The plaintiff, Sino-foreign Pharmaceutical Co., Ltd., has developed a drug "Aidit calcitol soft capsule" for the treatment of osteoporosis, obtained the marketing license in China, and has related invention patents in China, and registered accordingly. The defendant Wenzhou Haihe Pharmaceutical Co., Ltd. applied to the State Pharmaceutical Products Supervision and Administration for the listing license of the generic drug of the above-mentioned original drug, and declared that the generic drug did not belong to the protection scope of the plaintiff's relevant patent rights. On this basis, the plaintiff filed a lawsuit in Beijing Intellectual Property Court, requesting to confirm that the generic drug belongs to its patent protection scope.
After trial, the court held that the technical scheme of the defendant's generic drug was different from the technical scheme of the plaintiff's patent and did not belong to the scope of patent protection, and the judgment rejected the plaintiff's claim. After the verdict was pronounced, the plaintiff said that he would appeal, and the defendant said that he would obey the judgment of the first instance.
If pharmaceutical companies don't make a profit by selling drugs, they lack research and development motivation, and it is difficult to develop new drugs, and patients won't have good drugs, but if the price of new drugs is too high, patients can't afford them. The research and development cost of generic drugs is relatively low, and the price is not high, so ordinary people can afford it. Therefore, it is necessary to balance the interests of the original drug research enterprises and generic drug enterprises, and the "drug patent linking system" is the "legal gold prescription" issued by the new patent law to solve the above problems.
It is reported that article 76 has been added to the new patent law, and China's "drug patent linking system" has been formally established. Subsequently, the Supreme People's Court issued a supporting judicial interpretation, and determined that Beijing Intellectual Property Court would exercise centralized jurisdiction over such cases.
The presiding judge said that on the one hand, the drug patent linkage system enhanced the judgment of the original drug research enterprises on market certainty, enabling them to decide whether to increase continuous investment to promote the innovation and development of the industry, on the other hand, it also confirmed the listing risk for generic drug enterprises in advance, thus promoting the high-quality development of generic drugs. By balancing the interests of original drug research enterprises and generic drug enterprises, the accessibility of drugs will be promoted to the maximum extent, so that Chinese people can eat good drugs and cheap drugs.