We at CFIF often highlight the clear and present danger that drug price control schemes pose to American…
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New Lung Cancer Breakthrough Illustrates the Potential Peril of Drug Price Controls

We at CFIF often highlight the clear and present danger that drug price control schemes pose to American consumers, who benefit from our private pharmaceutical sector that leads the world - by far - in innovation.  A new lung cancer treatment breakthrough in the form of Amgen's Lumakras illustrates that interrelationship.

Simply put, Lumakras reduced the risk of progression by 34% compared to chemotherapy in patents with advanced lung cancer, which is particularly welcome considering lung cancer's especially low survival rate (18.6% over five years, and just 5% for advanced forms).  The breakthrough required years of research and enormous amounts of investment, however, which The Wall Street Journal notes makes Lumakras the type of innovation put at risk by new drug price controls…[more]

September 22, 2022 • 05:06 PM

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WTO Targets U.S. Drug Patents, and the Biden Administration Plots Surrender Print
By Timothy H. Lee
Thursday, May 05 2022
The WTO proposal is an affront to the rule of law and U.S. property rights, and will only mean fewer future vaccines and treatments.

Intellectual property (IP) rights – patents, copyrights, trademarks and trade secrets – have provided the United States a unique advantage fueling our unmatched history of innovation.  

On the heels of World IP Day, and during a week in which questions of constitutional rights returned to the fore of public debate, it’s worth highlighting that our Founding Fathers understood IP to be so invaluable that they specifically protected it in the text of Article I of the Constitution, even before such freedoms as religion, speech and the right to keep and bear arms in the Bill of Rights.  “Congress shall have the Power…,” they wrote, “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”  

Years later, Congress even established a legal cause of action in 28 U.S.C. § 1498(a) empowering patent owners to sue the United States government itself for patent violations:  

Whenever an invention described in and covered by a patent of the United States is used or manufactured by or for the United States without license of the owner thereof or lawful right to use or manufacture the same, the owner’s remedy shall be by action against the United States in the United States Court of Federal Claims for the recovery of his reasonable and entire compensation for such use and manufacture.  

The World Trade Organization (WTO), however, couldn’t care less about American patent rights, or any U.S. property rights at all, for that matter.  This week, the WTO released its plan through the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to suspend patent rights relating to Covid vaccines, and its arrogant disregard for U.S. patent rights defies credulity:  

Notwithstanding the provision of patent rights under its domestic legislation, an eligible Member may limit the rights provided for under Article 28.1 of the TRIPS Agreement (hereinafter “the Agreement”) by authorizing the use of patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic… 

Even more outrageously, the Biden Administration in its continuing weakness accepts that assault upon U.S. patent rights.  The WTO plan even mentions by name Biden’s favorite method for unilaterally disregarding established U.S. law – executive order:  

For greater clarity, an eligible Member may authorize the use of patented subject matter under Article 31 without the right holder’s consent through any instrument available in the law of the Member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not a Member has a compulsory license regime in place.  

Since when does the WTO or any other international bureaucracy instruct us that executive orders supersede Congressional statutory law?  

And how does a Biden Administration that constantly pretends to support “Made in America” countenance the WTO’s egregious attempt to violate U.S. pharmaceutical preeminence?  

Fortunately, Senators Thom Tillis (R – North Carolina), Marsha Blackburn (R – Tennessee) and Tom Cotton (R – Arkansas) are taking action demanding refusal to submit to the WTO’s demand:  

[T]his disastrous plan would destroy high-paying American jobs while handicapping our nation’s ability to develop life-saving medicines in the future.  Moreover, waiving intellectual property rights would enable any company or government – including hostile actors like China and Russia – to simply steal cutting-edge American technology.  

America’s robust protections for intellectual property are essential to the invention of lifesaving and life-changing medicines, from vaccines and cancer treatments to oral therapies and antibiotics.  It’s no accident that all three FDA-approved Covid-19 shots were developed by American firms and American workers, or that American companies develop two in three new medicines.  Strong intellectual property rights are the bedrock that supports the investment and innovation that has historically allowed the U.S. to lead the world.  

Moreover, the WTO plan is pointless, since treatments are already being provided to poor nations across the world, while the patents it targets are already being licensed at reduced prices or even for free.  Additionally, beneficiary nations themselves emphasize that obstructions to immunization relate more to local logistical distribution problems and vaccination hesitancy among the unvaccinated, not vaccine shortages.  In fact, biopharmaceutical manufacturers remain capable of producing 20 billion vaccine doses in 2022.  

As Senators Tillis, Blackburn and Cotton affirm, U.S. patent protections explain why we produce the overwhelming share of new drugs worldwide, including the Covid vaccines.  The WTO proposal is an affront to the rule of law and U.S. property rights, and will only mean fewer future vaccines and treatments.  If the Biden Administration won’t correct course, Congress must intervene to do so.

Quiz Question   
Which one of the following U.S. Presidents signed the executive order establishing the Federal Emergency Management Agency (FEMA)?
More Questions
Notable Quote   
 
"On December 15, 2021, President Biden released an Executive Order related to global drug trade and stated, 'I find that international drug trafficking -- including the illicit production, global sale, and widespread distribution of illegal drugs; the rise of extremely potent drugs such as fentanyl and other synthetic opioids -- constitutes an unusual and extraordinary threat to the national security…[more]
 
 
—Derek Maltz, a Retired Director of the Drug Enforcement Administration's Special Operations Division
— Derek Maltz, a Retired Director of the Drug Enforcement Administration's Special Operations Division
 
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