Keeping-up intellectual property lifelines for life science ventures.

• Author: Fernandez, Dennis

Today's biotechnology intellectual property ("IP") strategists find themselves in an unenviable position. Modern biological research brings about an avalanche of not only scientific data, but also of unprecedented ethical, policy, and philosophical questions. New or modified IP laws will undoubtedly result. IP, and especially patents, are typically crucial to the viability of biotechnology companies. Thus, critical IP strategy necessarily stands on the quicksand of biotechnology IP law. Some of the concerns of biotechnology companies in developing their intellectual property arsenal are explored in this article.

1. SEQUENCE PATENTS: UTILITY AND DESCRIPTION REQUIREMENTS

   DNA sequence patenting has been at the core of a vigorous debate for the past decade. Issues such as whether DNA should be patentable subject-matter and the detrimental effect DNA patents might have on biomedical research have been strongly disputed. (1) The controversy seems to be subsiding in light of established legal precedent and guidelines applicable to DNA patents adopted by the United States Patent and Trademark Office. As the dust settles, prior patents and current strategies need to be evaluated for compatibility with the emerging legal landscape.

   It is now recognized that nucleic acids and proteins are patentable in the US and under most foreign patent regimes. As discussed below, however, sequence data itself is insufficient and additional information is necessary. While the amount and type of additional information varies with particular sequences, it is fair to say that in general the strength of patent protection depends on the amount and quality of additional information. In fact, this additional information should ideally support sequence-independent creative claims because unquestionably valid sequence claims are usually quite narrow.

   To be entitled to patent protection inventions have always been required to be useful. The United States Patent and Trademark Office has recently promulgated utility guidelines to clarify this requirement. (2) While the guidelines are applicable to any invention, they are uniquely relevant to DNA patents. Accordingly, inventions must have credible, substantial, and specific utility. To be credible, an assertion of utility must be believable to a person of ordinary skill in the art. For example, a perpetual motion machine lacks credible utility. Substantial utility refers to "real world" inventions uses. For example, treatments for unspecified diseases or compositions useful only for further research do not meet this requirement. Finally, inventions must have specific (rather than general) utility. It is this requirement that prevents patenting of just any nucleic acid sequence. Because all nucleic acids can be used, for example, as chromosome markers or as gene probes, such uses are general, not specific. To clear the utility threshold, knowledge additional to the sequence itself must be presented. Such knowledge may come, for example, from simple homology studies in some cases, or functional studies in other cases. Consequently, it is not possible to claim numerous expressed sequence tags (ESTs) without any analysis to support an assertion of specific utility. Refer to Figure 1: Enabling Technologies in Gene Analysis.

   Additional constraints on DNA or amino acid sequence claims are imposed by the written description requirements. (3) In general, the requirement is that the patent specification must convey to those of skill in the art that the inventor was in possession of the claimed invention at the time the application was filed. This requirement is clearly met by any sequence listed in the Sequence Listing section of an application. Written description is not easily met for any "genus" of sequences, that includes the "species" in the Sequence Listing and other sequences with similar characteristics. To generically disclose sequences, as many features as are known should be described in the specification. In the case of polypeptides catalytic activities, such features may be exemplified...