Legal issues intellectual property

Patrice Mitchell carefully edited various versions of the manuscript, hopefully breaking me of many of my bad writing habits. 1 thank her for her patience and support. Rusty Elliott and Nathan Gk)lden at Sandia have been very helpful handling legal and intellectual property issues. 

INPADOC (International Patent Documentation Center) is the most comprehensive tttbliographic database of scientific and technological patent documents in the world. The stock encompasses more than 26 miUion patent documents, more than 59 miUion legal status data, and about 10 million patent famihes (January, 2003). The database contains more than 35 milhon patent citations from 71 patent-issuing organizations (European Patent Office, World Intellectual Property Organization (WlPO)) and is updated weekly with about 40 000 new citations. 

Canadian Legal Network. 2001. Canadian HIV/AIDS Legal Network and AIDS Law Project South Africa. TRIPS and Rights International Human Rights Law, Access to Medicines and the Interpretation of the WTO Agreement on Trade-Related Aspects of Intellectual Property. Available at http //www.aidslaw.ca/Maincontent/issues/cts/briefs/TRIPS-human-rights-briefPDF.pdf [Accessed June 20, 2005]. 

Many companies are at least aware of this intellectual property issue. For example, in my company I have paid for legal opinions on the freedom to operate, because I am concerned about this issue, but I do not know of any university that has ever done that. 

The basic building blocks of business development deals are, for the most part, contracts. These contain various degrees of complexity depending on the number of elements and parties to the contract. Partnerships and joint ventures are other legal forms with which the business developer will need to become familiar. Another part of the law which you will need to be familiar is intellectual property law which, in the pharmaceutical industry, underlies most of the value of the products. Some of the practical issues that need to be addressed by business development will be discussed in this book, but no attempt to pre-empt legal advice or interpret the legal mind will be made. 

When it comes to the legal requirements for the protection of intellectual property the position is not so clear-cut. For instance in the US the PTO issues patents on the basis of the date of invention, i.e. the date in the laboratory notebook, not the date of application as is the case with other countries. 

In November 2000, the European Chemical Industry Council (CEFIC) commented on the legal protection of traditional knowledge in a position paper.64 CEFIC began by acknowledging that the World Intellectual Property Organization (WIPO) is the appropriate body to deal with this issue and indicated that there are three separate issues to be dealt with ... 

This chapter will provide the reader with an overview of patenting in the pharmaceutical biotechnology industry and summarize some of the key legal and ethical issues related to the patenting of biomedical products and processes. It will examine the legal aspects of patenting before considering the ethical and policy issues. This essay will focus primarily on the U S patent laws, which are very similar to the European patent laws. The essay will note some differences between the US and European laws, and it will mention some relevant international intellectual property treaties. 

In addition, a reality of the pharmaceutical industry at present is the outsourcing of some of all of the synthetic chemistry for a project. To the list of existing questions must be added several others. Which contract research organization(s) will you choose, and what can they be expected to accomplish How will you handle electronic lab notebooks, documenting intellectual property issues and other legal issues How do you handle the logistics of quality assurance, shipping, and customs To help you address each of these, it is prudent to reach out into your broader network to get opinions from others not only in your company but also across the industry. 

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