When a plant gets patented
December 21st 2017, 14:01
You've probably heard about Big Pharma's patent cliff in the early part of this decade—when the patents of huge blockbuster drugs like Lipitor, Plavix and Singulair expired. The effect was a precipitous drop in sales. But the decline in use of these drugs didn't send disease rates skyrocketing, because people tend not to suffer from Lipitor, Plavix or Singulair deficiency diseases.
Pharma's woes are far from over, as we approach a second patent cliff for blockbuster drugs licensed around the turn of the new millennium. Pharma is managing this problem in a variety of ways. One is through growth of generic drugs.
When a drug's patent expires, anyone can sell generic versions of the drug provided that they have the knowhow and funds available to manufacture, license, distribute and market it. Many of us imagine that most generic manufacturers are Indian or Chinese outfits, but fewer know that Big Pharma has also set up generic manufacturing facilities in these and other emerging and developing countries. They can compete with other manufacturers in the hope that a Pfizer, Bayer, Merck or GSK logo on a drug will allure customers more than the unbranded drugs made by their competitors.
Pharma sales in the USA, Europe and other developed countries have stagnated in recent years. It looks like the era of blockbuster drugs may be not just over but unrepeatable. Sales of patent-free generics are growing especially in developing countries, where they often sell for 80 per cent less than their original patented versions.
To survive without the blockbuster pipeline, Big Pharma has turned its attention to developing a new category of drugs: highly specialized biologicals that target some of the complex conditions now on the rise, such as autoimmune diseases like Crohn's.
The Pharma pipelines currently have a few hundred of these specialty drugs under evaluation in clinical trials, which are needed for licensing. This is Pharma's only growth category, and it already represents around 20 per cent of global sales, almost entirely in the industrialized world. But in population-wide terms, it's unlikely these new drugs will have a big impact on the major killer diseases of the developed world, namely cancer, heart disease, diabetes and obesity. What's more, these diseases are gaining ground in developing countries as they increasingly adopt Western diets and lifestyles.
If Big Pharma and its generic counterparts get their way, the future of drug delivery in developing countries is predictable. They'll get most of the same drugs the industrialized world has been getting, but in much cheaper form, while the new biologics category will be too expensive. Generics will help some people, but as we've seen, these older drugs will do precious little to offset the rapid rise of chronic, degenerative diseases to which the developed world must now respond.
There is a more sinister aspect of the Pharma game plan. Most of the world's plant diversity, especially for plants with medicinal properties, exists in the tropics and subtropics, the very biogeographical region in which the vast majority of developing countries is found. Even today, it's estimated that around 70 per cent of all licensed pharmaceuticals are derived from natural sources—plants in particular. Common examples include aspirin from white willow bark and statin drugs from red yeast rice.
Now that nature is widely recognized to hold so many answers, Pharma is increasingly engaged in bioprospecting. This means going into rainforests, deserts and other indigenous habitats and seeing what's on offer, often being guided by knowledge that's been passed down from generation to generation among indigenous people.
Learning from traditional medicine men and women is one thing, but stealing information and, even more worryingly, intellectual property, is another. This shifts Pharma from bioprospecting to biopiracy. And it's going on right now.
The slimming herb Hoodia, used for thousands of years by the Kalahari bushmen to help them stave off their appetites on long hunting missions, is a recent example. Pharma is now trying to take control of this herb, without giving the bushmen any royalties. Pharma takes little risk, as it has seen the herb's popularity demonstrated as a herbal supplement widely available in health stores
Pharma's end game, no doubt, will be to manipulate the bioactive molecules so it can benefit from patents. The herb now finds itself on a hit list of botanical supplements that European authorities are trying to clamp down on internet sales of, claiming that they pose a risk to public health or are endangered. But the real motivation driving these authorities is more likely linked to competition. The justification that regulatory action is needed to protect biodiversity is commonly used even for products where most trade is in cultivated versions, which obviously pose no environmental threat.
When you next see a clampdown on botanicals, think twice about what the real driver might be. More than likely, Pharma is behind it.