Study: Manufacturers Device Hop to Extend Patent Protection

What pharmaceutical companies call line extensions, researchers call device hopping. A review of patents and regulatory exclusivities for inhalers found that manufacturers have been placing the same active ingredients in new devices to achieve to extended protection, according to a new study published recently in Health Affairs.

William B. Feldman, M.D., D.Phil.

Researchers, led by William B. Feldman, M.D., D.Phil., a research fellow in medicine Brigham and Women’s Hospital in Boston, assessed patents and regulatory exclusivities on inhalers for asthma and chronic obstructive pulmonary disease (COPD). They found 14 cases of device hopping in which manufacturers received a median of 28.1 years of patent protection.

In one example cited by the researchers, GSK received 35 years of patent protection on fluticasone with new inhaler devices: Flovent (approved in 1996), Flovent Rotadisk (1997), Flovent Diskus (2000), Flovent HFA (2004), and most recently Arnuity Ellipta (2014).

These additional patents have delayed generic competition, because generic versions of the older product are not interchangeable with the new product.

“Instead of developing new therapeutic modalities, manufacturers have changed the design of the devices that deliver inhaled medications and preserved their market shares through regulatory exclusivities and patents, particularly on these devices, which represent more than half of all patents listed by manufacturers for inhalers in our cohort,” they wrote.

“Manufacturers reuse the same patents on multiple inhalers from different classes and shift old ingredients to new devices. The upshot is that many protected brand-name inhalers contain active ingredients that were first approved decades ago,” researchers said.

Researchers analyzed patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020. They used the approval date from product labeling on Drugs@FDA and used the annual FDA Approved Drug Products with Therapeutic Equivalence Evaluations (often referred to as the Orange Book) for information about patents and exclusivities.

They analyzed 62 inhalers, and of these 53 were brand-name products. The remaining products included seven generic albuterol inhalers and two generic fluticasone-salmeterol inhalers. At the time of approval, the median duration of patent protection was 15.4 years. After FDA approval, manufacturers obtained 68 additional statutory exclusivities that were added at an average rate of one every 8.2 years per inhaler after inhaler approval.

Manufacturers also received 90 post-approval patents during the study period, or one

every 6.1 years after inhaler approval. Device patents represented 74% of post-approval patents. Overall, manufacturers received a median of 16.2 years of protection from regulatory exclusivities and patents after approval. Inhalers in the short-acting beta-agonist class achieved the longest median protection after FDA approval, at 19.6 years.

Robin Feldman

In an accompanying perspective article, Robin Feldman, Arthur J. Goldberg Distinguished Professor of Law, University of California Hastings Law in San Francisco, questioned whether these type of product modifications justify the extensive rewards available.

“To the extent that the company has simply figured out a new way to sell the product, that invention should not be patentable unless it uses an innovative approach. The patent system is not designed to reward marketing prowess, she wrote.

“If the government’s reward system is occupied with granting rewards for minor modifications, we may be creating incentives that drive inventors toward the mundane and away from the truly innovative work,” she said.