A draft bill entitled the “Genomic Research and Accessibility Act” was circulated last year in an effort to gain supporters before being introduced by Rep. Xavier Becerra (D-CA). The bill would enact a comprehensive ban on the patenting of genetic material, genetic testing methods, and an ambiguously broad array of genetically derived materials¹. This could effectively preclude 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.

Why does Genetic Alliance oppose this bill?

We are convinced that a sweeping – and unprecedented – ban on gene-related patenting would be highly disruptive to the advancement of medical progress.  Intellectual property protections are an indispensable component of the legal and financial infrastructure that fosters innovation. Patents may or may not be a significant motivating force behind academic, governmental, or nonprofit research into fundamental genetic discoveries, but the biotechnology companies that translate this basic science into treatments and tests are highly reliant upon patent protection. More than 70% of biotech companies that do not yet have approved products plan to spend 5-10 years and more than $100 million to develop commercially available products or services.  However, only 30% of biotechnology products currently being researched will ever make it to market.  Given that biotech ventures are exceedingly risky and costly investments, companies and investors will not fund these new technologies absent the promise of being able to recoup costs during the period of market exclusivity that our patent system provides.  Without capital from investors, basic genetic discoveries will essentially remain where they started – in nonprofits and academia – rather than being brought forward to actually benefit the individuals and families who are waiting for needed medical breakthroughs.

What is actually being patented in a “gene patent”?

Genes themselves, of course, are not the subject of patents – despite what you sometimes read and hear.  No one owns a part of another’s body, not under patent law in the United States or any other country. Rather, what we call “gene patents” are actually granted on human-made isolated and purified DNA molecules such as cDNA, which contains the same nucleotide sequences as the genes in nature, but is physically and functionally different from natural genes.  The differing structure of cDNA molecules, which typically include far fewer nucleotides than natural genes because they do not include the multitude of non-coding segments of the gene, enables them to be used for numerous purposes not possible with natural DNA.  These valuable uses of human-made cDNA include diagnosing a predisposition to disease, making recombinant proteins, and making PCR testing primers (like the genetic test that predicts which individuals will have a toxic reaction to a certain HIV medicine.)

Long-Standing, Global Precedent for Patenting Isolated DNA Molecules

The practice of patenting isolated DNA molecules patents is not novel or unique.  The US Patent and Trademark Office grants these patents pursuant to carefully balanced guidelines that provide that the molecules’ utility must be “specific, substantial, and credible.”  The Court of Appeals for the Federal Circuit has repeatedly upheld this type of patent for twenty years.  The laws of all developed nations, including Japan, Australia, Korea, India, China, and the EU, allow patenting of isolated DNA.  If the United States were to suddenly and recklessly disrupt the incentives and protections currently available to the biotech industry, we could expect investment in biomedical innovation to dwindle sharply here and eventually move elsewhere. Again, those waiting for new tests and treatments would be the losers.

The Myriad Gene Patent Lawsuit

The proponents of the Becerra bill are philosophically aligned with the ACLU and the plaintiffs in the currently pending case of Association of Molecular Pathologists et al v. USPTO, Myriad et al.  The plaintiffs are seeking a comprehensive judicial ban on patenting of genetic material and genetic testing.  The trial court granted summary judgment to the plaintiffs, and the case is being appealed to the Court of Appeals for the Federal Circuit.  Genetic Alliance filed amicus curiae briefs in the case opposing the plaintiffs’ demands for the same reasons we oppose the Becerra bill – because a gene patenting ban would impede innovation and thus harm individuals.  We invite you to read our briefs explaining our reasoning.

Potential Effects of a Gene Patent Ban on Medical Progress

An unfortunate aspect of our health world today is that we aren’t actually all that advanced.  Some 40% of treatments fail, and for complex diseases like certain cancers, that figure approaches 90%.  For many rare or genetic diseases, there is no treatment available at all.  Genetic Alliance is urgently working to bring about the kind of systemic, collaborative changes that can improve these numbers dramatically.  We would urge anyone evaluating legislation or litigation that seeks to ban patenting of isolated genetic material or genetic tests to consider carefully the likely effects.  Would such a ban deter investment in the translational work needed to make significant new biomedical advances become available to the individuals who need them?  We believe it would.