The good news for patients: medical procedures can’t be patented anywhere in the world, except the U.S.
The bad news for inventors: medical procedure patents can’t be enforced in the U.S.
Funny that intellectual property often becomes the first thing many people think about when hearing of the potential to save mankind from the agonies of aging. In my travels, I’ve met at least two doctors and “inventors” who claimed to have a patent or patent application on “young blood” – and, apparently, one of them actually had his patent accepted by the U.S. Patent and Trademark Office.
I’m not a patent attorney, but I have created and run intellectual property licensing companies that licensed technology to many, many multi-billion companies around the world. I’ve developed hardware and software products built on a foundation of intellectual property. I have reviewed, overseen, processed, and paid for over 200 patent applications…authored individually and collaboratively by some of the most talented scientists, engineers, chemists, and physicists in the world.
So when I met these two unrelated doctors, neither of whom knows the other, at different points in time, they seemed surprised to learn that medical procedures (or phenomena of nature) can't be patented.
I have nothing against intellectual property protections, or intellectual property attorneys -- I've employed or engaged many of them, obtained many patents. But the prohibition against patenting medical procedures (or enforcing them, as in the U.S.) has strong basis in humanitarian concerns, significantly different than a better smartphone or tablet computer.
Over 80 countries prohibit medical procedure patents. General Agreements on Tariffs and Trade Agreement on Trade Related Aspects of International Property Rights (GATT-TRIPs) exclude medical procedures from patentability: "Members may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals" (Article 27).
In the US, current law does not prohibit the patenting of medical methods, but it provides an exception for medical professionals in cases where medical method patents are infringed, thereby limiting the enforcement of patent rights on medical methods. Further, US case law is moving even further away from broad medical procedure patents. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. — (2012), the Court invalidated Prometheus's patent on a diagnostic method that involved administering thiopurines and observing chemical reactions in the body as a basis for dosing advice, stating that the patent improperly claimed a natural law. In 2013, a federal court invalidated a patent held by Sequenom covering the detection of cell-free DNA in the bloodstream of pregnant women. 2013 – Oct. the US District Court for the Northern District of California granted Ariosa Diagnostics summary judgment and invalidated US Patent No. 6,258,540, saying the patent covers a phenomenon of nature, which is “unpatentable.” I would expect these trends to continue as they have, despite many researchers' devoted attention to discovering and patenting the inner workings of nature itself.
Of course, medical devices and other inventions of people themselves can be patented. We could almost consider the difference to be like inventing a tool (patentable) v. using a tool (not patentable/enforceable).
Plenty of health care businesses created success without patents. Red Cross stands out, and Kaiser Permanente has made many meaningful business model and health care delivery innovations, both as non-profit corporations. With 7 billion people in the world, all of whom will reach an elderly age, we all have plenty of opportunity for many to both help mankind and run a successful healthcare business...without excluding others from doing the same.
Medicine today focuses largely on diagnosing existent medical conditions and remediating them, typically with surgery, drugs, chemicals, radiation, or some combination thereof.
Why wait for a problem to happen that you know will happen? Most people don't die of old age or one disease or condition: most people die of multiple diseases or chronic conditions stemming from or exacerbated by the confluence of common root causes: decline of immune system function, oxidative stress, and chronic inflammation.
We know diet and exercise can help mitigate these conditions. But even people with good diets and exercise die of diseases medicine cannot cure because they lack immune system functionality to combat the disease, and medicine or drugs often impair the body's ability to fight for itself. Jack Lalanne died of pneumonia at age 95, in nearly perfect health until a fatal moment. He wanted to live to 120, and believed he could through good exercise and diet. Diet and exercise matter but have limitations. Medicine helps but makes trade offs that further weaken the body's own immune functions.
What if we could better predict predisposition for disease? What if we could address systemic issues that form the root cause of many symptoms we call diseases? Heart disease, cancer, Parkinson's, dementia, Alzheimer's, Rheumatoid arthritis, sclerosis -- all inextricably linked to inflammation and aging of other tissues effected by declining immune function -- could be better predicted and better prevented from developing in the first place.
We hope in our study to develop indicators to predict potential for disease states before they occur, and treatment therapies to prevent those diseases from occurring at all. Many of the blood tests we perform have predictive potential, and we hope to extend our test suite as we accumulate data and discover patterns of commonality with rich, big data sets.
For us, a randomized clinical trial takes little to no incremental effort at all: no placebo effect can be attributed to blood plasma exchange, per se, so we simply gather random blood samples from people over 50 for 6 treatments, and subseqently, compare the results with subjects receiving Heterochronic Plasma Exchange therapy.
Nearly 8 years worth of data and study from the AMBAR pilot and follow-on studies demonstrate beneficial effects of TPE on a majority of subjects, for example. So, within our means, we will treat each and every one of our qualifying subjects with real HPE procedures, up to our initial study size of 1,000 patients, in the sincere hope of mitigating or improving any number of chronic conditions, or preventing the potential thereof.
For a risky new and unproven drug or drug-based immunotherapy with potential for cross reactivity, strict adherence to randomized clinical trial protocols with small population of volunteer subjects makes clear and regulatory sense.
Therapeutic Plasma Exchange, on the other hand, has decades ago been approved by the U.S. F.D.A. as well as numerous international regulatory bodies; TPE may be one of the lowest risk medical procedures available today. We intend to conduct clinical trials and to prove up beneficial effects we likely know to be the case, but has not been measured and documented for our study group demographic comprehensively. Yes, we do have data on improvements in Alzheimer's, and we have select data on accepted autoimmune conditions in older patients. But more comprehensive measurement of systemic root causes of age-associated disorders simply hasn't been treated with TPE and measured comprehensively. We know that most age associated disorders have common root cause in immune system decline, oxidative stress, and chronic inflammation -- all conditions which can be addressed and improved by TPE, or HPE in the application to systemic decline of aging immune systems. With supporting data, this treatment therapy might become broadly available as a medically insured prophylactic (preventive) treatment therapy for age-associated disorders. Given the pace of insurance companies and the medical establishment, that could take a few years, of course.
In light of the frenzy of activity and many failures surrounding anti-aging research over the last two decades, the obvious question that anyone should ask comes down to viability.
I’ll address the litany of failures in anti-aging research in a later post – it’s a big topic in need of its own commentary – but let's say the search for "magic bullets" has been futile.
As for our approach, the practical application of medically established treatment therapies to a new understanding of the aging process, here’s what we know and what we don’t know.
We know Therapeutic Plasma Exchange (TPE) is a safe and well-established therapy for a number of medical conditions with powerful immunomodulatory effects not requiring the use of drugs or artificial substances. (Technically speaking the FDA regulates blood products like drugs for safety reasons, but they are not synthetic, man-made drugs, they are real blood products from real humans). TPE removes pathogenic and proinflammatory factors accumulated in our blood via extracorporeal (outside of the body) processing. Further, plasmapheresis leads to normalization of key immune system indicators (e.g., CD4/CD8 ratio) that become abnormal, a condition that afflicts people with old blood, which exhibits immune function ratios similar to patients with autoimmune conditions. So, putting aside “anti-aging” or other beneficial possibilities per se, we know that the TPE removes inhibitory factors negatively effecting and contributing to the slow decline of the immune system, a naturally occurring phenomena of aging blood as it oxidizes over time. And, we know that patients with Alzheimer’s have stopped their decline or improved their condition as a result of TPE treatments. Generally, we know that prevention outweighs remediation; better to bolster the immune system early than wait for the onset of more complicated conditions. And we know that the procedure risk remains relatively low.
While we have strong empirical data to support what we know, we don't necessarily know how long the treatment therapy will last. And the answer may vary by individual based on environment, lifestyle, diet, and genetic history. If someone works 80 hours per week, never exercises, eats junk food, drinks heavily, smokes, takes drugs, and parties the rest of the time…those negative inputs may outweigh any benefits of any treatment therapy, of course. In the case of autoimmune disorders, frequency of treatment therapies varies by specific disease, as well as individual. While aging blood bears a similar profile to the blood of autoimmune patients, aging blood typically takes much longer to reach that state, an inexorable decline over time rather than a more acute condition. We don’t know how profound possible benefits may be, or if we’ll observe what has been observed in mice – growth in muscle cells, liver cells, and brain cells. Hence, the basis for our clinical trial, and, given the tremendous diversity of individual conditions, the reason we chose to conduct a trial at a greater scale, initially up to 1,000 patients.
A lot of people I've met have asked me why a non-profit corporation.... "Why not set up a for-profit operation?" they ask.
First, and foremost, we hope we can do something to help humanity, an intrinsic reward unto itself. Much of modern medicine unfortunately concerns itself with profits first, patients second, hoping to find a "magic bullet" to patent. Medical procedures, particularly a decades-old medical procedure, can't be patented or, in the U.S, enforced. Nor should they, in my opinion, and I've run companies that developed 100's of commercial patents. We have a unique opportunity in history to take a relatively low-risk approach and develop or refine a highly impactful anti-aging treatment therapy which could alter the course of mankind by preventatively mitigating age-associated disease extending life and/or extending well lived life. We plan to "open source" our findings, and like any open source initiative, we may spawn 100 or more for-profit entities which commercialize best practices and procedures that we develop. Good luck to all of them, and all of the world. Many good reasons exist to form for-profit companies, but making a profit may not always be one of them (more on this later). But before that can happen, we need to better data on the beneficial effects and best practices associated with aging.
Second, even though we begin with a fairly benign, low-risk procedure and significant upside for human health in aging states, we have much to learn. We can build from the experience and knowledge of the last several decades of immunology, and we have positive results with at least one age-associated condition, Alzheimer's disease, since 2009. But within this experience, protocols, treatment frequencies, and other nuances can vary by individual, disease, and actual condition. This treatment therapy works best to prevent negative outcomes; once a disease state has progressed to a highly degenerative condition, odds of improvement decline rapidly; hence, the Alzheimer's studies have focused on mild to moderate Alzheimer's, not severe cases.
Third, a nonprofit can purse objectives for the benefit of humanity without regard to investor interests and return expectations, other than the social benefit and humanitarian return of making a significant difference in the lives of many, possibly including those closest to you. Everyone has friends and family who will ultimately suffer from age-associated conditions. That said, donations to a non-profit organization provides a tax benefit, whereas payments to a for-profit organization come from savings after tax. Simply put, a $10 donation to a non-profit could result in a $3 deduction where a $10 payment to a for-profit requires $13 in income to make a $10 after tax payment. And while we depend on direct donations and grants, as a non-profit we can be more flexible and focused to plow all available resources into our product and humanitarian objectives, rather than worry about investor dividends, ultimately lowering cost of service well below what a for-profit operation could possibly achieve.
Finally, we have a lot of folks volunteering, working pro bono, and/or deferring compensation who have intrinsic motivation that we're doing something good for friends, family, and the world. Why not?
A few years back, when I first began investigating University findings that "young blood rejuvenated mice, I met with a prominent scientist at a prominent university, who shall remain unnamed so as not to personalize this commentary. In the privacy of his office, I learned two interesting and salient things through the course of his Powerpoint presentation to me.
First, when he came to a certain chart in his presentation which looked something like this...
he said, "here's the problem!" pointing at the oval entitled "young blood" and
"What's the problem?" I asked.
"Young blood cures everything, potentially all or most age-related diseases" he replied.
"Why is that a problem?" I asked
"Because all of the money for funding is inside each one of these silos" he replied, pointing at each age-related disease condition, one for Alzheimer's, one for Cancer, one for Heart Disease, and so on. "You can't fix everything or you'll never get funded."
While a number of efforts researching human plasma and beneficial factors contained within, do focus on one particular silo, we established the Young Blood Institute as a non-profit specifically to avoid this conflict. Why not do one procedure and measure everything? Yes, the blood testing may be more expensive. But the knowledge gained and the comprehensive data gathered, in our view, far outweighs the cost. And, if we do demonstrate that one prophylactic therapy can systemically prevent the onset or degradation of multiple diseases, mankind wins.
I attended RAAD Fest in San Diego this past August 4-7th. "RAAD" stands for Revolution Against Aging and Death, and brought together an amazing amalgamation of doctors, scientists, sociologists, researchers, authors, business people, entrepreneurs, and corporations dedicated to extending and enhancing life.
I began my professional career with IBM Biomedical Systems, developer of the 2997 Blood Cell Separator, one of the world's first automated apheresis machines. Originally developed in partnership with the National Cancer Institute (NCI) at the National Institutes of Health (NIH) by an IBM engineer, George Judson, this device spawned a little known renaissance in blood component exchange, blood treatment therapies, and immunology, ultimately contributing to cancer programs, autoimmune disorders, and even AIDS research and treatment therapies. The automation of blood component collection and exchange also fundamentally improved the blood donation/collection industry, before then limited to whole blood collections and manual blood separation techniques. Today, we use the product descendants of the IBM blood cell separator to collect stem cells from bone marrow.
After IBM sold its Biomedical Systems business unit to COBE Laboratories, I went on to work in more traditional IBM marketing and development groups, and later spun some technologies out of IBM to found an imaging technology licensing company, Applied Science Fiction, which developed 100's of patents and licensable software and hardware designs. Since then, I’ve run a number of other tech companies, developed numerous products, licensed and sold technologies worldwide, and managed significant new technology initiatives.
Now that I’m returning to my roots, as it were, I take comfort in the fact that not much has changed with apheresis equipment and procedures in 30 years, other than the natural evolution and refinement of those technical and medical breakthroughs of the 70's and 80's. Why? Because this historical evolution of apheresis equipment medical and best practices significantly reduces both technology risk and health/safety risk when re-focusing these evolutionary developments from rare and often niche conditions such as autoimmune disorders to the most significant challenge and opportunity we face as humankind: the natural autoimmunity of aging blood. We start from a solid foundation of long ago approved FDA (and international regulatory) procedures, decades of medical practice and experience, and an very low safety risk.
In the field of immunology and blood science, progress has been evolutionary and episodic over the last 100 years, beginning with Karl Landsteiner's discovery of ABO blood types in 1900, a discovery which, in the hindsight of a 7 billion person population, may have saved 10's or even 100's of millions of lives over the last century. Now, when the world has begun to cite a new medical buzzword "immunotherapy" -- particularly for age-associated diseases -- we can look to the most natural and historically proven immune system therapy in the world: our own plasma, and a medical practice well honed for many decades.