First, let me say that it is really a complete misnomer to refer to “gene patents” because despite what the popular press may write, and perhaps believe, genes are not patented. Nevertheless, I will cave into the masses and concede (at least for now) the linguistic high ground and refer to gene-related innovations that are examined by patent authorities and provide exclusive rights to owners as “gene patents.” This is, however, a big part of the problem facing the US patent system and patent systems around the globe insofar as genetics, bio-technology, software and business method patents are concerned. Because we live in a world dominated by sound bites and pithy commentary, reality and truth are frequent victims of easy, misleading and sometimes completely inaccurate reporting.

While it is admittedly important and necessary to dissect and present complex information to those who are unfamiliar but interested, this desire to inform cannot and should not be at the expense of accuracy. Intellectual honesty must not be replaced by dumbing down the debate to the point where people can understand the concepts, but the information conveyed is wrong. Individuals, including members of Congress, make decisions based on the information they receive, and when that information is inaccurate, misleading and/or wrong, bad decisions result, which cannot be deemed acceptable to anyone. It is critical to understand the broader context of the debate, and to get to the heart of the matter so that an open, honest and fair debate of the issues can take place.

With this in mind, lets explore how so-called gene patents came about. The overwhelmingly most important development was the United States Supreme Court decision in Diamond v. Chakrabarty, which occurred in 1981. In this case the US Supreme Court determined that living matter could be patented. This has lead to many throughout the anti-patent community to become incredulous, but how many of them have actually taken the time to familiarize themselves with the case or the patent involved? I suspect the answer is few, if any, have really explored what this case was all about, choosing rather to focus on the pithy sound bite explanation I set forth a few sentences ago, which is typically all the reporting you ever hear about the case.

[Bio-Pharma]

In this case the US Supreme Court determined that a live, human-made micro-organism is patentable subject matter under 101. The inventor, Chakrabarty, created a genetically engineered bacterium capable of breaking down multiple components of crude oil. This unique characteristic was possessed by no naturally occurring bacteria, and it was believed that this genetically engineered bacterium could have significant value for the treatment of oil spills.

The Supreme Court explained that Chakrabarty’s micro-organism constituted a “manufacture” or “composition of matter” within the meaning of US patent laws. Further, the Supreme Court explained that when Congress chose such expansive terms as “manufacture” and “composition of matter,” modified by the comprehensive “any,” the intention was unambiguously to give wide scope to the patent laws, at least in terms of what is capable of qualifying for patent protection. Of course, it is important to keep in mind that the fact that something is patentable subject matter is but one of the inquiries on the road to patentability. So many who are offended by some patents, such as software patents, business method patents and bio-tech patents, either intentionally or unknowingly think that if something is patentable that means a patent will issue. When those in the patent industry talk about something being patentable, at least in this context, we are referring to but one of the patentability requirements. An invention still has to be useful, new, non-obvious and described sufficiently to inform the relevant public how to make and use the invention.

In any event, while laws of nature, physical phenomena, and abstract ideas are not patentable, Chakrabarty claimed a heretofor previously unknown and unnatural creation; namely a nonnaturally occurring manufacture or composition of matter, which was a product of human ingenuity. If there is concern whether such human-created life should be patentable subject matter that is a matter of policy for Congress, not for the courts. The courts are supposed to interpret the law, not make the law. In this context the law is incredibly clear — “anything under the sun that is made by man” is patentable subject matter in the United States, and quite obviously the genetically created living matter at issue in Chakrabarty qualified as “made by man” and was, therefore, correctly determined to be patentable subject matter within the dictates of US patent law.

The History of Gene Patents Part II will pick up from here with discussion of patents related to genetically engineered oysters and the so-called Harvard Mouse, which were additional steps down the patent path, toward where we are today.