The study of non-obviousness in biotechnology patents following KSR and its possible impact to Taiwan patent examination
Date Issued
2010
Date
2010
Author(s)
Liu, Yen-Tzu
Abstract
Because biotechnology can help in health, agriculture and solving environment problems, it becomes an important industry now and in the future. However, it takes long time to develop and costs a lot, but the material is cheap, so it is important to protect the development by patent. We would like to develop bioindustry in our country, so we made a special chapter which is all about biotechnological and pharmaceutical patent in our patent law examination guidelines. The ratio of the courts used to reject the patent by lack of intentive-step is high, so it is important to know how the patent filled this requirement. Though we have a special chapter to protect BioPharma patent, the content is not enough so that the court will be reckless when they have to make a decision. Because most of our examination guidelines is followed the U.S., we must know what is the provisions of U.S. law before we check our law.
The requirement of intensive-step in our country is the non-obviousness requirement in the U.S.. Non-obviousness is the most subjective requirement of patent. The non-obviousness criterion was codified in the 1952 American Patent Act, but there were some arguments. The Supreme Court’s opinion in Graham v. John deere Co. is used to determine if the patent is obvious. The Federal Circuit has made TSM test to analyze if a combined patent is obvious. The Supreme Court in KSR disagreed with the Federal Circuit’s rigid application of the TSM test and favored an expansive and flexible expectation of Graham test. Thus USPTO has developed 2007 & 2010 KSR Guidelines Update. The Office has identified 7 rationales in 2007 KSR Guidelines Updates, and the most four rationales and the case in 2010 KSR Guidelines Update. These two Update make the officers and the applicants much more objective than before.
KSR’s art is about the much more developed field. Can the opinion restrict BioPharma which is much less developed? The cases after KSR showed that though BioPharma is much more unpredictable, the opinion of the Supreme Court in KSR can still restrict them. Even though BioPharma is much more unpredictable, we should use an expansive and flexible expectation of Graham test to analyze the case.
Because the criterion of BioPharma patent in our country is subjective, we have to think the current situation of us, and take into consider of the objective standard of the U.S..
Subjects
non-obviousness
intensive-step
biotechnology
BioPharma
KSR Guidelines Update
Type
thesis
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