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Biologics: The New Antitrust Frontier

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Text
TitleInfo
Title
Biologics: The New Antitrust Frontier
Name (authority = orcid); (authorityURI = http://id.loc.gov/vocabulary/identifiers/orcid.html); (type = personal); (valueURI = http://orcid.org/0000-0001-8494-775X)
NamePart (type = family)
Carrier
NamePart (type = given)
Michael A.
Affiliation
Dean's Office (School of Law-Camden), Rutgers University
Role
RoleTerm (authority = marcrt); (type = text)
author
Name (type = personal)
NamePart (type = family)
Minniti
NamePart (type = given)
Carl J.
Affiliation
Sch of Law-Cmd Dean's Office, Rutgers University
Role
RoleTerm (authority = marcrt); (type = text)
author
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NamePart
Dean's Office (School of Law-Camden)
Name (authority = RutgersOrg-School); (type = corporate)
NamePart
School of Law-Camden
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Article, Non-refereed
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Version of Record (VoR)
OriginInfo
DateIssued (encoding = w3cdtf); (keyDate = yes)
2018
Abstract (type = Abstract)
The pharmaceutical industry lies at the intersection of patent law, antitrust law, federal and state regulations, and complex markets. For the past several decades, courts and commentators have analyzed issues presented by brand-name and generic drug companies in the “small molecule” setting. But just as they have begun to comprehend the multiple moving parts, a new frontier has arisen involving large molecules known as “biologics.”

Biologics differ from small-molecule drugs along multiple axes. They are more expensive, costing hundreds of millions of dollars to develop. They cannot be precisely replicated, followed by “biosimilars” rather than generics. They are governed not by the Hatch-Waxman Act but by the Biologics Price Competition and Innovation Act. And they present a blank slate on which issues of innovation and competition will be hammered out in the decades to come. Given that biologics promise revolutionary advances like treatments for previously incurable diseases and cancer regimens offering substantial benefits over chemotherapy, the stakes could not be higher.

The small-molecule setting has been replete with collusive behavior such as “reverse payment” agreements by which brands and generics settle patent litigation and unilateral conduct by which brands modify their drugs to block generics, file frivolous government petitions, manipulate the regulatory regime, and deny materials generics need to enter the market. How likely are these (or other) forms of conduct to appear in the biologics industry? And if these behaviors occur, how should antitrust law respond? This Article addresses these questions, offering an antitrust framework for the conduct most likely to arise. In particular, it concludes that in the biologics setting, “citizen petitions,” the disparagement of biosimilars, and collusion between biologics and biosimilars will be more frequent and that “product hopping” and reverse-payment settlements will be less typical. This Article also recommends utilizing an antitrust analysis similar to what courts have applied in the small-molecule setting and applying a modestly more deferential analysis for citizen petitions.

Antitrust finds itself at a unique and crucial moment: poised at the precipice of a new industry but able to draw on decades of case law in an analogous setting that has addressed issues of competition and innovation. It is far from obvious how much courts can—or should—take from that setting. This Article assists in this task by determining which antitrust principles and doctrines should be exported to the biologics setting while appreciating the differences that counsel against such extrapolation. Given the importance of life-saving cancer treatments and an impending $400 billion market, there is no time to waste.
Language
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English
PhysicalDescription
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application/pdf
Extent
70 pages
Extension
DescriptiveEvent
Type
Citation
DateTime (encoding = w3cdtf)
2018
AssociatedObject
Name
University of Illinois Law Review
Type
Journal
Relationship
Has part
Detail
1-70
Identifier (type = volume and issue)
2018(1)
Reference (type = url)
https://illinoislawreview.org/print/vol-2018-no-1/biologics/
RelatedItem (type = host)
TitleInfo
Title
Carrier, Michael A.
Identifier (type = local)
rucore30244100001
Location
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NjNbRU
Identifier (type = doi)
doi:10.7282/T3QV3QWQ
Genre (authority = ExL-Esploro)
Journal Article
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Copyright for scholarly resources published in RUcore is retained by the copyright holder. By virtue of its appearance in this open access medium, you are free to use this resource, with proper attribution, in educational and other non-commercial settings. Other uses, such as reproduction or republication, may require the permission of the copyright holder.
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Copyright protected
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Open
Reason
Permission or license
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Permission or license
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Type
License
Name
Multiple author license v. 1
Detail
I hereby grant to Rutgers, The State University of New Jersey (Rutgers) the non-exclusive right to retain, reproduce, and distribute the deposited work (Work) in whole or in part, in and from its electronic format, without fee. This agreement does not represent a transfer of copyright to Rutgers.Rutgers may make and keep more than one copy of the Work for purposes of security, backup, preservation, and access and may migrate the Work to any medium or format for the purpose of preservation and access in the future. Rutgers will not make any alteration, other than as allowed by this agreement, to the Work.I represent and warrant to Rutgers that the Work is my original work. I also represent that the Work does not, to the best of my knowledge, infringe or violate any rights of others.I further represent and warrant that I have obtained all necessary rights to permit Rutgers to reproduce and distribute the Work and that any third-party owned content is clearly identified and acknowledged within the Work.By granting this license, I acknowledge that I have read and agreed to the terms of this agreement and all related RUcore and Rutgers policies.
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ContentModel
Document
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1.5
DateCreated (point = end); (encoding = w3cdtf); (qualifier = exact)
2018-01-12T09:29:34
DateCreated (point = end); (encoding = w3cdtf); (qualifier = exact)
2018-06-25T15:33:24
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