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Five Solutions to the REMS Patent Problem

Descriptive

TypeOfResource
Text
TitleInfo
Title
Five Solutions to the REMS Patent Problem
Name (type = personal)
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)
Sooy
NamePart (type = given)
Brenna
Affiliation
Dean's Office (School of Law-Camden), Rutgers University
Role
RoleTerm (authority = marcrt); (type = text)
author
Name (authority = RutgersOrg-Department); (type = corporate)
NamePart
Dean's Office (School of Law-Camden)
Name (authority = RutgersOrg-School); (type = corporate)
NamePart
School of Law-Camden
Genre (authority = RULIB-FS)
Article, Non-refereed
Genre (authority = NISO JAV)
Version of Record (VoR)
OriginInfo
DateIssued (encoding = w3cdtf); (keyDate = yes)
2017
Abstract (type = Abstract)
Two principles collide in the pharmaceutical industry. On the one hand, the U.S. Food and Drug Administration (“FDA”) approves potentially dangerous drugs under Risk Evaluation and Mitigation Strategies (“REMS”) programs when a drug’s benefits outweigh its risks. But on the other hand, brand firms can prevent generic competition by patenting these programs. REMS patents, which claim compliance with FDA-imposed REMS programs, pose two problems—one procedural, the other substantive. First, current practice is to list REMS patents in the Orange Book even though such listings may be invalid, with this conduct allowing the brand to obtain an automatic 30- month stay of generic approval. Second, because a REMS program appears on a product’s label and generics must copy that label, REMS patents threaten generics with claims of induced infringement. We offer five solutions to these problems. First, we target brands’ listings of REMS patents in the Orange Book, proposing that generic firms sued for infringement file counterclaims to delist REMS patents and that the FDA issue guidance making clear that REMS patents cannot be listed. Second, we suggest more rigorous scrutiny of REMS patents in the courts and at the U.S. Patent and Trademark Office. Third, we apply the Supreme Court’s four-factor eBay test to conclude that courts should award damages rather than injunctions in cases of infringement. Fourth, we suggest that Congress amend the Food and Drug Administration Amendments Act of 2007 to mitigate the effects of REMS patents. And fifth, we recommend that, similar to the treatment of tax-strategy patents in the America Invents Act, Congress deem REMS patents to fall within the prior art.
Language
LanguageTerm (authority = ISO 639-3:2007); (type = text)
English
PhysicalDescription
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application/pdf
Extent
47 p.
Extension
DescriptiveEvent
Type
Citation
DateTime (encoding = w3cdtf)
2017
AssociatedObject
Name
Boston University Law Review
Type
Journal
Relationship
Has part
Detail
1661-1707
Identifier (type = volume and issue)
97(5)
Reference (type = url)
https://www.bu.edu/bulawreview/archives/volume-97-number-5-october-2017/
RelatedItem (type = host)
TitleInfo
Title
Carrier, Michael A.
Identifier (type = local)
rucore30244100001
RelatedItem (type = host)
TitleInfo
Title
Sooy, Brenna
Identifier (type = local)
rucore30244300001
Location
PhysicalLocation (authority = marcorg); (displayLabel = Rutgers, The State University of New Jersey)
NjNbRU
Identifier (type = doi)
doi:10.7282/T3V69NNQ
Genre (authority = ExL-Esploro)
Journal Article
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RightsDeclaration (AUTHORITY = FS); (TYPE = [FS] statement #1); (ID = rulibRdec0004)
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.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Disciplinary norm
Note
Law review openly available on the journal's website.
RightsEvent
Type
Permission or license
AssociatedObject
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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Technical

RULTechMD (ID = TECHNICAL1)
ContentModel
Document
CreatingApplication
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1.5
DateCreated (point = end); (encoding = w3cdtf); (qualifier = exact)
2017-10-04T16:36:13
DateCreated (point = end); (encoding = w3cdtf); (qualifier = exact)
2018-01-18T14:56:29
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Acrobat Distiller 11.0 (Windows)
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