H. Lee Moffitt Cancer Center & Research Institute

General Information

A United States patent is an intangible property right from the Federal Government excluding others from making, using, selling or importing the invention or discovery claimed in the patent. The term for a U.S. patent in which the patent application was filed after June 8, 1995, is 20 years from the date of filing the patent application. A patent that was in force on June 8, 1995, or that was issued on an application that was filed before June 8, 1995, has a term that is the greater of the 20-year term or 17 years from the patent grant.

In order for an invention to be patentable it must satisfy the following requirements:

NOVELTY
The invention must be new over the prior art. The prior art covers both documentary and non-documentary sources. Examples of documentary sources include scientific papers, patents, and printed publications. Non-documentary sources include activities performed by the inventor such as public use or offer for sale. Other examples of non-documentary sources include public knowledge or used by others.

The important implication of the novelty requirement is that the activities of the researcher can have a profound effect of the patentability of his/her invention. Routine activities such as publishing an article and giving a presentation may constitute a novelty-destroying act and hence preclude patentability.

NON-OBVIOUSNESS
One of the most difficult concepts in patent law is that of non-obviousness. Non-obviousness means that a person "with ordinary skill in the art" would not be likely to develop the same invention, even knowing all there was to know in the prior art. The non-obviousness requirement prevents the United States Patent and Trademark Office ("USPTO") from granting a patent to an invention that is a trivial extension from the prior art. In most cases, if the invention is novel, it is relatively easy to distinguish it over the prior art. On the other hand, a rejection that an invention is obvious requires only that the USPTO show that the invention would have been apparent if someone skilled in the art had combined elements of prior art to arrive at the same result as the inventor. This is easier for the USPTO to show and thus a much tougher barrier to patentability.

To understand the obviousness rejection, assume a person invents and patents a pair of scissors designed for a right-handed person. Later, someone else files a patent application for the same scissors redesigned for left-handers. Even if no left-handed scissor patent had existed and even if no one had ever thought of making left-handed scissors before, the USPTO could conclude that "knowing it was possible to make right-handed scissors, it would be obvious to one skilled in the art (e.g., a scissors-maker) that it would also be possible to make left-handed scissors.” Hence, the patent application for the left-handed scissors would be rejected by the USPTO, and the inventor would probably not be able to overcome this non-obviousness rejection. .

UTILITY
In order to satisfy the utility requirement, the utility needs to be specific, substantial, and credible. Specific utility means the utility is specific for the claimed invention. Indicating that a compound may be useful in treating unspecified disorders, or that the compound has useful biological properties, would not be sufficient to define a specific utility. Similarly, a claim to a polynucleotide whose use is disclosed simply as a gene probe or chromosome marker would not be considered specific in the absence of a disclosure of a specific DNA target.

Substantial utility is defined as a utility that has real world value. Some examples where substantial utility has not been met are inventions to basic research such as studying the properties of the claimed product itself, a method of treating an unspecified disease or condition, or a claim to an intermediate product for use in making the final product. All of these examples do not have substantial use.

Credible utility means that the invention is capable of achieving a useful result. A small degree of credible utility is sufficient. The claimed invention must only be capable of performing some beneficial function. Situations where an invention is found to be inoperative and therefore lacking utility are rare, and rejections maintained solely on this ground by the Federal Court even rarer.

STATUTORY SUBJECT MATTER
The patent statute contains the following classes of patentable subject matter: process, machine, manufacture, composition of matter, or improvements. Both Congress and the courts support a broad construction of the classes of patentable subject matter. The Committee reports accompanying the 1952 Act indicate that Congress intended the classes of subject matter to “include anything under the sun that is made by man…” The Supreme Court has noted in Diamond v. Chakrabarty that genetically modified bacteria capable of digesting oil for use in environmental protection against oil spills to be patentable. Furthermore, compositions or compounds isolated from nature are also patentable. For example, Louis Pasteur received a U.S. patent 141,072 in 1873 claiming “yeast, free from organic germs of disease.” Also, a Federal court held a patent directed to making adrenaline available for any use by removing it from the other gland tissue in which it was found was valid.

DNA molecules are also eligible for patent protection when isolated from their natural state and purified or when synthesized in a laboratory from chemical materials. If a patent application discloses only a nucleic acid molecular structure for a newly discovered gene, and no utility for the claimed isolated gene, the claimed invention is not patentable. When the inventor also discloses how to use the purified gene isolated from its natural state, the application satisfies the utility requirement. That is, where the application discloses a specific, substantial, and credible utility for the claimed isolated and purified gene, the isolated and purified gene composition may be patentable. A patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature. A DNA sequence is not patentable because a sequence is merely descriptive information about a molecule. An isolated and purified DNA molecule may be patentable because a molecule is a “composition of matter” one of the four classes of patentable subject matter. The utility of a claimed DNA molecule does not necessarily depend on the function of the encoded gene product. The utility could be the DNA sequence has a gene regulating activity.

The courts have placed certain limitations on the scope of patentable subject matter. The following are expressly prohibited by the Federal court to be patented: laws of nature (E =mc²), physical phenomena (mineral discovered in the earth or a new plant found in the wild), and abstract ideas (laws of gravity).

Examples of possible claimable subject matter for biotechnology inventions include:

Manufacture

1. Isolated DNA molecules, recombinant DNA molecules, DNA fragments, or antisense oligonucleotides
2. RNA molecules or constructs, catalytic RNAs, ribozymes, modified ribozymes, or antisense RNAs
3. Peptides or proteins
4. Antibodies, modified antibodies, antigens, cell surface receptors, monoclonal antibodies specific for different epitopes, or vaccines
5. Ligands
6. Vectors, bacterial strains, or virus strains for gene transfer
7. Transformed cell lines
8. Microorganisms newly isolated in pure form from a natural source or genetically engineered microorganisms
9. Transgenic or knock-out animals>

1. Methods of making a new compound
2. Methods of treatment or diagnosis using new or old compounds
3. New kits for example containing a new combination of materials or of materials and equipment used for diagnosis or treatment
4. Business method

1. DNA sequencing, mapping, process of labeling nucleotide segments, or purification methods
2. Protein sequencing or purification methods
3. PCR related technologies or methods of amplifying nucleic acid
4. Library screening methods
5. In vitro methods for predicting the response of a protein to a drug
6. Methods of treating humans or animals by therapy