`
`www.frontiertherapeuticsnweom
`
`Jason Greer
`Executive Manager
`406.370.7177
`jason@frontiertherapeuticsnw.com
`
`VIA EMAIL
`CONFIRMATION BY FEDEX
`Ms. Terri Shoemaker
`President & CEO
`
`Medac Pharma, Inc.
`29 North Wacker Drive, Suite 704
`Chicago, IL 60606
`tshoemaker@medacpharma.com
`
`January 8, 2016
`
`Re: Rasuv0® and Orange Book-Listed U.S. Patent No. 8.664.231
`
`Dear Ms. Shoemaker:
`
`My company, Frontier Therapeutics, LLC, is a pharmaceutical company focused on
`commercializing both generic and innovative drug products. Frontier has uniquely
`positioned itself to achieve its strategic objectives through its industry relationships.
`
`Frontier is currently focused on identifying branded products that it believes are
`artificially propped up by Orange Book—listed patents that are likely invalid and/or
`unenforceable. During this process, Frontier has identified significant weaknesses with
`U.S. Patent No. 8,664,231, which has been listed on the Orange Book for Medac’s
`product, Rasuvo®. Enclosed for your review is a draft petition for inter partes review of
`the ’23l Patent (IPR), which includes five invalidity grounds demonstrating issued claims
`1-22 are anticipated and/or obvious over the prior art. As you will see, these five
`invalidity positions mirror the grounds for which the Patent Trials and Appeals Board
`(PTAB) previously instituted a review of the ’23l Patent. See Petition for Inter Partes
`Review byAntares Pharma Inc. et al., [PR 2014—Ol091, Paper No. 7, January 6, 2015.
`
`Given the strength of its invalidity positions, and the fact that the PTAB previously
`instituted an inter partes review of the ’231 Patent, Frontier is confident its IPR will
`demonstrate a reasonable likelihood of invalidity, and that the PTAB will again institute
`an IPR of the ‘231 Patent. When that occurs, Frontier intends to approach its
`development partners to prepare and file an ANDA for Rasuvo®.
`
`Medac Exhibit 2001
`
`Frontier Therapeutics v. Medac
`IPR2016-00649
`
`Page 00001
`
`Medac Exhibit 2001
`Frontier Therapeutics v. Medac
`IPR2016-00649
`Page 00001
`
`
`
`FRONTIER ‘iii Q %5?3.a§£53%&E
`
`Before finalizing and filing its IPR petition, Frontier would like to explore the possibility
`of reaching an amicable resolution to this matter. Given the noted vulnerabilities of the
`’23I Patent and the current challenges Medac has experienced with the prosecution of
`other key patent applications in its portfolio (notably, U.S. Application No. 14/ l 95,1 17),
`we hope you agree that a confidential and expeditious resolution would be in the best
`interest of Medac and its stakeholders.
`
`Now that Frontier has disclosed the accompanying copyrighted draft of its IPR, time is of
`the essence. If you are interested in holding settlement talks, please Contact Frontier’s
`legal counsel, Jim Johnston, before the close of business on January 15, 2016. You
`may reach Mr. Johnston at (425) 890-2367 or iiohnstongqziohnston-law.com.
`
`Sincerely,
`
`Jason Greer
`
`cc:
`
`Jim Johnston (jjohnston@johnston-law.com)
`
`William Cronin (wcronin@corrcronin.com)
`
`Frank DiGiglio (fsd@ssmp.com)
`
`Edward Grolz (egrolz@ssmp.com)
`
`Page 00002
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