THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • This week, amid public outcry and pressure from groups like CAPA, drugmaker Gilead withdrew its request for the FDA to grant orphan-drug status for remdesivir, an experimental drug that is being tested as a possible treatment for COVID-19. Receiving orphan-status would have given Gilead a seven-year monopoly on a potential cure in the midst of a global pandemic. Make sure to check out CAPA’s statement on Gilead’s decision. 
  • “This situation highlights that while there will always be a critical need for continued innovation and public-private partnerships to develop medicines, we must still be vigilant against corporations claiming more than their fair share.  We applaud Gilead’s decision to do the right thing and rescind its orphan drug status.” – Matthew Lane, Executive Director of the Coalition Against Patent Abuse
  • Yesterday, Slate published a must-read op-ed by Matthew Lane, Executive Director of the Coalition Against Patent Abuse, on the need for transparency around the taxpayer costs for COVID-19 drug research so American patients are guaranteed a fair price when a coronavirus drug comes to market. As our nation confronts the coronavirus pandemic, it crucial that American patients are assured of fair prices for the drugs they help to fund.
  • “We don’t need to stay in the dark. Information gathering should be a key part of how we learn from this pandemic to better prepare for the future. Hopefully, that means being armed with the information needed to be good investors with our public dollars.” – Matthew Lane, Executive Director of the Coalition Against Patent Abuse

WHAT YOU SHOULD BE READING:

Bloomberg: Virus Delays Stir Deadline Concerns In Generic Drug Patent Cases
Matthew Bultman

  • New coronavirus-related disruptions to federal courts are causing attorneys’ concerns about meeting tight deadlines unique to generic drug patent disputes. Under the Hatch-Waxman Act, a patent infringement lawsuit by a brand company typically triggers a 30-month stay on federal approval of generic drugs. Many judges create drug patent trial schedules to allow the cases to be completed within that time frame, attorneys said. But those schedules are under pressure with courts limiting access and attorneys cutting back on travel.

Bloomberg: Generic Drug Competition Gets Boost Under FDA Policy
Jacquie Lee

  • The market for drugs with flagging competition will get a boost thanks to new FDA guidance that aims to cut down on drugs produced by a single company or supplier. Companies looking to make drugs that have no patents yet face inadequate competition can apply for a special designation that speeds up their drug’s approval time and offers 180 days of exclusivity under certain circumstances, according to the industry guidance. Inadequate competition is when there’s not more than one FDA-approved drug available to patients.

STAT News: Global Spending On Drugs May Hit $1.1 Trillion By 2024, But The Rate Of Growth Is Forecast To Slow
Ed Silverman

  • Global spending on prescription medicines is forecast to increase between 2% and 5% annually over the next five year and exceed $1.1 trillion overall by 2024, up from $955 million last year, thanks to increased overall use of treatments and costlier specialty therapies, according to a new report. Despite the big numbers, the growth in spending is actually expected to be slower than during the previous five-year period, when the compounded growth rate was 4.2%. The slower rate at which spending is forecast to grow reflects pricing pressures and the loss of patent or marketing exclusivity for brand-name drugs, according to projections by the IQVIA Institute for Human Data Science.

Daily Beast: Senators Who Led Pro-Pharma Patent Reform Get Drugmaker Cash
Emmarie Huetteman

  • Early last year, as lawmakers vowed to curb rising drug prices, Sen. Thom Tillis was named chairman of the Senate Judiciary Committee’s subcommittee on intellectual property rights, a committee that had not met since 2007. As the new gatekeeper for laws and oversight of the nation’s patent system, the North Carolina Republican signaled he was determined to make it easier for American businesses to benefit from it—a welcome message to the drugmakers who already leverage patents to block competitors and keep prices high.

Inside Health Policy: Report: Pharma Industry Won’t Dramatically Change Due To Covid-19
Ariel Cohen

  • The coronavirus pandemic will likely disrupt the supply chain for active pharmaceutical ingredients, hurt demand for prescriptions not related to COVID-19, set back drug research and development and restrict travel for FDA inspectors, S&P Global Ratings reports, but the impact on the drug industry won’t be as severe as on other sectors. The risk of supply chain problems is greater for generic drug companies than brands. Generics have small profit margins, so cost increases for pharmaceutical ingredients would hurt them more than brands.

POLITICO Pro: Patent Politics — Coronavirus Test Faces Patent Infringement Roadblock
Kayla Sharpe & Maria Carrasco

  • Development of three new coronavirus tests could be halted due to a patent infringement lawsuit between health startup BioFire and Fortress Investment Group’s Labrador Diagnostics. — Back in 2017, Fortress Investment Group purchased several patents from a little company you might know called Theranos. In the suit filed March 9, Fortress alleges that the Film Array technology used by BioFire to develop its coronavirus tests violates a pair of medical patents Fortress owns. — Fortress says it was unaware that BioFire was using the technology to develop coronavirus tests at the time of filing, and has since offered royalty-free licenses to third-party companies developing tests to thwart the global pandemic.

The National Law Review: The Global Patent Race For A COVID-19 Vaccine
Rebeca Harasimowicz

  • As COVID-19 is causing chaos around the globe, the world’s largest economies are competing to be the first to find a cure to this new pandemic and taking measures to ensure that their citizens will have access to any vaccines or treatments once available.  COVID-19 has introduced a whole new global arms race–the race to own patent rights to a COVID-19 vaccine. A patent is an exchange between inventor and national government in which the inventor discloses to the public exactly how to recreate the claimed invention (e.g., a vaccine) and is in return given an exclusivity period during which it may choose who, when, where, and how that invention is made, used, or sold. 

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