During his testimony, he focused on drug-device combinations, including inhalers and insulin injectors, which are particularly susceptible to patent manipulations. Firms will seek out numerous patents around both the active formulation and the devices themselves, establishing so-called “patent thickets.”
They also engage in “product hops,” making minor modifications to the drug or the device and then releasing new versions with fresh patent protections. These new products often offer no clinical benefit over existing products, Dr. Feldman explained.
At the Senate hearing, Dr. Feldman suggested additional solutions that would piggyback on four pending bills already under consideration. They include granting the US Food and Drug Administration more authority to evaluate patents for drugs and drug-devices and giving the organization more resources to approve generic drug-device combinations that differ slightly from brand-name reference products (while still containing the same active ingredients).
Some positive developments have occurred in recent years. Notably, there are now generic inhalers for five brand-name products since they first reached the market in 2019—though that’s far from enough for optimal health care delivery, Dr. Feldman noted. Additionally, some companies have been pulling improperly listed device-only patents in response to action by the Federal Trade Commission, which remains ongoing.
After years of advocacy work from experts like Dr. Feldman, several drug companies have also announced $35 price caps on their inhalers—though clinicians would still do well to direct their patients to download coupons from company websites to ensure the discount is applied at the pharmacy, he said. In theory, these discounts should be applied automatically at the counter, Dr. Feldman said, but this doesn't always happen the way it should. It is also important to note that more than half of the inhalers dispensed in the United States every year are to patients covered by Medicare or Medicaid, and the $35 cap on out-of-pocket expenses does not apply to them.