I-MAK Report Takes on Humira's Patent Estate

Samantha DiGrande

The Initiative for Medicines, Access, and Knowledge (I-MAK) report notes that 89% of these applications were filed in the United States after Humira was already on the market, and 49% were filed after the first patent expired in 2014.

The Initiative for Medicines, Access, and Knowledge (I-MAK) recently released a case study on AbbVie’s brand name adalimumab (Humira), the world’s highest-selling drug.

According to I-MAK, drug makers of the 12 top-selling medicines have sought, on average, “38 years of attempted monopoly protection through patents and patent applications.” The report noted that among these top 12 best-selling medicines, without the threat of competition, all but 1 has increased in price.

For Humira specifically, development began in 1993 through a joint venture, with initial patents filed in 1994. The biologic was subsequently approved by the FDA in 2002. To date, Humira is covered by 247 total patent applications in the United States. The report notes that 89% of these applications were filed in the United States after Humira was already on the market, and 49% were filed after the first patent expired in 2014.

Click here to read more about Humira’s patent estate.

Comparatively, the number of patent applications filed on Humira to date at the European Patent office is only 76. “What is noticeable from the European Patent Office data compared to the [United States] is that a number of AbbVie’s patent applications after 2002 that would have significantly extended its monopoly were either withdrawn, refused during examination, or revoked after patent challenges,” said the report.

Just last year, Humira generated $18 billion in global sales—$12 billion of which came from US payers. For Medicare and Medicaid specifically, from 2012-2016, taxpayers spent a total of $9.2 billion on Humira. “If Humira were a standalone company, it would be larger than many Fortune 500 companies, including Visa, General Mills, and Monsanto.”

Though the first biosimilar adalimumab is not set to hit the US market until 2023, Europe will be feeling the benefits of a lower cost option much sooner as the first biosimilar will be made available next month. The report notes that, even after these products are brought to market, the developers will have to pay royalties to license AbbVie’s Humira patents. Typically, the cost of these royalties are “likely to be passed down to the consumer.”

I-MAK closed its report by calling for the US Patent and Trademark Office and Congress to hold hearings and invite public comments on pharmaceutical patenting practices and their impact on drug prices for payers and patients in America.