Patents competition

The three main sources of competitive advantage in the manufacture of high value protein products are first to market, high product quaUty, and low cost (3). The first company to market a new protein biopharmaceutical, and the first to gain patent protection, enjoys a substantial advantage. The second company to enter the market may find itself enjoying only one-tenth of the sales. In the absence of patent protection, product differentiation becomes very important. Differentiation reflects a product that is purer, more active, or has a greater lot-to-lot consistency. 

Many competitive programs to perfect a metallic anode for chlorine arose. In one, Dow Chemical concentrated on a coating based on cobalt oxide rather than precious metal oxides. This technology was patented (9,10) and developed to the semicommercial state, but the operating characteristics of the cobalt oxide coatings proved inferior to those of the platinum-group metal oxide. 

This article provides a basic, step-by-step approach to problem solving in the practice and management of patents and trade secrets. The significance of aggressive patent and trade secret protection to the economic well-being of a business or organization should not be underestimated. Without patents and trade secrets, the marketplace is reduced to competition on the basis of price, which may be very difficult. 

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

If the production of vinyl chloride could be reduced to a single step, such as dkect chlorine substitution for hydrogen in ethylene or oxychlorination/cracking of ethylene to vinyl chloride, a major improvement over the traditional balanced process would be realized. The Hterature is filled with a variety of catalysts and processes for single-step manufacture of vinyl chloride (136—138). None has been commercialized because of the high temperatures, corrosive environments, and insufficient reaction selectivities so far encountered. Substitution of lower cost ethane or methane for ethylene in the manufacture of vinyl chloride has also been investigated. The Lummus-Transcat process (139), for instance, proposes a molten oxychlorination catalyst at 450—500°C to react ethane with chlorine to make vinyl chloride dkecfly. However, ethane conversion and selectivity to vinyl chloride are too low (30% and less than 40%, respectively) to make this process competitive. Numerous other catalysts and processes have been patented as weU, but none has been commercialized owing to problems with temperature, corrosion, and/or product selectivity (140—144). Because of the potential payback, however, this is a very active area of research. 

The combination of diafiltration and batch concentration can be used to fractionate two macrosolutes whose retentions differ by as little as 0.2. It is possible in principle to achieve separations that are competitive with chromatography. When tanks and other equipment are considered, as well as the floor space they occupy, the economics of membrane separation of proteins may be attractive [R. van Reis, U.S. Patent 5,256,294 (1993)]. 

Although the first two materials discussed in this chapter, the polyphenylenes and poly-p-xylylenes, have remained in the exotic category, most of the other materials have become important engineering materials. In many cases the basic patents have recently expired, leading to several manufacturers now producing a polymer where a few years ago there was only one supplier. Whilst such competition has led in some cases to overcapacity, it has also led to the introduction of new improved variants and materials more able to compete with older established plastics materials. 

As patents expire, exclusivity of producing a trade-nemed product will pass and competitive-versions of the basic drug will be marketed under generic names (or other new trade nemes) by new manufacturers. It has been estimated that 40% of the drugs on the market in 1990 will be generic drugs. 

Computers have been widely used in the daily practice of the medicinal chemist to search the literature of research articles and patents for competitive intelligence. They have also been extensively used for structure-based... 

Finally, factors such as originality (is our catalyst sufficiently original for a new patent or is it covered under an existing patent owned by the competition ) and economics have to be considered before our catalyst will be adopted. 

OS 31] ]R 16a] ]P 23] For benzene nitration, the results achieved in the capillary-flow micro reactor were benchmarked against results claimed in the patent literature (see Table 4.2) [97]. An analysis of conversion, by-product level, reaction time and reaction rate showed that the results achieved in micro reactors and conventional equipment are competitive, i.e. were similar. As tendencies, it seemed that the micro reactor can lead to a lower by-product level owing to its better temperature guiding and that reaction times can be further shortened. However, the corresponding results are not absolutely comparable in terms of reaction conditions and hence further data are required here. 

Innovation has historically been a strength of U.S. industry. In recent years, the United States appeared to be losing its position to foreign competition, particularly the Japanese. Table I (J) illustrates, for 1991, the number of patents obtained by several firms. Japanese companies hold the top few positions, but several U.S. companies have shown continued progress. 

Establish a program to monitor the publications, patents, and announcements of competitors and communicate these to the analytical group. If there is a genuine commitment in the organization to "be the best", a good first step is to recognize the very skilled competition to be faced. 

Drug price competition and patent term restoration act of 1984, Public 98-417, 98 Stat. 1585-1605, Sept. 24, 1984. 

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