COMPARED TO most sections of the Patent Act, Section 101 seems simple: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.” But its simplicity belies some of the most controversial issues in patent law today, particularly in regard to patenting polynucleotide and polypeptide/protein inventions.
Section 101 has been cited as a bar to the patentability of such diverse inventions as computer programs and transgenic bacteria. More recently, its applicability to the field of genomics has come into the spotlight. Modern research capabilities have forced the Patent Office to re-examine the law as set forth by Congress and applied by the courts to determine what constitutes a “useful” invention. Its conclusions form the Utility Examination Guidelines issued by the PTO on January 5, 2001 (http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf ).
The utility guidelines impose three requirements: a “useful” invention must have a specific, substantial and credible utility. The PTO has derived these requirements from cases such as Brenner v. Manson and In re Ziegler . But the guidelines are based upon a restrictive reading of these cases and seem to conflict with the spirit of other cases, such as Juicy Whip v. Orange Bang , which generally hold that to violate the utility requirement, an invention must be “totally incapable of achieving a useful result.” Thus, the fate of these guidelines if they are challenged in court is uncertain. Regardless of the legal standing of the utility guidelines, however, genomics researchers should consider them when filing a patent application or prosecuting pending applications.
To satisfy the specificity requirement, the invention must have a utility specific for the claimed invention. A general utility for inventions of that class, such as generic use “as a probe” will not suffice. Recitation of such a specific utility may also be necessary to fulfill the “how to use requirement.”
An invention must also have a substantial use, i.e. , one that is feasible in the real world. This requirement excludes utilities such as the use of a transgenic mouse as snake food. Precisely what constitutes a substantial utility is unclear, but arguments may be presented in support of any use that is not infeasible or irrational.
Finally, an invention must have a credible use. This means that one of skill in the art would accept that the invention is currently available for that use. Satisfaction of this requirement may be shown through information not contained in the application, such as test data and publications, and such materials will often be required for a convincing argument.
These requirements have various implications for different types of genomics inventions. For expressed sequence tags (ESTs) and other partial sequences, patentability is severely hampered or may even be precluded. The Patent Office comments published along with the guidelines and the guidelines themselves make clear that such partial sequences will fail the utility requirement unless a rather detailed utility is alleged. For instance, generic use as a probe will not constitute an adequate utility. However, their use as a probe for a specific disease, chromosomal location, or for a specific and narrowly defined type of gene or protein will likely be sufficient.
Inventions comprising entire open reading frames (ORFs) fare better. A use for ORFs that encode for proteins of known function can almost always be established based upon the function of the protein. An ORF encoding a protein of an unknown function may satisfy the utility requirements if it has sufficient sequence homology to known proteins for a particular function to be likely. The Patent Office specifically approved of comparisons through sequence homology in its comments on the guidelines. However, unique ORFs with too little homology to establish a likely protein function may fail the utility requirement. As in the case of ESTs, use as a probe for a protein or gene of unknown function is not a sufficient utility.
The utility guidelines are not favorable to many early-stage genomics inventions, but several steps can be taken to prevent or overcome rejections under the guidelines. First, each DNA molecule claimed should be tied to some function. Homology searches will often turn up a hypothetical protein function or a type of protein or gene for which the sequence may be used as a probe. The function does not have to be the most useful function for the DNA molecule or even one that eventually works in practice. It need only be a function specific for the molecule that would be deemed plausible by one skilled in the art and that might have some real world value.
Second, if a specific, substantial and credible utility may not be apparent to the patent examiner, spell one out in the application. Be certain to point out that other utilities may exist, but include at least one utility. This will help prevent the hassle of trying to establish the utility later after receiving a rejection from the examiner.
Third, keep in mind that the examiner must provide a well-reasoned explanation for any rejection based upon lack of utility. This explanation is preferably also supported by evidence. If such an explanation is not provided with a rejection for lack of utility, remind the examiner of the requirement. If the explanation is scientifically or logically flawed, explain the errors and include documentation if possible.
Though the utility guidelines may make it more difficult to obtain patents for some genomics inventions, the guidelines do not prevent patentability of all such inventions. In some cases, the guidelines may even serve as a tool to prevent examiners from raising the utility bar too high or failing to provide adequate explanations for their rejections.
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 and a registered patent agent. They can be reached at [email protected] and [email protected] .
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