Individuals and businesses might be able to patent human genes in the future. What is a gene patent? It is a patent by which the government gives an individual or business the exclusive rights to a specific D.N.A. sequence or gene. The congressional Intellectual Property Subcommittee of the U.S. Senate Judiciary recently held three days of hearings on the subject. The hearings specifically addressed proposed legislation called Section 101 Reform that would, as the name indicates, reform the contested section 101 of the U.S. Patent Act.
The debate regarding the proposed legislation has been hearty. Opponents of the draft legislation contend that it would allow companies to patent specific currently unpatenable genes to the detriment of scientific research. Proponents point out that U.S. Supreme Court rulings have created uncertainty about patent enforcement, which stifles innovation.
Are you concerned that the United States Patent and Trade Office (USPTO) will declare your patent invalid? Are you a scientific research company wondering how the proposed law could affect you? Whatever your patent-related questions, the attorneys at A.U. L.L.C. is here to help. We are an emergent, boutique intellectual property law firm. Located in Chicago, we specialize in taking on complex business, privacy, and I.P. matters throughout the United States. Contact us to set up a consultation today.
Recent Supreme Court Rulings Regarding Patenting Human Genes
Peter O-Neill, chief executive director of the Cleveland Clinic Innovations, states that USPTO regulations and the rulings of federal courts are incongruent. This inconsistency leaves U.S. businesses unsure as to what genes are patentable.
The Cleveland Clinic received a patent for Myeloperoxidase (M.P.O.) in 2007. M.P.O. is an enzyme that indicates a person’s cardiovascular disease risk level. The USPTO validated the patents after two challenges. Conversely, the U.S. District Court for the Northern District of Ohio found that three out of four patents held by the Cleveland Clinic were invalid. The Supreme Court’s rulings have not made the delineation of what is patentable much clearer.
For example, the Supreme Court struck down a patent for the BRCA breast cancer gene mutations. In doing so, the Court cited the Supreme Court case of Mayo Collaborative Services v. Prometheus Laboratories, Inc. as legal precedent. In Mayo, the Court applied the rule that businesses cannot patent laws of nature, natural phenomena, and abstract ideas. The Court found that because human D.N.A. is a “product of nature,” a business cannot patent it in the U.S. In other words, because discovering a gene does not create anything new, there is no intellectual property to protect with a patent.
The Mayo case, in particular, had a massive impact on intellectual property cases. Before the ruling, companies successfully patented over 4,300 human genes. As a result of the Mayo ruling, those patents became invalidated. As a result, companies, scientists, and research firms can access those genes for commercial genetic testing. Federal courts have subsequently thrown out other patents that the USPTO previously validated leaving the Clinic and others wondering how to proceed in the uncertainty of what patents the Court will uphold.
It is important to note that the Mayo ruling did not disallow D.N.A.’s manipulation to be patented. Companies can still patent D.N.A. manipulation because these gene sequences do not exist in nature due to their scientific alteration. In the Mayo ruling, the Court noted that synthetically produced complementary patent D.N.A. (cDNA) is still a patentable process.
The Proposed Legislation Would Contradict U.S. Supreme Court Rulings
The bi-partisan proposed legislation would allow for patent protection of scientific discoveries that include natural biological processes such as human genes. As noted, the U.S. Supreme Court has held that patent eligibility does not extend to the laws of nature, abstract ideas and natural phenomena.
The draft legislation would essentially statutorily override exceptions to patent eligibility created by Supreme Court rulings. The potential law would legislatively override the Court’s decisions that limit patent eligibility to the following:
- Fundamental scientific principles
- Products that exist solely and exclusively in nature
- Pure mathematical formulas
- Commercial or economic principles, and
- Mental activities
Criticism and Support of Section 101 Reform
If the draft legislation becomes law, it will up-end over 150 years of patent law in the United States. Critics worry that if companies could patent natural processes such as gene sequencing, it will stifle scientific research. Scientists who wish to perform necessary basic research into human genomes would continuously worry about patent violations.
Lawmakers who support the bill contend that it would not give companies the power to patent fundamental research discoveries or human genes. Critics argue that the vague language of the proposed bill’s language could allow businesses to patent human genes. Charles Duan of Washington D.C.’s R Street Institute notes that the language in the proposed legislation “could make it possible to obtain patents on pure scientific research.” Will the proposed bill become law? Only time will tell.
How can a Business Tell What Ideas are Patentable?
The recently proposed patent law legislation illuminates the often complex nature of patent law. Not only are regulations and decisions put forth by the USPTO controlling, but businesses must also consider the rulings of the Supreme Court and other federal courts. One of the best ways to discover the likelihood of your possible patent withstanding challenges is to speak with skilled patent law attorneys at A.U. L.L.C., our patent attorneys will evaluate your invention in light of the patentability requirements outlined in 35 U.S.C. §§ 101-103.
The Patent Attorneys at A.U. L.L.C. Assist in Business, Intellectual, and Property Law
The A.U. L.L.C., our attorneys employ extensive written and legal oral advocacy skills to persuasively advocate for their clients. We analyze every client matter from a fresh perspective, maintaining a business-minded approach to resolving legal issues. We understand how essential patents are to our clients. Whether you need assistance applying for a utility or design patent, or you need a Chicago patent litigator to fight for your rights in Court, we can help. Contact A.U. L.L.C. today to set up an initial consultation.