Intellectual property rights are under attack – above all in the pharmaceutical industry. Dr Henry McKinnell argues that patent protection is vital. Without it, he says, huge benefits to science, health care, education and human life will be lost –
Back in 1982 Pfizer was on the verge of shutting down a research programme run by a chemist called Michael Bright. For eight years Bright and his team – along with a rival company – had been on the trail of an antibiotic that promised to cure diseases that no one had seen cured before. There had been successes along the way with a compound that Bright called CP62993. But now his team seemed to have hit a dead end.
Then Bright rushed into a meeting at the Pfizer labs in Groton, Connecticut. He was carrying test results so new that he had only had time to photocopy a few sheets. He laid the pages in front of our former senior scientist, John Niblack, and some others. There was a tense moment while everyone scanned them. Then Niblack looked up smiling.
“Isn’t this the most exciting thing we’ve ever seen?” he said.
The compound CP62993 was what became Zithromax, the antibiotic that cures staphylococcal infections, inner-ear conditions and many other diseases. It was a victory for science and for the ingenuity and tenacity of our scientists and those at our rival, the Yugoslav company Pliva.
It was also a victory for one other thing – intellectual property rights or patents. Patent protection is under attack these days, particularly in our industry. Although the US Congress is willing to extend protection for entertainment, there are those who want to cut it back for pharmaceuticals.
This attack is wholly misguided. Without the incentive of patents – which Abraham Lincoln said “added the fuel of interest to the fire of genius” – we would not have Zithromax or many of the drugs we use to fight tuberculosis, polio, depression, AIDS or the other scourges that rob human beings of life and good health.
Why is that? One reason is obvious: innovative people will work better if they are rewarded for their efforts. But when it comes to the pharmaceutical industry, there are other reasons.
First, discovering the drugs that are revolutionizing health care involves a long time and a lot of money. It commonly takes more than a decade and $800 million to turn a molecule into a pill that can be taken safely by a patient.
Second, even with that effort, the odds of success are long. As Bright puts it, finding the right compound is like “finding a needle in a Kansas cornfield”. We get one profitable drug out of every 5,000 to 10,000 compounds we test. On average, the proceeds from only about three in 10 drugs exceed R&D; costs. Who could afford this herculean effort without incentive?
R&D; investment in Mexico tripled after the introduction of full intellectual property protection in 1991. Economists have charted similar effects in South Korea, Japan and Italy. And we are just beginning to see the benefits to science and education in those countries.
Critics of intellectual property rights say high prices, caused by a 20-year patent monopoly, keep drugs from patients who need them, particularly in Africa. Those who argue this mean well, but do not know the facts. Patents in pharmaceutical research simply do not equal monopoly. There is too much competition.
In fact, drugs do not get 20-year protection. Because it takes such a long time after patents are granted before the drugs appear on a pharmacist’s shelf, it is more like 12 years. Sometimes, because regulatory reviews are so complex, and because of the lack of data protection in some countries, it is even less.
More important, while the AIDS epidemic in sub-Saharan Africa is a monumental human tragedy, the evidence shows that patents play little role in restricting access to AIDS drugs.
One detailed survey of company-held patents published in the Journal of the American Medical Association found that in most sub-Saharan countries patents on the key AIDS medications do not exist. It concluded that “patent protection laws are not a major barrier to treatment”.
I would go further. Far from being a barrier, patents are the springboard that has allowed us to leap over barriers. The world’s response to the most important health crisis of our time has been made possible by an extraordinary response from our industry.
Since 1981, when few scientists had even an inkling that this new epidemic had begun, researchers have developed 64 drugs to treat AIDS. Of these, 57 have come directly from the laboratories of our industry. We have 83 more drugs for AIDS in clinical trials. Our company has another drug that treats opportunistic infections striking AIDS victims. We are making it available free of charge to needy patients in several African countries and plan to extend this to the world’s 50 poorest countries. And we are by no means the only company with such a policy.
Africa, of course, is bedevilled by other terrible illnesses. If we are to meet these health scourges head-on, we cannot afford to snipe at each other. We must work in partnership.
One such partnership involves Zithromax, the drug that so elated Bright in 1982. The road to market was long, but in the end Pfizer developed the drug under licence from Pliva and eventually doctors could prescribe it.
And then, in addition to the uses we had predicted, Zithromax turned out to have another. A single dose can cure trachoma, the leading cause of blindness in the world and a devastating problem for Africa.
That was certainly true in Morocco. Health officials there had struggled for decades to eradicate the disease but nothing worked. Then, two years ago, we began donating Zithromax to Morocco. Now, 2 million doses later, the results are in. We have cut trachoma there by 75%. And we are cutting infection rates in other African countries, too.
That is why Edna Mukuta, a 37-year-old mother of three, turned up at a treatment centre in the Dodoma region of Tanzania. She did not know what trachoma was, or what caused it.
“We were just told the medicine is good, so we came to get it,” she said, taking the single dose of Zithromax that would cure her.
The medicine is good. As a young Pfizer employee, I remember hearing about the painstaking, elegant manipulation of molecules that Mike Bright and his team went through. I wish I had the space here to detail the exciting story of how they brought that compound from test tube to animals and then to human beings.
“But these miracle drugs wouldn’t exist if we didn’t have the investment,” says Bright.
While there are those who argue that we put “patent rights” before “patient rights”, the truth is that patent rights are precisely what give patients hope. We need to defend the patents on drugs, not discourage them. For there are too many promising avenues to explore.
Do we want a cure for AIDS? We are seeking one. Do we want a cure for the common cold? A promising medicine is being tested now. Do we want to beat antibiotic resistance? Researchers are working on a derivative of macrolides – like Zithromax – called ketolides, that could deliver. Do we want to find a vaccine against CMV, the herpes virus that is the leading infectious cause of birth defects in the US? Or one for cervical cancer? Both are in development. None of these innovations will succeed without the incentive made possible by patents.
It was more than 200 years ago that Thomas Jefferson, the third president of the US, faced a dilemma. He disliked monopoly but was an inventor himself.
His designs still exist for a new plough, a macaroni machine and the swivel chair. Jefferson knew that patents “encourage men to pursue ideas which may produce utility”.
The brilliant idea that he and his successor as president, James Madison, came up with was to reject the British models of monopoly (granted at the king’s discretion) and issue limited protection. This concept, in itself an invention, has fostered so many others.
Since knowledge is available to anyone who can read the research filed with a patent application, the spread of knowledge is facilitated. It is thus a reflection of everything Jefferson had hoped for from a democratic society – openness, transparency, competition and benefit to the citizenry.
It is simply the best way we know of encouraging good ideas. Like the idea that Mike Bright had in Groton, Connecticut.
The idea he called CP62993 was made possible by Jefferson’s idea. And it has made life possible for millions.
The global business community must fight to preserve this concept, which has fuelled such massive economic and social development in the US. We must encourage its adoption throughout the world so that other countries can enjoy the same benefits.
Only if we do that will it remain possible for scientists of the future to have moments when they look at the data, see the possibilities stretching before them and exclaim, as John Niblack did 20 years ago, “isn’t this the most exciting thing we’ve ever seen?”
Dr Henry McKinnell, Jr
Dr Henry McKinnell, Jr is chairman and CEO of Pfizer Inc.