This Shield of Patents Protects the World’s Best-Selling Drug

Humira, a treatment for inflammatory diseases such as rheumatoid arthritis and psoriasis made by AbbVie Inc., is the planet’s best-selling drug. It’s also been around almost 15 years. Those two facts alone would normally have rival drugmakers eagerly circling, ready to roll out generic versions that could win a piece of the aging medicine’s $16 billion in annual sales. Yet last year, when the patent on Humira’s main ingredient expired, not a single competitor launched a copycat version. Figuring out how to manufacture it wasn’t the obstacle. The real challenge was the seemingly impregnable fortress of patents AbbVie has methodically constructed around its prized moneymaker.

The more than 100 patents AbbVie has secured over Humira’s lifetime make it difficult for another company to replicate the drug without using processes and techniques to which the pharma giant continues to hold rights. Many of those patents were issued over the past few years as the expiration of Humira’s main patent grew closer. Typical drugs, made through chemical synthesis, usually have no more than a dozen or so patents, if that. But biologic medicines such as Humira, which accounts for more than 60 percent of AbbVie’s revenue and can carry a list price of more than $50,000 per patient, are typically made in living cells rather than chemically manufactured. That process often involves more steps and a higher level of complexity, which opens the door to more potential steps to patent. What’s more, companies can claim any changes to their drugs over the years—say, using a slightly different medium in which to grow cells or adjusting the dosing—warrant new legal protections that can keep generic competitors at bay.