I-MAK Report Calls AbbVie "The Worst Patent Offender" in Pharma

The Initiative for Medicines, Access, and Knowledge (I-MAK), a public interest team of attorneys and scientists who seek to ensure that patents do not obstruct patient access to affordable medicines, has issued a new report that details the number of patents drug makers have attempted to secure for the highest-grossing drugs in the United States.

Drawing on data from drug makers’ own reports, patent databases, and IQVIA data, I-MAK found that the 12 top-selling drugs in the United States during 2017 included the high-cost biologics Humira (adalimumab), Rituxan (rituximab), Enbrel (etanercept), Herceptin (trastuzumab), Remicade (infliximab), and Avastin (bevacizumab), all of which are targeted by biosimilar developers. These products cost the US health system a total of $96 billion in 2017.

On average, the sponsors of these drugs attempted to secure 125 patents per product (range, 48-247), with the United States granting an average of 71 patents per drug (range, 27-132). According to I-MAK, these patents “are filed with a strategic intent to extend the commercial monopolies far beyond the intended [20] years of protection,” and have resulted in an average of an additional 38 years of market exclusivity per drug. This lack of competition, says the report, has allowed companies to raise their prices by an average of 68% per product since 2012.

I-MAK calls AbbVie “the worst patent offender,” having both attempted 247 patents for its Humira and raised prices by 144% since 2012. Amgen was not far behind, having raised prices on its Enbrel by 155% in the same time period, though it attempted far fewer patents (57). Roche raised its prices on Avastin by 16%, and sought to gain 219 patents for its product.

The only product for which a price decrease (—58%) was observed since 2012 was Roche and Genentech’s Herceptin, though I-MAK notes that patents pending for the drug could extend its market exclusivity until 2033.

In order to allow for price competition for these high-grossing drugs, concludes the report, the United States will need “significant policy reform.”

In an interview with The Center for Biosimilars^® earlier in 2018, Tahir Amin, DipLP, the cofounder and director of intellectual property for I-MAK, said that one key way to reform the US system is to improve upon the standard of what can be patented.

“I feel the law has not kept up with the advances with how [research and development, R&D] is done, and how scientific knowledge has been accumulated over the last 50 years,” said Amin. He explained that, “In order to get your patent, you’re judged by whether it’s novel, based on what’s known in the field, or if it is obvious to someone in the field. The obviousness standard is not applied in the correct way. It’s almost as if techniques from 50 years ago are still not obvious to people, and I think the law hasn’t kept up.”

Among I-MAK’s goals, Amin said, is “…bringing that standard up to where science is today, and we’ll find that a lot of things are obvious. Patents would not be granted so readily, and only the really high-end inventions would be [patentable]. That’s where a lot of the focus needs to be on.”