Today is World Intellectual Property (IP) Day, a time to celebrate the storied achievements of innovators and entrepreneurs across the globe. From Laffy Taffy to weatherproof Halloween costumes to movies to lifesaving drugs, IP can take on many memorable forms. But, few inventions have been as game-changing as the artificial heart. Without the determination of researcher Robert Jarvik (and his team at the University of Utah), millions of patients needing heart transplants would have little prospect of recovery. Thanks to Jarvik’s brainchild, heart recipients can live healthy and fruitful lives post-implant and spend quality time with their loved ones. America’s IP system rewards innovators such as Jarvik and ensures that patients will continue to benefit from quality care. Robert Jarvik is a Profile in Courage, and it’s critical that future Profiles in Courage benefit from continued IP protection.
From an early age, Robert Jarvik harnessed innovation to help patients. As a teenage orderly at Stamford Hospital, Jarvik invented an automatic surgical stapler to simplify the clamping and tying of blood vessels during operations. The patented Jarvik Suture Machine would prove pivotal for nurses struggling with sutures and reduce unnecessary surgical complications. A family tragedy prompted him to think even bigger. Jarvik’s father suffered from a heart disease-related condition called an aortic aneurysm and needed open heart surgery. Unfortunately, he died soon after his surgery. Jarvik recounts, “I knew that my father was going to die of heart disease, and I was trying to make a heart for him. I was too late.” While he could not save his father, Jarvik knew that advances in artificial heart technology could change the lives of millions of patients with similar, deadly diseases. Jarvik earned his medical degree from the University of Utah College of Medicine in 1976 but declined the usual path of internship and residency to work full time on his burgeoning artificial heart idea. He teamed up with Dutch-born physician Willem Kolff, who had already been testing artificial heart prototypes in animals for years in hopes of finding a sustainable design for humans. After five years of tireless work at the University of Utah, Jarvik and Kolff were confident enough in their prototype design (made of dacron polyester, plastic, and aluminum) to try and implant an artificial heart into a human patient. The Food and Drug Administration (FDA) agreed in 1981, but the notoriously risk-adverse agency set such strict criteria on eligibility that it took more than a year before the artificial organs team could find their match. As Syracuse University Magazine writer Renee Gearhart Levy notes, the team finally found their patient in 1982. She writes, “On December 2, 1982, a retired dentist suffering from cardiomyopathy-degenerative and irreversible heart disease-made history by receiving the first permanent artificial heart. Dr. William DeVries of the University of Utah performed the seven-and-a-half hour surgery; Jarvik assisted. With Ravel's Bolero playing in the background, Barney Clark was given a second chance at life.” Clark lived for 112 days with his artificial heart, a remarkable achievement that Jarvik and his team have managed to improve on. Patients can now survive years with an implanted artificial heart, and transplant innovation continues at a breathtaking pace.
And, thanks to his ability to profit off his life-saving inventions, Jarvik and his team barely needed any taxpayer money for research. Writing in 1989, Levy noted, “Opponents of the artificial heart frequently cite the $240 million drained out of the NIH [National Institutes of Health] in the last 24 years for artificial heart research. But less than $10 million of those funds were used on development of the Jarvik-7, the majority supporting heart-assist devices, bioinstrumentation, and biomaterials. No federal monies have assisted any of the Jarvik-7 patients, permanent or bridge.” According to Jarvik, the problem with NIH funding is that, “they have pretty much dictated the things that people had to do in order to get funding...Some of the more creative and better ideas could not even be submitted under the contract programs.” In other words, IP protections are a far more dynamic, reliable way of ensuring innovation than relying on taxpayer dollars. Policymakers should learn from Jarvik’s example and make sure that creators are rewarded for their successes without taking others’ hard-earned dollars. Robert Jarvik is a Profile in Courage, and just one of many innovators who have bettered our lives.
This World IP Day, Governments Must Embrace Patent Protection
As previously mentioned, World IP Day is an occasion to champion the protections that have resulted in countless life-saving treatments for patients. Unfortunately, not everyone appreciates the value that IP brings to modern healthcare. In an April 9 letter to the Department of Health and Human Services (HHS), three groups (Knowledge Ecology International, Union for Affordable Cancer Treatment, and Universities Allied for Essential Medicines) urged the federal government to issue a compulsory license for the prostate cancer drug Xtandi. The groups expressed concern that the medication sold by Pfizer and Astellas is marketed “at a price three to six times higher in the United States than it is priced in other similar high-income countries.” The letter envisions a system where generic manufacturers are free to ignore Xtandi’s patents and produce and price this drug (and others) as they wish. This reckless licensing scheme would set back healthcare innovation and send all the wrong signals to researchers and entrepreneurs. The U.S. must embrace IP protections, not throw them by the wayside.
Since being approved by the Food and Drug Administration (FDA) in 2012, Xtandi has significantly prolonged the life of men with metastatic castration-resistant prostate cancer who have already undergone chemotherapy. Over the past 12 years, researchers have learned that Xtandi is more than just a “last ditch” treatment against the deadly disease. Even in cases where prostate cancer is not metastatic but patients have a high risk of their cancer spreading, taking Xtandi boosts survival odds. All this research demonstrating the safety and efficacy of medications such as Xtandi is not free. According to a 2020 study by Johns Hopkins and the George Washington University researchers, each large and randomized trial that the FDA relies on to approve a drug or expand labeling costs about $20 million. These studies usually come at the tail-end of a decade-long and $2 billion effort to study and tinker with medications. High initial medication prices are the way producers recoup soaring drug development costs. In the case of Xtandi, research on non-metastatic prostate cancer cases is ongoing and resulted in the FDA expanding use indications for high-risk patients. Innovation suffers when these researchers are stripped of their patents and cannot continue to recoup their costs. According to a 2016 analysis in the American Economic Review, the weakening of IP protections for medications leads to lower availability and delayed launch times for new drugs. The authors examined data on the “launches of 642 new molecules in 76 countries during 1983-2002” and found that, all else equal, “longer and more extensive patent protection strongly accelerated diffusion [of new drugs], while price regulation delayed it.” This demonstrates the dangers of not just compulsory licensing, but also price-fixing proposals championed by the Biden administration and lawmakers. A more recent preliminary analysis by Princeton scholars confirms these findings. The issuing of an additional compulsory license “is associated with 5.10% decrease in innovation. Specifically, when the market share affected by compulsory licensing increases by 1%, patenting rates for the licensed disease decrease by 12.7% to 16.3%.”
For all this havoc, compulsory licensing seldom leads to lower prices or greater availability. For example, the Brazilian authorities, “granted a CL [compulsory license] for [HIV drug] Efavirenz in 2007 and the local production of the drug started in 2009. Since then, the price of the local generic manufactured version has not changed while the lowest international price has reduced by 77%. If only imports had been considered, then [the Brazilian government] could have saved approximately 25% more.” Rather than trying to tamper with IP protections, the Brazilian government should have embraced free trade policies and let markets work their magic. Compulsory licensing is a recipe for disaster and leads to fewer options for millions of patients. This World IP Day, governments around the world must embrace patents and give innovators the tools they need to churn out life-saving treatments.
Blogs:
Monday: Louisiana Lawmaker Adds Blatant Family Cronyism to Broadband Bill
Tuesday: The DOJ Case Against Apple Looks Pretty Rotten
Wednesday: Democrats Should Join the Call for FDA to Accelerate Approval of Smokefree Products
Thursday: TPA Slams FCC Vote on Burdensome Net Neutrality Regulations
Friday: Profile in Courage: Robert Jarvik, M.D.
Media:
April 19, 2024: National Review ran TPA's op-ed, "The DOJ's Case Against Apple Looks Pretty Rotten."
April 21, 2024: The Dallas News (Dallas, Texas) quoted TPA in their story, “Should TX Deny Most Minors Social Media Access?”
April 22, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about the Unites States Postal Service.
April 22, 2024: FloridaDaily.com ran TPA’s op-ed, “FCC Should Not Grant Waivers To Derelict Grantees Of Federal Broadband Funds.”
April 22, 2024: Issues & Insights ran TPA’s op-ed, “Postal Crime Remains Rampant.”
April 22, 2024: WBFF Fox45 (Baltimore, Md.) quoted me in their story about federal tax dollars going to non profit organizations.
April 22, 2024: Filter Magazine ran TPA's op-ed, "Charting US Public Health's Disastrous Mission Creep on Smoking."
April 23, 2024: National Review mentioned TPA in their article, “The Conservative Movement Is Defending Free Markets — from Both Sides.”
April 23, 2024: Townhall.com ran TPA’s op-ed, “With Cigarette Sales Declining, More Evidence Supports the Role of Flavored Vapes in Helping Adults Quit.”
April 23, 2024: The Baltimore Sun (Baltimore, Md.) ran TPA’s op-ed, “Call in the Carrier Pigeons: Repeatedly raising the price of stamps doesn’t work.”
April 24, 2024: The Blaze ran TPA's op-ed, “Why does the Postal Service treat basic spending data as top secret?”
April 24, 2024: The Washington Examiner (Washington, D.C.) ran TPA’s op-ed, “Biden EV policies leave government chasing its own tail.”
April 24, 2024: WBFF Fox45 (Baltimore, Md.) quoted me in their story, “COVID glove factory fails to open despite $100 million in federal funding.”
April 24, 2024: Arca Max ran TPA’s op-ed, “Call in the carrier pigeons: Repeatedly raising the price of stamps doesn't work.”
April 24, 2024: Pantagraph.com ran TPA’s op-ed, “Raising stamp price doesn’t work.”
April 25, 2024: WBFF Fox45 (Baltimore, Md.) interviewed me about Baltimore’s PILOT program.
April 25, 2024: I appeared on WBOB 600 AM (Jacksonville, Fla.) to talk about electric vehicles and government spending.
April 25, 2024: The Richmond Times Dispatch (Richmond, Va.) ran TPA’s op-ed, “Hiking stamp prices is not going to work; Commentary: Call in the carrier pigeons: Repeatedly raising the price of stamps doesn't work.”
April 25, 2024: The Daily News (Longview, Wash.) ran TPA’s op-ed, “Hiking stamp prices doesn't work.”
April 25, 2024: The East Bay Times (Walnut Creek, Calif.) ran TPA’s op-ed, “Call in the carrier pigeons — raising the price of stamps doesn’t work.”
April 25, 2024: The Mercury News (San Jose, Calif.) ran TPA’s op-ed, “Call in the carrier pigeons — raising the price of stamps doesn’t work.”
April 25, 2024: West Hawaii Daily (Kailua, Hawaii) ran TPA’s op-ed, “Call in the carrier pigeons: Repeatedly raising the price of stamps doesn’t work.”
April 25, 2024: The Washington Examiner quoted TPA in their article, "FCC Votes to Restore Net Neutrality Ended During Trump Administration."
April 26, 2024: Real Clear Markets ran TPA's op-ed, "This World IP Day, Governments Must Embrace Patent Protection."
Have a great weekend!
Best,
David Williams
President
Taxpayers Protection Alliance
1101 14th Street, NW
Suite 1120
Washington, D.C. xxxxxx
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