Patent claims define the rights of the inventor. The scope of patent claims determines the extent of the inventor’s monopoly protection, and is thus an important issue to be considered when designing and applying national patent laws. This issue is particularly relevant to health-related inventions, due to the prevailing practices of patenting in this area (see Section V below). Recently, scholars have warned that overly broad patents in the field of biotechnology could remove important research tools from the public domain and block whole areas for further research66. The broad protection sometimes conferred in the case of inventions related to pharmaceuticals has also been questioned67.
66 See, e.g., White, 1998/1999.
67 See, e.g., Zaveri, 1998; Keayla, 1999.
Patent claims essentially consist of a one-sentence definition of the invention where the technical contribution made by the inventor should be unambiguously spelled out. The scope of patent protection and, therefore, the room left for independent research and third party competition, is determined by the wording used in claims. Issues such as how a product is described and the coverage of the patent are of particular importance. The following discussion illustrates some of the possible forms and coverage of product patent claims.
A chemical product can generally be described in structural terms, by specifying, for instance, its chemical composition. This type of description offers the safest way of delineating the scope of protection.
Some countries accept, under certain conditions, functional claims whereby the invention is described in terms of what it does rather than what it is. Such claims can allow extremely broad coverage, since they confer exclusive rights on any means that is appropriate to achieve the claimed functions, i.e. all ways of solving a problem are protected.
Another form of claims are the so called product-by-process claim68, where a product is characterized by the process by which it is obtained and not by its elements and structure. These claims are in particular relevant for biological products that cannot be described in terms of their structure or composition (for instance, in cases in which a macromolecule is secreted by a micro-organism). These are accepted by the European Patent Office only if the products themselves are new and inventive, and therefore, patentable69.
68 These claims may read, for instance, “compounds X when prepared by a process as Y”. In the USA the concept of “means-plus-function” claims is used to describe claims in which the invention is expressed as a means or step for performing a specified function without the recital of structure, material or acts in support thereof.
69 See, e.g., Cook, Doyle and Jabbari, 1991, p. 73 and 76.
Use-bound claims protect the use rather than the product. An infringement of a use-bound claim can only occur when a product is prepared or sold for the specific use claimed in the patent.
In terms of coverage, claims can be more or less precise and focused. A claim may refer to a well-defined compound of therapeutic value. Often, however, in the chemical and pharmaceutical field, patent claims are drafted in a manner that covers hundreds if not thousands of compounds. This is the result, for instance, of describing a family of chemical compounds by showing the common structural nucleus of all members with a variable substituent70.
70 In the case of process patents, many possible variants may result from broad numeric parameters describing a reaction temperature.
National laws, including those of developed countries, deal with these issues in very different ways. Functional claims have generally been admitted in the United States, though broad functional language that may impede further research and development has been condemned71. The European Patent Office (EPO), on the other hand, accepts functional claims only when there is no other means to describe the invention in a more precise manner. “Product-by-process” claims are generally admitted by the EPO and some European countries only if it is impossible to define a product by its structural features72, and if the obtainable product as such is new and inventive. Under “product-by-process” claims, protection is generally only extended to a product obtained with the claimed process; hence, the same product if obtained by another process would not infringe on an existing claim73.
71 See e.g., Sears and Hahn, 1999, p. 70.
72 See, for instance, the decision of the Board of Appeals of the European Patent Office T0150/82 (07.02.84).
73 This limitation in the scope of protection may be overcome if it is interpreted that any product obtainable with the process is protected, a solution that, however, has been refused by many patent offices (Grubb, 1999, p. 203).
Acceptance of non-structural and broad coverage claims expands the domain under the control of patent owners. Broad claims may have a negative impact on research and unduly block competition. They are also likely to lead to a great number of legal conflicts, ultimately increasing the costs for companies and consumers. Narrowing the scope of patents through strict claim description and coverage requirements creates more room for innovation and competition. From a health policy perspective, an appropriate balance needs to be found.
The TRIPs Agreement is absolutely silent on these matters. Nothing in the TRIPs Agreement obliges Members to admit functional or other types of claims as described above. Provided that there is no discrimination based on the field of technology, the TRIPs Agreement provides Members full freedom to determine the form and limits of allowable claims. Any WTO Member may require that, wherever possible, a product invention be precisely defined in terms of its specific composition or structure74, particularly in the field of chemical substances, in order to avoid excessively broad claims and ensure the practicability of the invention. This requirement may be particularly useful in fostering the role of patent documents as a source of information and to facilitate the negotiation of contractual licenses and the actual use of patented inventions.
74 This was, for instance, the practice followed by Japan till the revision of its patent law in 1994.
Regulations for implementing patent law may also contain specific instructions for claims corresponding to different fields of technology, such as chemicals, digital and mechanical inventions, in order to take into account the characteristics of each field.