2022 Azbee Awards of Excellence

Category

All Content > Case History > Mid Atlantic

Awarded to

Jonathan Gardner, Senior Reporter; Ned Pagliarulo, Lead Editor; Julia Himmel, News Graphics Developer

Entry details

A three-decade monopoly: How Amgen built a patent thicket around its top-selling drug

Issue or publication date: 11/1/21
Publication name: BioPharma Dive
Publishing/parent company: Industry Dive
Website home page: https://www.biopharmadive.com/

About the publication's mission and readership:

https://www.biopharmadive.com/about/

Description of the enterprising work that went into this entry and its significance or impact on readers:

Patents allow pharmaceutical companies to earn a return on their investment in risky research and development for new medicines, granting them a time-limited monopoly before other companies can produce the same drug. But in recent years, drugmakers have been accused of manipulating the law to extend patent protection for their top-selling medicines.

For this story, BioPharma Dive senior reporter Jonathan Gardner dug into the wall of patents biotech company Amgen built around its arthritis drug Enbrel, a defense from competition commonly termed a “patent thicket.”

Enbrel has earned the company nearly $75 billion since its approval in 1998. But low-cost generic competitors won’t be able to enter the U.S. market until 2029, nearly four decades after Nobel Prize-winning scientist Bruce Beutler first sought a patent for a discovery that would later become the foundation for Enbrel, and 17 years after it expired.

To uncover how Amgen extended its monopoly, Gardner sifted through dozens of SEC filings and annual reports, tracked down Beutler as well as an executive involved early in Enbrel’s development, and interviewed experts in law and healthcare policy. Gardner also reviewed court filings and patent reports to develop an accompanying data visualization that illustrated the length and breadth of Enbrel’s patent protection.

Gardner’s story gives BioPharma Dive readers a deeper understanding of how drug companies use patent thickets to keep competitors off the market for years after original patents expire. Gardner also detailed the policy debate surrounding thickets and the challenges faced by lawmakers seeking reform.

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