As the health care debate limps forward, it's time to consider a related but entirely overlooked topic: the availability of medicines. Ironically, the greatest barrier to making existing medicines more available or innovating new ones is an abused patent system. One major step forward -- especially in developing countries -- is to stop approving many frivolous drug patent applications.
Yes, stop. As intellectual property lawyers, we know that without legal protection, scientific and commercial daring will wither. But in the pharmaceutical field, the patent system has recently become less a legitimate ally of invention and more a manipulative crutch for profit seeking. Fortunately, change may be coming for the patients who most need it -- HIV/AIDS sufferers.
Here's how the system works in theory: when a drugmaker is granted a patent, the company is usually given a 20-year window of exclusivity to sell the medicine, after which the drug compound becomes available in the public domain. Quite often, generic manufacturers then enter the market and produce the medication at significantly lower prices. Pharmaceutical companies anticipate the end of exclusivity and pour resources into developing the next innovative treatment.
Private actors who work hard to innovate should get a competitive advantage and the monopoly protection a patent confers. Private actors who bankroll lawyers to "innovate" multiple frivolous patent applications should not get the same privileges. But they are. Instead of looking for what's next, the global pharmaceutical industry is exploiting its current stockpile. Often easier than creating new medicines, companies use patent laws around the world to harden their monopolies and protect their sales.
Their method is to make slight changes to medications and submit new patent applications claiming entirely new innovations. These alterations usually don't change the therapeutic impact of the drug. They don't generate additional clinical benefits but rather simply represent a different method of manufacture, delivery, or storage.
Frivolously extending old patents halts generic production and sales. The results are especially disastrous for HIV/AIDS sufferers. Especially in the developing world, when lower-cost generic versions of medications are not available, millions of poor people go without treatment because they cannot afford the patented drug.
But there may be hope. Recent decisions by the Indian Patent Office establish a new standard of clinical benefit for the patient, by which patent applications are judged, making it more difficult for pharmaceutical companies to keep claiming exclusivity.
This standard will be very helpful in a pending case. Abbott Laboratories has filed a patent application for the drugs Lopinavir/Ritonavir, arguably the most vital protease inhibitors in the world and essential to prevent the onset of AIDS in HIV-positive patients.
But this is not the first time Abbott has sought a patent for Lopinavir/Ritonavir. In fact, it is the 30th time. Since 1992, the company has made dozens of minor modifications to the basic compound and sought patent approval around the globe in order to cement its monopoly. This time, in India, Abbott has combined several existing -- and already patented! -techniques to help patients store the medicine without refrigeration, and take fewer pills.
We applaud this move. But it is simply not a new invention, and each modification Abbott is adding has already been patented. Pharmaceutical companies can't hide behind the periodic table of elements to defend their manipulation of patent systems.
If the Indian Patent Office follows its new string of decisions and rejects the application, generic drugmakers are ready. Indian generic companies already supply developing countries with the cheapest possible HIV drugs. Competition led by the Indian manufacturers has brought ARV prices down from $10,000 per patient, per year, in 2000 to $130 in 2009.
The numbers that really count are human. Generic Lopinavir/Ritonavir could save 200,000 lives in 43 countries. One drug, one rejected patent, one cost savings, 200,000 lives.
And that's just the beginning. Worldwide, there are almost ten million patients who need HIV drugs. Most can't afford them. If the developing world flexed its new global muscles and established a 21st century standard of clinical benefit for patenting pharmaceuticals, tens of millions of lives would be healthier.
From the patent office to human betterment. Isn't that what the UK Parliament had in mind in 1624 when it authorized the first patent system? Let's bring it into the modern age for modern needs. Let's make denying weak patents the new frontier of science for patients.
We’re basically your best friend… with better taste. Learn more