Gene Patents

In the U.S., the laws do not allow patents on products of nature because the public would not gain anything new if an individual were allowed to, for example, patent air and charge us each a license fee whenever we breathed. Nor are patents allowed on scientific formulas.

When the international Human Genome Project proposed to spend billions of dollars of taxpayer money identifying all 30,000 human genes, most biological scientists had no expectation they would actually own the genes they studied. In fact, the idea at the time seemed absurd. They were in it for Nobel Prizes, academic advancement, status. Yet today, with thousands of gene patents having been awarded over genetic sequences, intense international opposition to these patent rights is mounting.

Industrialized nations around the world share a belief in the importance of a strong patent system. The framers of the U.S. Constitution realized two centuries ago that it was important to create incentives for technological innovation with Article I of the United States Constitution, giving Congress the power ñto promote the progress of Science and useful Arts. In European nations, patent law is codified in the European Patent Convention, an international agreement among 27 nations, and the Directive 98/44/EC of the European Parliament and Council of the European Union.

Internationally, 146 nations, including the U.S., are signatories to the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), which is an instrument of the World Trade Organization that addresses the protection and enforcement of patent rights. A specific public health exception to TRIPS provides that a patent may be denied by any nation for an invention if the commercial exploitation is prohibited for reasons of public order or morality. Other permitted exclusions are for diagnostic, therapeutic and surgical methods. While these seem like broad enough exceptions to apply to gene patents over genetic sequences, they are rarely, if ever, used by national patent offices to deny patent protection.

Under standard patent law provisions in industrialized nations, the patent applicant must show that his or her invention is novel, non-obvious, and useful. When a patent is granted, the inventor has the right to exclude others from making, using or selling his or her invention for 20 years. The patent laws are designed to assure that the public benefits from a new invention in exchange for these exclusive rights.

In the U.S., the laws do not allow patents on products of nature because the public would not gain anything new if an individual were allowed to, for example, patent air and charge us each a license fee whenever we breathed. Nor are patents allowed on scientific formulas. The U.S. Supreme Court has pointed out, The laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law E=mc²; nor could Newton have patented the law of gravity. Such discoveries are ïmanifestations of . . . nature, free to all men and reserved exclusively to none.

But genes seem to be both a product and a formula. Consequently, some groups question the granting of patents on genes, arguing that genes are an inherent product of nature. Numerous international organizations, such as the Council of EuropeÍs Committee on Legal Affairs and Human Rights and UNESCO, view genes as belonging to the common heritage of mankind. Group opposition to gene patents is also coming from researchers, politicians, indigenous groups, patient groups, and medical professional organizations. A growing body of research suggests that gene patents create barriers to research and development of technologies and impede healthcare by hindering access and increasing costs. Gene patent holders can use their exclusive control over genetic material to prevent other researchers from utilizing the specific genetic sequence for further research and can charge excessive fees for diagnostic testing of medical patients. Scientific collaboration is stifled because some researchers refuse to share patient tissue samples or preliminary findings because they each want to be the first one to discover the profitable gene.

While it may be appropriate to award patent rights to a genetic diagnostic kit or a genetic therapy in order to motivate biotechnology companies, academic institutions, and individual researchers to innovate, concern is growing over providing patent protection over an isolated sequence or a clone of a gene.