Patenting, biotechnology

Three biotechnological patents have been awarded to Sekiyu Sangyo Kasseika Center and Mitsubishi Oil, which are focused on three different application areas, namely separation, demetallization, and desulfurization ... 

Because of the international nature of the biotechnology, patent coverage may be necessary in a number of countries, and this is made more difficult by the legal and procedural differences in... 

Protection of intellectual property through patents forms a vital part of entrepreneur and investor confidence in any industrial endeavor. Until 1990, 3378 biotechnology patents were issued in the US, with an average waiting period of 25.6 months, which is significantly longer than the 18 months required for all patents (PMA Survey Report, 1991). Of these, 1321 patents were healthcare related. The influx of patent applications... 

Meyer, S.J. (1991). Legal issues in biotechnology patenting. In Recombinant DNA Technology and Applications. 

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. 

U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology Patenting Life, OTA-BA-370, U.S. Government Printing Office, Washington, D.C., April 1989. 

La Jolla Drive, Suite 700 San Diego, CA 92122 Fax 858-597-1585 E-mail ccampbell candf.com biotechnology patent law firm employing Ph.D. chemists as scientific advisors... 

Biotechnology Patents, Public Policy, Public Opinion, and Morality 1396... 

BIOTECHNOLOGY PATENTS, PUBLIC POLICY, PUBLIC OPINION, AND MORALITY... 

Claims can describe various types of inventions or embodiments of the same invention. The most common types of claims are product claims and process claims. Product claims confer protection over any aspects of a product specified, regardless of how that product was derived. Process claims describe a particular means of making a product, and it is the described process that is granted patent protection. Also relevant for biotechnology patents are Markush claims, which are used where embodiments of the invention can include a class of compounds (e.g., chemicals or DNA sequences). By opting to use a Markush claim, the applicant need not spell out every possible combination individually, instead he can claim a range of products that may be used in an embodiment of the invention. This range is compiled on the basis of a limited number of representative samples. 

Caulfield T (2004). Biotechnology Patents, Public Trust and Patent Pools The Need for Governance Health Biotechnology and Intellectual Property A New Framework. Hosted at the European University Institute, Florence, Italy. 

Clarke J, et al. (2000). Patent Pools A Solution to the Problem of Access in Biotechnology Patents United States Patent and Trademark Office. Available http //www. uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf. 

After a decade of slow, steady growth, biotechnology patent awards began a steep ascent in 1995, when nearly 4000 patents were granted. Since then, the number of patents has skyrocketed at a rate of 25% or more each year. 

In addition, the majority of the relevant biotechnology patents are related to specific methods for production, sometimes even restricted to a specific expression system, rather to appear as broad substance patents. This is related to the fact that recombinant versions of already known natural proteins, in principle, lack novelty. The recombinant protein itself was not regarded as new if the natural protein was state of the art. Therefore, patents have to claim a recombinant protein in combination with modes of production, including vector constructs, expression systems, and purification methods, or more importantly, together with an application. It is obvious that for nearly all examples of products, which are mentioned in Table 2, one will not find a monopolistic market situation. Typically, parallel developments using distinct solutions lead to two or more competing products. 

Critics of biotechnology patents have also claimed that patents on human body parts, such as genes, cell lines, and DNA, are unethical because they treat people as marketable commodities [19, 21, 22, 26]. Some have even compared patents on human... 

One of the most important ethical and policy concerns raised by the critics of biotechnology patenting is that patenting... 

Restricting the scope of biotechnology patents in order to allow for work around inventions and to promote competition [3,16]. 

Patent Laws Governing Applications of Biotechnology Patents Related to Agricultural Products... 

Between fiscal years (FY) 1994 and 1995, biotechnology patent applications submitted to the US Patent and Trademark Office (PTO) increased by... 

This is almost double the 1% increase in overall patent applications submitted to the PTO between FY 1993 and FY 1994. The PTO has responded to the growing demand for patents by the biotechnology industry by increasing the number and sophistication of biotechnology patent examiners. In FY 1988, the PTO had 67 patent examiners. By 1998, the number of biotech examiners more than doubled to 184. 

FY 1997 Biotechnology Patent Application Submissions FY 1996 Biotechnology Patent Application Submissions... 

Average pendency time for a biotechnology patent (FY 1997) 27.1 months... 

The group of Zucker and Darby [141 -143] found a positive impact of research universities on nearby firms related to a positive impact on the firms research productivity, increasing the number of biotechnology patents, more products in development, and more products on the market, as of 1989-1990. Arts and Veugelers [144] and Arts et al. [145] discussed indicators derived from patent documents to capture the nature and impact of technological inventions, and to compare and validate these indicators within the field of biotechnology. However, the studies suffer from a lack of interdisciplinarity, which may be considered necessary for such work. 

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