`PharmFilm Technology
`
`November 21, 2016
`
`Michael J. Harrington
`Sr. Vice President and General Counsel
`
`Lilly Corporate Center
`
`lndianapolis, Indiana 46285 USA
`
`Dear Mr. Harrington,
`
`It has been brought to our attention that Eli Lilly and Company and ICOS Corporation ("Lilly")
`
`have filed multiple Complaints for patent infringement against multiple Abbreviated New Drug
`
`Application ("ANDA") filers. As you are aware, these Complaints are for infringement of U.S.
`
`Patent No. 6,943,166 (the "'166 patent”).
`
`We have also been informed that Lilly filed its first Complaint on September 2, 2016. This is one
`
`day after the USPTO denied IntelGenx’s request for an Inter Partes Review ("IPR") of the ‘166
`
`patent.
`
`Finally we note IntelGenx’s press release on November 21, 2016 announcing a binding term
`
`sheet between IntelGenx and Lilly for the licensing of the ‘166 patent to lntelGenx.
`
`MonoSol Rx is developing a branded oral soluble film version of tadalafil. This branded product
`
`will be detailed by pharmaceutical sales representatives with a focus on urologists. We believe
`
`this product offers important choice and differentiation to sufferers. Specifically, our product
`
`can be taken with or without water, is packaged on an individual basis for discreteness and
`
`portability, and may be easier to swallow for patients suffering from dysphagia.
`
`MonoSol Rx believes the ‘166 patent can be invalidated. We have reviewed the USPTO’s
`
`response to lntelGenx and believe a stronger request for Opening an IPR can be provided to the
`
`USPTO. To this end, we are attaching a draft IPR that we plan on filing with the USPTO on
`
`December 5th. We believe this IPR will lead to the invalidation of ‘166 and we are prepared to
`
`ICOS Exhibit 2004
`MonoSol v. ICOS
`IPR2017-00412
`
`Page 1 of 2
`
`
`
`vigorously pursue institution of an IPR focused on ‘166. Using analogs of a typical IPR process,
`
`we would expect the USPTO to invalidate the '166 patent in early 2018.
`
`Given that our product will be non-AB rated and that we are taking a branded approach to the
`
`marketplace, we believe there is a more amenable way for MonoSol Rx to access the market.
`
`We would prefer to license the ‘166 patent from Lilly rather than pursue invalidation via the
`USPTO.
`
`MonoSol Rx is prepared to offer Lilly reasonable business terms in order to achieve a mutually
`
`agreeable position. We politely request a response from you indicating your level of interest in
`
`discussing an amenable solution.
`
`We appreciate your consideration of our proposal and look forward to hearing from you.
`
`
`
`Keith Kendall
`
`Chief Executive Officer
`
`kkendallQmonosolrx.com
`
`(908) 941—1906
`
`Page 2 of 2
`
`
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