Mike Bloomberg joins a growing chorus of Democratic presidential candidates threatening to go after drug patents
As the mayor of New York City, Mike Bloomberg had a few modest ideas about lowering prescription drug prices in the Big Apple that gained little traction. Now on the campaign trail on a faint hope of clinching the Democratic presidential nomination, the billionaire has some bigger plans — including one that would alter the patent system central to the biopharma business.
In a barebones drug pricing plan posted on Monday, Bloomberg came out blasting President Donald Trump for failing to deliver his promise to lower drug prices, and then making misleading claims about them. The price of over 3,000 drugs still increased at a rate five times higher than inflation in the first six months of 2019, he wrote.
So how will he fix it? Bloomberg lists a few widely discussed policy proposals, including authorizing Medicare to negotiate drug prices (a key goal of Nancy Pelosi’s recently passed House bill), allowing Americans to buy medicine from other countries (something the HHS has released a plan on), and capping out-of-pocket costs for Medicare beneficiaries.
He also pledged to eliminate “payoffs” — presumably the arrangement commonly known as rebates — from drugmakers to pharmacy benefit managers. The White House had set out to do the same but changed course to kill rebate reform back in July.
But Bloomberg’s most eye-catching proposal is this: “Bring generic drugs to the market faster by limiting brand-name drug makers to one patent that lasts 20 years.”
Accelerating the speed of generics approval had been a key goal for former FDA Commissioner Scott Gottlieb, who called out branded drugmakers for “shenanigans” to delay generic drug competition. During his tenure, Gottlieb also implemented new policies aimed at barring pharma from exploiting REMS requirements for their benefit.
But changing patent and IP laws could be a drastic expansion of that effort. AbbVie has reportedly secured more than 100 patents to protect Humira, the best-selling drug on the planet and a multibillion-dollar franchise.
While the 20-year term is in line with current limits, Bloomberg also didn’t specify if his solution would allow for patent extensions (maximum 5 years) under the Hatch-Waxman Act.
The other part of Bloomberg’s reform would have drug companies pay royalties to the NIH if they use NIH IP and turn it into a commercial product — which can be controversial as illustrated in Gilead’s recent disputes with the HHS over HIV patents. Bloomberg stopped short of spelling out the consequences for any pharma players who don’t comply with his policies. Senators Elizabeth Warren and Bernie Sanders — who are polling ahead of Bloomberg — have both suggested that they would seize or break drug patents over what they view as egregious pricing.