THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • The Coalition Against Patent Abuse (CAPA) along with Niskanen Center, Engine, R Street Institute and other public and private interest groups signed on to a letter sent to the House and Senate Judiciary Committees encouraging them to exercise their oversight authority to investigate procedural changes recently made by the Patent Trial and Appeal Board (PTAB) that will weaken the inter partes review process. Check out the full letters to the House and Senate.
    • “We write to express concern that Congress’s efforts to mitigate the harm of low-quality patents and abusive litigation are being unraveled, and to ask that Congress investigate policy directives implemented and actions taken by the Patent Trial and Appeal Board (‘PTAB’) which have significantly weakened inter partes review (‘IPR’). The PTAB is increasingly refusing to institute otherwise-meritorious IPR petitions for purely procedural reasons. And it is doing so through self-declared precedential decisions that promulgate new PTAB policies without notice-and-comment rulemaking or the possibility of judicial review. We are concerned that the current trend—and its problematic consequences—will continue unchecked unless Congress intervenes.”
  • Recently, Lauren Aronson, executive director of the Campaign for Sustainable Drug Pricing (CSRxP), authored an op-ed in Morning Consult urging Big Pharma to suspend their traditional biennial Summer price hikes amid historic economic uncertainty brought on by the coronavirus pandemic. While millions of American patients face financial hardships, Big Pharma continues to profit under anticompetitive and price-hiking practices. To read the full op-ed, click here

WHAT YOU SHOULD BE READING:

The Wall Street Journal: America Needs Leadership on Prescription Prices
Sen. Chuck Grassley (R-IA)

  • Many issues that were top of mind only a few months ago have been sidelined by the coronavirus pandemic, its economic fallout, and social unrest related to police brutality and racial inequality. As a co-author of bipartisan legislation to reduce prescription drug prices, I can tell you that receding media attention is doing the American people a disservice. Congress must not let events serve as an excuse for doing nothing about drug prices. This is the time to address the crisis of health-care affordability. President Trump campaigned in 2016 on bringing affordability and fairness to the prescription drug market. In May 2018, he called on lawmakers to pass an overhaul of the drug pricing system. Democrats went on to win the House later that year, largely on issues like health-care affordability. If leaders in both parties recognize the system is broken, why isn’t it being fixed? Three reasons: a bipartisan lack of political courage, an unwillingness to compromise, and a powerful lobby with deep pockets.

The National Law Review: USPTO Announces A New Initiative To Expedite Examination Of COVID-19 Related Patent Applications
Daniel N. Yannuzzi & Xin Xie

  • The USPTO has authorized an initiative to prioritize examination of patent applications having COVID-19 uses that would require FDA approval. A pilot program only for small and micro entities has been implemented effective from May 14, 2020 to prioritize examination of applications having one or more claims related to COVID-19. The pilot program waives the associated petition fee, which would otherwise be $2000 for a small entity. The program is currently scheduled to last until 500 such requests have been approved. As of June 18, 2020, 35 requests have been approved.

Health Affairs: How Orphan Drug Policy Could Impede Access To COVID-19 Treatments
Kao-Ping Chua & Rena Conti

  • The Orphan Drug Act of 1983 was passed to promote the development of rare disease treatments. To qualify for incentives under the act, sponsors must first receive “orphan drug designation” from the Food and Drug Administration (FDA). In almost all cases, the FDA grants an orphan drug designation because the disease treated by the drug affects 200,000 or fewer Americans. Most orphan-designated drugs are never FDA-approved to treat a rare disease; those that have at least one such approval are called “orphan drugs.” According to our search of studies registered on clinicaltrials.gov as of April 20, 2020, many drugs being evaluated to treat or prevent COVID-19 have orphan drug designation (exhibit 1). We will explain how orphan drug policy could unintentionally impede access to orphan-designated COVID-19 drugs by facilitating high prices. Furthermore, we will suggest reforms to mitigate price-related barriers to accessing such drugs.

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