Killing Healthy Patents

By Peter Pitts
Published 11/26/2007 12:07:45 AM http://www.spectator.org/dsp_article.asp?art_id=12332

Ah, the glorious patent -- such a simple concept, and yet so utterly essential to a properly functioning society. In basements and R&D departments across the country, innovators are hatching newfangled gadgets, widgets, and services -- products that will fuel economic growth and improve lives -- because they are reasonably confident that a patent will prevent competitors and criminals from stealing their inventions.The folks at pharmaceutical companies are no different. Yes, that's right, drug companies, like most innovators, are in business to make money. They invest huge sums in research that leads to life-saving medical advances, and they hope to be rewarded for their efforts. Without strong patents protecting new drugs and processes, much of the research simply cannot continue.How distressing, then, that the U.S. Senate has taken up a bill that would pretty much decimate patents as we know them. The Patent Reform Act of 2007, a version of which has already passed the House, would require every patent application to be published on the Internet only 18 months after filing.Considering the years of research underlying most medical innovations, it is madness to require pharmaceutical companies to reveal their secrets so early. It seems even more unfair when you consider that it often takes in excess of 36 months after filing a patent to actually have it approved. This means that competitors and criminals will have a window of at least 18 months to replicate new drugs and medical research.Proponents of the bill claim that medical patents are being applied to inventions that are so small that they routinely overlap. They add that since many patented chemicals and processes are discovered through incremental advances, competing claims on them have stifled progress in the medical field.But as any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time. Companies more often profit by improving existing chemicals and making processes more efficient than by revolutionizing the whole field with new products. And even the smallest innovations are made only after large amounts of very expensive research.What's more, those clamoring for congressional action are seriously exaggerating the problems of the present system. They often cite, for example, the case of Myriad Genetics, a company that in 1998 patented a test for a genetic variation that, according to the company's website, increases a woman's risk of breast cancer.Instead of licensing its expertise, Myriad has decided to charge clinicians $3,000 a pop to perform the test. And since it will not open the test to outside scrutiny, other researchers have been unable to verify the procedure's effectiveness. Critics say the public has been ill-served.It is true that $3,000 seems expensive for a test, but one should not underestimate the cost of developing this procedure. And in any case, as Claire Driscoll, Director of the National Human Genome Research Institute, recently told Reason magazine, situations like Myriad's are the exception. "In my 10 or 15 years of doing this," she said, "I hear the same five or six examples [including Myriad Genetics] repeated over and over."The vast majority of patents are on medicines and procedures that have undergone extensive outside scrutiny. According to the Center for the Study of Drug Development at Tufts University, of every 5,000 compounds tested, only 250 enter pre-clinical testing, only five make it to clinical testing, and only one eventually receives FDA approval. There is no reason why a medicine so thoroughly vetted should not enjoy the protection of a patent that prevents outsiders from snooping into the specifics of how it works.Even as the U.S. Congress considers weakening America's patent law, officials in other countries are recognizing the importance of protecting intellectual property. Singapore, for example, has made a point of luring biotech and drug companies with promises to protect their inventions. "No pharmaceutical company is going to have its precious patents disclosed," former Singaporean Prime Minister Lee Kwan Yew told Der Spiegel magazine in 2005.Indeed, America's strong patent law is a major reason why many pharmaceutical companies are still based here, instead of, say, Canada, where laws are weaker. If the Senate passes the Patent Reform Act of 2007, some companies might pack up and leave. Or, more worryingly, they might simply halt research on what could be tomorrow's life-saving cures.Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.