Amgen Opens Trial In Fight Over Neulasta Generic - Law360
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` Crowell & Moring
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`Amgen Opens Trial In Fight Over
`Neulasta Generic
`
`By Carolina Bolado
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`Law360, Fort Lauderdale (July 11, 2016, 11:27 PM ET) -- Amgen Inc.
`began its pitch Monday to a Florida federal judge to block Canadian
`generics maker Apotex Inc. from making a copy of Amgen's blockbuster
`biologic Neulasta by arguing that the proposed biosimilar infringes a
`patent designed for industrial-scale protein production.
`
`In day one of a bench trial before U.S. District Judge James I. Cohn,
`Amgen argued that Apotex's proposed biosimilar uses a process for
`refolding proteins described in U.S. Patent Number 8,952,138.
`
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`Sections
`Florida
`Intellectual Property
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`
`Case Information
`Case Title
`Amgen Inc. et al v. Apotex Inc.
`et al
`Case Number
`0:15-cv-61631
`
`On the witness stand, Amgen's scientific director Roger Hart, who
`specializes in proteins and helped develop the patent, said the ’138
`patent was developed to address the company's need to make large
`quantities of proteins necessary for products. The process described in
`the patent, however, was not used in the production of Neulasta,
`according to Hart, who told the court that Amgen would have had to get a
`new license from the U.S. Food and Drug Administration to make the
`change.
`
`Court
`Florida Southern
`
`Nature of Suit
`Patent
`
`Judge
`James I. Cohn
`
`Date Filed
`August 6, 2015
`
`“A process was already in place, and it was already licensed and well
`controlled and reliable, so there was no need to alter the refolding
`process,” Hart said.
`
`But he added that the process would likely work with granulocyte-colony
`stimulating factor, or G-CSF, the protein from which Neulasta and related
`
`Law Firms
`Cozen O'Connor
`Hogan Lovells
`Paul Weiss
`Companies
`Amgen Inc.
`Apotex Inc.
`Government Agencies
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`http://www.law360.com/articles/814748/amgen-opens-trial-in-fight-over-neulasta-generic[8/5/2016 11:41:43 AM]
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`APOTEX EX1048
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`Page 1
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`
`Food and Drug Administration
`Patents
`8,952,138 - Refolding proteins
`using a chemically controlled
`redox state
`5,824,784 - N-terminally
`chemically modified protein
`compositions and methods
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`Amgen Opens Trial In Fight Over Neulasta Generic - Law360
`
`drug Neupogen are made, because the protein used when developing
`the patented process is similar.
`
`Apotex has maintained that the method of manufacturing its Neulasta
`biosimilar requires a protein concentration that falls outside of that
`claimed in the '138 patent. The generics maker also argues that the
`patent does not disclose a method of folding any specific protein, much
`less G-CSF.
`
`In addition to the '138 patent, Amgen also claimed that Apotex's
`proposed product would infringe U.S. Patent Number 5,824,784, which
`describes a way of enhancing the mobilization of stem cells in patients
`undergoing stem cell transplants. The parties agreed to dismiss that
`patent from the suit last month.
`
`Amgen sued Apotex in August over its proposed biosimilar to Neulasta, a
`drug that helps reduce the infection risk in people with non-bone-marrow-
`related cancers and low white blood cell counts as a result of
`chemotherapy.
`
`Neulasta brought in $3.65 billion in profit for Amgen in 2014 in the U.S.
`alone.
`
`Apotex does not yet have an FDA license for its biosimilar, which the
`agency started reviewing last year. In December, Judge Cohn granted a
`preliminary injunction and found that biosimilar makers must always
`provide 180-day notice of sales to brand-name rivals when using a
`streamlined approval pathway. The ruling, which Apotex has appealed,
`would delay Apotex's copy of Neulasta and potentially reverberate
`industrywide.
`
`Judge Cohn's ruling addressed a key question left unanswered by the
`Federal Circuit's landmark interpretation last year of a pathway created
`by the Biologics Price Competition and Innovation Act, which includes a
`provision directing biosimilar makers to give 180-day notice to brand-
`name drugmakers. Judge Cohn ruled that making notice mandatory in all
`circumstances would avoid messy and unnecessary patent litigation.
`
`The patent-in-suit is U.S. Patent Number 8,952,138.
`
`http://www.law360.com/articles/814748/amgen-opens-trial-in-fight-over-neulasta-generic[8/5/2016 11:41:43 AM]
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`Amgen Opens Trial In Fight Over Neulasta Generic - Law360
`
`Amgen is represented by John F. O'Sullivan, Allen P. Pegg and Jason D.
`Sternberg of Hogan Lovells and Nicholas Groombridge, Catherine
`Nyarady, Eric Alan Stone, Jennifer H. Wu, Jennifer Gordon, Peter
`Sandel, Conor McDonough, Ana Friedman, Arielle K. Linsey and Stephen
`A. Maniscalco of Paul Weiss Rifkind Wharton & Garrison LLP, and in-
`house by Wendy A. Whiteford, Lois M. Kwasigroch and Kimberlin Morley.
`
`Apotex is represented by Simeon D. Brier, Matthew B. Criscuolo, W.
`Blake Coblentz, Kerry B. McTigue, Barry Golob, Milton A. Marquis, Aaron
`S. Lukas, Marilyn Neiman and Keri L. Schaubert of Cozen O'Connor.
`
`The case is Amgen Inc. et al. v. Apotex Inc. et al., case number 0:15-cv-
`61631, in the U.S. District Court for the Southern District of Florida.
`
`--Additional reporting by Jeff Overley and John Kennedy. Editing by Brian
`Baresch.
`
`Correction: A previously published version of this story listed an
`additional patent that is no longer part of the suit.
`
`Related Articles
`
`Apotex Accuses Amgen Of Sham Patent Litigation
`
`Amgen Calls For Halt To Neulasta Biosimilar Marketing
`
`Amgen Urges No Exceptions To Biosimilar Notice At Fed. Circ.
`
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