January 4, 2019 at 5:00 am ET
In response to the fact that Americans spend more on prescription drugs than the rest of the developed world, lawmakers on both sides of the aisle have now called for pegging U.S. drug prices to the kind of listings seen abroad. But what exactly are those other countries doing differently?
A big part of it comes down to public participation in the patent system.
Consider India, a country where more than 2 million people are estimated to live with HIV. Between 2000 and 2010, the pharmaceutical giant Abbott Laboratories filed a series of unmerited patent applications on the HIV treatment Aluvia, which threatened to halt generic production of the medicine and leave patients in India and other low-income countries hostage to Abbott’s higher annual price tag. Absent public engagement with the patent applications, millions of patients would have been deprived of life-saving treatment.
But patients and activists mobilized to stop these unjustified patents from being granted. Doctors Without Borders launched a global campaign. People marched in the streets. My organization, the Initiative for Medicines, Access & Knowledge, pored over thousands of pages of documents related to Abbott’s patent applications.
We dug up years-old documentation that called Abbott’s claims of inventiveness into question and challenged four of its patent applications at the Indian Patent Office. All four were later withdrawn or rejected. Since then, generic competition has saved governments in low- and middle-income countries more than $200 million.
Unlike in India, Brazil, Argentina, a majority of countries in Europe and elsewhere, the American public has little say in the patent system, even though patents drive high drug prices and affect the health and well-being of millions of people. Under the U.S. system, members of the public have no ability to challenge drug patents before they are granted. They can only submit evidence that the applications should not be granted, but the patent office is free to disregard it (and usually does).
In the United States, the entire patent examination process is tilted heavily in favor of companies, ruling out the kind of robust public scrutiny that led to India’s rejection of Abbott’s patents on Aluvia. Third parties can challenge patents after they’ve been issued, but only after the damage has been done and patients have been subjected to monopoly pricing. And those “after the fact” challenges are used almost exclusively by other pharmaceutical companies seeking to sell generic versions of branded drugs. What is lacking in the patent system is a genuine representation of public and patient interests.
The need for greater public participation in the U.S. patent system couldn’t be more urgent. About 60 percent of Americans take at least one prescription medicine, and 44 percent are worried about being able to afford the drugs they need. A third of people have skipped filling a prescription in the last year due to cost.
Consider that, as America struggles to confront a growing diabetes crisis, drugmaker Sanofi has filed 50 percent more patent applications in the United States on its leading diabetes drug Lantus than at the European Patent Office. It has filed three times as many patent applications in the United States as in Japan.
And that’s just one drug. There are an average 125 patent applications filed and 71 patents granted per drug on the top-12 grossing drugs in America. Since 2012, these drugs have increased in price by an average of nearly 70 percent — even though they have been on the U.S. market for an average of 15 years.
Each patent deters generic competition in the market, and far too many patents are granted on drugs that don’t meet legal standards for inventiveness. The result is decades of monopoly power at the expense of patients.
There are models for how the U.S. Patent Office can better engage patients and families directly affected by high drug prices. The Environmental Protection Agency, for example, holds public hearings with impacted communities, often in multiple cities, that provide a forum for people to present data, views and arguments related to proposed rules.
Similarly, when deciding whether or not to approve a new drug or medical device, the Food and Drug Administration holds open public hearings. That public input makes a difference. An analysis of FDA decisions showed that when public sentiment was skewed in favor, the relevant committee voted for approval 81 percent of the time. When public sentiment was opposed, it opposed approval 73 percent of the time. The odds of approval were 11 times higher when that decision was in keeping with the public will.
While the U.S Patent Office hosts roundtables and hearings, these tend to prioritize industry, not affected communities. The agency should take a more inclusive approach that reflects the concerns of patients and families as seriously as it does industry lobbyists.
The consequences of the current approach are painfully clear. Americans spend more on health care and have worse health outcomes compared with other developed countries. Our social safety nets, Medicare and Medicaid, are cracking under the weight of high drug prices. Americans are rationing medicines while our system generously hands out patents that send drug prices soaring.
It’s long past time to subject the U.S. patent system to the same scrutiny to which we subject other federal agencies and give people a meaningful stake in decision-making that affects their health. Anything less isn’t just undemocratic. It’s inhumane.
Priti Krishtel is the co-founder and co-executive director of I-MAK.org, a global nonprofit organization comprised of attorneys, scientists and health experts who have worked to lower drug prices for 15 years.
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