Gene patents in the United States

A gene patent is a patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims. Gene patents are a part of the broader category of biological patents.

Gene patents may claim the isolated natural sequences of genes, the use of a natural sequence for purposes such as diagnostic testing, or a natural sequence that has been altered by adding a promoter or other changes to make it more useful. In the United States, patents on genes have only been granted on isolated gene sequences with known functions, and these patents cannot be applied to the naturally occurring genes in humans or any other naturally occurring organism.

History
The United States has been patenting chemical compositions based upon human products for over 100 years. The first patent for a human product was granted on March 20, 1906 for a purified form of adrenaline. It was challenged and upheld in Parke-Davis v. Mulford Judge Hand argued that natural substances when they are purified are more useful than the original natural substances.

In 1980, the U.S. Supreme Court, in Diamond v. Chakrabarty, upheld the first patent on a newly created living organism, a bacterium for digesting crude oil in oil spills. The patent examiner for the United States Patent and Trademark Office had rejected the patent of a living organism, but Chakrabarty appealed. As a rule, raw natural material is generally rejected for patent approval by the USPTO. The Court ruled that as long as the organism is truly "man-made," such as through genetic engineering, then it is patentable. Because the DNA of Chakrabarty's organism was modified, it was patentable.

Examples
The "Chakrabarty patent", owned by General Electric, issued after the Supreme Court decision discussed above. This patent and the Supreme Court case "opened the floodgates for protection of biotechnology-related inventions and helped spark the growth of an industry."

The "Cohen/Boyer patents" were invented by Stanley Cohen of Stanford University and Herbert Boyer of University of California, San Francisco. The patents cover inventions for splicing genes to make recombinant proteins that are foundational to the biotechnology industry. Stanford managed the patents and licensed them nonexclusively and broadly, earning over $200 million for the universties.

The "Axel Patents" were invented by Richard Axel,Michael H. Wigler, and Saul J. Silverstein of Columbia University. These patents covered cotransformation, a form of transformation, another foundational method of biotechnology; Columbia licensed these patents nonexclusively and broadly and earned about $790 million.

Key methods to manipulate DNA to create monoclonal antibodies are covered by a thicket of patents, including the "Winter patent" was invented by Gregory P. Winter of the Medical Research Council which covers methods to make chimeric, humanized antibodies and has been licensed to about fifty companies. Abgenix owned a patent on methods of making transgenic mice lacking endogenous heavy chains. The "Boss patent" was owned by Celltech and covered methods of making recombinant antibodies and antibody fragments, together with vectors and host cells useful in these processes. Genentech owned the "Old Cabilly" patent that covered altered and native immunoglobulins prepared in recombinant cell culture, as well as the "New Cabilly" patent that covers artificial synthesis of antibody molecules. Medarex owned a patent that covered high affinity human antibodies from transgenic mice. These patents have been broadly licensed and have been the subject of litigation among patent holders and companies that have brought monoclonal antibody drugs to market.

A patent application for the isolated BRCA1 gene and cancer-cancer promoting mutations, as well as methods to diagnose the likelihood of getting breast cancer, was filed by the University of Utah, National Institute of Environmental Health Sciences (NIEHS) and Myriad Genetics in 1994; over the next year, Myriad, in collaboration with University of Utah, isolated and sequenced the BRCA2 gene, and the first BRCA2 patent was filed in the U.S. by the University of Utah and other institutions in 1995. Myriad is the exclusive licensee of these patents and has enforced them in the US against clinical diagnostic labs. This business model led from Myriad being a startup in 1994 to being a publicly-traded company with 1200 employees and about $500M in annual revenue in 2012 ; it also led to controversy and the Association for Molecular Pathology v. Myriad Genetics lawsuit mentioned below. The patents expire, starting in 2014.

Controversy
Law professor Rebecca S. Eisenberg argues that gene patents produce an "anticommons" at odds with an ideal scientific commons.

Others claim that patents have not created this "anticommons" effect on research, based on surveys of scientists.

Professional societies of pathologists have criticized patents on disease genes and exclusive licenses to perform DNA diagnostic tests. In the 2009 Myriad case, doctors and pathologists complained that the patent on BRCA1 and BRCA2 genes prevented patients from receiving second opinions on their test results. Pathologists complained that the patent prevented them from carrying out their medical practice of doing diagnostic tests on patient samples and interpreting the results.

Another example is a series of lawsuits filed by the Alzheimer’s Institute of America (AIA) starting in 2010, concerning a gene patent it controls. The patent covers a genetic mutation that predisposes to Alzheimer's, and more importantly, it applies to transgenic mice carrying the mutation. These mice are widely used in Alzheimer's research, both by academic scientists doing basic research and by companies that use the mice to test products in development. Two of these suits are directed to companies that were started based on inventions made at universities (Comentis and Avid), and in each of those cases, the university has been sued along with the company. While none of the suits target universities that are conducting basic research using the mice, one of the suits is against Jackson Labs, a nonprofit company that provides transgenic mice to academic and commercial researchers and is an important repository of such mice.

While there is some controversy concerning the patenting of isolated genes and the way those patents are used, and there is controversy concerning patents on the diagnostic uses of genes (the real source of dispute in the Myriad court case), it is difficult to find controversy surrounding patents on genes that are used to manufacture therapeutic proteins (for an example of patents on therapeutic proteins, the drug candidate that is the subject of the early part of the movie 'Extraordinary Measures' was covered in part by a classic gene patent, US Patent 6,770,468.) There is also little controversy concerning the role of gene patents in the chemical industry—for instance in the manufacture of enzymes used in consumer products or industrial processes.

Myriad Genetics case
Association for Molecular Pathology v. Myriad Genetics No. 11-725 is a case challenging the validity of gene patents in the United States, specifically challenging certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences.

The case was originally heard in the United States District Court for the Southern District of New York, which ruled that all the challenged claims were not patent eligible. Myriad then appealed to the United States Court of Appeals for the Federal Circuit. The Circuit court overturned the previous decision in part, ruling that isolated DNA which does not exist alone in nature can be patented and that the drug screening claims were valid, and confirmed in part, finding the diagnosic claims unpatentable. The plaintiffs appealed to the Supreme Court, which granted cert and remanded the case back to the Federal Circuit. The Federal Circuit did not change its opinion, so on September 25, 2012, the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari with the Supreme Court with respect to the second Federal Circuit Decision. As of December 2012 isolated genes remain patentable in the US.

On November 30, 2012, the Supreme Court agreed to hear the plaintiffs' appeal of the Federal Circuit's ruling. It is anticipated that the court will rule on whether isolated genes are patentable.