A drug worth a Nobel prize but not a patent
In awarding half of this year’s prize in medicine to the discoverer of artemisinin, an antimalarial drug, the Nobel Prize committee said the drug would have immeasurable consequences in terms of improved human health and reduced suffering. If a patent were applied for, however, in the United States, it would fail.
The problem starts with Association for Molecular Pathology vs. Myriad Genetics, the U.S. Supreme Court case that determined purified genes were patent ineligible. Applied broadly, the court’s logic in Myriad prohibits the patenting of any purified natural product. Currently, the U.S. Patent and Trademark Office will not grant patents on any purified natural product. Artemisinin comes from the sweet wormwood plant, so it is patent ineligible.
For over half a century, lower courts had a different interpretation of Supreme Court precedent. This seems to bother neither the Supreme Court nor the patent office. Neither Merck v. Olin Mathieson, which upheld a patent on a purified form of vitamin B12, nor Parke-Davis v. Mulford, which upheld a patent on purified adrenalin, were mentioned in Myriad by the Supreme Court in 2013. In addition, the patent office has not explained why a case filled with limiting language that can easily be interpreted as applying only to genes requires such a drastic policy change.
Furthermore, common sense and economics teach why a purified compound is truly a new state of matter. It takes an enormous amount of money to isolate the active compound from a natural source. Unless the return is economically justifiable, incentive is removed to spend this money. We may lament the fact that companies expect to be paid for work and investment as much as we like, but it doesn’t change this fundamental aspect of business. A business that invests millions of dollars in isolating an active ingredient with no hope of making that money back could actually be sued for ignoring its fiduciary duties by shareholders.
As our current battery of antibiotics becomes unusable, do we really want to remove the business justification for finding viable natural replacements? Expecting debt-strapped governments to pick up the slack is naïve.
Vitamin B12 is produced by the liver of cows and other organisms, but I know no vegetarians who would say eating liver is permissible because taking Vitamin B12 is permissible. No one who has had the exquisite pleasure of eating an orange would claim that purified Vitamin C is the same state of matter. The multibillion-dollar vitamin supplement industry belies the fact that purified vitamins are the same as the foods where they are found. Even when only non-acetylated aspirin was available, no one would have claimed purified aspirin was the same state of matter as the willow bark from which it was purified. How many people do you know who treat headaches with willow bark?
Purified artemisinin is an incredible treatment for malaria, but no one would say that wormwood should be used instead. If developers have no desire to patent their medications, they are certainly free not to do so. In the world the Supreme Court and the U.S. Patent and Trademark Office have given us, artemisinin is important enough to win a Nobel Prize but not important enough to be granted patent protection.
Daniel W. Cole of Chapel Hill is a licensed patent agent and attorney.
This story was originally published October 30, 2015 at 5:31 PM with the headline "A drug worth a Nobel prize but not a patent."