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Closure of a Patent Foramen Ovale PFO: An Intervention Sequence

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Patent litigation could make 2017 no 'dancing' matter.

Managed Care (Langhorne, Pa.)

|January 26, 2017

Summary

2016 saw significant progress for biosimilars, but legal battles with originator drugs continue. Patent lawsuits have largely prevented new biosimilar market entries despite advancements.

Area of Science:

Biopharmaceutical industry
Intellectual property law

Background:

The year 2016 marked a notable period for biosimilar development and market activity.
Ongoing legal and regulatory challenges persist between originator biologics and biosimilar competitors.

Purpose of the Study:

To analyze the landscape of biosimilar market entry in 2016.
To examine the impact of legal strategies on biosimilar launches.

Main Methods:

Review of market data and legal filings related to biosimilar approvals and launches.
Analysis of patent litigation trends impacting the biopharmaceutical sector.

Main Results:

Originator companies have successfully utilized patent lawsuits to delay or block biosimilar market entry.

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Despite a banner year for biosimilars, significant hurdles remain for new entrants.

Conclusions:

Patent litigation remains a primary strategy for originators to defend market exclusivity.
The legal and regulatory environment significantly influences the commercialization of biosimilars.