THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • Today, Roll Call published an op-ed by Matthew Lane, executive director of the Coalition Against Patent Abuse praising the ongoing bipartisan efforts to rein in Big Pharma’s abuse of the American patent system.
    • “Finding common ground isn’t easy in today’s divided Washington. We are even seeing it in the broader drug pricing debate with competing proposals in the House and Senate. But it is encouraging to see bipartisan consensus emerging on patent reform. If Congress is serious about making prescription drugs more affordable, then reforming the patent system, ending product hopping and finally putting an end to Big Pharma’s abuses are a must for 2020. American patients cannot afford to wait any longer.”
  • A groundbreaking report from Axios recently found that major pharmaceutical companies began the new year by raising prices on over 440 drugs with an average price hike of 5 percent.
    • “Pharmaceutical companies began 2020 the same way they begin every year: with price hikes on hundreds of drugs…The price increases are salt in the wound following Congress’ failure to pass meaningful drug price legislation in 2019, and are already being used to make the political case for action this year…As of Friday, drug companies had increased the prices of 445 products by a median of 5%, according to an analysis by 3 Axis Advisors. More hikes are expected throughout January.”
  • Last week, the Washington Post published an important analysis highlighting how drugmaker AbbVie uses tactics like patent thickets to continue raising the price of their drug Humira and also prevent more affordable generic alternatives from coming to market.
    • “With no competition, AbbVie has a free hand to boost prices in the United States for another three years. That potentially allows it to make up for slower sales in Europe, where generic competition is taking a bite out of Humira sales.”
  • Senator John Cornyn (R-TX) penned an opinion piece for the Austin American Statesman highlighting the bipartisan legislation he and Senator Richard Blumenthal (D-CT) have authored to help lower prescription drug costs.
    • “Drugs cost too much — for all Texans. In response to countless conversations with Texas families, I’ve authored two bipartisan bills to help lower these costs. The Affordable Prescriptions for Patients Act encourages price competition among drug companies by defining anti-competitive patent abuse, and it’s supported by AARP.”

WHAT YOU SHOULD BE READING:

TED: Why Are Drug Prices So High? Investigating The Outdated US Patent System
Priti Krishtel

  • We haven’t gotten drastically more inventive. Corporations have gotten drastically better at gaming the system. Drug patents have exploded — between 2006 and 2016, they doubled. But consider this: The vast majority of medicines associated with new drug patents are not new. Nearly eight out of 10 are for existing ones, like insulin or aspirin.”

Politico Pro: FDA Approved Record Number Of Biosimilars In 2019
Sarah Owermohle

  • The FDA approved a record number of biosimilars in 2019 and 48 novel drugs, including 21 to treat rare diseases, the agency notes in a report today. The agency approved 10 biosimilars, bringing the total on the market to 26, to be used in place of nine popular brand-name medicines including Remicade, Rituxan and Enbrel. But many of the 26 are tied up in legal battles and not being marketed. FDA approved two biosimilars in 2019 for AbbVie’s bestseller Humira, for example, but they can’t be sold in the U.S. until 2022 when AbbVie loses patent exclusivity. As U.S. patents and exclusivity protections for biologics expire, companies are submitting many new biosimilars for approval, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in the report.

STAT News: They Did What? Celgene Backs Out Of A $55 Million Deal To Settle Claims Of Thwarting Generics
Ed Silverman

  • In what is being described as a highly unusual move, the Celgene unit at Bristol-Myers Squibb (BMY) has backed out of a $55 million settlement of a class-action lawsuit that accused the company of hiding behind a mandated safety program in order to thwart generic competition. A patient advocate and several pension funds had claimed that Celgene exploited an FDA program that is designed to boost safety so that it could deny samples of two of its cancer drugs, including Revlimid, which generic companies need to conduct product testing in order to win regulatory approval. Consequently, patients were precluded from spending less for medications.

NBC News: Meet The Billionaire Who’s Out To Make Insulin More Affordable
News Staff

  • Insulin is a lifeline for many diabetics, yet its cost has nearly doubled over the last five years. Harry Smith introduces TODAY viewers to Harold Hamm, a billionaire entrepreneur who’s out to change a situation he calls “unconscionable.”

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