THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • This week, the Coalition Against Patent Abuse submitted comments to the FDA/FTC Workshop on Competitive Marketplace for Biosimilars. The FDA and FTC have an important role to play in promoting competition in the pharmaceutical marketplace and encouraging the implementation of sound drug pricing policy that leads to lower prescription drug prices for American patients. 
  • “To prevent abuse, we encourage the FDA and FTC to continue working together to advise Congress when these anticompetitive abuses are occurring and to make recommendations on methods to fix legislation to close any loopholes open to abuse. This is not only important for existing legislation, but also for future legislation currently being contemplated to address drug prices and other drug related issues.” – Matthew Lane, Executive Director of the Coalition Against Patent Abuse
  • Last week, the ERISA Industry Committee (ERIC) released a study on the potential savings employers and employees could have with increased biosimilars in the marketplace.  According to reporting from Inside Health Policy, the study found that found that biologics – the most expensive class of pharmaceuticals – amount to less than 1 percent of prescription drugs available, yet they account for 40 percent of total drug spending by employers. This study highlights the incredible price saving opportunities offered by biosimilar drugs.
  • ““This is a welcome study on the positive impact biosimilars can have in the marketplace if they are allowed to enter and compete effectively.  In many cases, biologic pharmaceutical companies create barriers to entry for biosimilars which drives out-of-pocket costs up for millions of Americans.  With increased options in the marketplace for life-saving medications, American patients and employers would save on costly prescription drugs to treat chronic conditions.” – Matthew Lane, Executive Director of the Coalition Against Patent Abuse
  • As first reported by Politico, a new study from the JAMA Network found that the drug Humira has been reduced to one-fifth its original cost in Denmark due to the introduction of more affordable biosimilar alternatives. Humira, sold by drugmaker AbbVie, is among the most profitable drugs in the U.S. and its cost is exponentially higher here due the absence of more affordable alternatives.
  • “In Denmark, where drugs are bought by national tenders, biosimilar versions of global best-seller Humira have pushed the price to less than one-fifth of its original cost, researchers said in a JAMA Network Open analysis this week. Humira, used against rheumatoid arthritis and other autoimmune conditions, made $19.9 billion worldwide in 2018. There are five FDA-approved biosimilars in the U.S. but none are on the market because of patent disputes—the first rival is expected in 2023. The shift to biosimilars in Denmark was immediate once the patent expired in October 2018, the authors write. Three biosimilars won the national tender and biosimilar use shot up to 95.1 percent by December. Meanwhile Humira’s cost dropped 82.8 percent from September to the end of the year.” – Politico

WHAT YOU SHOULD BE READING:

The Hill: Opinion: New Coronavirus Legislation Shows Flaws With Patent Policy In America
Charles Duan

  • If patents encourage new inventions, why would Congress need to remove patents in response to a crisis? The answer is by giving inventors 20 years of monopoly use on an invention, patents eliminate the competition that reduces prices, cap the supply of the invention at the willingness of the patent holder to produce, and limit the ability of other bright minds to improve upon the invention. 

Bloomberg: Trump Urged To Limit Patent Rights On Ventilators, Treatments
Susan Decker & Malathi Nayak

  • Some researchers and lawmakers are calling on President Donald Trump to follow the lead of Germany and Israel in restricting patent rights for work on coronavirus treatments. “When the lives of a significant population of a country are at stake, it is the inherent sovereign right of a government to override private property rights to protect the lives and health of its citizens,” said Fred Abbott, a Florida State University professor who’s advised the World Health Organization and United Nations on patents and drugs. Trump has asked companies to start producing ventilators and respirators, but his administration has stopped short of taking steps that would give some level of protection from patent lawsuits.

Bloomberg: INSIGHT: IP’s Role In Covid-19 Tests, Treatments, And Vaccines
Drew Woodmansee & Catherine Wicker

  • For patents developed without federal funds, the second (and more likely) tool at the administration’s disposal is 28 U.S.C. §1498. Under that section, a patented invention may be “used or manufactured by or for the United States without” a license from the patent owner, provided the government gives “reasonable and entire compensation for such use” to the patent owner for it. Note that Section 1498 permits a product to be manufactured “for” the U.S. by contractors or “any firm or corporation.”

Financial Times: Big Drugmakers Under Pressure To Share Patents Against Coronavirus
Donato Paolo Mancini

  • Drugmakers are facing mounting calls to give up their patent rights for potentially life-saving treatments and vaccines for coronavirus as authorities worldwide race to curb the pandemic’s death toll. The heads of the World Health Organization and Unitaid, a UN-backed group funding global health innovation, have welcomed a proposal devised by Costa Rica for companies voluntarily to pool their intellectual property for all medical interventions — including treatment, vaccines and diagnostics.

EFF: Lengthening Patent Terms By 10 Years Is Exactly The Wrong Response To COVID-19
Joe Mullin

  • Governments around the world are taking steps to make sure that private corporations don’t use the coronavirus pandemic as an excuse to make unjustified monopoly profits. They’re doing that by ensuring that governments can override patents and issue compulsory licenses for COVID-19 related treatments, vaccines, and tools. Canada’s recent COVID-19 bill authorizes the government to make and use patented inventions as needed in fighting the pandemic. Governments in Chile, Ecuador, Germany, and Israel have taken similar steps.

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