| Title |
The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents
|
|---|---|
| Published in |
Applied Health Economics and Health Policy, August 2018
|
| DOI | 10.1007/s40258-018-0420-8 |
| Pubmed ID | |
| Authors |
Jonathan J. Darrow, Reed F. Beall, Aaron S. Kesselheim |
| Abstract |
Most new brand-name drugs are protected by patents from generic competition, but these patents are occasionally granted in error. Invalidating such patents has traditionally been accomplished via court litigation by generic manufacturers, which is expensive and time consuming. In 2011, Congress created an administrative alternative to court litigation of patents, called inter partes review, intended to be much faster and less expensive. To evaluate the use of inter partes review to challenge pharmaceutical patents, including the number of challenges, the number of associated drug products, and the extent to which challengers have been successful. We obtained data pertaining to inter partes review proceedings, including identity of patent challenger, duration of proceedings, and outcome, from September 16, 2012 through April 24, 2017 from UnifiedPatents.com, and combined it with information about drug products and their associated patents, including patent type, contained in the US Food and Drug Administration's Orange Book. Generic drug manufacturers have embraced the new inter partes review process, succeeding in overturning all challenged claims in 43% of the patents they have targeted since 2011, and some challenged claims in an additional 8%. Inter partes review for drug patents has consistently been completed within 12 months, as required by statute. Successful challenges have been brought most frequently against drug patents covering new formulations or methods of use, rather than drug patents covering active ingredients. In the pharmaceutical market, the inter partes review process can meaningfully contribute to ensuring that invalid patents do not block timely availability of generic drugs. |
X Demographics
The data shown below were collected from the profiles of 4 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 3 | 75% |
| Unknown | 1 | 25% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 3 | 75% |
| Scientists | 1 | 25% |
Mendeley readers
The data shown below were compiled from readership statistics for 19 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 19 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 4 | 21% |
| Student > Master | 3 | 16% |
| Student > Bachelor | 1 | 5% |
| Student > Doctoral Student | 1 | 5% |
| Researcher | 1 | 5% |
| Other | 1 | 5% |
| Unknown | 8 | 42% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 16% |
| Business, Management and Accounting | 2 | 11% |
| Arts and Humanities | 1 | 5% |
| Biochemistry, Genetics and Molecular Biology | 1 | 5% |
| Agricultural and Biological Sciences | 1 | 5% |
| Other | 2 | 11% |
| Unknown | 9 | 47% |
Attention Score in Context
This research output has an Altmetric Attention Score of 576. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 17 April 2022.
All research outputs
#35,325
of 23,555,482 outputs
Outputs from Applied Health Economics and Health Policy
#2
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Outputs of similar age
#753
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Outputs of similar age from Applied Health Economics and Health Policy
#1
of 29 outputs
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