experience in intellectual property matters, including patent prosecution and litigation, invalidity and non-infringement opinions, licensing of patents and computer technology, as well as trademark and copyright protection. He has been the author of a blog dedicated to patent law issues and strategies called Inventive Step since 2008, which can be found at http://inventivestep.net. 4501 Highwoods Parkway Suite 210 Glen Allen, Virginia 23060 804.346.0600 Phone 804.346.5954 Fax mosenga@goodmanallen.com www.goodmanallen.com patented? To meet the patentability requirements of the Patent Act, an invention must be useful, novel and non-obvious. The invention must be described in sufficient detail to permit one of ordinary skill in the art to make and use the invention. Are there any other limitations on what can be patented? Should there be? A recent Supreme Court opinion says yes, limiting the types of inventions that may be patented, particularly in the field of biotechnology. patent is set forth in 35 U.S.C. § 101: new and useful process, machine, manufacture, or composition of mat- ter, or any new and useful improve- ment thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. Chakrabarty, the Supreme Court decided patented. The inventor had developed a bacterium capable of breaking down crude oil that could be used in cleaning up oil spills. The United States Patent and Trademark Office (PTO) rejected his patent application on the basis that living things are not patentable subject matter. The Supreme Court reversed, holding that the bacterium was not naturally occurring and qualified as patentable subject matter as a "manufacture" or "composition of matter" under the § 101. The Court cautioned that limitations should not be read into the statute that Congress has not expressed. In what is now considered the high point of the permissiveness of patentable subject matter, the Court quoted the leg- islative history of § 101 that patentable subject matter includes "anything under the sun made by man." Chakrabarty is widely viewed as the case that spurred the nascent field of biotechnology. The PTO took the Supreme Court's injunction literally and began issuing patents on isolated Isolating DNA sequences has permitted biotechnology companies to develop tests for genetic diseases and to create research tools to permit us to learn more about the human body and how to treat various diseases. These inventions are leading to personalized medicine, including customized medical decisions, practices and products tailored for individual patients. While patents may have been the incentive to spur on these advances in biotechnology and medicine, patents also permit their owners to exclude use of the claimed technology for the term of the patent. This has raised the debate on access to these new medical breakthroughs. More than 30 years later, the Supreme Court has waded into the field once more and decided that isolated DNA is a product of nature and is therefore not eligible to be patented. Pathology v. Myriad Genetics humans and other organisms. Each gene is encoded as DNA that occurs within the organism. Scientists can extract and isolate DNA from the genes for research, as mentioned above. Through manipula- tion, they can develop synthetic DNA in Biotechnology Can be Patented |