IN OUR last article, we described the basic components of a genomics patent application. While it is critical to correctly prepare and file an application, that only gets you to the starting line. Once you've applied, there is still a long race ahead with many hurdles, i.e. the statutory bars to patentability, to overcome. Like a good runner, if you have studied the course and prepared well before the race, you will find it much easier to leap these hurdles as they arrive. In this article we discuss some of the major hurdles, ways to prepare for them, and ways to deal with them if you are taken by surprise.
The initial hurdle for all patents lies in 35 U.S.C. §101, the utility requirement. Every invention must be new and useful. The Patent office recently raised this bar for genomics inventions when it issued a set of utility guidelines ( http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf ). An inventor must assert a specific and substantial utility that is credible. Of particular interest in genomics, this requirement means that an EST may not be claimed as a research tool unless there is some indication of what one might specifically detect by using it (i.e. usefulness in diagnosis of a particular condition). All inventors must spell out a specific, substantial and, credible utility in the application itself. Only one such utility is required.
Thereafter, most genomics companies will also have to present claims in compliance with 35 U.S.C. §112, paragraph 2. This law requires the inventor to present "one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention." Problems under this section often arise when inconsistent terminology is used throughout the entire application to define important aspects of the invention. Varied forms of description may be appropriate in many other forms of writing, but consistency is the key to a good patent application. Some inventors may be caught by surprise because certain terms have developed specific meanings in patent law that differ slightly from the common understanding. To avoid this problem, look at what terms are used in other genomics patents and speak with someone familiar with patents.
Section 112 contains two additional hurdles. One, the written description requirement, indicates that the inventor must show that he or she had "possession of the invention" at the time of filing. Possession is determined by examining whether "one skilled in the art" (i.e. an average person in the field of the invention) would believe the inventor had completely conceptualized or made the invention at the time of filing based upon the application itself and general knowledge in the field. The Patent Office recently issued another set of guidelines explaining the written description requirement in detail. (See http://www.uspto.gov/web/offices/com/sol/notices/writdesguide.pdf )
Several portions of the guidelines are of particular applicability to the field of genomics and will be the topic of a future article. In general, a patent application should provide a thorough description of the invention including any specific genetic or protein sequences.
The other significant hurdle of Section 112, first paragraph, is the enablement requirement. A patent application must teach one skilled in the art how to make and use the claimed invention without undue experimentation. To jump this hurdle, the application should include examples that describe in detail the methods someone would need to know to do or make what is claimed. Even if the invention has not yet been physically completed, a description of how to complete it in a prophetic example may be sufficient. Of course, if the precise methods are known and data is available, this should all be included for a stronger application.
After overcoming the Section 112 hurdles, an inventor speeds quickly along to 35 U.S.C. §102. The Section 102 hurdle is often known as "anticipation" (or lack of novelty). The claimed invention may be "anticipated" if every element of it has been previously invented or publicly described. Anticipation may be avoided by not telling anyone outside of your lab or company about the invention until a patent application is filed. If a disclosure of any sort is made, a patent application should be filed within a year.
Additionally, a "prior art" search should be performed. Such a search usually involves looking for publications that make disclosures very similar to the patent application. You can keep any references found in the search from becoming a big hurdle by explaining in the patent application itself how your invention is different. Of course, the claims should be carefully written so they do no match exactly with this prior art.
The biggest obstacle of all for most patent applications is 35 U.S.C. §103. Under this section, a patent may be denied if the invention is "obvious" in light of the prior art. This means that anything the Patent Office may have cited against the application under Section 102 if it had disclosed all of the claimed elements may be combined with other such references to allow the Patent Office to say that the invention is obvious. As one might expect, application of this provision is often plagued by 20/20 hindsight.
Sometimes even the best-prepared applications have difficulty overcoming an obviousness challenge. However, the prior art search described above may identify references that are likely to also become problems under Section 103. The application can explain why the invention is not obvious in light of them. Additionally, when Section 103 problems are encountered, an inventor can often overcome them by citing additional references and making logical arguments that contradict the assumptions and conclusions made in the Patent Office.
As this overview makes clear, the patent laws are complicated and obtaining a patent is rarely easy. Beginning with our next article, we will discuss in greater detail some of the problems that specifically plague the field of genomics.
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 Ph.D. 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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