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Corporate management, potential investors and others may need to determine the quality of biotechnology patents in a company’s patent portfolio. For example, if a choice needs to be made between paying maintenance fees for two patents, then the one that has a higher quality should be selected, all other things being equal. Likewise, if a decision whether to invest in a company is being made, then some indication of the quality of the patent portfolio is desirable. Patent quality goes beyond whether the patents would merely be held valid and enforceable, and includes consideration of the patent’s scope and content. The general principles used to determine patent quality are independent of technology. However, biotechnology patents can require closer consideration of some aspects of quality than other patents. This article discusses guidelines for assessing quality of patents, including biotechnology patents. A patent applicant is required by 35 U.S.C. � 112 to provide a written description of the claimed invention to show that the applicant possessed the claimed invention and to put the public in possession of the invention. Many biotechnology patents include claims that recite a genus of subject matter (e.g., polynucleotide molecules) to cover numerous ways in which the invention can be practiced. “Genus” claims often are of greater value than “species” claims. One indicator of biotechnology patent quality is the extent to which the written description supports genus claims. In Fiers v. Revel, the U.S. Court of Appeals for the Federal Circuit in 1993 held that adequate description of a genus requires precise definition of the genus, and that this definition must distinguish the claimed subject matter from other material of the same type. In Regents of the University of California v. Eli Lilly in 1997, the Federal Circuit emphasized the value of providing a chemical formula for support of genus claims, such as a recitation of the sequence of nucleotides that make up DNA. While functional language can be used to help define claimed subject matter, the Federal Circuit held in Enzo Biochem v. Gen-Probe in 2002 that functional language by itself may be insufficient to describe claimed inventions adequately. Courts also look to a patent’s written description to define the scope of the claims. As stated by the Federal Circuit in Gentry Gallery v. Berkline Corp. in 1998, “[C]laims may be no broader than the supporting disclosure, and therefore that a narrow disclosure will limit claim breadth.” In Lockwood v. American Airlines in 1997, the Federal Circuit clarified that the written description requirement is satisfied “by describing the invention, with all its claimed limitations, not that which makes it obvious.” Thus a quality patent will include a broad and specific disclosure of the claimed subject matter. An applicant also is required by 35 U.S.C. � 112 to describe how to make and use the claimed invention, which is known as the “enablement” requirement. The Federal Circuit clarified in Vas-Cath v. Mahurkar in 1991 that the written description requirement is distinct from the enablement requirement. Enablement is a concern for determining the quality of a biotechnology patent because when biological material essential to making or using the invention is not publicly available, the invention can be enabled by depositing a source of the biological material in a public repository. Nevertheless, Enzo demonstrates one of the dangers of relying on a deposit for enablement instead of a written description — the deposit is not a substitute for an adequate written description of the claimed subject matter. Thus, reliance on a deposit for support for enablement without a supporting written description of the deposited material can adversely affect biotechnology patent quality. Further, 35 U.S.C. � 112 requires disclosure of the inventor’s “best mode” of practicing the invention. This requirement does not extend to details that would be apparent to a skilled artisan. For example, the Federal Circuit held in Eli Lilly v. Barr Labs in 2000 that failure to disclose an improved way of producing a common precursor that is not within the scope of the claims is not required, but failure to disclose a novel intermediate required to practice the invention is required. The best mode does not have to be identified as such (i.e., the words “best mode” need not be used), but the inventor’s subjective best mode must be disclosed. Therefore, it may be necessary to discuss with the inventor whether this has been done. If an inventor is no longer with the company and works for a potential infringer of the patent, the possibility that the inventor could attack the patent for violation of the best mode requirement should be considered. CLAIM SCOPE The scope of a patent’s claims define the exclusive property right. A claim’s scope is defined by its literal wording and its equivalents, less subject matter dedicated to the public. The Federal Circuit held this year in Johnson & Johnston Assoc. v. R.E. Service that disclosed but unclaimed subject matter, including disclosed but unclaimed equivalents of a claim element, is dedicated to the public. Subject matter surrendered by narrowing claims can also be considered dedicated to the public. Thus, failure to claim properly subject matter disclosed in a patent can provide competitors with a roadmap for practicing the invention without infringing the patent. Prosecution history refers to statements and amendments made by patent applicants and examiners during the process whereby a patent application is permitted to become a patent. Statements and amendments made during prosecution can limit the scope of patent claims. While the Supreme Court has held in Festo Corp. v. Shoketsu Kinzoku Kogyo Kaushiki in 2002 that such amendments do not pose an absolute bar under the doctrine of equivalents, their effect can still be substantial. In addition, the Federal Circuit held in Elk Corp. v. GAF Bldg. Materials Corp. in 1999 that intentional misconduct by the attorney or inventors, such as the intentional failure to disclose material prior art, can result in the invalidation of patent claims. The patent’s prosecution history should be considered when determining patent quality. The principles for assessing patent quality are common across technical fields. Biotechnology patents can require specialized analysis of compliance with statutory requirements such as the written description, best mode and enablement requirements.

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