PERSPECTIVES navigate them successfully. Another difficult SCIENCE AND SOCIETY area involves the discovery of biological mech- anisms that do not directly identify new drugs or therapies, but make such later identification Patenting neuroscience: possible. Recent case law has addressed and refined challenges and opportunities in issues in several of these areas, and provides much of the impetus for the present review. an interdisciplinary field Throughout this review, United States and European approaches will be compared and contrasted. However, before delving into Edward R. Ergenzinger Jr, Michelle L. Cunningham, Philip M. Webber the nuances of these topics, it is necessary to and W. Murray Spruill provide an overview of the requirements that must fulfilled to obtain a patent. The study of the nervous system draws from 1970, to more than 34,000 today (FIG. 1).This Patent primer many disciplines, including biology, chemistry, increase in the number of scientists associat- Patents are territorial rights: to obtain protec- medicine, psychology and engineering. A ing themselves with the field of neuroscience tion for an invention in a particular country consequence of this interdisciplinary has, not surprisingly, been coupled with the inventor must be granted a patent for that approach is that discoveries in one discipline an explosion in neuroscience research and invention by the patent office of that country. can inform and supplement other disciplines, publications. Almost all countries in the world now have and certain intellectual property issues might Despite the dramatic growth of the field, patent systems, and there are also some be encountered more frequently. For some commentators have raised the concern regional patent systems, such as the European example, if a new neurological indication is that neuroscience research, especially from patent system, which is discussed below. discovered for a known drug, can this new academic institutions, is not well represented Although the general principles are the use be patented? And what about the in patents or marketed inventions1.This same, the rules of these patent systems are not discovery of biological mechanisms that do might be partly because of difficulties in com- identical2. not directly identify new drugs or therapies, piling data on patents that are classified by but make subsequent identification possible? research field, particularly where inventions Patentability in the United States. There are Here, we will explore the extent to which can be categorized into more than one disci- several types of patent that can be obtained in these discoveries are patentable. pline. It might also be due to the fact that the United States. However, the type that is of the legal requirements for patentability might most interest for the present review is a utility Thirty years ago, neuroscience was just starting prevent some findings from being captured in patent. To obtain a utility patent in the United to be recognized as a separate field. Scientists patent applications. These include fields that States, the inventor(s) must submit an studying aspects of the nervous system benefit particularly from an interdisciplinary application to the United States Patent and through traditional disciplines, such as approach, such as research on the basic mech- Trademark Office (USPTO) (BOXES 1, 2) anatomy, physiology, behaviour and develop- anisms that underlie nervous system function and demonstrate that the invention meets the ment, began to appreciate the value of coming and anatomy. statutory requirements for patentability. The together in a collaborative field of study, where One of the results of an interdisciplinary most important requirements are: utility, the unifying factor was not the approach, approach is that discoveries in one discipline novelty, non-obviousness, written description but the organ system. Such an interdisciplinary can inform and supplement others. In addi- and enablement 3. approach held the promise that great strides tion, certain intellectual property issues might Although there are many aspects to the could be made if a problem was approached be encountered more frequently. For example, statutory requirements described above, from many different directions. although methods of using a known drug in the general issues associated with each are as The great potential that was predicted has the context of a newly discovered neurological follows. The requirement of utility means now been realized, and is reaffirmed every day. indication might be patentable, there are par- that an invention must perform some func- The Society for Neuroscience has grown from ticular obstacles of which inventors and their tion that is beneficial to society. Novelty and about 500 members when it was founded in patent counsel need to be aware if they are to non-obviousness deal with comparisons of NATURE REVIEWS | NEUROSCIENCE VOLUME 5 | AUGUST 2004 | 657 © 2004 Nature Publishing Group PERSPECTIVES 35,000 prior art is the date of invention. All other countries use a ‘first to file’ system, in which 30,000 patents are compared with prior art from the filing date of the patent application. The sec- 25,000 ond difference surrounds the procedure for dealing with public disclosures. Although most 20,000 other countries will not allow a patent if there has been any public disclosure of the invention, 15,000 the United States allows inventors a one-year period to file a patent application after publish- Number of members 10,000 ing, placing on sale or publicly using the inven- tion. The main differences between the United States and European patent systems are sum- 5,000 marized in TABLE 1. 0 1980 1984 1988 1992 1996 2000 2004 New uses for known compounds Year The word ‘new’ generally conjures up images of a device or machine that, in whole or in Figure 1 | Society for Neuroscience: growth in membership 1980–2003. Data from The Society for Neuroscience and REFS 18,19. part, did not exist before. Although these things are certainly new, this characterization fails to take into account more incremental the invention to what has come before. countries is usually obtained through the EPO advances that take existing machines and Specifically, novelty requires that an invention (and not through the patent offices of the modify them in such a way that their function cannot be identical to a previous invention or individual member states). However, there is significantly enhanced. The identification of disclosure, and non-obviousness requires that is currently no centralized procedure for a new neurological indication for a known it cannot be so similar to a previous invention enforcing rights of European patents against compound is akin to this kind of incremental or disclosure that it would have been obvious infringement; enforcement of granted Euro- advance, and is recognized as patentable by to those in that discipline to create it. Finally, pean patents is carried out on a country-by- the USPTO and EPO. That is, however, if the the requirements of written description and country basis through the patent offices and prior art allows, and if the application is enablement pertain to how the invention is courts of the individual member countries. drafted with special rules in mind. presented in the patent application. Written The requirements for patentability at the description requires the invention to be EPO are similar to those of the USPTO. The Issues in the United States. Although the dis- described in a manner sufficient to convince EPC provides patent protection for inven- covery of a new use for a known compound others in the discipline that the inventor was tions that are susceptible of industrial applica- will not confer patent protection to the com- actually in possession of the claimed inven- tion, that are new, and that involve an inventive pound itself, a new use for an old product is tion, whereas enablement requires that the step. The stipulation that the invention must be patentable in the United States. In an early patent application describes the invention new requires that the invention must not have case dating back to the late 1940s, a claim was in sufficient detail to allow others with skill in been made available to the public by any allowed for a method that was based on the the discipline to make or use the invention. means before the filing date of the patent appli- new discovery that the chemical compound cation. The EPC also imposes a requirement dichlorodiphenyltrichloroethane (DDT) was Europe in comparison with the United States. that patented inventions contain an ‘inventive useful for killing insects4.Thepatentee had In Europe, patent protection for new inven- step’, which is similar to the non-obvious not identified DDT, or even discovered how tions can be obtained either from the patent requirement of the USPTO. Although to dissolve it in a solvent, but they received a offices of the individual European countries European inventions must also be susceptible patent containing a claim for a “Method of (which provide patent protection for those of industrial application, this is generally not killing insects which comprises dissolving the countries alone) or through the European an important hurdle in Europe. In contrast to chemical compound [DDT] … in a solvent Patent Office (EPO). The EPO was established the United States, several areas are excluded liquid and spraying the liquid so as to bring in 1973 under the European Patent Convention from patentability in Europe, such as methods [DDT] into contact with the insects.” (EPC) to provide a centralized procedure for of surgical or therapeutic treatment of humans Although DDT was not new, and the step of granting patents that cover one or more of the or animals, and inventions that are deemed to dissolving it was not new, the claim was member countries of the EPC. At present, 28 be immoral or unethical. granted on the basis of the new use. European countries are members of the EPC.