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The highest court of the European Union limits the legal protection of a biotechnology invention(07/15/10)
Monsanto Technology LLC v. Cefetra BV (Court of Justice, July 6, 2010).
The highest European Union court determined in Monsanto v. Cefetra that soybean meal imported from Argentina (where Monsanto has no patent on genes added to soybeans to increase resistance to herbicide) to Europe (where such genes of modified soybeans are patented) is not forbidden. The court determined that Article 9 of Directive 98/44/EC of the European Parliament and the Council of 6 July 1999 pre-empted Netherlands law and excluded patent protection because the patented genes are not performing their customary service in Europe. The imported soybean meal is dead material. Although it contains the modified genes, these genes are not used or expressed in Europe even though they were active when the soybean plants were alive (in Argentina) and even though they could be extracted in Europe and used in living plants.
This decision limits the ability of biotechnology patent owners to exclude others from benefiting in Europe from the use of patented genes. Monsanto is one of the world’s largest suppliers of seed for genetically modified plants and particularly plants that may safely be exposed to herbicide in order to kill surrounding weeds (here, the “Roundup Ready® System” plants such as corn, canola, soybeans, and cotton). Monsanto’s European patent will allow Monsanto to exclude farmers from growing plants from Roundup Ready seed in Europe but will not prevent anyone from importing and selling the resulting foodstuffs as long as the plants were grown elsewhere. This creates an export opportunity for countries with weaker patent protection for genes or genetically-modified organisms, such as Argentina.
Under the interim instructions, examiners should continue to examine patent applications for compliance with the machine or transformation test that the Bilski court said was no longer the sole test for patent eligibility. A claimed process is likely to be patent-eligible if it meets this test unless the examiner perceives a “clear indication that the process is directed to an abstract idea.” The examiner should reject it as being not being patent-eligible under Section 101 of the Patent Code should the claimed process not meet the machine or transformation test, unless there is a clear indication that the process is not directed to an abstract idea. The applicant will have the opportunity to explain why a claimed process, rejected as being patent-ineligible, is not directed to an abstract idea. Drafting a patent application to show that a claimed process is not merely directed to an “abstract” idea will help avoid later difficulties.
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