1983, Bolar company is a flurazepam hydrochloride imitation of Roche sleeping pills that can be listed as soon as possible. Before the patent of this product expired (1984 65438+ 10/7), 5kg of raw materials were imported from abroad, and the pharmaceutical, stability and bioequivalence required to apply for the marketing license from the FDA of the United States were studied, and Roche sued for patent infringement. After the second trial, the Federal Circuit Court finally ruled that Bolar Company was infringed. However, the court is also aware that it takes many years for a drug to obtain a marketing license. If the relevant trials of generic drugs are started after the patent expires, the patentee actually obtains the exclusive right outside the patent period. The Federal Circuit Court believes that this is a conflict between the federal food, drug and cosmetic law and the patent law. The court is not the appropriate institution to solve this problem, and this problem should be submitted to the National Assembly.
1984, the us congress amended the patent law, stipulating that "the act of obtaining and submitting the information required by the FDA does not infringe the patent right". The revised patent law holds that the above-mentioned Bolar company's behavior does not infringe the patent right, that is to say, the experimental research, such as clinical trials, required for drug registration and approval during the patent period does not infringe the patent right.
Since then, American courts have adopted an increasingly loose interpretation of the scope of application of the Bolar exception. Expand "patented products" to medical devices other than medicines; As long as the data needed for FDA approval is collected, whether it has commercial purpose or not, it belongs to the category of "reasonable correlation"; Even considering the high failure probability of drug screening, even if the information collected in preclinical research is not submitted to FDA, as long as the information is suitable for submission in the formal procedures of FDA, the "Bolar exception" can be applied. In addition, the Supreme Court of the United States also ruled that the Bora exception is not limited to experiments on humans, but also includes experiments on animals. In the case of Amgen v Roche in 2007, the United States Court of Appeals for the Federal Circuit (CAFC) held that the Bolar exception applies to the import of both patented products and drugs produced by patented methods. The defendant (Roche) in this case can apply the Bolar exception if his behavior is reasonably related to obtaining the data required by FDA and his behavior is not regarded as infringement. After the United States, Bolar exception is widely recognized by many countries and regions through legislation or precedents. In the third revision of China's patent law, something similar to the Bolar exception was added, which had an important impact on the development of the pharmaceutical industry.
Germany did not explicitly stipulate it in its legislation, but gradually established the special rules applicable to the "Bolar exception" in specific cases: the German Constitutional Court in June 5438 +2000 10. BGH's judgment on Kli-nischeVersucheⅱ II case is affirmative: the use of patented drugs to obtain information before the patent expires (whether the information is about the second indication that the drug is not protected by patent or the same indication that is protected by patent), even if the purpose is to obtain marketing approval data, is an exception to experimental use and does not constitute infringement.
Article 69 of the Japanese Patent Law (1) stipulates the exception of experiments: "The validity of patent right does not extend to the use of patent for the purpose of experiments and research". On the basis of this clause, the Supreme Court of Japan made a case of exceptional non-infringement of Bolar.
In 1993, Canada stipulated the "Bolar" clause in Article 55. Patent Law 2 (1).
In addition, Argentina, Israel, Australia and Malaysia have also introduced the "Bolar exception" principle. This shows that the system value of Bolar exception principle has been recognized by most countries, and this system design balances the interests of patentees and the public. Theoretically speaking, the rationality and legitimacy of this exception stems from Article 30 of TR IPS Agreement: "Members may make limited exceptions to the exclusive right granted by patents, as long as this exception does not unreasonably conflict with the normal utilization of patents or unreasonably harm the legitimate interests of patentees, but the legitimate interests of third parties should be considered". As some scholars have summarized [4], the "BOLAR exception" exempts generic drug manufacturers from the tort liability of researching and using drugs before the expiration of the patent term, eliminates the extra extension of the patent term brought by the examination and approval, and does not affect the patentee's right to enjoy market monopoly and obtain expected economic returns from it within the legal patent term. Therefore, the "BOLAR exception" fully meets the authorization conditions of Article 30 of TRIP.