THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • CAPA Files Amicus Brief Urging the Supreme Court to Preserve IPR to Lower Drug Prices. DID YOU KNOW – 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). In an amicus brief filed recently, CAPA outlined its concerns regarding the lower court’s decision to eliminate job protections for PTAB judges who were tasked by Congress to ensure that issued patents meet patentability standards.
    • “The PTAB’s ability to conduct inter partes review proceedings free from political pressure is critical to addressing the pressing policy crisis caused by ever-lengthening patent monopolies that has resulted in rising drug prices and limited access to medications that American patients rely on. At the end of the day, IPR proceedings conducted by the Board must remain apolitical and ensure outcomes are decided on the basis of science and law rather than politics,” stated CAPA Executive Director Matthew Lane.

CAPA argues that the inter partes review process is necessary to stop Big Pharma from gaming the system and that impartiality in the patent review process is vital to increase Americans’ accessibility to affordable medicines. Read more here.

  • IN CASE YOU MISSED IT: A New Report Shows Big Pharma is Continuing with Price Hikes as Americans Grapple with Financial Hardships.
    • Prior to the COVID-19 pandemic, more than 58 millionAmericans struggled to afford their prescription drugs. As the economic impact of this global health crisis leaves millions of American workers, families and seniors struggling to stay afloat, patients are now facing rising costs for critical medications that treat COVID-19 related effects. This new report by the Patients for Affordable Drugs finds that Big Pharma is proceeding with business as usual, raising prescription drug prices and making it harder for American patients to afford their medications at the most challenging of moments.

In a closer look at 10 price hikes being taken, one drug – Fanapt – is available at a steep price, with one month’s supply rising in price from about $1,100 to $1,385 during the pandemic.

  • “… Without action to reform the patent system, Big Pharma will continue to repeatedly hike prices and reap the profits by engaging in a host of anti-competitive schemes that block generic and biosimilar competition… While pharmaceutical companies make life-saving treatments and cures, it does not give them the right to price-gouge hardworking families to pad their own bottom lines” – Read CAPA Executive Director Matthew Lane’s full statement and more on the report here

WHAT YOU SHOULD BE READING:

National Law Review: Arthrex Amicus Briefs – Novel Arguments For The Court To Consider

  • On December 2nd, amicus briefs in support of Smith & Nephew and the United States were filed with the Supreme Court in the Arthrex cases. There were also several amicus briefs filed in support of no party… Further briefs were submitted by Acushnet, Apple, Inc., Coalition Against Patent Abuse, Computer & Communications Industry Assoc., AIPLA, High Tech Inventors Alliance, Intellectual Property Law Association of Chicago, and Engine Advocacy and Electronic Frontier Foundation.

STAT News: PhRMA Took In A Record $527 Million In 2019, New Records Show

  • PhRMA, the pharmaceutical industry trade group, took in nearly $527 million in revenue last year, a $68 million increase from 2018 that came as the industry faced unprecedented opposition in Washington. The new revenue figure, made public late this year in PhRMA’s federal tax disclosures, highlights the group’s diverse efforts to influence Washington in a year when both the White House and newly empowered Democrats in the House of Representatives were intent on capping drug prices.

Law 360: Senate Passes Bills On Drug Patent Listings

  • The upper chamber approved H.R. 1503 on Tuesday and H.R. 1520 on Thursday … The bill had also attracted support from the biosimilars industry. A representative of one of the trade groups representing the industry, the Association for Accessible Medicines, told Law360 on Friday that it had been avidly following both pieces of legislation.

STAT News: In A Petition, Boehringer Warns FDA Its Definition Of ‘Strength’ Threatens Biosimilar Competition

  • Arguing the Food and Drug Administration is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to alter its interpretation of the word “strength” found in a federal law that has made it possible to sell these medicines. The move reflects a wonky, behind-the-scenes dispute that, nonetheless, holds potentially great significance for the burgeoning growth of biosimilar treatments in the U.S., which is expected to reach $80 billion in aggregate sales over the next five years, according to one recent forecast.

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