Patenting Strategies on Inhaler Delivery Devices

Area of Science:

• Pharmaceutical policy and intellectual property law
• Respiratory medicine and drug delivery systems

Background:

• Patients with asthma and chronic obstructive pulmonary disease (COPD) depend on inhalers for symptom management.
• High costs of these essential medications are partly attributed to extensive patenting of brand-name inhalers, including their delivery devices.
• Antitrust scrutiny is increasing regarding the listing of device patents with the U.S. Food and Drug Administration (FDA), especially when patents do not cover active ingredients.

Purpose of the Study:

• To investigate how manufacturers have utilized device patents to maintain market exclusivity for brand-name inhalers.
• To quantify the impact of device patents on extending market protection for asthma and COPD inhalers.

Main Methods:

• Analysis of brand-name inhaler patents approved between 1986 and 2020 using the FDA's Orange Book.
• Extraction of patent data from LexisNexis TotalPatent One and Google Patents.
• Examination of device patents for mentions of active ingredients or specific features linking them to the drug product; calculation of extended market protection duration.

Main Results:

• Of 53 brand-name inhalers approved (1986-2020), 39 had at least one device patent, totaling 137 distinct patents (49% of all listed patents).
• A significant majority of device patents (77%) did not mention active ingredients, and 72% lacked specified features linking them to the drug.
• Device patents extended market protection by a median of 5.5 years beyond the last non-device patent for the 39 affected inhalers.

Conclusions:

• Device patents are frequently used to extend market exclusivity for asthma and COPD inhalers, often without direct claims on active ingredients.
• This practice contributes to delayed generic competition and higher medication costs for patients.
• Patent and regulatory reforms are necessary to foster generic competition and improve patient access to affordable respiratory medications.