Patenting Strategies on Inhaler Delivery Devices

Demkowicz, Brandon J.; Tu, S. Sean; Kesselheim, Aaron S.; Carrier, Michael A.; Feldman, William B.

doi:10.1016/j.chest.2023.02.031

Cited by 4 publications

(3 citation statements)

References 11 publications

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“…Regulatory uncertainty remains about which types of device patents manufacturers should list in the Orange Book [28]. But, as with earlier work on inhalers [21], our study underscores the prevalence of key device patents listed on products in the Orange Book with no mention of active ingredients in their claims. The Federal Trade Commission recently announced plans to scrutinize these types of patent listings [55].…”

Section: Plos Medicinesupporting

confidence: 54%

“…For example, a recent study of inhalers, another important class of drug-device combinations, found that more than half of patents were listed on the delivery device and that manufacturers frequently launched products in new devices with the same active ingredients as existing products (so-called "device hopping") [19]. A federal appeals court recently found that certain types of device patents listed in the Orange Book-namely, those with no mention of active ingredients in their claims-may be improperly listed [20], and yet more than threequarters of device patents on inhalers approved from 1986 to 2020 made no such mention of active ingredients [21]. While new devices can provide benefits to patients, such as simplifying methods for self-administration and increasing adherence, patents on these devices can lead to delayed competition.…”

Section: Introductionmentioning

confidence: 99%

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Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019

Olsen,

Beall,

Knox

et al. 2023

PLoS Med

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Background Insulin is the primary treatment for type 1 and some type 2 diabetes but remains costly in the United States, even though it was discovered more than a century ago. High prices can lead to nonadherence and are often sustained by patents and regulatory exclusivities that limit competition on brand-name products. We sought to examine how manufacturers have used patents and regulatory exclusivities on insulin products approved from 1986 to 2019 to extend periods of market exclusivity. Methods and findings We used the publicly available Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to identify all approved biosynthetic insulin products. Individual products approved under the same New Drug Application (NDA)—e.g., a vial and pen—were considered as separate products for the purposes of analysis. We recorded all patents and regulatory exclusivities listed in the Orange Book on each product and used Google Patents to extract the timing of patent application and whether patents were obtained on delivery devices or others aspects of the product. The primary outcome was the duration of expected protection, which was determined by subtracting the FDA approval date for each product from its last-to-expire patent or regulatory exclusivity (whichever occurred later). We performed a secondary analysis that considered overall protection on insulin lines—defined as groups of products approved under the same NDA with the same active ingredients manufactured by the same company. We also examined competition from follow-on insulin products—defined as products approved with the same active ingredients as originators but manufactured by different companies (approved via a specific drug approval pathway under section 505(b)(2) of the Food, Drug, and Cosmetic Act). During the study period, the FDA approved 56 individual products across 25 different insulin lines and 5 follow-ons across 3 different insulin lines. Thirty-three (59%) of the 56 products were drug-device combinations. Manufacturers of 9 products approved during the study period obtained patents filed after FDA approval that extended their duration of expected protection (by a median of 6 years). Approximately 63% of all patents on drug-device combinations approved during the study period were related to delivery devices. The median duration of expected protection on insulin products was 16.0 years, and the median protection on insulin lines was 17.6 years. An important limitation of our analysis is that manufacturers may continue to add patents on existing insulin products while competitors may challenge patents; therefore, periods of protection may change over time. Conclusions Among several strategies that insulin manufacturers have employed to extend periods of market exclusivity on brand-name insulin products are filing patents after FDA approval and obtaining a large number of patents on delivery devices. Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have access to low-cost drugs.

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Section: Plos Medicinesupporting

confidence: 54%

Section: Introductionmentioning

confidence: 99%

Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019

Olsen,

Beall,

Knox

et al. 2023

PLoS Med

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“…Such reliance on disconnected device patents goes beyond what has been observed for other drug-device combinations: 23% of distinct FDA-listed device patents on inhalers and 15% on insulin pens mention the products’ active ingredients in their claims compared with no such mentions among device patents on GLP-1 receptor agonists.…”

Section: Discussionmentioning

confidence: 98%

Delivery Device Patents on GLP-1 Receptor Agonists

Alhiary,

Gabriele,

Kesselheim

et al. 2024

JAMA

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Availability and Pricing of Drugs Prescribed by Otolaryngologists Through a Direct‐to‐Consumer Pharmacy: Medicare Savings Implications

Erickson,

Pletcher,

Soler

et al. 2024

Otolaryngol.--head neck surg.

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High prescription drug prices can financially strain patients and insurers, with substantial clinical repercussions. In recent years, direct‐to‐consumer (DTC) pharmacies have emerged as potentially lower‐cost alternatives for patients to fill prescriptions. We evaluated whether drugs commonly prescribed by otolaryngologists were available at a national DTC pharmacy (Mark Cuban Cost Plus Drug Company [MCCPDC]) and estimated potential Medicare savings from DTC pricing. We identified drugs and prices paid by Medicare Part D plans using the 2021 Drug Spending Dashboard. Our analysis included 16 generic drugs within the MCCPDC formulary, which offered lower prices for 14 (87.5%) drugs. If plans had secured MCCPDC pricing for all 16 drugs, Medicare patients and plans would have saved $2.9 billion (relative reduction: 62.3%) in 2021. Estimated total savings were greatest for budesonide‐formoterol ($1.9 billion), dexlansoprazole ($464.6 million), and levothyroxine ($327.4 million). Otolaryngologists and insurers may consider utilizing DTC pharmacies with lower drug prices, though patients may face challenges projecting out‐of‐pocket costs across pharmacies, medications, benefit phases, and formulary tiers.

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Patenting Strategies on Inhaler Delivery Devices

Cited by 4 publications

References 11 publications

Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019

Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019

Delivery Device Patents on GLP-1 Receptor Agonists

Availability and Pricing of Drugs Prescribed by Otolaryngologists Through a Direct‐to‐Consumer Pharmacy: Medicare Savings Implications

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