The Bolar exception originated in the United States as a patent infringement exception spawned by the Bolar v. Roche case, also known as the Safe Harbor provision.
In 1983, in order to market Roche's generic version of the sleeping drug flurazepam hydrochloride as early as possible, Bolar imported 5kg of raw materials from abroad before the expiration of the product's patent (January 17, 1984) to conduct the research necessary for applying for marketing authorization to the U.S. FDA for the study of formulations, stability, and bioequivalence, etc., and was then sued by Roche for patent infringement. After a second trial, the Federal Circuit ultimately ruled that Bolar had infringed the patent. However, the court also recognized that it takes many years to obtain marketing approval for a drug, and that if generic-related trials are initiated after the expiration of the patent term, the patentee will effectively be granted an exclusivity right that extends beyond the patent term. The Federal Circuit held that this was a conflict between the federal Food, Drug, and Cosmetic Act and the Patent Act, and that the courts were not the proper forum to resolve the issue, which should be left to Congress.
The U.S. Congress amended the Patent Act in 1984, which states that "relevant conduct intended solely for the purpose of obtaining and submitting information required by the FDA does not infringe a patent", and the amended Patent Act held that the aforementioned Bolar's conduct did not infringe a patent, i.e., during the patent period In other words, the conduct of clinical trials and other experimental studies required for drug registration and approval during the patent period does not infringe the patent.
The U.S. courts have since adopted an increasingly liberal interpretation of the scope of application of the "Bolar exception". The "patented product" has been expanded to include medical devices other than drugs; as long as the data is collected for the purpose of FDA approval, regardless of whether it has a commercial purpose, it falls into the category of "reasonably related"; even in view of the high failure rate of drug screening, the "Bolar Exception" is not applicable to preclinical studies, even if the data collected in preclinical studies is not used for the purpose of FDA approval. Even if the information collected in preclinical studies is not submitted to the FDA, the Bolar exception applies as long as the information is suitable for submission in the FDA's regular program. In addition, the U.S. Supreme Court has ruled that the Bolar exception is not limited to experiments on humans, but also applies to experiments on animals. In the 2007 Amgen vs. Roche case, the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the "Bolar Exception" can be applied to the importation of patented products as well as to the importation of drugs manufactured by patented methods. The defendant in this case (Roche) acted in a way that was reasonably related to obtaining the data required by the FDA, so the Bolar exception can be applied and its behavior is not considered as infringement. After the United States, the Bolar exception has been widely recognized in many countries and regions through legislation or jurisprudence. The addition of the Bolar exception in the third revision of China's Patent Law will have a significant impact on the development of the pharmaceutical industry.
Germany did not explicitly provide in the legislation, but the specific cases gradually established a special rule applicable to the "Bolar exception": In October 2000, the German Constitutional Court (German Constitutional Court) affirmed the BGH's decision on the Kli - nische Versuche. In October 2000, the German Constitutional Court affirmed the decision of the BGH in the case of Kli - nischeVersuche II, that the use of a patented pharmaceutical product before the expiration of the patent expiration date to obtain information from a trial (regardless of whether the information is on the second indication of the pharmaceutical product that is not covered by the patent, or on the same indication that is covered by the patent), even if the purpose of the act is to obtain the data of the approval of the marketing, belongs to the exception of the use of the trial, and does not constitute an infringement.
Article 69 (1) of the Japanese Patent Law provides for the experimental use exception: "The effect of a patent shall not extend to the use of the patent for the purpose of experimentation and research". The Supreme Court of Japan has relied on this provision to decide that the Bolar exception is not infringed.
In 1993, Canada introduced a "Bolar" type provision in section 55.2 (1) of the Patent Act.
In addition, Argentina, Israel, Australia and Malaysia have also introduced the "Bolar exception" principle. This shows that the principle of "Bolar exception" system value has been recognized by most countries, this system design balances the interests of the patentee and the public. From the theoretical basis, the rationality and legitimacy of this exception is rooted in Article 30 of the TRIPS Agreement, which stipulates that "Members may provide for limited exceptions to the exclusive rights conferred by patents, provided that such exceptions do not unreasonably conflict with the normal utilization of patents or unreasonably prejudice the legitimate interests of the patent owner, but shall take into account the legitimate interests of third parties". ". As some scholars have summarized [ 4 ], "Bolar exception" exempts the generic drug manufacturers in the expiration of the patent period in order to obtain the approval of the data on the use of the infringement of data on the drug, eliminating the approval of the additional extension of the patent period, and does not affect the patentee in the statutory patent period to enjoy the monopoly of the market and obtain the expected economic returns, the right of the patentee to enjoy the market monopoly and get the expected economic returns, the patentee should take into account the legitimate interests of third parties. The Bolar Exception is therefore fully compatible with the authorization conditions of Trip s 30.