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The New Biotechnology

The main forms of intellectual property that are relevant to inventors and companies working in the new biotechnology—for example, rDNA, cell fusion, and novel bioprocessing techniques—are patents, plant breeders' rights, and trade secrets. Biological and medical inventions are excluded from patent protection in many countries. Whereas U.S. patent law, as a result of Diamond v. Chakrabarty, allows for the patenting of a broad range of subject matter, including plants and animals, the laws in Europe and Japan generally do not. The European Patent Convention, for example, prohibits patent protection for "plant or animal varieties or essentially biological processes for the production of plants and animals" (Benko, 1987:44).

The new biotechnology is affected particularly by the patent doctrine that excludes scientific discoveries, because of the increasing frequency with which such discoveries can be turned quickly into commercial products. Moreover, because academic scientists are playing such an important role in its development, biotechnology is affected particularly by differing criteria of novelty as reflected in the variable length of grace periods. Some universities, however, require research results to be published within 6 months of completion of the research, which may not be long enough to allow a patent search and application process to be completed. On the other hand, some of the universities that have developed major research support relationships with private industry now permit longer delays between discovery and publication. Previous publication is a bar to patentability in many countries, as in the case of the Cohen-Boyer patent mentioned earlier.

In many countries, a deposit of the microorganism is required to obtain protection.2 In countries that publish unexamined patent applications (the majority of developed countries), deposited cultures are usually released to the public at the same time—generally 18 months after the application is filed. The culture thus can become publicly available before any patent rights have been granted.3 This effectively negates the potential for protection under trade secret law (which requires the inventor to take measures to keep the invention secret) if a patent is not issued. As a recent Office of Technology Assessment (OTA, 1984:389) report noted: "In essence . . . the

2  

The United States is party to the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purpose of Patent Procedure, under which member states recognize in their own patent procedures a microorganism deposit made in another country if the deposit is made in a depository that meets the requirements of the treaty (Office of Technology Assessment, 1984:389).

3  

In the approach taken by the United States and Japan, release is deferred until the date of grant of the patent, because it is considered inequitable for the depositor to lose control of the microorganism before receiving an enforceable, exclusive right (Beier et al., 1985:91).



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