YOU OR a fellow scientist have discovered a new gene. Amidst the furious paper and grant writing that follows, someone wonders, " Can we get a patent for this?" Everyone stares blankly, then goes back to work. You realize 10 years later that you lost out on millions of dollars of profits from the invention.
Though most scientists, scientific organizations, and companies are now familiar enough with the US patent system to avoid the scenario above, a great deal of confusion as to what is patentable still exists throughout the scientific community. The confusion is greatest at the cutting edge of research, where the applicability of US patent law to various innovations is far from settled in both the Patent and Trademark Office and in the courts. This is especially true in the field of genomics, where questions such as " Can we get a patent for this?" deserve more than blank stares, but are still not easily answered.
Because so many aspects of patentability of genomics inventions are unsettled, it is critical to first understand the basic criteria for patentability and the US patenting system. Through a series of articles, we intend to explain the parts of a patent application and the patenting process, paying special attention to those components most applicable to genomics. In later articles we will address the nuances of genomics patenting. We will also discuss the patentability and prosecution pitfalls of specific genomics inventions.
There are several types of patent applications, but genomics inventions should be filed using only utility or provisional applications. The requirements for format and patentability of these two types of applications are set forth in Title 35 on the United States Code (http://www.uspto.gov/web/offices/dcom/olia/aipa/PatLaws1214.pdf). Patent Office rules, which implement these laws by filling in the procedural details, may be found in Title 37 of the Code of Federal Regulations (http://www.uspto.gov/web/offices/dcom/olia/aipa/PatRules1218.pdf).
The most common type of patent application is the utility patent application. A utility application must contain at least three parts: a specification, a drawing, if the invention can be depicted in a drawing, and at least one claim. These requirements are set forth in 35 USC. §§111-113.
The specification may begin with a short summary of the field of the invention. Next, a background section similar to that of a scientific paper sets forth the state of the art at the time of the invention, often citing published references and pointing out the problems that the invention will overcome.
After the background, a summary of the invention that largely mirrors the claims is usually included. This is followed by a brief description of the drawings. At least one drawing must be included if the invention can be reduced to drawing form. Almost every genomics invention can at least be shown as a sequence or a flow chart for a process. These may be labeled as drawings. The drawings themselves may not be accompanied by descriptions or extensive labeling. Descriptions and explanations that might be included with a figure in a scientific paper should, therefore, be placed in the brief description of the drawings section.
Finally, one comes to the most substantial parts of the specification, the detailed description of the invention and the examples. The detailed description of the invention should set forth both general information about the invention with all of its potential permutations and uses and specific information about important forms and uses. This section should also make clear how the invention overcomes the problems set forth in the background. This portion of the specification is most analogous to the conclusion section of a scientific paper.
The examples are something like the results section of scientific paper. Essentially, each experiment should be described in detail in a separate example. Results should also be presented in the example either by reference to the drawings accompanied by an explanation, or through the use of a table. Unlike scientific papers, a patent application does not necessarily require data. Prophetic examples that simply set forth the techniques to be used and describe the anticipated results may be adequate for patentability. However, serious problems can arise if later experimentation shows prophetic examples to be not quite on the mark. This is especially likely to occur in fields such as genomics where it is relatively difficult to know in advance if a proposed experiment will work at all or produce the intended results. Therefore, genomics applications should include examples derived from prior experiments and should present the data obtained.
In most applications, the specification ends after the examples. In genomics applications, however, a sequence listing will usually be necessary. All applications that contain a nucleic acid or protein sequence of more than a few base pairs or amino acids must be accompanied by a sequence listing. The sequence listing does not add anything not already present in the specification and is not a major consideration when writing the application.
After the specification, every utility patent application contains at least one claim; usually there are several. The claims are what set forth what the invention really is. Like a land claim, they draw the boundaries of what belongs to the inventor and no one else. The patent, like a deed, serves as a public record of who owns a specific portion of human knowledge. This portion is the inventor's intellectual property. Due to a recent ruling, the inventor is largely limited to what explicitly comes within the boundaries of the claims and may not prevent the use of anything that is merely close to those boundaries. (http://www.law.emory.edu/fedcircuit/nov2000/95-1066.wp.html). Therefore, care must be taken to make sure that the claims cover as much intellectual ground as possible, so long as that ground is truly part of the invention.
Patent claims come in two general types, dependent and independent. Independent claims set forth the invention and make no reference to any other claims. Dependent claims set forth an additional component of the invention and make reference to another claim. Dependent claims are an important means of determining what is patentable during patent prosecution. They are also often critical in recovering for infringement of a patent if broader claims, such as independent claims, are found by the court to be invalid. Therefore, dependent claims covering details of important embodiments of the invention should be included in the application.
Finally, the patent application contains an abstract of the disclosure. This abstract will be printed on the front page of any patent that issues from the application. Because the abstract has recently been used to limit the scope of patents, it should be much briefer and less detailed than an abstract in a scientific paper.
Another type of application that may be useful for genomics inventions, the provisional application, is very similar to a utility patent application. Like a utility patent application, the provisional application must have a specification and at least one drawing, if possible. However, the provisional application does not require a claim. Furthermore, a provisional application may not have the normal structure of a utility patent application. For instance, a scientific paper may be filed as a provisional application, if necessary to protect rights to its subject matter. The provisional application serves mainly to establish that its contents were provided to the Patent Office as of its filing date.
Familiarity with the content and purpose of all parts of a patent application is key to working successfully and efficiently with patent attorneys and agents preparing a patent application. Knowledgeable inventors are also more likely to have all patentable aspects of an invention included in their patent application and, by providing more meaningful information and advice, may be able to substantially reduce the costs of preparing an application. In our next column we plan to address the basic requirements for patentability. These requirements influence the content of the patent application as filed, its prosecution in the Patent Office, and the validity of any issued patent.
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] .
TrendSpotter is a weekly column that will focus on how trends in politics, patent law, and the US and European markets will affect the genomics industry. The column will appear every Friday. Next week Ira Leiderman, managing director of the Palladin Group, will write about current market trends.