THE REFILL: Latest Dosage of Rx Patent Abuse


  • Recently, Barron’s highlighted a study that showed how biosimilars of AbbVie’s Humira have saved Europe a bundle.  Biosimilar versions of the antibody product adalimumab have taken some of Humira’s market in Europe and other countries, dropping AbbVie’s foreign sales of Humira by 27% last year.
    • “Biosimilar versions of the antibody product adalimumab have taken some of Humira’s market in Europe and other countries, dropping AbbVie’s foreign sales of Humira by 27% last year. Now, a team of researchers have detailed the large savings enjoyed by Denmark since it started using adalimumab biosimilars in place of Humira. The researchers’ study appeared on Tuesday in the Journal of the American Medical Association—Internal Medicine. In midday trading Tuesday, AbbVie stock (ticker: ABBV) was down 0.3%, at $90.45. Humira’s patent in Denmark expired in mid-October 2018. Although a substitution of biosimilars for Humira prescriptions was not required by the country’s authorities, Denmark’s pharmaceutical regulators recommended the biosimilars made by three approved suppliers. The change was swift. By December 2018, 95% of prescriptions went to biosimilars, the JAMA report says. And Denmark’s spending on the antibody dropped 83%.”
  • An opinion by Congresswoman Jan Schakowsky (IL-9) and Congressman Francis Rooney (FL-19) in Newsweek recently highlighted the importance of affordability for coronavirus treatments and vaccines and the immediate need for bipartisan reforms. Over the past decade, almost every new medication brought to market was also in part funded by taxpayer dollars. While drugs are developed in the interest of a greater public good, accountability for public funding has not prevented pharmaceutical corporations from hiking up prices on new and existing drugs for patients. 


Inside Health Policy: FDA Asks Stakeholders How It Can Improve Orange Book, Patent Listings
Beth Wang

  • FDA on Friday (May 29) took several steps to improve and ramp up use of the agency’s Orange Book in a bid to provide more timely and accurate information about generic drugs and spur generic drug competition. The agency is asking stakeholders what type of patent information should be included in the Orange Book, how they use the publication and how the database can be improved. FDA is particularly interested in stakeholders’ views on how to list patents when a device constituent is part of a combination product; a device’s use is referenced in an approved drug label; an established risk evaluation and mitigation strategy (REMS) is involved; and digital applications, including those related to clinical decision support software and software as a medical device, are part of patent claims. The agency also published a draft question-and-answer guidance clarifying how drug sponsors can use and access the Orange Book.

Institute For Policy Innovation: Attempts To Degrade Drug Patents Are Counterproductive In This Pandemic
Tom Giovanetti

  • During the 2008 recession, Rahm Emanuel reminded Americans, “You never want a serious crisis to go to waste.” Today, opponents of the system that protects intellectual property are taking Emanuel’s strategy to heart, exploiting the COVID-19 crisis to try to degrade patent protections for pharmaceuticals. If they succeed, the result will be less timely access to effective therapeutics and vaccines in a pandemic and less pharmaceutical innovation in the future. The assaults are both ironic and dangerous. They come at a time when the innovative pharmaceutical industry is proving its value. Backed by tens of billions of dollars of capital, scientists are working to find a prevention or a treatment for COVID-19.

Bloomberg: Long-Delayed Drug-Price Bill Not Dead Yet, Grassley Says
Riley Griffin & Emma Court

  • Senate Finance Committee Chairman Chuck Grassley said that he intends to push for a vote this year on a bill that would limit drug-price increases, even as pharmaceutical companies race to find treatments and vaccines for Covid-19. The drug industry has been pouring resources into researching new therapies as the pandemic wreaks havoc on Americans’ health and the country’s economy. That has helped quiet a long-running debate over rising prescription costs, as policy makers prioritize finding treatments and helping businesses safely re-open.

The Center For Biosimilars: AAM Makes A Plea To Save The BPCIA
Tony Hagen

  • Even if the Affordable Care Act (ACA) is ruled unconstitutional, the Biologics Price Competition and Innovation Act (BPCIA), which is part of that legislation and allows for biosimilar licensing, should be preserved, according to a brief argument filed by the Association for Accessible Medicines (AAM). The Supreme Court’s deadline was this month for receiving briefs in the case of the constitutionality of the ACA. In December, the Fifth Circuit Court of Appeals agreed with a lower court that the individual mandate requiring individuals to purchase insurance under the ACA was unconstitutional, a move that put the survivability of the ACA and the BPCIA in doubt. “FDA-approved biosimilars offer patients and taxpayers enormous cost savings on life-saving treatments,” said the AAM’s interim CEO and general counsel, Jeff Francer, in a statement. “If a constitutional challenge to some provisions of the Affordable Care Act (ACA) resulted in the invalidation of the entire ACA, including the BPCIA, a decade of progress by AAM and its members would be lost—and at a crucial moment.”


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