Apr 18, 2013

Why Medical Research and Treatment Patents Are Bad for Patients

As the Supreme Court is hearing arguments regarding the patentability of human genes, I like to argue in this post why I believe human genes should not be patentable. Additionally, I’d like to emphasize why over-patenting in medicine has hindered “patient-centric” research and outcomes.



Background

The lawsuit which has lead to today’s Supreme Court hearing was brought by a group of researchers, medical groups and patients against Myriad Genetics, a Utah biotechnology company. Myriad Genetics discovered and isolated the BRCA 1 and BRCA 2 genes which are associated with hereditary breast and ovarian cancer. By being able to patent these genes and discovery, Myriad has been granted a 20-year monopoly over the use of the genes for research, diagnostics and treatment. Myriad and other pharmaceutical companies alike argue that patenting genes encourage innovation and discoveries by ensuring financial rewards through protecting these discoveries from being used by others for free. On the other hand, the opponents of gene patenting argue that these patents hinder innovation and collaborative discoveries by preventing the rest of the medical and research communities to use, apply, utilize and improve upon these discoveries and life-saving treatments. 

What Does Patent Law Say?
As a former Patent Examiner at the U.S. Patent & Trademark Office, I find it very surprising that these patents (as well as 4000 other patents on human genes) were granted and approved by the USPTO in the first place. The U.S. Patent Law makes it clear that products or laws of nature can not be patented. So for example, “it might have taken Einstein a long time to figure out that E=mc^2, but he couldn’t have patented this law of nature”. In fact, as noted by NPR, Dr. Jonas Salk the inventor of the revolutionary polio vaccine, when asked in 1955 if he had a patent on the vaccine, replied, “There is no patent...could you patent the sun?”
"We do know Myriad did a lot of work," says New York University law professor Rochelle Dreyfuss, a nationally known patent expert who is not associated with either side in this case. But that's not enough, she says, because the court still has to answer this question: "Is the thing that's isolated significantly different from the way that it was when it was in nature?"
The ambiguity, however, that exists in this case which according to Myriad make their patents valid, is as follows:
...the 20,000 genes in the human body are part of a 6-foot-long molecule that's "coiled and compacted and stuffed into each cell. What Myriad was able to do is sort through all those 20,000 genes and find the two that were highly linked to hereditary breast and ovarian cancer." The gene is like "a single grain of sand" hidden in a building the size of the Empire State Building, says Gregory Castanias, Myriad's lawyer. He will tell the justices that isolating the two genes justifies a patent because "it is the final step in an extraordinarily complicated set of inventive actions that led to the creation of this molecule, which had never been available to the world before."
That said, those challenging the patent claim that regardless of the process Myriad went through to discover these genes, the discoveries are products of nature and exist as part of the human DNA. As Christopher Hansen of the American Civil Liberties Union points out, 
It is no different than taking a kidney out of the body. Just because you are the [first] person who takes the kidney out of the body doesn't entitle you to a patent on kidneys. A patent isn't a reward for effort. A patent is a reward for invention. And Myriad didn't invent anything. The gene exists in the body. All Myriad did is find it.
Why Over-Patenting Is Bad for Patients
Aside from the legal and research implication of the case above, I believe that over-patenting in general in the medical field is bad for patients. The pharmaceutical and medical devices industries have argued as noted above that they need to protect and be financially rewarded for their discoveries that they often spend billions of dollars on to research and develop. They view their research projects first as investments measured in terms of financial ROI where patient experience and outcome is only a means to an end of more profits. Obviously, it is possible for both of those incentives to be aligned but pharmaceutical companies, as evaluated by Wall Street, are measured by balance sheets and quarterly statements not necessarily patient impact.

Gregory Castanias, Myriad's lawyer:
"At some level it is about money," he says, because "medicine doesn't happen for free. ... If you look at the enormous amount of investment — and not everything works that you invest in — the patent system is critical to medical care" by incentivizing companies to invest in needed scientific research and development.
However, though big Pharma’s argument does make sense that they deserve financial returns for their expensive R&D efforts, evidence shows that Big Pharma has abused the patent system to create monopolies and therefore profits from patients with little or no discovery to show for it. 

Nexium vs. Prilosec: Twin Drugs Separated by Patent Protection
The best example for this is a drug called Prilosec (Omeprazole) made by AstraZeneca which is prescribed to patients suffering from Acid Reflux Disease (Heartburn). 
In early 2001, this branded version of generic omeprazole was available only by prescription–$4.00 per pill. Now the brand name is available for 63¢ each. The generic form is only 40¢. The Prilosec patent ran out in 2001. Until then, AstraZeneca had a monopoly on omeprazole. Demand let them set the price sky-high. But in 2001 they had to scramble to save their cash cow. Generic companies would soon be able to sell the generic form of Prilosec and charge amounts more in line with production costs. One corporate strategy was to develop a replacement drug for Prilosec, rename the drug, and get a new patent. Their R&D team came up with Nexium, an isomer of Prilosec. An isomer is a compound almost identical to the parent compound, with a molecule or two tweaked. Unfortunately, the new drug performed no better than Prilosec. It was basically the same compound with a new name and a higher price.
By tweaking a few molecules AstraZeneca was able to make a case for a new patent even though these changes had little or no impact on patient experience. As such, currently Nexium is heavily marketed and prescribed by doctors over it’s identical patentless twin Prilosec OTC (costs 10 times less than Nexium). Nexium sales generated $6.3 Billion for AstraZeneca in 2009 alone. 

The Big Pharma Patent Vault
Aside from the dangers of patents being abused as means to create monopolies and controlling prices, the Big Pharma patent vault also holds countless patents on discoveries no longer being pursued or utilized. What this means is that there are millions of patented discoveries and research methods that are sitting on pharma databases, unused and inaccessible to other researchers or scientists that might be able to leverage them to make novel discoveries or findings in other areas. 

Where Patents Don’t Exist: Internet, Food and Fashion
One of the biggest argument by Big Pharma has always been that without patents researchers or drug companies will have very little incentive or motivation to invest in R&D efforts. However, this claim does not hold in industries such as fashion, food and the internet. All web sites or web apps for example, by design are open source and their code and interface design can be viewed and copied. Further, in the food and restaurant industry, patent protection would be awful as chefs always copy and improve upon one another’s recipes and techniques making the restaurant business an extremely competitive and innovative industry. Lastly, the fashion world is extremely vibrant, exciting, dynamic and volatile precisely because the healthy competitive environment that is enabled by the lack of patent protection in fashion. Of course the startup cost of drug development and research is astronomical compared to fashion, web sites or food, however, what these IP-free industries show is that, less patents mean more competition, not less, more collaboration and less monopolies, more volatility and uncertainty for companies but better quality, cost and outcome for consumers.

Patients vs. Profits
At the end of the day, it is obvious that patent protection is more about protecting financial investments and short and long term profit sources than patient outcome. Of course large investments in money and human capital are needed to research and develop drugs, however, once these drugs are merely viewed as consumer products from the CEO/Wall Street perspective, profits come first and patent law is just a means to an end. The inventor of one of the most revolutionary drugs in history that cured Polio sought neither profits nor patent protection for his discovery. His invested time, money and passion was solely for the purpose of helping patients and curing this disease. It’s not hard to observe such acts of altruism and selflessness by individuals in the medical community today. It is however, those powerful institutions with their outdated business models that often get in the way of patient-centric innovation and research through their Wall Street dictated balance sheet goals and metrics and insecure market position.

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