THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • MUST READ: CAPA Warns Recent Federal Circuit Court Decision Could Erode Hatch-Waxman, Lead to Even Higher Drug Prices

    Matthew Lane, executive director of the Coalition Against Patent Abuse (CAPA), recently authored an op-ed in Bloomberg Law around the Federal Circuit’s recent decision in GlaxoSmithKline LLCTeva Pharmaceuticals USA, Inc.:
    • “The Federal Circuit’s decision in GlaxoSmithKline v. Teva undermines this skinny label framework by holding that a generic manufacturer who uses a skinny label can still be liable for induced infringement merely by accurately describing its product as therapeutically equivalent to the branded drug. This equivalency, a requirement for FDA approval of generic medicines, is essential safety information for doctors and pharmacists treating their patients.”
    • “The repercussions from this ruling cannot be understated. As a result, Teva has been subjected to a $234 million judgment, including damages for the period of time that it used a template skinny label the FDA itself provided. And Teva made only $74 million in sales during the relevant period. Generic companies simply cannot use a skinny label with this level of exposure.”
    • “If allowed to stand, the Teva case will further erode the Hatch-Waxman Act, destroy the balance that was reached by Congress after months of deliberation, and cause higher drug prices for patients. The Federal Circuit should grant a rehearing to restore the proper functioning of the skinny label process. If it does not, congressional intervention will likely be necessary.”
  • IN CASE YOU MISSED IT: A New Report Shows Big Pharma is Continuing with Price Hikes as Americans Grapple with Financial Hardships.
    • Two leading experts from Brigham and Women’s Hospital/Harvard Medical School outlined how a Biden White House could take immediate steps address rising drug prices for patients and families by fixing our patent system… “First, the PTO should give examiners more leeway to reject ineligible applications… Second, the PTO should give examiners more time to do their jobs… Finally, because the PTO has the power to set its own fees, the agency can reduce its dependence on revenue from granting patents.”
  • CAPA IN THE NEWS: Looming Judge Fight Threatens Generics’ Favored Patent Forum (Bloomberg Law)
    • The U.S. Supreme Court is reviewing Arthrex Inc. v. Smith & Nephew Inc. to determine the constitutionality of the Patent Trial and Appeal Board (PTAB). CAPA argues in their amicus briefthat if the Supreme Court rules to uphold the Federal Circuit’s decision, job protections for PTAB judges could be eliminated.
    • “That may empower the pharmaceutical industry to pressure the agency into outcomes unfavorable to patients, the Coalition Against Patent Abuse told the justices. The Federal Circuit read the Constitution ‘to encourage—even require—executive power to meddle with Board decisions,’ CAPA said in a brief. ‘Congress structured the Board to conduct inter partes reviews impartially based on the law, largely free of political pressures from powerful lobbies such as the pharmaceutical industry,’ CAPA said.”

Drug Patent Database Revamp Falls Short of Tackling High Costs (Bloomberg Law)

  • “A new law updating the FDA’s drug patent database aims to increase access to generic medications but falls short of addressing barriers to lower prices, attorneys say. [H.R. 1503] was introduced to make it easier for more generic producers to enter the marketplace. But health policy watchers say the effort doesn’t tackle deep systemic problems that lead to higher drug costs.”  
  • “’The main problem is that there’s just a lot of patents that get added to extend the life of the drug that we feel shouldn’t have been issued and aren’t valid,’ Matthew Lane, executive director of the Coalition Against Patent Abuse… Lane said the legislation marks ‘an incremental step in the right direction,’ by boosting transparency and clarifying steps for removing invalid patents from the Orange Book.”

WHAT YOU SHOULD BE READING:

STAT News: The Prices Of 7 Drugs Were Hiked Without Proof Of New Benefits, Costing The U.S. $1.2 Billion In 2019
Ed Silverman

  • During 2019, drug makers raised prices on seven widely used medicines by substantial amounts without any new clinical evidence to justify the increases, leading patients and insurers in the U.S. to spend an added $1.2 billion that year, according to a new analysis… Amgen (AMGN) boosted the price of its Enbrel medicine for rheumatoid arthritis and other ailments by 8.9%, after rebates and fees, which cost the U.S. health care system an extra $403 million.

Inside Health Policy: Brand Drug Companies Start 2021 With Round Of Price Hikes
Ariel Cohen

  • Brand drug companies kicked off 2021 by increasing drug prices on at least 582 drugs. Pharmaceutical companies have received billions in taxpayer dollars to develop COVID-19 drugs and vaccines, and consumer advocates say the pandemic price hikes should spur lawmakers to crack down on drug companies. The average price hike at the beginning of the year for brand drugs is 4.2%, compared to the 3.1% average price increase last summer, according to drug pricing analysts at GoodRx. 

STAT News: Generic Drug Makers Fear A ‘Skinny Labeling’ Court Ruling Will Pose A Huge Threat
Ed Silverman

  • An arcane regulatory term known as skinny labeling may have a funny ring to it, but to generic drug makers, it is no laughing matter. What has the generic industry upset is a recent court ruling that, legal experts say, could effectively negate a key aspect of a decades-old law which makes it possible to supply Americans with many of cheaper generic alternatives to pricey brand-name medicines. As a result, a federal appeals court is being urged to review the controversial decision over concerns that countless patients could be deprived of access to generic drugs, an outcome that would further strain an already over-burdened U.S. health care system and have long-standing ramifications for pharmaceutical manufacturers and patients.

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