THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW:

  • DID YOU KNOW: Biosimilar Competition Could Reduce Costs for Patients and Drive Accessibility to Lifesaving Medications
    Recently, Inside Health Policy covered a new Cardinal Health report showing as many as 43 biosimilars slated to enter the market will lower U.S drug spending by $133 billion by 2024.

    Key excerpts:
    • “Cardinal Health analysts predict that biosimilar insulin will serve as ‘the ultimate case study’ for how managed care systems handle biosimilars and whether pharmacy benefit managers favor them in formulary designs. Two biosimilars for Novo Nordisk’s Novolog are expected to enter the market this year.”

    • “Seven FDA-approved biosimilars for Humira are being launched in 2023, and there are three more waiting for approval that will be launching soon afterwards. Other immunology and rheumatology treatments with biosimilars that are launching in the next few years include Johnson & Johnson’s Stelara, Genentech’s Actemra and Amgen’s Enbrel.”

    • Cardinal also predicts that biosimilar drug makers and their commercial partners will look to garner more real-world evidence (RWE) of the effectiveness and safety of biosimilars to boost prescribers’ knowledgeability and gain their trust. Many healthcare providers still question whether biosimilars can deliver the same outcomes for patients as their reference products.”

Read the entire Inside Health Policy story here.

  • ICYMI: New Study Reveals Patent Monopolies Hinder Biosimilar Competition, Keeps Drug Costs High for American Patients

    Recently, STAT News’ Ed Silverman reported on a new analysis by Health Affairs revealing anti-competitive tactics by inhaler manufacturers to block market entry by generic competition.

    Key excerpts:
    • “For more than three decades, drugmakers have used various tactics to win and extend monopolies on inhalers for combating asthma and chronic obstructive pulmonary disease, which thwarted lower-cost generic competition that could have saved patients and payers countless dollars.”

    • “The researchers examined 62 inhalers approved by the Food and Drug Administration between 1986 and 2020, and found 53 — or 85% — were brand-name products with an average of 16 years of patent protection. Yet only one inhaler contained an active ingredient with a new mechanism of action, while more than half of the patents were on devices, not any of the ingredients.”

    • One tactic used to preserve monopolies and revenue streams is known as device hopping. Basically, a manufacturer places the same active ingredient into a new device with patents and exclusivity periods that ensure longer protection from competition. GlaxoSmithKline, for instance, won 35 years of monopoly after the FDA approved its fluticasone inhalers and released several new devices.”

    • “In what the researchers call a ‘notorious example,’ Boehringer Ingelheim released a new version of its Combivent inhaler in 2011 with 25 patents, all of which were for the device rather than the drug ingredients. The company now has a total of 34 years of monopoly beginning with the initial approval in 1996 and running through 2030, when the last patent on a chlorofluorocarbons-free version expires.”

Read the full STAT News article here.

  • The Evidence Exists: Discover the Truth Behind Out-of-Control Drug Prices
    For decades, Big Pharma has fought to ensure prices remain high for patients, mainly through hindering the ability of generics to enter the market. In fact, a June 2020 study from Health Affairs found that Medicare spent an average of $109 million a year from 2010 to 2016 due to delayed generic entry.

    A July 2020 paper from SSRN revealed that current examiner time allocations in the patent review system are causing patent examiners to issue low quality secondary drug patents on the margin. The study found that one year of improved examinations would save $8.7 billion in the future by preventing the issuance of low quality patents that would be used to prevent competition.

Read more on drug makers’ patent abuses here.

WHAT YOU SHOULD BE READING:

STAT News: Abbvie Dramatically Boosts Its Spending On Lobbying
Nicholas Florko and Rachel Cohrs

  • The pharma giant AbbVie spent nearly $4 million on lobbying in the first three months of 2022 alone — more than any other drugmaker spent in the same period, and nearly a million dollars more than the company spent in the same period last year. AbbVie was the seventh-highest corporate lobbying spender last quarter, ahead of giants like Lockheed Martin, CVS Health, and, AT&T, federal records show. The number is eye-popping even for the pharmaceutical industry, which is known for its omnipresence on Capitol Hill, and its nearly unlimited lobbying budgets.

The BMJ: Improving The Quality Of US Drug Patents Through International Awareness
Doni Bloomfield, Zhigang Lu & Aaron S Kesselheim

  • Prescription drugs are one of the most prevalent and useful interventions in medicine, accounting for 13.7% of US healthcare expenditure. Per capita spending on drugs in the US is greater than in comparable high income countries, driven by the high prices of brand name drugs (recently approved medicines sold by a single manufacturer and typically protected from direct competition by patents).

Bloomberg Law: Moderna’s Vaccine Patent Defense Poses Shield For US Deal Makers
Ian Lopez

  • Covid-19 vaccine makers may find shelter from patent lawsuits under a legal theory Moderna’s floating in a case that could shape post-pandemic deals between drugmakers and the government. Moderna Inc. is fighting an attempt by Arbutus Biopharma Corp. and Genevant Sciences GmbH to seek royalties for sales of its Covid-19 vaccine. It argues their claims are misdirected and should instead be brought against the government, citing a law designed to protect government suppliers.

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