You may have heard about the “breast cancer gene patent wars.” Most likely, you have heard from various individuals and popular media asking “how can someone patent my genes?” One can’t and never could patent your genes as they are in you.
One side in the “gene patent war” has nevertheless convinced the Supreme Court to weigh in on the issue of whether DNA sequences derived from the human genome are patentable, in Association for Molecular Pathology (AMP) v. Myriad Genetics, while disingenuously labeling the patents at issue as “human gene patents.”
Myriad (the “other” side) owns several patents with claims directed to “isolated” nucleic acid molecules (e.g., DNA) and fragments thereof which are referred to as either “probes” or “primers,” based on their function. Probes anneal, i.e., bind, to a particular part of a DNA and are used to detect the presence of certain genes which indicate abnormalities or disease states. Primers anneal to particular parts of a DNA and are used to make additional pieces of DNA, e.g., make multiple copies of a single abnormal sequence such that it is readily detectable and/or become capable of being utilized in other useful applications, e.g. forensic science.
Following the well-established Patent Law principle that natural products are not patentable, since the dawn of biotechnology in the 1980’s, in order for claims to DNA to be patent eligible, the DNA must be “isolated” or synthesized or modified such that the claimed DNA is not as it is found in nature. In other words, no DNA patent claim encompasses a gene as it exists in you.
The Biotech Industry was founded upon patent protection for isolated DNA and similar products, which enabled small start-up companies to compete with established Big Pharma. By now, the Biotech Industry employs millions each year, and more importantly provides life-saving technologies.
In the United States, we enjoy patent rights that are stronger than patent rights elsewhere in the world and because of the strength of US patent rights, many industries, including the Biotech Industry, thrive in the US. In fact, the US Biotech Industry has become orders of magnitude larger – and concomitantly more productive and employs more individuals– than that in all of Europe, or any other country/region. Changing the principles of our patent system to exclude patent protection for isolated DNA will likely cause a ripple effect with detrimental consequences on our economy and American interests.
As the public relations prong of their attack in the war, in AMP v. Myriad, AMP and other petitioners have disseminated additional highly inflammatory untruths, including: that isolated DNA is simply a product of nature, patents prevent further research and development, and that such isolated DNA patents prevent access to personalized medicine and care.
Let’s set the record straight.
Personalized medicine is based on the principle that medical treatments can and should be tailored to an individual according to the individual’s biochemical and genetic makeup that is often different from the majority of those afflicted. This necessarily means researching and developing a variety of treatments for a plurality of small subsets of the population. No company is going to spend the millions and billions of dollars required to conduct the R&D and obtain FDA approval for such a small subset when, without patent protection (for limited times), that company is unlikely to recoup the millions and billions spent.
A correlation between orphan diseases and drugs can be drawn to personalized medicine and treatments based on genetic diagnostic tests. Rare diseases are diseases which affect a small percentage of the population, i.e. about 1 in 1,500 people in the US. The term “Orphan Disease” is often used to refer to a rare disease because of the lack of available treatments and medicines. The lack of available treatments and medicines for such Orphan Diseases is the result of the fact that only a small percentage of the population is afflicted and, as such, companies (without Government incentives) are unlikely able to recoup the costs of bring the treatments and medicines to the public and keeping them available to the public. Many Orphan Diseases have known etiologies and known treatments, but the drugs and medicines are not available to the public because of the costs involved in the FDA approval process and commercialization.
Thus, Congress enacted the 1983 Orphan Drug Act which provides various incentives, including exclusivity periods and monetary incentives in the form of grants and discounts on various FDA approval and user fees. Because of these incentives, companies have found it economically viable to risk millions of dollars in R&D with the hope of bringing treatments, medicines, and even cures to small populations afflicted with a rare disease.
Personalized medicine will likely go the way of treatments and medicines for orphan diseases prior to the 1983 Orphan Drug Act, if patent protection for isolated DNA, biomarkers, genetic assays, and treatments in view of such isolated DNA, biomarkers and genetic assays becomes unavailable. Although academia may still continue such research, who is going to spend, more appropriately, risk millions to conduct the additional R&D to take that basic research and make a product available to the public so that one can have medical treatment that is personalized for that person?
With the current budget constraints on our Federal government, it’s not likely that we’ll see additional Federal research grants for universities to conduct the basic research that results in potential products, e.g., diagnostic tests, which are essential for personalized medicine. Additionally, it is not likely that Congress will allocate additional money and resources for setting up incentives, e.g., grants, user fee discounts, and limited exclusivity periods (like that provided for orphan drugs), for companies to run the last 20 yards to bring such basic research to publicly available products that benefit an afflicted minority.
Thus, without patent protection for Biotech inventions, no one would be willing to make the substantial investment required to research, develop and bring such small-market products through the multi-year FDA approval process. So, no patents for isolated DNA and diagnostics means “one size fits all” as the investment in R&D will only be made for what can be sold for the masses. Say “goodbye” to personalized medicine.
The opponents in AMP v. Myriad Genetics have proposed, however, that Biotech patents inhibit the development of and access to personalized medicine, because universities and other institutions are prevented from doing their own research and testing. This argument ignores that even if a drug or treatment is available, if the necessary investment has not been made to receive FDA approval, the payors in the system (Medicare, Medicaid and medical insurance companies) will not reimburse for it. Thus, without patents to enable one to recoup the costly R&D for FDA approval, public availability of newer and better treatment options for various diseases, including cancer, would likely be much more severely limited as a result.
With regard to breast cancer, most women facing the gut-wrenching decision of whether to have a mastectomy want to know whether they have the breast cancer gene in order to make an educated decision about getting a mastectomy. Without the research and innovation driven by patents, it is unlikely breast cancer gene diagnostics would be available today. In other words, patents give rise to the innovation that results in the creation of such diagnostics and treatment options based thereon, but access thereto is a question of whether or not insurance will pay for it.
One should note that many insurance plans cover prophylactic mastectomies as a medical necessity where one has a family history of breast cancer or has the breast cancer gene mutation as evidenced by a genetic diagnostic test (which is also covered by many insurance plans). However, many individuals do not have a family medical history. Thus, without the breast cancer gene diagnostics at issue in the breast cancer gene wars, prophylactic mastectomies would not likely be available to many as a reimbursable medical expense.
As for patents inhibiting further research and development, the history of the US Biotech Industry and of virtually every other American industry of significance (i.e., those industries where companies hold large numbers of patents), suggests exactly the opposite. Our Founding Fathers were wise enough to understand that patent protection promotes innovation, and they delegated regulation of the patent system exclusively to Congress, in the Constitution. Throughout the years, our Congress has been equally wise and enacted laws that put limitations on patent rights so as to promote further innovation. And US Courts have, until recently, been wise enough to sufficiently reward the innovators without stagnating further innovation.
Patent protection is for a limited time. After the patent term, the invention is dedicated to the public, i.e., anyone can make, use, or sell it freely. Moreover, even before patent issuance, most US patent applications are published, and all patents are published and available following issuance. Thus, anyone can view the patent (or published application) and use it to design around and/or invent a better design, and that person can be rewarded by his inventive efforts with a patent of his own.
With regard to medicines and diagnostic patents, activities which are related to the development and submission of information to the FDA are excluded from being acts of patent infringement. This means that despite one’s patent rights, another can perform the R&D to bring better products, such as medicines and diagnostics, through the approval process and to the public. In short, patents promote further R&D.
It seems that everyone wants something for free. But if everything is free, there will be nothing to be had. Without the incentives of our patent system, it is quite unlikely that the breast cancer diagnostic test at issue in AMP v. Myriad Genetics would be publicly available today. If needed tests or medications are too costly to allow wide access, it seems the cost should be borne without crashing the engine of American innovation.
About the Authors
Eric P. Mirabel is an intellectual property attorney practicing in Houston, with extensive experience representing start-up biotechnology companies; both in therapeutics and in diagnostics.
Suzannah K. Sundby is a partner with Smith, Gambrell & Russell, LLP. Prior to becoming a patent attorney, Suzannah was a cytogeneticist on one of the major genome projects.
The opinions and actions expressed herein are those of the authors and should not be attributed to any other person or client of the authors and Smith, Gambrell & Russell, LLP.