Biotechnology products patent issues

A current trend is that more biotechnology products (see Chapter 2.11) are applying for orphan drug designation. The main reason for this phenomenon is that biotechnology patents are so difficult to obtain and orphan drug protection is valuable, while the inventors wait to see if a strong patent will issue. 

Different problems are encountered for approval of copies of bio technologically derived products. The issue is of practical relevance as the patent of many biological products has or is going to expire. Biotechnology derived products may represent a... 

Farnley and colleagues [96] have recently reviewed the complexity of intellectual property around biotechnology and biotechnology products. The authors note that the IP issues for small molecules and macromolecules, with a few exceptions, may be more similar than commonly assumed. The most important difference relevant to this overview is that each step in the discovery process may potentially be subject to different intellectual property considerations, which the authors note as unusual. The major differences between small-molecule and macromolecule patenting are shown in Table 1.3-11. 

Approximately 80% of the healthcare and engineering patents issued in the USA in 1995 were to US pharmaceutical and biotechnology companies (PhRMA, 1996). CBER regulates over 85% of the 284 biotechnology medicines currently known to be in development (PhRMA, 1996). This indicates not only the large number of products in development but also CBER s experience base in review. 

A special regulatory issue regarding biotechnology-based pharmaceuticals relates to the generic products or follow-on protein products, as patent protections for a number of first-generation biotechnology-based protein products are about to expire. Because of... 

C45 BioTech Updates includes abstracts from Chemical Abstracts and business information from Chemical Industry Kotes related to biotechnology processes, people in the industry, government activities, production, and pricing internationally. Each issue is divided into four sections patents, papers, books and reviews, and BioTech Industry Notes. Each issue also contains keyword and author indexes. 

A further problem is the issue of the patent thicket that surrounds much biotechnological innovation. There may be multiple patents held by multiple parties for constituent ingredients, processes required for the development of biopharmaceuticals, and the products involved in those processes (e.g., gene and protein patents). Navigating the thicket to ensure that a biogeneric violates no extant patents may be quite challenging. Thickets greatly impede FTO. 

The debate about compulsory licenses for patented products occurred in the context of access to HIV/AIDs drugs in Africa. At issue was the effect of patent rights on the accessibility and affordability of pharmaceutical products and vaccines in developing nations. Similar concerns around access and cost are likely to develop with biopharmaceuticals and other innovations resulting from research in health biotechnology. 

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. 

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