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All patents and patent applications contain two principal parts: the specification and the claims. Although only the claims define the patent owner’s rights, the specification provides critical support for the claims. It does this by describing the invention in detail. In the area of biotechnology, the patent specification often also includes examples of experiments embodying the invention and showing that it works. The law sets the amount of detail and examples required in the written description and enablement requirements. The scope and implication of these requirements are not always clear, but several recent court decisions have provided some enlightenment. The written description and enablement requirements are significant because, if they are not met, the patent may not be issued or it later could be challenged or invalidated. The written description requirement for a U.S. patent application is found in 35 U.S.C. �112.1, which provides that “[t]he specification shall contain a written description of the invention. …” Furthermore, the specification must not only describe the invention, but also “the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art [the scientific field] … to make and use the same. … “This is known as ‘enabling the invention.’ “ As the inclusion of the written description and enablement requirements in the same sentence of the law make clear, they are closely related. The differences between these requirements and how they interact with other laws are being explored in the courts. The first major decision to address the written description requirement for biotechnology was a 1997 decision by the U.S. Court of Appeals for the Federal Circuit, Regents of the University of California v. Eli Lilly. Lilly requires that a patent application provide a written description of the invention in sufficient detail to demonstrate that the applicant was in possession of that invention. This may be done by providing a specific definition of what is claimed, followed by specific structure, formula, method of preparation, relevant physical and/or chemical properties, and “whatever other characteristics sufficiently distinguish the invention.” Furthermore, Lilly held that one could teach how to make and use a claimed invention, thereby enabling it, but still fail to provide a written description. Specifically in Lilly, the University of California owned a patent claiming DNA for all mammalian insulin, including human insulin. However, the university only had rat insulin DNA when it filed a patent application and only described rat insulin. It sued Eli Lilly for using human insulin DNA to create human insulin. The Federal Circuit held that, although a scientist would know how to make and use human insulin based on the university’s patent, it was not sufficiently described in the patent. This was true even though rat insulin DNA is more than 95 percent identical to human insulin DNA. As Lilly makes clear, when describing DNA and other nucleic acids, proteins and other biotechnology inventions, written description can be a difficult standard to meet. This is particularly true when the DNA or protein claimed can be from several animal species, but an example for only one or a few species is provided in the application. ‘ENZO’ AND ‘FESTO’ How examples are provided was further addressed in 2002 in Enzo BioChem Inc. v. Gen-Probe Inc. In that case, the Federal Circuit addressed the issue of whether a public deposit of a nucleic acid (usually DNA) in a public bank as specified by law could be relied upon to meet the written description requirement. Deposits of biological materials were initially allowed to address the enablement requirement. With many biological materials, such as DNA, bacteria and even transgenic mice, no one can practically make and use the material without first obtaining a sample of it. By placing a deposit in a public bank, the inventor gives other scientists a way to obtain the required starting material. The patent then provides other information about the material in the written patent specification. In Enzo, the Federal Circuit held that a deposit of biological material also is sufficient for meeting the written description requirement even though the invention is not described fully in words in the specification. However, if the claims in the patent extend beyond the material deposited, additional disclosure in the specification may be necessary. Although, as the above decisions indicate, the standards for written description and enablement may be difficult for even courts to discern, the requirements recently have taken on new importance in light of the U.S. Supreme Court’s Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. decision of 2002. Claims as filed in a patent application are frequently amended during prosecution of the application and usually differ from those ultimately issued in a patent. In Festo, the Supreme Court determined that any claim amendment made during prosecution of a patent application to satisfy the U.S. Patent Act’s requirements (which include the written description and enablement requirements) might cause prosecution history estoppel. Prosecution history estoppel arises when a claim amendment is made to secure a patent and the amendment narrows the claim’s scope. If an applicant narrows a claim to obtain a patent, he disavows his claim to the broader subject matter. This prosecution history may be reviewed later, after the patent has issued, and used against the patent owner by parties accused of patent infringement. Accordingly, after Festo, a patent application filed without sufficient written description and enablement of the claims may result in a patent that is not as broadly enforceable. It may be best to include more description and examples to enable and provide written description support for broader claims. As the above cases make clear, meeting the written description and enablement requirements for a biotech invention can be a difficult endeavor. Generally, a great deal of evidence and a thorough description of the invention are required. Failing to fully meet these requirements during the initial application process can result in higher prosecution costs, delay in patent issuance and creation of prosecution history estoppel that may severely limit the range of protection available for an invention after the patent issues. The safe navigation of this issue frequently requires a practitioner who is not only familiar with the law, but also the underlying science so that new advances in biotechnology can be adequately understood and described. Dr. Kate Musemeche has been on the faculty of several medical schools, including the University of Texas Health Science Center in Houston and the University of New Mexico School of Medicine. Her legal practice as an associate at Baker Botts in Austin centers on intellectual property and general trial matters relating to medical and biological issues. Michelle LeCointe is an associate with the intellectual property department of the firm. She practices patent prosecution, licensing and litigation in the biotechnology field. If you are interested in submitting an article to law.com, please click here for our submission guidelines.

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