THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • BREAKING NEWS: CAPA releases guidance for next Administration and Congress encouraging Washington to address Big Pharma’s abuses of the patent system that keeps drug prices high for patients and the entire U.S. healthcare system.  Continued exploitations of the U.S. patent process results in deadweight losses that get saddled on the backs of patients and taxpayers.  As the nation works to combat the coronavirus pandemic, the need for reforms that lowers overall healthcare costs is imperative. 
    • CAPA Executive Director Matthew Lane stated, “Americans pay almost four times more for drugs than any other countries, creating one of the largest problems facing the U.S. healthcare system today… Policies that reduce anticompetitive gaming of the patent system and support the robust entry of generic medications would produce tremendous savings for Americans – and millions of voters are casting their ballot for a candidate who will do just that.” Read the full statement here
  • CAPA recommends the following four goals for the next Administration & Congress:
    • Work to remove incentives to create patent thickets while preserving innovation. Support Inter Partes Review as an efficient way to remove invalid patents. Strengthen drug policy to prevent regulatory gaming. Keep drug pricing in mind when setting any new policy.
  • Key Facts:
    • Americans individually pay 3.7 times more for drugs than other countries. In 2015, prescription drug spending in the U.S. totaled $1,000 per person.
    • In 2018, the U.S. saved $293 billion from generic competition. Brand-name drugs represent only 10 percent of prescriptions but 77 percent of drug spending.
    • Many expensive older drugs already have competition in other countries but not in the U.S. due to the lapse of exclusivities. These drugs would be 79% less expensive today if they followed the average savings from generic entry. As for biosimilars, an IQVIA report, using an estimated savings of about 30%, projects $100 billion in savings from biosimilar competition over the next five years, although the authors note that higher discounts have occurred and are possible in the future.

WHAT YOU SHOULD BE READING:

Law360: Humira Buyers Get Backing Against AbbVie’s ‘Patent Thicket’
Matthew Perlman, Lauraann Wood and Jeff Overley

  • An Illinois federal judge failed to consider the cumulative impacts of AbbVie’s bid for more patent protection and the settlements it cut with rival companies who were seeking to market their own versions of the treatment, according to amicus briefs filed Friday from the National Association of Chain Drug Stores Inc., Consumer Action and U.S. Public Interest Research Group, Open Markets Institute, and 66 economics, law, business and medical professors.

Patent Progress: Cert Granted In Arthrex Case On PTAB Appointments
Josh Landau

  • … the Supreme Court granted certiorari in a set of related cases between Arthrex and Smith & Nephew, as well as the federal government.  The cases revolve around one fundamental question: are judges of the Patent Trial and Appeal Board (PTAB) principal officers of the United States?  That question controls the constitutionality of their appointment… While this case focuses on PTAB judges, it seems likely that the Court took it to more broadly explain the distinction between inferior and principal officers, a distinction likely to have impacts throughout the federal government.

The Wall Street Journal: As Supreme Court Case On Affordable Care Act Looms, GOP Divided On How—And Whether—To Replace It
Stephanie Armour

  • A looming Supreme Court decision on the Affordable Care Act is pitting Republicans who believe the party should release a replacement proposal against other GOP lawmakers and health policy experts who have played down the need for a plan because they say the court is unlikely to strike down the law.

STAT News: Hundreds Of Advocacy Groups Urge WTO To Waive IP Rights To Covid-19 Drugs And Vaccines
Ed Silverman

  • Amid growing concern over access to Covid-19 medical products, hundreds of advocacy groups are urging the World Trade Organization to waive some provisions in a trade deal governing intellectual property rights so drugs and vaccines can be more easily obtained, especially by low-income countries.

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