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dc.creatorMandel, Gregory N.
dc.date.accessioned2021-05-05T19:44:35Z
dc.date.available2021-05-05T19:44:35Z
dc.date.issued2006
dc.identifier.citationGregory N. Mandel, The Generic Biologics Debate: Industry’s Unintended Admission that Biotech Patents Fail Enablement, 11 Va. J. L. & Tech. 8 (2006).
dc.identifier.citationAvailable at: https://www.vjolt.org/volume-11
dc.identifier.urihttp://hdl.handle.net/20.500.12613/6363
dc.description.abstractThis Article reveals that many already issued and actively enforced medical biotechnology patents may be invalid. Biologics, medical therapeutics derived through biotechnology techniques, are the fastest growing and most promising pharmaceutical sector. They represent a $45 billion a year industry that is anticipated to double in five years and that already provides novel treatments for cancer, diabetes, and heart disease. Due to unforeseen consequences of past decisions, manufacturers currently are significantly limited in their ability to sell generic copies of biologics even after the pioneer biologic patents expire. As early biologics are starting to go off-patent, this regulatory mix-up is having a notable impact on the availability of biologics and raising the cost of health care. The generic biologics debate has dramatically heated-up recently due to proposed legislation to create a new regulatory process for generic biologics, the biotechnology and pharmaceutical industry defending the status quo, and the Food and Drug Administration struggling to handle the situation. This Article exposes for the first time that industry's own arguments have an unintended, striking consequence many of their biologic patents fail enablement, and therefore are not valid in the first instance.
dc.format.extent25 pages
dc.languageEnglish
dc.language.isoeng
dc.relation.ispartofFaculty/ Researcher Works
dc.relation.haspartVirginia Journal of Law and Technology, Vol. 11, Iss. 4 (Fall 2006)
dc.relation.isreferencedbyThe University of Virginia School of Law
dc.rightsAll Rights Reserved
dc.subjectIndustry
dc.subjectIntellectual property law
dc.subjectFood and drug law
dc.titleThe Generic Biologics Debate: Industry’s Unintended Admission that Biotech Patents Fail Enablement
dc.typeText
dc.type.genreJournal article
dc.relation.doihttp://dx.doi.org/10.34944/dspace/6345
dc.ada.noteFor Americans with Disabilities Act (ADA) accommodation, including help with reading this content, please contact scholarshare@temple.edu
dc.description.schoolcollegeTemple University. James E. Beasley School of Law
dc.temple.creatorMandel, Gregory N.
refterms.dateFOA2021-05-05T19:44:35Z


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