Guarding Big Pharma’s Crown Jewel

Issue 09-11-17   |   Reviewer:   James Richardson, Ph.D.


The best selling drug in the world, Humira, has been around for 15 years, and the patent on its main ingredient expired last year. But its maker, AbbVie Inc., has protected its $16 billion annual sales with more than 100 patents covering ingredients, manufacturing processes, and methods of treatment. Humira is a biologic drug, manufactured in living cells rather than chemically manufactured, which creates many more opportunities for patenting the complex process.

Most drugmakers have been scared off, but Amgen Inc. has engaged in a legal battle to produce a biosimilar to Humira, which AbbVie claims will violate 61 of their patents. Even though Congress settled on 12 years of protection for biological pharmaceuticals, AbbVie’s patent strategy could give it 20 more years.

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