Democratic presidential candidate Mike Bloomberg has a beef with Mark Twain.
Twain once said “a country without a patent office and good patent laws” would only travel “sideways or backwards.” In contrast, as a Fortune article put it, Bloomberg wants to take a “buzz saw” the U.S. patent system. STAT News said the former New York City mayor wants to “blow up” the model Twain revered.
At least he wants to blow it up for some companies. (We’ll remind readers that Bloomberg Finance .) Specifically, candidate Bloomberg wants to limit new drugs to one patent that lasts 20 years.
This plan would have a devastating effect on pharmaceutical companies’ ability to recoup the time and money they invested in their discoveries—an outcome that would lead to reduced revenues for future research and development.
The John and Laura Arnold-funded I-MAK praised the idea. We have addressed I-MAK’s arguments against the current system here, but here are some other points for the Bloomberg campaign to consider.
The 20-Year Clock Doesn’t Start Ticking When Drugs Come Onto the Market.
As Institute for Policy Innovation Resident Scholar Merrill Matthews explained in The Dallas Morning News: “That patent countdown clock starts as soon as a company files a patent application. At that stage of the research process, a medicine is better described as a hope than a product.” Matthews noted it takes about 10 years for that hope to make it through clinical trials and FDA approval, and most experiments, even if patented, never become a “product.” (This article contains more information about the length of patents from brand launch to generic launch.)
The Number of Patents Often Relates to the Complexity of the Treatment.
It is true that drugs sometimes have multiple patents, but at IPWatchdog David Forman has argued that fact simply “stems from the nature of biological drugs.” These treatments are molecularly complex and “may be quite sensitive to changes in manufacturing processes.” The “complexity often creates substantial scientific and manufacturing challenges and can greatly increase the costs and risks associated with developing and producing biologics. Overcoming these problems may result in multiple discoveries that are patentable.” Why shouldn’t a researcher or company own that intellectual property?
A Secondary Patent Does Not Impede Developing a Generic of the Original.
Back to Matthews’ column in the Morning News. He explained that when drug companies offer improved versions of products, and patent them, it “doesn’t extend the patent life of the original drug. Generic manufacturers may sell a generic version of the original, just not the new version.” Again, why shouldn’t a scientific or manufacturing advancement be patentable?
Even Small Improvements Are Valuable.
As we explained in the blog post linked to above, the Arnold-funded I-MAK has derided secondary patents, saying they have little value. Matthews disagrees, arguing even improvements that simply require patients to take fewer doses are extremely beneficial. These innovations make it easier for patients to comply with their treatment regimen and since “patient noncompliance causes an estimated 1-in-10 hospitalizations and costs between $100 billion and $289 billion annually,” these improvements could result in significant savings across the health-care system.
Matthews was arguing against a piece of legislation offered by Sen. John Cornyn when he made those arguments. He said the senator’s bill “would essentially deter companies from making improvements to their medicines.” Bloomberg’s proposal would do the same.
In a statement to STAT News, our Executive Director Patrick O’Connor said: “I would expect the founder of such an innovative company to appreciate the absurdity of capping innovation in one of the country’s most cutting-edge industries. Mayor Mike always struck me as a thoughtful politician, but parts of this plan feel more like pandering.”
It is pandering that ultimately will hurt American patients. As former FDA Associate Commissioner Peter Pitts wrote last year in the Houston Chronicle: “Without the ability to protect their inventions through reliable IP laws, drug companies would have far less reason to expend the resources necessary to make genuine breakthroughs. That would be disastrous for patients, especially those suffering from conditions for which no suitable treatment yet exists.”