Gene patents
Encyclopedia
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 patent
s.
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. The courts have upheld claims on altered sequences, but courts and lawyers' opinions have been mixed on upholding the use of natural sequences and particularly the sequence itself. 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.
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.
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.http://patft1.uspto.gov/netacgi/nph-Parser?patentnumber=6770468) 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.http://nzic.org.nz/ChemProcesses/biotech/12H.pdf In descriptions of the controversy over "gene patents", it is rare to find references to these everyday uses of genes and gene patents.
and the U.S. Patent and Trademark Office by professional medical organizations, doctors, and patients, represented by the American Civil Liberties Union
and the Public Patent Foundation of the Benjamin N. Cardozo School of Law, New York, in the U.S. District Court for the Southern District of New York
The complaint challenged specific claims on isolated genes and diagnostic methods in seven of Myriad's 23 patent
s on BRCA1
and BRCA2
. Some of these patents are owned by Myriad and some of them were licensed from University of Utah
. More specifically, the plaintiffs wanted certain claims declared invalid on the grounds that they are not patentable subject matter
- that the isolated genes are unpatentable products of nature and that the diagnostic method claims are mere thought processes that do not yield any real world transformations.
Many patent lawyers had predicted that the courts would throw out this case.
However, United States District Court
Judge Robert W. Sweet
accepted the case, and on March 29, 2010 ruled that the claims were invalid.
Other claims, which were not challenged in the lawsuit, still stand.
Judge Sweet's 152–page decision ruled that the challenged claims to the isolated gene sequences had been "improperly granted" because they claimed unpatentable subject matter; the claims to the diagnostic methods were found invalid under the recent In re Bilski
decision. Because the case could be decided with patent law, Judge Sweet did not look at the challenge on First Amendment grounds and dismissed them without prejudice.
However, on March 30, 2010, Myriad announced that it will appeal the decision. On June 16, 2010, Myriad filed its Notice of Appeal. Oral arguments were heard at the Federal Circuit on April 4, 2011.
On July 29, 2011 the Federal Circuit overturned the District court in part, and upheld the decision in part. The Federal Circuit overturned the District Court's finding that the claims covering isolated gene sequences are invalid and also overturned the invalidity of some of the diagnostic claims; the Federal Circuit upheld the finding that the claims for the diagnostic methods that only compare or analyze sequences - that have no transformative step - are invalid. Further appeals are likely; on October 12, 2011 the ACLU and the Public Patent Foundation said they intended to petition the Supreme Court to overturn the decision.
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
on a specific isolated gene
Gene
A gene is a molecular unit of heredity of a living organism. It is a name given to some stretches of DNA and RNA that code for a type of protein or for an RNA chain that has a function in the organism. Living beings depend on genes, as they specify all proteins and functional RNA chains...
sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims
Claim (patent)
Patent claims are the part of a patent or patent application that defines the scope of protection granted by the patent. The claims define, in technical terms, the extent of the protection conferred by a patent, or the protection sought in a patent application...
. Gene patents are a part of the broader category of biological patent
Biological patent
A biological patent is a patent relating to an invention or discovery in biology. It can be a composition of matter, a method for obtaining or using one or more thereof, or a product combining such things...
s.
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. The courts have upheld claims on altered sequences, but courts and lawyers' opinions have been mixed on upholding the use of natural sequences and particularly the sequence itself. 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
Learned Hand
Billings Learned Hand was a United States judge and judicial philosopher. He served on the United States District Court for the Southern District of New York and later the United States Court of Appeals for the Second Circuit...
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
Diamond v. Chakrabarty
Diamond v. Chakrabarty, , was a United States Supreme Court case dealing with whether genetically modified organisms can be patented.-Background:...
, 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
United States Patent and Trademark Office
The United States Patent and Trademark Office is an agency in the United States Department of Commerce that issues patents to inventors and businesses for their inventions, and trademark registration for product and intellectual property identification.The USPTO is based in Alexandria, Virginia,...
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.
Controversy
Law professor Rebecca S. Eisenberg argues that gene patents produce an "anticommons" at odds with an ideal scientific commons.[Update and expand]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
BRCA1
BRCA1 is a human caretaker gene that produces a protein called breast cancer type 1 susceptibility protein, responsible for repairing DNA. The first evidence for the existence of the gene was provided by the King laboratory at UC Berkeley in 1990...
and BRCA2
BRCA2
BRCA2 is a protein that in humans is encoded by the BRCA2 gene.BRCA2 orthologs have been identified in most mammals for which complete genome data are available....
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
Extraordinary Measures
Extraordinary Measures is a 2010 medical drama film starring Brendan Fraser, Harrison Ford, and Keri Russell. It is distributed by CBS Films and was released on January 22, 2010. It is about parents who form a biotechnology company to develop a drug to save the lives of their children, who have a...
' was covered in part by a classic gene patent, US Patent 6,770,468.http://patft1.uspto.gov/netacgi/nph-Parser?patentnumber=6770468) 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.http://nzic.org.nz/ChemProcesses/biotech/12H.pdf In descriptions of the controversy over "gene patents", it is rare to find references to these everyday uses of genes and gene patents.
Myriad Genetics case
In 2009, a lawsuit, Association For Molecular Pathology, et al., vs. United States Patent and Trademark Office, et al. was filed against Myriad GeneticsMyriad Genetics
Myriad Genetics, Inc. is a molecular diagnostic company based in Salt Lake City, Utah. Myriad employs a number of proprietary technologies that permit doctors and patients to understand the genetic basis of human disease and the role that genes play in the onset, progression and treatment of disease...
and the U.S. Patent and Trademark Office by professional medical organizations, doctors, and patients, represented by the American Civil Liberties Union
American Civil Liberties Union
The American Civil Liberties Union is a U.S. non-profit organization whose stated mission is "to defend and preserve the individual rights and liberties guaranteed to every person in this country by the Constitution and laws of the United States." It works through litigation, legislation, and...
and the Public Patent Foundation of the Benjamin N. Cardozo School of Law, New York, in the U.S. District Court for the Southern District of New York
United States district court
The United States district courts are the general trial courts of the United States federal court system. Both civil and criminal cases are filed in the district court, which is a court of law, equity, and admiralty. There is a United States bankruptcy court associated with each United States...
The complaint challenged specific claims on isolated genes and diagnostic methods in seven of Myriad's 23 patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
s on BRCA1
BRCA1
BRCA1 is a human caretaker gene that produces a protein called breast cancer type 1 susceptibility protein, responsible for repairing DNA. The first evidence for the existence of the gene was provided by the King laboratory at UC Berkeley in 1990...
and BRCA2
BRCA2
BRCA2 is a protein that in humans is encoded by the BRCA2 gene.BRCA2 orthologs have been identified in most mammals for which complete genome data are available....
. Some of these patents are owned by Myriad and some of them were licensed from University of Utah
University of Utah
The University of Utah, also known as the U or the U of U, is a public, coeducational research university in Salt Lake City, Utah, United States. The university was established in 1850 as the University of Deseret by the General Assembly of the provisional State of Deseret, making it Utah's oldest...
. More specifically, the plaintiffs wanted certain claims declared invalid on the grounds that they are not patentable subject matter
Patentable subject matter
Patentable, statutory or patent-eligible subject matter is subject matter which is susceptible of patent protection. The laws or patent practices of many countries suggest that certain subject matter is or is not something for which a patent should be granted.Together with novelty, inventive step...
- that the isolated genes are unpatentable products of nature and that the diagnostic method claims are mere thought processes that do not yield any real world transformations.
Many patent lawyers had predicted that the courts would throw out this case.
However, United States District Court
United States district court
The United States district courts are the general trial courts of the United States federal court system. Both civil and criminal cases are filed in the district court, which is a court of law, equity, and admiralty. There is a United States bankruptcy court associated with each United States...
Judge Robert W. Sweet
Robert W. Sweet
Robert Workman Sweet is an American jurist and currently a senior United States federal judge serving on the United States District Court for the Southern District of New York.-Early life and career:...
accepted the case, and on March 29, 2010 ruled that the claims were invalid.
Other claims, which were not challenged in the lawsuit, still stand.
Judge Sweet's 152–page decision ruled that the challenged claims to the isolated gene sequences had been "improperly granted" because they claimed unpatentable subject matter; the claims to the diagnostic methods were found invalid under the recent In re Bilski
In re Bilski
In re Bilski, 545 F.3d 943, 88 U.S.P.Q.2d 1385 , was an en banc decision of the United States Court of Appeals for the Federal Circuit on the patenting of method claims, particularly business methods. The Federal Circuit court affirmed the rejection of the patent claims involving a method of...
decision. Because the case could be decided with patent law, Judge Sweet did not look at the challenge on First Amendment grounds and dismissed them without prejudice.
However, on March 30, 2010, Myriad announced that it will appeal the decision. On June 16, 2010, Myriad filed its Notice of Appeal. Oral arguments were heard at the Federal Circuit on April 4, 2011.
On July 29, 2011 the Federal Circuit overturned the District court in part, and upheld the decision in part. The Federal Circuit overturned the District Court's finding that the claims covering isolated gene sequences are invalid and also overturned the invalidity of some of the diagnostic claims; the Federal Circuit upheld the finding that the claims for the diagnostic methods that only compare or analyze sequences - that have no transformative step - are invalid. Further appeals are likely; on October 12, 2011 the ACLU and the Public Patent Foundation said they intended to petition the Supreme Court to overturn the decision.
See also
- Human Genome ProjectHuman Genome ProjectThe Human Genome Project is an international scientific research project with a primary goal of determining the sequence of chemical base pairs which make up DNA, and of identifying and mapping the approximately 20,000–25,000 genes of the human genome from both a physical and functional...
- Implications of US gene patent invalidation on AustraliaImplications of US gene patent invalidation on AustraliaOn 29 March 2010, the US District Court for the Southern District of New York found several of the patent claims on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics to be invalid...
External links
- Genomics Law Report. Newsletter published by law firm of Robinson Bradshaw & Hinson.
- The Human Genome Project information pages
- Human Genome Project pages on Genetics and Patenting
- Bioethics and Patent Law: The Cases of Moore and the Hagahai People by Anja von der Ropp and Tony Taubman, WIPO Magazine, September 2006.