Freedom Line Blog

This week, Senator Elizabeth Warren (D – Massachusetts) and a group of fellow liberals submitted a letter to the United States Department of Health and Human Services (HHS) demanding that the federal government employ so-called “march-in” rights under the Bayh-Dole Act of 1980 to disregard private patent rights on the critical cancer drug Xtandi.

Here’s why that’s a terrible and potentially deadly idea that the HHS, other lawmakers and the American public must oppose.

Simply put, disregarding patent protections for pharmaceutical innovators will bring innovation to a halt and deprive Americans of lifesaving drugs.  America currently produces two-thirds of all new drugs worldwide, and that’s because our nation honors and protects patent rights, it doesn’t violate them.

It’s especially outrageous that Senator Warren and her cohorts seek to leverage the Bayh-Dole Act of 1980 to facilitate their scheme.  The Bayh-Dole Act was passed in order to extend patent rights to universities and nonprofit research entities whose research was assisted by federal funds, not weaken them.  Prior to Bayh-Dole, very few innovations partially funded by federal dollars were ever commercially pursued – only 390 in the year prior to its passage.  Four decades later, however, that number approaches 7,500, with over 420,000 inventions and 13,000 new startup enterprises formed.

That explains why The Economist magazine labeled Bayh-Dole the most important bill of the past half-century:

Possibly the most inspired piece of legislation to be enacted in America over the past half-century was the Bayh-Dole Act of 1980.  Together with amendments in 1984 and augmentation in 1986, this unlocked all the inventions and discoveries that had been made in laboratories throughout the United States with taxpayers’ money.”

Alarmingly, however, this groups seeks to undermine patent rights for Xtandi by exploiting a “march-in” provision within Bayh-Dole to empower the federal government to commandeer new drugs and license the patents on inventions partially funded by federal dollars to third parties.   According to their flawed logic, the market prices of some drugs render them insufficiently available to the general public, and on that basis they encourage federal bureaucracies to forcibly license those drugs’ patent rights to other third parties for manufacture and sale.  That would constitute a frontal assault against private pharmaceutical innovators, disregarding their patent rights and the enormous investments they’ve made over years and decades to conceive, perfect, produce and distribute those drugs.  It would also contravene the statutory terms of Bayh-Dole itself.

Indeed, Senators Birch Bayh and Bob Dole themselves confirmed that the law bearing their names did not intend or allow cost to become a mechanism for imposition of de facto drug price controls:

Bayh-Dole did not intend that government set prices on resulting products.  The law makes no reference to a reasonable price that should be dictated by the government.  This omission was intentional;  the primary purpose of the act was to entice the private sector to seek public-private research collaboration rather than focusing on its own proprietary research.”

That’s precisely why the National Institutes of Health (NIH) has rejected every one of the “march-in” petitions that it has received during the Bayh-Dole Act’s existence.  It has consistently and correctly ruled that attempts to leverage price allegations to justify march-in would undermine the very goal of the act and ultimately harm American consumers.

People like Sen. Warren and her cohorts nevertheless claim that federal funding toward pharmaceutical research justify government march-in intrusion, falsely asserting that pharmaceutical innovators somehow enjoy a free ride at taxpayer expense.   That’s false.

Private funding for research and development actually dwarfs public funding.  According to the NIH itself, private sector R&D far exceeds NIH funding throughout recent years and decades.  In 2018, as another example, the NIH spent $3 billion on clinical trials involving new or existing drugs, compared to $102 billion in R&D by the U.S. biopharmaceutical industry.  Indeed, the pharmaceutical industry stands as the single largest source of business R&D funding in the U.S., accounting for 17.6% of all U.S. business R&D.  The next-closest counterpart is the software sector at 9.1%, with the automobile industry at 5.9% and the aerospace industry at 4.1%.

Senator Warren and her cosigners also allege that inflation somehow justifies their demand, but the fact is that drug prices significantly trail overall inflation.

Accordingly, the facts show that strong U.S. patent protections and the Bayh-Dole law promote pharmaceutical R&D investment, and there’s simply no legal or logical basis for advocating march-in regarding Xtandi.  Pharmaceutical innovation demands billions of dollars in sunk costs of investment, not to mention potential product liability lawsuits for any errors.  Strong patent protections, which Bayh-Dole codifies, help ensure that those costs and risks will be fairly and sufficiently rewarded.  They provide innovators and investors the incentives to create pharmaceuticals that save millions and even billions of lives worldwide.

The demand by Senators Warren and her cosigners would dangerously jeopardize that.

When pondering the origins of American Exceptionalism, and what makes us the most innovative, prosperous nation in human history, look first to our tradition of protecting intellectual property (IP) – patent, copyright, trademark, and trade secret property rights.

After all, other nations match or even exceed the U.S. in free market rankings (24 nations in the latest annual Index of Economic Freedom, in fact).  No nation, however, can match us for sheer innovation.  America accounts for less than 5% of the world’s population, and even with the world’s largest economy we account for under 25% of the global economy.  In contrast, no nation can match our scientific innovation, from flight to space exploration to the internet.  Nor can any nation match our artistic leadership, from the film industry to television to music, or claim as many instantly recognizable trademarks, from Coca-Cola to Apple.

Year after year, that’s why the U.S. leads global rankings of IP protection.

Perhaps most conspicuously, the U.S. accounts for fully two-thirds of all new lifesaving pharmaceuticals introduced to the world each year.  In an era increasingly reliant on pharmaceutical treatments for everything from Covid to cancer to Alzheimer’s, that is a leadership of which we should remain both proud and protective.

Inexplicably, however, some voices seek to undermine that IP leadership position.  A group called I-MAK offers the latest assault, with a “study” entitled “Overpatented, Overpriced,” which attempts to show “how excessive pharmaceutical patenting is extending monopolies and driving up drug prices.”  We employ scare quotes around the term “study” because I-MAK’s work has been previously debunked and exposed by leading IP scholars like George Mason University and Antonin Scalia Law School Professor Adam Mossoff and Senator Thom Tillis (R – North Carolina) for using defective and non-transparent supporting data.

Indeed, we highlighted earlier this year how drug prices have remained far, far below overall inflation.  Efforts like I-MAK’s would only end up suffocating drug innovation, not reducing prices, as we’ve also highlighted:

Of all new cancer drugs developed worldwide between 2011 and 2018, 96% were available to American consumers.  Meanwhile, only 56% of those drugs became available in Canada, 50% in Japan, and just 11% in Greece, as just three examples.  Patients in nations imposing drug price controls simply don’t receive access to new pharmaceuticals as quickly as Americans, if they ever receive them at all.”

Even the World Health Organization (WHO) acknowledges that overseas consumers’ lower access to pharmaceutical innovations stems from their governments’ imposition of price control regimes:

‘Every time one country demands a lower price, it leads to lower price reference used by other countries.  Such price controls, combined with the threat of market lockout or intellectual property infringement, prevent drug companies from charging market rates for their products, while delaying the availability of new cures to patients living in countries implementing those policies.’”

The irrefutable reality is that U.S. patent protections explain why we produce the overwhelming share of new drugs worldwide, including the Covid vaccines.  Efforts like I-MAK’s latest “study” continue a bizarre ongoing affront to property rights, the rule of law and IP.  If successful, they would only mean fewer future vaccines and treatments, and must be flatly rejected.

CFIF has continuously sounded the alarm on dangerous drug price control efforts, which will only do what artificial price controls always do – cause shortages of the very products they attempt to regulate.  The numbers speak for themselves.

Today, The Wall Street Journal editorial board cogently addresses the looming bankruptcy of Medicare and Social Security, and along the way nicely makes that point that we and others have been making, while also pointing out that drug prices have actually remained flat while prices for other products and services have skyrocketed:

Democrats blame Big Pharma for bankrupting Medicare, but annual Part D prescription drug costs have grown on average 1% over the last five years.  That’s far less than inflation, GDP and other Medicare spending. Even expensive drugs that grow spending in the short run can reduce long-term health spending.

Consider Hepatitis C treatments, which public-health scolds lambasted as too pricey when they launched nearly a decade ago.  Prices have since plummeted 75% from about $100,000 per course thanks to market competition.  A Department of Health and Human Services analysis estimates the treatments reduce patient health costs by about $16,000 annually and will save Medicaid $12 billion after this year.

Once the hospital trust fund runs dry, spending will have to be slashed by 10%.  The Democratic solution is to let Medicare “negotiate” drug prices — their euphemism for price controls.  But this will reduce the incentive to develop innovative treatments for hard-to-treat conditions like Alzheimer’s.  The result may be higher Medicare spending over the long term.“

Artificial government efforts to impose price controls never work, whatever the product, whatever the time and whatever the flimsy rationalization.  America leads the world in producing lifesaving pharmaceuticals – 2/3 of all new drugs introduced worldwide, in fact – so we mustn’t tolerate Biden Administration or Congressional efforts to try this failed proposal yet again.  The stakes for us all are too high to re-learn that lesson the hard way.

In our latest Liberty Update, we highlight an eye-opening new study confirming how drug price controls kill pharmaceutical investment and innovation at the worst possible time, when America and the entire world depend upon them more than ever.

In similar vein, American Enterprise Institute (AEI) Adjunct Fellow and healthcare expert Michael Rosen nicely illustrates how the omicron variant of Covid has paused the destructive global effort to suspend enforcement of patent rights belonging to lifesaving vaccine developers:

But the new omicron variant of the virus has intervened, shelving the planned WTO meeting and throwing into continued contrast the supposed haves and have-nots of vaccine protection…  But the EU has held firm in resisting the vaccine waiver, and rightly so.”

Unfortunately, even the EU remains too accommodating of calls to kill the goose that lays the golden vaccine eggs, but hopefully this latest experience brings greater collective wisdom.  If we seek to maximize healthcare and pharmaceutical innovation, the solution isn’t any secret.  Get bureaucrats and suffocating price controls and patent threats out of the way.

In the wake of this month’s catastrophic election results for Joe Biden and his party, many leftists stubbornly rationalized that voters were upset that Biden hadn’t seen more of his agenda passed, and that the answer to Biden’s and Democrats’ ills was to step on the gas and pass more of that agenda.  Well, the new ABC News/Washington Post poll offers and instant rebuttal.  The survey is nothing short of catastrophic for Biden and Democrats as 2022 approaches, with Republicans scoring record preferences (see image below).  But note something else:  This poll was conducted November 7 – 10, AFTER Biden’s “infrastructure” spending bill was passed.

“Build Back Better” Is a Loser

We at CFIF have detailed the catastrophic potential effects of passing Biden’s even larger spending bill currently before Congress, including its potentially devastating consequences for American healthcare and pharmaceutical innovation:

Specifically, they’re attempting to cement agreement on provisions that would empower the federal government to begin “negotiating” drug prices with manufacturers and imposing draconian penalties upon providers that don’t play ball.

That constitutes a scheme to bring price controls to American healthcare, with catastrophic effects, according to analyses from both the non-partisan Congressional Budget Office (CBO) as well as the University of Chicago.”

This new ABC News/Washington Post poll should offer a cautionary tale for Senators Joe Manchin (D – West Virginia), Kirsten Sinema (D – Arizona) or anyone else even contemplating voting for it.

As we’ve highlighted, the dangerous effort to weaken critical patent protections for U.S. pharmaceutical innovators often minimizes the role of private investment and exaggerates the role of public funding.  This offers a critical corrective at a moment when American drug and vaccine innovation is more important than ever:

The Critical Role of Private Pharmaceutical Investment

In this week’s Liberty Update, we highlight how cheap slurs against “Big Pharma” have suddenly and rightfully fallen silent amid the coronavirus pandemic, as people understand that private pharmaceutical innovators offer the best hope for new vaccines and treatments.  Along with strong patent protections, one of the key components in unleashing America’s pharmaceutical innovators – who lead the world by producing an astounding two-thirds of new medicines worldwide – is an emphasis on free-market principles, as opposed to socialized models that stifle innovation and prevent new drugs from reaching even developed nations’ consumers.  Our friends at the Heritage Foundation offer a nice illustration of that correlation:

Freedom Means Innovation

.

Think a dollar doesn’t go as far as it used to?  Think again.  Let’s hear it for capitalism and the underappreciated progress that it brings:

Three Cheers for Capitalism

.

Reasonable people understand that nations more protective of property rights and the rule of law enjoy higher levels of innovation and prosperity.  The fields of pharmaceutical advancement and biomedical innovation more specifically are no exception.

In a cogent new piece, U.S. Chamber of Commerce Executive Director of Intellectual Property Policy Patrick Kilbride demonstrates how strong intellectual property (IP) protections fuel biomedical innovation that benefits the world:

[E]conomies with the strongest IP protections are 60 percent more likely to provide environments conducive to biotech innovation.  And economies with specific protections for the life sciences field see an average of 13 times more biomedical investment than those lacking IP protections…  [A]s intellectual property systems have strengthened over time, public and private investment in health care has increased, as well as individual earnings to support heath costs.”  (emphasis in original)

Why does that matter?  Because international and even domestic forces seek to  undermine IP protections, threatening the goose that continues to lay golden eggs:

We live in a world where concerted efforts are being made daily to erode intellectual property rights, based on the false premise that IP somehow threatens access to medical care.  While the facts simply don’t support this theory, it hasn’t stopped activists around the world from spreading misinformation and chipping away at the very IP protections that produced life-saving medicines in the first place.  Just a few short years ago, India stripped a leukemia drug of its patent, claiming that it inhibited access by its citizens.  The result?  Due to government interference, fewer Indian citizens had affordable access to this medication than before the patent was annulled.  In Canada, an overzealous judiciary revoked 25 previously granted pharmaceutical patents and sparked a case involving NAFTA protections that could do lasting harm to future investments in life-saving medicines.  And Colombia’s prime minister of health has repaid medical researchers scrambling to find a cure for the Zika epidemic by pursuing an arbitrary and dangerous attack on others in the industry, effectively stripping a pharmaceutical company of its patent for another drug.  It is also against this backdrop that the United Nations Secretary General has pressed for establishment of a High-Level Panel on Access to Medicines (HLP) to quickly produce a report, based on the same false premise:  that ‘failure to reduce the costs of patented medicines is resulting in millions of people being denied access to lifesaving treatments.'”

As Abraham Lincoln observed, “The patent system added the fuel of interest to the fire of genius.”  It’s incumbent upon us to safeguard IP protections that continue to fire the genius of medical innovation.  Too many lives are at stake across the world to allow the grim alternative.

In letters sent today to the Federal Communications Commission (“FCC”), the Center for Individual Freedom (“CFIF”) joined with more than 150 other organizations, state legislators and bloggers in urging the FCC to abandon its plans to regulate the Internet.

The letters were organized by Americans for Tax Reform.  One of the letters reads in part:

Despite universal acknowledgement that Americans enjoy a free, open, and vibrant Internet, the FCC is relentlessly pursuing a massive regulatory regime that would stifle broadband expansion, create congestion, slow Internet speeds, jeopardize job retention and growth, and lead to higher prices for consumers.

We oppose the FCC’s effort to regulate the Internet under Title II of the Communications Act of 1934, which was written during the depression era to regulate telephone monopolies – 60 years before the Internet was ever conceived. … This regulatory ‘reclassification’ would effectively turn innovative private Internet services into a public utility.

“The already free and open Internet has sparked unprecedented growth and innovation over the last decade precisely because it hasn’t been burdened with unnecessary regulation and taxation,” said CFIF President Jeffrey Mazzella.  “The reckless desires of three unelected FCC commissioners and a few radical fringe groups on the left that wish to turn the Internet into a government-controlled public utility now threaten to grind those wheels of Internet growth and innovation to a halt.

“The Courts have spoken.  A rare bipartisan majority in Congress opposes the FCC’s plans.  And, the American people reject this unnecessary and job-killing regulatory regime sought by the FCC,” Mazzella continued.  “It’s past time for the FCC to listen and abandon its plans for a government takeover the Internet.”

To read the letters send to the FCC, click here and here.

The Hill’s popular Hillicon Valley blog mentions the letters here.