnology, intellectual property, and patent issues. She also has a PhD in human genetics. Michelle LeCointe is an associate at Baker Botts, where she specializes in biotechnology patents and licensing. They can be reached at [email protected] and [email protected] .
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