ArticlePharmaceutical patent analyst2024
Contradicting rulings of the US patent office on double patenting jeopardize the generic and biosimilar drugs.
Article in Pharmaceutical patent analyst, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Non-signaling protein therapeutics: a mechanism-based regulatory framework to modernize biosimilar development and global harmonization.Frontiers in medicine · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Obviousness-type double patenting is allowed only in the US, but only if a terminal disclaimer and the same ownership are made for the expiry of the patent. Historically, this provision has hampered the entry of generic and biosimilar drugs due to the legal complexity and cost burden of resolving patent thickets accumulated by the originator companies. The United States Patent and Trademark Office (USPTO) proposed a change in the ruling in March 2024 to avoid double patenting if the patent to which it is tied in terminal disclaimer has any claims that have been invalidated as anticipated or obvious. This rule change aimed to promote innovation and competition by deterring strategies that leverage multiple patents for obvious variants to obstruct competitors. However, after receiving 349 comments on the proposed rule change, the USPTO withdrew its plan in December 2024 despite most comments favoring it. In a contrary move, the USPTO secured a court ruling that the terminal disclaimers do not apply to extended patent expiry due to the failure of the USPTO to prosecute a patent on a timely basis. The double patenting must end to enable more affordable generic and biosimilar drugs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.