向仿製藥廠商提供專利活性藥物成分是否侵犯專利權：歐盟的安斯泰來訴波爾製藥案與Bolar例外的適用

Whether the supply of patented active pharmaceutical ingredients to generic drug producers can infringe the patent rights: The EU's AsteHas v. Polpharma pharmaceutical case and the application of Bolar exemption

我國與歐盟的Bolar例外規則存在著諸多差別。從歐盟安斯泰來訴波爾製藥案提出的問題，即第三方供應商向仿製藥廠商提供專利活性藥物成分時能否主張Bolar例外來看，歐盟及其成員國的立法仍隱晦不明。相比之下，我國專利法的Bolar例外規則給出了肯定的答案，從而為仿製藥市場的發展提供了更好的法律預期。但為了更好地平衡專利權人與仿製藥產業的利益，針對這種提供行為，應突出強調供應商的相關注意義務，確保其提供的活性藥物成分僅用於Bolar例外所允許的為獲取行政審批所需信息的研究和試驗活動。

There are many differences in term of the Bolar exemption between EU and China. As to the dispute raised by Astellas v. Polpharma that whether the supply of patented active pharmaceutical ingredients to generic drug producers can enjoy the Bolar exemption, the law in EU Directive and EU member states offer no c1ear answer. By contrast, Bolar rule in Chinese Patent Act give a positive and c1ear answer which offers a better legal certainty to the generics industry. However, to strike a better balance between the patentee and the generics industry, China should place emphasis on the supplier's duty of case, make sure the active substance he supplies wi1l exc1usively be used for privileged approval studies.