S. Tu

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Articles

Author Correction: The cost of drug patent expiration date errors - Nature Biotechnology

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.
Use of Track One Prioritized Examination for Pharmaceutical Patents

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.
The cost of drug patent expiration date errors - Nature Biotechnology

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.
Biologic patent challenges under the America Invents Act - Nature Biotechnology

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.
Patents on Risk Evaluation and Mitigation Strategies for Prescription Drugs and Generic Competition

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.
Biologic Patent Thickets and Terminal Disclaimers

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).
Ancillary Product Patents to Extend Biologic Patent Life

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...
Preserving Timely Generic Drug Competition with Legislation on “Skinny Labeling”

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.
Changes in the Number of Continuation Patents on Drugs Approved by the FDA

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.