Ted Hagelin, The Experimental Use Exemption to Patent Infringement: Information on Ice, Competition on Hold

58 Fla. L. Rev. 483 (2006) | | | |

INTRODUCTION :: The U.S. patent system is built upon a delicate balance between the rights of patent owners, the rights of the public at large, and the rights of market competitors. The patentee is granted broad rights to exclude others from making, using, or selling the patented invention in order to reward the patentee’s investment in creating the invention. In exchange for the grant of patent rights, the patentee is required to disclose the details of the invention in a patent application. This disclosure benefits both the general public by adding to the store of scientific knowledge, and market competitors by providing information about rival products and processes. In essence, the patentee’s property rights come at the expense of enabling challenges to the value of those rights through further scientific advances and increased competitor know-how. Conversely, the access by the public and market competitors to the information contained in the patent application comes at the expense of abiding by limitations upon the use of that information.

Experimentation with patented inventions is an activity that is central to the patent system balance. On the one hand, if researchers and competitors are able to use patented inventions for their intended purposes under the guise of experimentation, then patentees are deprived of economic benefits and the incentive to invest in inventive activities is diminished. On the other hand, if the public and competitors are unable to use patented inventions for genuine experimentation, then scientific knowledge is retarded and market competition is limited. Today, there are two types of experimental use exemptions to patent infringement. The first, the common law experimental use exemption, was developed through a long line of judicial decisions and applies to all inventions. The second, the Hatch-Waxman statutory experimental use exemption, was enacted by Congress in 1984 and applies only to drugs and medical devices.


Properly reconciling the interests of patentees, the public, and market competitors has never been more important. Invention of new technology is critical to the success of U.S. companies, the growth of the U.S. economy, the health and welfare of U.S. citizens, and U.S. competitive advantage in global trade. Perhaps because of its growing importance in our technology-based society, or perhaps because of its inherent interest to an array of professionals, experimental use of patented inventions has been the subject of a great deal of thoughtful scholarship. Writers have considered the development of both the common law and Hatch-Waxman experimental use exemptions, reviewed their operation in different research contexts, discussed enacted and proposed legislative changes, presented arguments in favor of expanding and contracting the scope of the experimental use exemptions and, most of all, proposed a myriad of law reform measures to shape the future development of the experimental use exemptions. This Article will attempt to synthesize the considerable scholarship in the field, provide additional context to the debate, and propose a new statutory experimental use exemption that would treat all inventions in the same way.

Part I of this Article will discuss the common law and Hatch-Waxman experimental use exemptions to patent infringement. The discussion of the common law experimental use exemption will consider the different tests that courts have developed to distinguish between permissible and impermissible experimental uses of patented technology and the rationales that have been advanced in support of these tests. The discussion of the Hatch-Waxman experimental use exemption will describe the Hatch- Waxman Act and consider the cases that have arisen under the Act with special attention to the most recent case, which was decided by the U.S. Court of Appeals for the Federal Circuit, and later reviewed by the U.S. Supreme Court. Part II of this Article will discuss the common law experimental use exemption in the context of other U.S. and foreign patent law policies. The U.S. patent law policies considered are the policy of requiring adequate disclosure of the invention in the patent application and the policy of not allowing the lawful scope of the patent to be expanded by private contract. The foreign patent law policies considered are the policies of individual countries and international organizations that expressly allow for the experimental use of patent subject matter in a variety of circumstances. Part III of this Article will discuss and critique the various law reform measures that have been proposed to reconcile the competing interests in the experimental use of patented technology. These law reform measures will be considered in terms of three aspects of experimental use: the nature of the organization conducting the experimentation, the purpose of the experimentation, and the nature of the patented technology used in the experimentation. The discussion of the law reform proposals will be organized from the most limited proposed exemptions to the broadest proposed exemptions.

Part IV of this Article will propose a new statutory experimental use exemption. The proposed experimental use exemption would be asymmetric in nature, and differentiate the patented subject matter that could be experimentally used by corporations, small businesses, and nonprofit research organizations. For corporations, the proposed experimental use exemption would only allow the use of patented subject matter owned by other corporations. For small businesses and nonprofit research organizations, the proposed experimental use exemption would allow the use of patented subject matter owned by corporations, small businesses, and nonprofit research organizations. The proposed experimental use exemption would permit the same experimental uses of all patented subject matter for corporations, small business and nonprofit research organizations. Those allowed uses would be for the purposes of education, scientific research, evaluating patent specifications, disclosures and claims, improving upon the patented subject matter, engineering around the patented subject matter, and developing competing, non-infringing patent subject matter. Part IV will also describe a means to distinguish between permissible and impermissible uses of patented subject matter under the proposed exemption, suggest statutory language to implement the proposed exemption, and discuss the benefits of the proposed exemption.

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