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Oct 8, 2024 | 
nature.com | S. Tu
Correction to: Nature Biotechnology https://doi.org/10.1038/s41587-024-02298-w, published online 17 July 2024. In the version of the article initially published, the dates displayed in the “Corrected patent expiration date” column of Table 1 relied on the original patent expiration date information provided by the US Patent and Trademark Office1.
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Jul 19, 2024 | 
jamanetwork.com | S. Tu |William B. Feldman
Introduction
Pharmaceutical manufacturers obtain patents at various points leading up to and following US Food and Drug Administration (FDA) approval of new drugs.
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Jul 16, 2024 | 
nature.com | S. Tu
Errors in the US Patent and Trademark Office’s automated program to calculate patent expiration dates could result in hundreds of millions of dollars in added costs to drug prices.
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Mar 14, 2024 | 
nature.com | S. Tu
Administrative patent review procedures are an effective way of correcting erroneously granted biologic patents and may help promote timely drug competition for the benefit of patients and the US healthcare system.
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Feb 22, 2024 | 
jamanetwork.com | Ameet Sarpatwari |S. Tu |Aaron S. Kesselheim
Certain prescription drugs are associated with harms that the US Food and Drug Administration (FDA) concludes can be mitigated with safeguards, such as laboratory testing or prescriber and patient education. For these drugs, the FDA may require manufacturers to implement risk evaluation and mitigation strategies (REMS) encompassing such measures.1
Some manufacturers have obtained patents on these REMS, which provide 20 years of market exclusivity and can frustrate generic competition.
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Dec 14, 2023 | 
jamanetwork.com | S. Tu |Rachel H. Goode |Fresenius Kabi USA
Spending on biologics in 2021 represented $260 billion or 46% of all spending on prescription drugs in the US.1 Biosimilar competition can lower prices, but biosimilar entry is often delayed by expansive patent thickets (dozens or hundreds of patents directed toward the same product).
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Nov 13, 2023 | 
jamanetwork.com | Rachel H. Goode |Fresenius Kabi USA |William B. Feldman |S. Tu
In 2021, 46% ($260 billion) of all gross prescription drug spending in the US was on biologic products.1 Patents are government-granted monopolies that last 20 years; by obtaining multiple patents for different aspects of the same product, biologic manufacturers create “patent thickets” that can block or delay biosimilar competition to protect market share.2,3 Although patent gamesmanship by biologic manufacturers has been well documented, a key strategy that has not received sufficient...
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Oct 24, 2023 | 
ascpt.onlinelibrary.wiley.com | S. Tu |Aaron S. Kesselheim
Patents prevent generic drug entry. Brand firms file new “method of use” patents for old drugs to prevent generic entry. Congress addressed this issue by creating the “skinny label” pathway, which allows generic firms to use the drug label to indicate that the old drug can only be used for non-patented uses. This pathway is now in jeopardy due to a recent court case. This paper outlines the issues and suggests possible legislative solutions.
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Aug 1, 2023 | 
jamanetwork.com | S. Tu |Aaron S. Kesselheim |William B. Feldman |Kathrine Wetherbee
Changes in the Number of Continuation Patents on Drugs Approved by the FDA Brand-name pharmaceutical manufacturers often sustain high prices in the US by obtaining patents that delay generic competition.
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May 9, 2023 | 
jamanetwork.com | S. Tu |Aaron S. Kesselheim
Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation
In 1983, the Orphan Drug Act was enacted to provide incentives for pharmaceutical companies to invest in developing prescription drugs targeting rare diseases, later defined as those affecting fewer than 200 000 US individuals.
