Patent Exhaustion In Gene Patents

The patent exhaustion doctrine is a defense to patent infringement. According to the patent exhaustion doctrine, the right to use and the right to resale the patented product are exhausted after the patented product was legally sold. However, the patent holder still control the right to make. In judicial practice, the court often use "use/make" doctrine to judge whether the patent exhaustion doctrine apply to the alleged infringement. However,unlike the ordinary patent product, due to the gene patents’ self-replicating features, in some cases, the use of gene patent is often accompanied by self-replicating, namely "make" offspring gene patents. In such cases,the patent exhaustion doctrine is difficult to apply.These offspring gene patents has the same properties with parental gene patents. If the patent holder can’t control the buyer’s any way of use once after the gene patentwas sold, the patentee’s all interests on the patentwill beended by just one transaction. If the the patent exhaustion doctrine is not applied on gene patents, the buyer’s right to use will begreatly limited. How to balance the interests between the patentee and the buyers,and how to apply the patent exhaustion doctrine on gene patentsreasonably are the problems that this paper going to solve.Theoretical, comparative and empirical analysisare all adopted in this paper. This paper can be divided into three parts, such as introduction, text and conclusion. The text has four chapters.The first chapter overviews the concepts of gene and gene patents,especially the self-replicating features which brings about the dilemma of application of the patent exhaustion doctrine on gene patents.In addition, this partintroduces the gene industry both at home and abroad, because it is related to the policy choices on how to apply the patent exhaustion doctrine on gene patents.The second chapter talks about the problems on the application of patent exhaustion doctrine on gene patents. Genes patents’ self-replicating features challenges the application of the patent exhaustion doctrine on gene patents, such as whether the gene patent and its offspring can be regarded as a whole, whether the offspring can be seen as being sold by the permission of the patent holder, whether the self-replicating behavior can be regarded as “use” or “make”, and how to balance the interests between the patent holder and the buyers. The most important thing is how to distinguish “use” and “make”.The third chapter focuses on other countries practice. America adopted two differentpractice on the application of the patent exhaustion doctrine on gene patents. One is to use contract to exclude the application of the patent exhaustion doctrine, the other one is to regard the self-replicating as “make” so that exclude the application of the patent exhaustion doctrine on the gene patents. But these two paths are not suitable for our country. The EU’s paths protect the interest of gene patent holder to the greatest extent, and at the same time, also properly balance the interests of the buyer,which is worth learning.The fourth chapter explores how to deal with the issue of the application of the patent exhaustion doctrine on gene patents in our country. By considering the three factors which effect the application of the patent exhaustion doctrine on gene patents such as the balance of interests between the patentee and the buyer, the research situations and the demand for patent protection of gene patents, and the alternative between the offspring with parental gene patents, this paper holds the view that in our country the patent exhaustion doctrine should be applied separately on parental gene patent and offspring. The patent exhaustion doctrine should be applied on parental gene patents, while offspring is not. At the same time, in order to protect the interests of the buyers, three behaviors should be considered to be in the scope of the patent exhaustion doctrine, namely the autonomous self-replicating without consciousness, the inevitably self-replicating, and the private use.