Patent protections

Patent databases aie databases containing information gathered froin patent documents [46]. These describe both the technical aspects and the scope of a patent (patent protection) and arc specific to a country or a group of countries (Tabic 5-4). 

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. 

The market for antiulcer agents (Fig. 1) is large and is comprised of both prescription and over the counter (OTC) products. The estimated prescription market is over 3 biUion aimuaHy in the United States, whereas the more difficult to estimate OTC market is in the range of 500 million aimuaHy. Several pharmaceutical companies are attempting to obtain approval for OTC use of prescription-only agents, and patent protection for several of the histamine antagonists mns out in the mid-1990s. 

Best Mode. The patent appHcant must disclose the best mode of practicing the invention known to the inventor at the time the appHcation is filed. Concerns over best mode often arise when a patent appHcant seeks patent protection for an invention but, at the same time, desires to keep as a trade secret one aspect of the invention necessary to the production of a commercial product. This action denies the pubHc access to this information and undermines the poHcies of the patent system. This would effectively deprive the pubHc of information on the amount of disclosure made in exchange for the 17-yr patent grant, and hence it invaHdates the patent grant. 

For many years, the method of obtaining foreign patent protection corresponding to a U.S. patent appHcation was to file separate, individual patent apphcations in selected foreign countries. Each of the appHcations had to be written to conform with the national requirements of the country in which it was filed. 

An alternative to patent protection for advances, developments, ideas, and appHcations is to treat such information as a trade secret. The protection of trade secrets reHes on the development of ideas, appHcations, and advances which are not found ia the pubHc domaia. Trade secrets, by defiaitioa, are kept ia coafideace by their owaer, dissemiaated only to those who accept an absolute obligation of confidentiaHty, and then only for purposes of which the trade secret owner knows and approves. 

Patents are the most important and strongest type of intellectual property. Patents protect inventions or technical innovations. Patents do not protect new designs (these are protected by copyright or registered designs), nor do... 

Finally, the category external factors consists of three parts - raw material availability, susceptibility to regulatory changes and patent protection - for which points are awarded, up to a maximum of 14 for a high VVF product. 

While the tripartite countries of the more developed regions of the world have their own patent laws, and while they honor each other s property protection rights, some countries do not. Patent pirates in these countries freely copy (pirate) innovator drugs and drug products that are under patent protection in the United States and elsewhere without compensating patent holders. India is perhaps the worst pirate offender,... 

When a new chemical product is first developed, it can often be protected by a patent in the early years of commercial exploitation. For a product to be eligible to be patented, it must be novel, useful and unobvious. If patent protection can be obtained, this effectively gives the producer a monopoly for commercial exploitation of the product until the patent expires. Patent protection lasts for 20 years from the fifing date of the patent. Once the patent expires, competitors can join in and manufacture the product. If competitors cannot wait until the patent expires, then alternative competing products must be developed. 

The pharmaceutical industry is precisely one of the sectors in which patents have most impact. The general arguments that are formulated on the subject of technical information are fully applicable to the pharmaceutical environment. Thus in Spain, for example, pharmaceuticals are the third sector in terms of investment, behind automobiles and food. The two questions we must ask are whether there would be less investment and poorer results if patents did not exist, and to what extent results are achieved with the existing patent protection. Nevertheless, these two questions are not easy to answer. Furthermore,... 

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