Ethics Tech Transfer

Between 1790 and 1860, the Patent and Trademark Office of the federal government issued just 36,000 patents- licenses that give an inventor the exclusive rights to make, use or sell an invention for a set period of time

To balance these competing interests, Harvard agreed to receive an equity stake in the company, and Syndexa would pay Harvard a small up-front fee to license the patents that Hotamisligil had developed. For Syndexa one of the key parts of negotiations was centered on the research that the start-up intended to fund in Hotamisligil’s lab at Harvard. Harvard had major concerns with how the Syndexa-sponsored research will be separated from the other funds (government- or foundation-funded projects) that Hotamisligil receives. Harvard cannot funnel federally funded inventions to companies, however at the same time Syndexa was looking for assurance that they would have first crack at intellectual property for a technology that they funded. Another major issue extending negotiations was the conditions under which Syndexa would make royalty payments to Harvard for products that were not covered under Harvard patents, but discovered using Harvard technologies. To ensure that Harvard would receive a reasonable return on the patents it was licensing, Syndexa agreed to pay a small royalty rate if they developed a new therapeutic cure for diabetes using its Harvard license. Both parties agreed to the concept of an ‘identified product’, essentially a drug discovered through the use of patents, targets and assays being licensed from Harvard. Negotiations over what constituted an ‘identified product’ continued through the rest

Rannazzisi, J. T. (2010). Role of Authorized Agents in Communicating Controlled Substance . Retrieved from http://www.gpo.gov/fdsys/pkg/FR-2010-10-06/html/2010-25136.htm

Chapter 25 – 1976-1988 – This chapter details the history of patenting living organisms — 1980 Supreme Court ruling which declared that Ananda Mohan Chakrabarty could patent a bacterium genetically engineered to consume oil and to help clean up oil spills.

“The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. What is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. Once a patent is issued, the patentee must enforce the patent without aid of the USPTO” (ALEXANDRIA 1).

Article I, Section 8 of the U.S. Constitution provides the federal government with the power to issue patents and copyrights in order “to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries” (U.S. Const. art. I, § 8). A patent provides the inventor with an exclusive right to “use, license or sell and invention,” (U.S. Const. art. I, § 8), as such the product, service, process or design becomes the personal property of the inventor(s).

Acquiring patents for inventions in the chemical and pharmaceutical industry is a major part of my work here at Technology Law, PLLC. Chemical patents differ from other types of patent because of the high research costs involved and the risk in bringing new drugs on to the market. It is specialized work and I have years of experience in doing it. Patent protection lasts for 20 years from the date of its first filing, and in the US patent rights are enforced by litigation in federal district courts.

In the case of university patents, the problem was that of technology transfer, moving inventions and technology created in universities to the marketplace. The three phases involved in the construction of the institution of university patenting were the formation of a proto-institution by a skilled actor, the development and growth of a professional community, and finally the Bayh-Dole Act. The success of the institutionalization of university patenting was due to the social skill and resources utilized to elicit collective action.

The patenting race takes advantage of the same computer technology that made the sequencing possible. Companies seeking patents have been using automated DNA-sequencing machines to identify genes easily and cheaply. At the time when they file for the patents,

The U.S. constitution gave Congress the power to “ promote the devellopment of the useful arts” by granting exclusive rights to inventers for a limited period of time. The purpose of a patent was to assurre the rights of the creators in exchange for not keeping these inventions secret, thus overall knowledge base grows.

However, “Significant Use” is NOT a consideration in determining ownership of inventions by any UPR faculty as a part of or a continuation of federally sponsored research, because the Bayh-Dole Act provides for University ownership in such cases.

A patent on a gene is not an exclusive ownership right but excludes others for a limited time from commercial use. Research is still possible. Investments are only possible if their results can be

Therefore, protection of patents is one of the key conditions necessary for further development of the pharmaceutical industry. At the same time, non-efficient legislation that does not provide the necessary level of patent protection is one of the factors that hamper expansion of “Big Pharmaceutical” companies to the developing countries8.

government, in response to pressures from corporations in the United States, is seeking to force all countries to accept U.S.-style patent laws. For example, the government threatened to end science and technology agreements with India, unless the Indian patent laws were extended to cover pharmaceutical and agricultural products. The public is only just realizing the speed and scope of this privatization of biological material. For instance, Monsanto owns a patent covering all genetically engineered cotton, and Duke University has patented genes involved in Alzheimer's disease. Human Genome Sciences has patented the entire genomes of certain bacteria that can cause serious diseases in humans, to gain a monopoly on the development of new antibacterial agents. Myriad Genetics owns patents on the human genes that, when damaged, lead to breast cancer. And Axys Pharmaceuticals has applied for patents on the cells and genes of New Guinea tribes, for their presumed value in the development of certain treatments against viruses to which the tribes may have developed

The concept of product patent for pharmaceutical products is likely to make life saving medicine beyond the reach of the poor and deprived section of the society around the world.