Pharmaceutical industry characteristics patents

Three submarkets of the pharmaceutical market can be distinguished innovative patented products sold by prescription, products whose patent has expired and are sold by prescription, and products sold without a prescription. The public regulation of prices in the first of these submarkets, and often also in the second, is a fact that can be observed in most Western countries, with certain notable exceptions such as the USA. Concern about the particular characteristics of the pharmaceutical market (for example, the existence of patents and the pharmaceutical industry s rate of return), together with the desire to provide the majority of the population with access to medicines, regardless of their ability to pay (in many countries the public sector is the main buyer in this market), has led to the fairly widespread adoption of more or less strict price intervention and control policies for pharmaceuticals. 

The following sections of this paper examine the economic characteristics of the R D process in pharmaceuticals that make patents so crihcal. Sections 30.2 to 30.4 discuss the costs of innovation in pharmaceuhcals and the effects on innovative and imitative competition of the 1984 Hatch-Waxman Act. Section 30.5 considers whether the biotech industry is different from the pharmaceuhcal industry in terms of R D costs. Section 30.6 considers the distribution of returns on R D in these industries. The final section presents conclusions and policy considerations. 

Infrared spectra are now widely used in the examination of pharmaceuticals. The sixteenth revision of The Pharmacopoeia of the United States (U.S.P.) and the eleventh edition of the National Formulary (N.F.) have presented identification tests which used infrared spectroscopy, whereas no infrared tests were used in U.S.P. XV or N.F. X. Infrared spectra have attained acceptance in legal considerations and are now given in patent applications as characteristics of antibiotics of unknown structure. In the pharmaceutical industry there are many applications for quantitative infrared analyses in research and development work, pharmacy research, and in various phases of pharmaceutical production. For example, infrared data are used to characterize reaction conditions and yields, to assay the purity of intermediate products, to examine such problems as the stability of a drug in the material in which it is suspended, and to maintain quality control in the chemical production of bulk drugs. A recent review (Papendick et al, 1969) has given many references to fractionation and isolation methods for pharmaceutical analysis, such as the various types of chromatography, electrophoresis, countercurrent distribution, and extraction. The authors presented many references to infrared analyses for a wide variety of compounds (Table 16.1). 

The use of ttaditional disperse systems, e.g., macroemulsions, in the pharmaceutical industry has been limited due to manufacturing complexity and stability problems [117]. The characteristic properties of nano-emulsions (kinetic stability, small and controlled droplet size, etc.) make them interesting systems for pharmaceutical applications. Indeed, nano-emulsions are used as drug delivery systems for administration through various systemic routes. There are numerous publications on nano-emulsions as drug delivery systems for parenteral [17,18,28,29,118-124], oral [25,125-129], and topical administration, which includes the administration of formulations to the external surfaces of the body skin [32,130,131] and to the body cavities nasal [30,132] as weU as ocular administration [31,133-136]. Moreover, many patents concerning pharmaceutical applications of nano-emulsions have been registered [17,18,25,137-145]. An application of nano-emulsions in this field has been in the development of vaccines [33,146-147]. 

Prescription drugs have many complex characteristics, which, when taken together, have led to major controversies in public policy arenas, including pricing, patents, and incentives for research and development, as well as excess industry profits. Each characteristic is not unique to pharmaceuticals, but rather it is the characteristics, taken in combination, that make the industry unique. 

D-Limonene Another class of low-temperature HTF is based on naturally derived terpenes such as D-limonene. U.S. Patent 3,597,355 describes o-limo-nene as being particularly preferred among all the monocycloterpenes because of its characteristic properties such as low viscosity at low temperatures. D-Limonene is the major component in the oil of citrus fruit and is present in trace quantities in orange juice. It is recovered in commercial quantities by distilling orange oil obtained from citrus peels. Being derived from the citrus industry, o-limonene is considered a safe and environmentally friendly HTF, and hence it is preferred in many food and pharmaceutical processes. However, the melting point of D-limonene is about —78°C. Below this temperature, it becomes a thick white gel like substance that is impossible to pump. Therefore, the use of o-limonene is limited to... 

Complex formation between surfactants and aromatic compounds revealed two important characteristics one is an enhancement of the solubility of insoluble drugs in water the other is an improvement in thermal stability of unstable aromatic compounds. Such characteristics will surely be useful for pharmaceutical and industrial chemistries. The improved characteristics of aromatic compounds obtained by the complex formation with the surfactants were registered as a patent at the Japanese Patent Office (Patent No. 3900237). 

The empirical investigation is based on a random sample of 10,000 European chemical and pharmaceutical patents applied for at the EPO (European Patent Office, 1998) in 1986-1997. Each patent is allocated to a specific branch of the chemical industry biotechnology, materials, organic chemistry, pharmaceuticals and polymers. I use the zip code contained in the address of the inventors to assign each patent to the European region in which it was invented. Information on the characteristics of the innovations, of the regions in which these innovations are invented, and of the firms that developed them are collected from the EPO database and other data sources. 

---