THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • Last week, CAPA hosted an online panel on the importance of balancing the needs of innovation, access, and affordability when it comes to drug policy. The panel entitled, “Drug Pricing Debate: Why Drug Innovation, Access & Affordability Matter More Than Ever During COVID-19” welcomed discussion with leading experts in the field.  To watch the full panel, click here. Key Excerpts from Panelists:
    • Tahir Amin with I-MAK discussed how the pandemic has shown that we need to reexamine aspects of drug development to better support the discovery of drugs, particularly for pandemics and rare diseases for which patents are an imperfect incentive. You can find out more in his recent article in STAT.  
    • Polly Webster with Kaiser Permanante discussed how important drug prices are to Kaiser Permanente’s ability to provide patients the affordable care they need. You can find out more about KP’s support for a fair patent system in the policy briefing. 
    • Dan Takash with the Niskanen Center explained that patent reform is not only important for drug prices but eliminating the economic waste from bad patents could also be a vital part of economic recovery.
  • If you missed it, please check out this piece by CAPA Executive Director Matthew Lane in Morning Consult last week around reforming the patent system to balance competition and innovation so that American patients have access to affordable drugs, especially as both the private and public sectors work to quickly discover a treatment for COVID-19.  In this timely op-ed, Lane pushes back against claims that longer patents will help speed the development of coronavirus drugs.

WHAT YOU SHOULD BE READING:

Townall: Opinion: Pandemic Shines Spotlight on Problem of Bad Patents
Wayne Brough

  • Poor quality patents can have a significant impact on innovation and economic growth.  In an ideal world there would be no bad patents; but in the real world, with resource constraints, rushed examinations, and opportunists seeking to game the system, bad patents exist, sometimes with bad actors behind them.  As an alternative to expensive, time-consuming lawsuits, which typically favored the party with deeper pockets, the AIA established an inter partes review (IPR) process for challenging the validity of a patent.

POLITICO Pro: FDA Moves To Speed Coronavirus Reviews Could Stick Around [Excerpt]
Sarah Owermohle

  • THE COST OF DELAYING GENERICS — Branded drugmakers’ habit of fighting generic competition for their profitable medicines could have cost Medicaid more than $750 million in recent years, according to an analysis from researchers at Brigham and Women’s Hospital and Harvard Medical School in the latest Health Affairs. Researchers looked into 69 branded medicines expected to lose market exclusivity between 2010 and 2016. They found that generics for 31 of them — or 45 percent — were stalled from launching mostly due to litigation around secondary patents for the branded drugs.

Bloomberg: Rush For Generic Go-Ahead On Novel Drugs Roils Pharma Industry
Valerie Bauman

  • Generic drugmakers are increasingly lining up to bring competing versions of brand-name products to the market at the earliest possible date. But that might be bad for consumers. It’s no longer just one company seeking to be the first to bring a generic to the market—a status that affords drugmakers 180 days of market exclusivity. Instead, multiple companies are simultaneously seeking and sharing that first-filer status, spurring more litigation for brand-name drugmakers that must then defend their patents. The trend is growing as the pharmaceutical industry faces increased government pressure over drug pricing and transparency. It raises concerns over whether the current system is working for drugmakers and consumers.

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