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Biological patent

A biological patent is a patent relating to an invention or discovery in biology.

History

The 1970’s marked the first time when scientists patented methods on their biotechnological inventions with recombinant DNA. It wasn’t until 1980 that patents for whole-scale living organisms was permitted. In Diamond v. Chakrabarty, the Supreme Court overturned a previous precedent allowing the patentability of living matter. The subject for this particular case was a bacterium that was specifically modified to help clean-up and degrade oil spills.

Since legal changes have occurred starting in 1980, there has been a general trend of patenting inventions on living matter. More knowledge and data has become available in recent years that have never before been available. However, for us to get to the point where it is making a significant difference in peoples’ lives, a tidy sum of money needs to be invested. Biotech and pharmaceutical companies in recent years have found out how lucrative biological research can be. These firms foster many research opportunities by funding made possible only through the private sector. Patents have provided an impetus for research to be pursued in that the end goal of money can be envisioned by companies with the funding cash. Especially during the genomic era, more patents were issued. Companies and organizations like the University of California were patenting whole genomes.

In 1998, the U.S. Patent and Trademark Office (PTO) issued a broad patent claiming primate (including human) embryonic stem cells, entitled "Primate Embryonic Stem Cells" (Patent 5,843,780). On 13 March 2001, a second patent (6,200,806) was issued with the same title but focused on human embryonic stem cells.

Recently, there has been a slowdown and backlash against patenting biological material worldwide.

Controversy

Some feel that natural occurrences are not invented and thus should not be patentable. This is especially true if the biological matter being patented can be found in humans, such as sequences of DNA. The reason for the controversy associated with patenting biological material is less clear in the United States whose patent process differs from the rest of the world. The term invention, which is much more broadly interpreted, must prove to have a utility instead of industrial application. According to Nielson and Whittaker (2002), the “notion of ‘utility’ is less specific, it means it is useful” .

Many outside the United States feel that the patenting of stem cells was rash and are seeking to reverse patent rulings. In December 2006, Germany made an important precedent when it annulled the validity of a stem cell patent. The German Federal Patent Court declared that anything made from human tissue cannot be patented. In more general terms, the European Patent Office has ruled that stem cell lines are not to be granted a European patent. This convention includes 32 countries and 5 that recognize European patents. Worldwide, people are questioning the validity of stem cell patents. Wisconsin Alumni Research Foundation has sought to gain approval for its US patent in Europe without success.

The backlash against stem cell patents is also occurring in the United States, but to a lesser degree. Especially in the genomic era, Also, many today feel that the stem cell patents awarded to WARF were undeserved. Currently, an appeal against the patents is being processed by two non-profit organizations: The Foundation for Taxpayer & Consumer Rights and Public Patent Foundation along with molecular biologist Jeanne Loring of the Burnham Institute. They are fighting the validity of the patents by arguing that two of the patents cover a technique published in 1992, already patented by an Australian scientist. Another claim is that the techniques tied up with the patents are rendered obvious under a 1990 paper and two textbooks.

Advocates who speak against biological patents suggest that the techniques and processes associated with the discovery could be patentable but not the actual biological matter itself. For example, an advocate against biological patents would suggest that a gene associated with cancer should not be patented, but the test used to detect the gene could be.

Effects on research

Some feel that the increase in patenting biological information leads to inefficiency in research. Many scientists are coming up against patent thickets, which are masses of information that they must obtain permission (and often pay large fees to utilize) before they can ever work with the information. Michael Heller and Rebecca Eisenberg (2005) explain that there is a recent trend of patenting more and more steps along the research path. This creates a "tragedy of the anticommons," whereby "each upstream patent allows its owner to set up another tollbooth on the road to product development, adding to the cost and slowing the pace of downstream . . . innovation" . A report shows that notwithstanding escalating funding, in the past half-decade biomedical innovation has slowed markedly. The number of drugs approved by the Food and Drug Administration has fallen below previous eras. The technologies approved, it continues, are less influential than previous innovations approved. The current trend of patenting what previously were thought of as basic science insights have raised the financial bar for other scientists wanting to use such insight. The overall trend of more patents may be slowing innovation.

However, others point out that patents are necessary for research. Without them, scientists would keep secret all discoveries for fear of colleagues and others stealing their ideas. There would also be little incentive for large-scale investments from the private sector.