Intellectual property right

Intellectual property rights are the most sensitive interface between a fine-chemical company and its customer. This is particularly the case if the latter is a pharmaceutical company. Most of the profits of the industry derive from drugs protected by patents. Any dissipation or misuse of IP, on either the product or the manufacturing process, can cause serious damage. The company, its board, executives, and employees may be held liable. It is, therefore, imperative that strict procedures for safeguarding the IP are put in place, such as the following  

A one-way nondisclosure agreement (CDA) has to be signed by board members, management, employees, and external consultants. The individuals are bound to the CDA also in the case, that they leave the company (see also item 7, below). 

The first aspect of intellectual property law we shall consider is the legal protection of confidential information. This can protect programs, data and ideas. It is especially important that information should be kept confidential if a patent application is to be made.  

Three conditions must be satisfied before an action for breach of confidence can succeed  

the information must have been disclosed in circiunstances which give rise to an obligation of confidence  

there must be an actual or anticipated unauthorized use or disclosure of the 

The action to prevent unauthorized use or disclosure of confidential information is a civil one. The criminal law is rarely involved. However, the Law Commission have proposed that there should be a new offence covering the misuse of a trade secret and this will be 

Exhibit 11.13 FDA s Oversight on Gene Therapy and Cancer Vacdne 

Several gene therapies have received orphan drug designation these are treatments for cystic fibrosis, Gaucher disease, and metastatic brain tumor. 

Source Food and Drug Administration, Center for Biologies Evaluation and Research. Cellular Gene Therapy, http //www.fda.gov/cber/gene.htm [accessed September 21,2007]. 

While the FDA is adopting a cautious approach to cancer vaccine, such as DCVax-Brain, the Swiss Institute of Public Health has conditionally allowed the use of this vaccine by patients. DCVax consists of a patient s dendritic cells that have been pulsed with antigens derived from a tumor cell lysate prepared from surgically resected glioblastoma (brain cancer) tissue. It was developed by a company in the United States but has not yet been approved by the FDA. 

Source Fox JL. Uncertainty surrounds cancer vaccine review at 7T A,Nature Biotechnology 25 827-828 (2007). 

Intellectual property rights (IPR) are an important asset for the pharmaceutical industry. Most successful companies have suites of patents to protect their IPR. The effect of IPR protection is amply demonstrated by the Prozac case. Fluoxetine (Prozac, Eli Lilly) was a blockbuster drug for many years. During the first half of 2001, when Prozac was protected by patent, the sales were US 1.3 billion. Within one year of patent expiration, generics from other companies were released to the market. The sales of Prozac were reduced to US 380 million for the first half of 2002. 

It should be noted that at times pharmaceutical firms have to waive their IPR for a certain segment of the market. This is shown in Exhibit 11.17. 

The AstraZeneca patent on omeprazole expired in October 2001. AstraZeneca went to court to seek extended patent protection for a special formulation of omeprazole. The special formulation consists of a subcoating layer inserted between the core of the drug s active ingredient, and the outer coating. The subcoating is formulated to protect the drug from being broken down quickly by the harsh acids in the stomach. 

In October 2002, a US federal judge ruled that three generic companies have infringed on AstraZeneca s patent. However, a fourth company that has its own patent for coating the drug was cleared to market the drug in generic form. source Debaise, C Wall Street Journal, October 12 (2002). 

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Trade secret protection is probably the weakest of all intellectual property rights. The US Uniform Trade Secret Act defines a trade secret as information, including a formula, pattern, compilation, program device, method, technique, or process, that (1) derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use and (2) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy [33]. 

Obtaining IP protection is only the first step. The intellectual property rights obtained are only useful if they can be exploited and—ultimately—unauthorized users of the rights can be stopped from exploiting them. 

The use of computers in developing new pharmaceutical products is nowadays commonplace, and a number of tools and databases have been developed to improve their use. Although intellectual property rights have to date rarely been the subject of court cases, protection is available and the courts are prepared to enforce these rights, even in an international context. 

Shavell, S. and T. Ypersele (1999), Rewards versus intellectual property rights , Cambridge NBER working paper no 6956. 

Other proposals question the efficiency of the present system of intellectual property rights as an incentive to innovation and point to a more radical change in the way R D on pharmaceuticals is organized these proposals... 

A new kind of relationship is emerging between universities and industry in the chemical sciences, influenced in part by the Bayh-Dole Act of 1980, which allowed universities to retain intellectual property rights from federally funded research.2 As large industrial organizations have fewer and smaller departments doing long-range or basic research, they look to universities both for fundamental research and for students. In contrast to previous decades, in which many compa-... 

Holman, M.A. and S. Munzer, "Intellectual Property Rights in Genes and Gene Fragments A Registration Solution for Expressed Sequence Tags," Iowa L. Rev., 85, 735-848 (2000). 

At IIT Roorkee, he founded Intellectual Property Rights Cell in the. year 2000, organized several Conferences and Workshops on IPR till 2003 and formulated IPR Policy in Oct 2003, and also formulated Policy on Plagiarism in Dec 2012. He served as Dean of Students Welfare Member-Board of Governors Member-Finance Committee Head-Chemistry Department Chairman-Library Advisory Committee (Central Library), during the years 2005 to 2014. 

Novel chemical structure with intellectual property rights protected... 

It should be noted that at times pharmaceutical firms have to waive their IPRs for a certain segment of the market due to commercial or political issues. This is shown in Exhibit 11.16. Another recent case is the decision by Novartis to exit from the Indian market when its intellectual property right for Gleevec was not recognized by the Indian government. 

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