Activist Lawyer Discusses AbbVie and Patent System Shortcomings

In this abbreviated interview, Senior Editor Tony Hagen talks with Tahir Amin, Dip LP, a former intellectual property attorney who is now co-executive director of I-MAK (The Initiative for Medicines Access and Knowledge), which lobbies to overcome unfair trade practices and make medicines more widely available to patients. He recently testified on AbbVie’s drug patenting and pricing practices before the House Committee on Oversight and Reform.

Amin talked about some of the concerning practices he witnessed during his early career in patenting. He said that patent filers will carefully word patents to allow for multiple ongoing filings. This enables them to build large portfolios of patents that represent legal tangles for biosimilar competitors.

Regarding patents for the reference product adalimumab (Humira), Amin said so many have been filed by AbbVie that it’s too costly and difficult for biosimilar developers to contest them all. This is a failing of the US patent system, he says, because these webs of patents cannot be undone.

He discussed Alvotech’s ongoing attempt to fight AbbVie patents on adalimumab and said he is hopeful that Alvotech will be successful, but he noted that Boehringer Ingelheim previously went to court with AbbVie over adalimumab and eventually settled. This, he said, demonstrates that the patent system is being “weaponized” by originator companies.

Amin described AbbVie as having a “drip feed strategy” in which it files for patents broadly and over time. Originator companies will carefully patent every aspect of biosimilar development they can think of, even if they are no longer using the process that they’re patenting, and this, too, serves as an obstacle to biosimilar competitors.

Additionally, Amin commended Representative Katie Porter (D-California) on her questioning of AbbVie’s CEO, Richard Gonzalez when he testified before the House Committee on Oversight and Reform. According to Porter, AbbVie is not spending as much as it claims on innovation. The company has previously defended the high price of Humira by saying that much of the revenues are reinvested in development of new products to improve the health and lives of Americans.

Originator companies may lose the idealism that leads to new and better products and, instead, simply focus on maximizing their current revenue stream from existing products, Amin said.

Amin talked about the history of the patent system from the 1950s through the 1980s, saying how innovation boomed in the 1950s and then in the 1970s an economic downturn led to a shift in priorities. He said that, today, 11 million patents have been filed and roughly 50% are likely “junk.” That large number of patents is being used as a measure of innovation, which Amin doesn’t think is right.

When asked about his hopes for the Patent and Trademark Office (PTO), Amin said the incoming director should take into account the public interest and effects of drug pricing because the PTO, he said, has never acknowledged the role that patents play in rising drug prices.

Finally, Amin discussed how the COVID-19 pandemic has underscored the patent system problems, because protection of intellectual property and corporate profits has impeded getting the vaccine out to everybody who needs it. However, the public health crisis is causing more people to engage with these issues, and Amin said that this could lead to policy changes that improve the patent system.

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