The term “gene patent” refers to intellectual property protections that generally cover isolated and purified genes or small portions of DNA from a gene. The patents do not cover genes in a living body or in the form found in nature. Since scientists have been able to correlate some diseases with specific genetic mutations, the availability of intellectual property protections for genetic material can have significant implications for diagnosing diseases and the research and manufacture of potential treatments for these diseases. Gene patenting has recently generated considerable controversy, partly due to the inaccurate perception that patents cover genes as found in their natural state. Although a federal lawsuit seeking a broad ban on gene patenting is now pending, Genetic Alliance believes that banning gene patents would seriously impede the research and development of genetic tests and treatments.
Where do We Stand on Gene Patenting?
Genetic Alliance believes gene patents provide important incentives and protections that facilitate the research and development of life-saving tests and treatments. While we recognize that proponents of a ban on gene patents have legitimate concerns, such as the affordability of genetic testing, we believe that abolishing gene patents would not remedy these concerns and would have significant detrimental effects. Please read further for more details.
- Brief of Amicus Curiae Genetic Alliance in Opposition to Certain Positions of the Plaintiffs, AMP v. USPTO et al.
- Filed in the District Court For the Southern District of New York
The American Civil Liberties Union brought a lawsuit challenging Myriad Genetic’s patents relating to the BRCA1 and BRCA2 breast cancer genes and seeking a broad ban on gene patenting. On December 23, 2009, Genetic Alliance filed a brief opposing this position. Our brief highlights the importance of gene patents and the government’s attempts to protect gene patents through legislation and policy. The brief also debunks the plaintiff’s contention that DNA molecules are “products of nature” and therefore not patentable subject matter. Genetic Alliance points out that the isolated DNA molecules are made by scientists and have different composition and functions than genes in a living organism. Please read further for more details.
- Brief for Amicus Curiae Genetic Alliance in Support of Reversal, but Not in Support of Either Party, AMP v. USPTO?et al.
- Filed in the Court of Appeals for the Federal Circuit
Genetic Alliance filed a brief in the appeal of the District Court’s opinion. Genetic Alliance argues that isolated DNA molecules, as claimed in the BRCA patents, have a different chemical composition than native DNA in genes, are made by human intervention, and have different uses than DNA in genes. For these reasons, the subjects of gene patents are not products of nature. Furthermore, Genetic Alliance contends that invalidating gene patents is legally untenable and would have undesirable policy effects. Please read further for more details.
- Amicus Briefs in AMP v. USPTO: Genetic Alliance
- Article Posted in Patent Docson November 10, 2010; written by Donald Zuhn.
Donald Zuhn adeptly summarizes Genetic Alliance’s amicus brief and provides a useful overview of Genetic Alliance’s position. He provides a list of all amicus briefs filed in the AMP v. USPTO appeal and links to articles on the topic. Please read further for more details.
- Genetic Alliance Opposes Draft Bill to Ban Gene Patents
A draft bill was circulated last year in an effort to gain supporters before being introduced. The bill would have enacted a comprehensive ban on the patenting of genetic material, genetic testing methods, and an ambiguously broad array of genetically derived materials. This would have effectively precluded patents on all naturally-occurring proteins with important medical uses, such as Factor VIII that is used to treat hemophilia and EPO that helps patients receiving bone marrow transplants, regardless of how the proteins are produced. Please read further to see why Genetic Alliance believes that legislation like this would be disruptive to the advancement of medical progress.
- GeneWatch Volume 23, Issue 5, October-December 2010
GeneWatch volume 23 issue 5 provides an in-depth look at the arguments on both sides of the gene patent debate. The issue includes articles written by leading scholars and advocates in the field and interviews with attorneys for the American Civil Liberties Union and Myriad Genetics, the main parties in AMP v. USPTO. Sharon Terry, the President and CEO of Genetic Alliance and the President of PXE International, explains her position in Why Banning Patents Would Hurt Patients. She contends that the subjects of gene patents would not exist without human manipulation and that upholding the U.S. Patent and Trademark Office’s position that gene patents are valid is vital for biomedical advancements. She provides insight into the importance of gene patents, and how they can be used to advance research, tests, and treatments, through her experience as a co-patent holder for the method of detecting a genetic disease, pseudoxanthoma elasticum. Please read further for more details.
