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Case 1:16-cv-01221-LPS Document 58-2 Filed 06/13/18 Page 1 of 4 PageID #: 540
`
`Exhibit B
`
`

`

`Case 1:16-cv-01221-LPS Document 58-2 Filed 06/13/18 Page 2 of 4 PageID #: 541
`
`
`
`
`
`
`
`
`Shelleaha L. Jonas
`Direct Dial: 612-436-9607
`E-mail: sjonas@carlsoncaspers.com
`
`VIA EMAIL
`
`
`May 1, 2018
`
`
`
`
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington, DC 20005
`
`
`RE: Bayer Healthcare LLC, et al. v. Teva Pharmaceuticals USA, Inc., et al.
`Civil Action No.: 16-1221 (LPS)
`
`
`Dear Counsel:
`
` I
`
` write to memorialize the parties’ meet and confer of April 30, 2018.
`
`
`
`Claim Construction
`
`
`The parties continued their discussion of proposed claim terms to be construed. With
`
`respect to the ’834 patent, Bayer confirmed it will not assert claim 4.
`
`
`With respect to the ’553 patent, Defendants agreed to withdraw their proposed
`constructions at this time.
`
`
`With respect to the ’124 patent, Bayer confirmed that it agrees that the preambles of the
`asserted claims of the ’124 patent are limiting. Bayer next stated that it will send proposed
`constructions of “acquired resistance” and “a subject who has been treated with imatinib,”
`including citations to the portions of the specification supporting the proposed construction.
`Bayer maintains that the term “effective amount” is not indefinite and stands by its construction
`of this term. Bayer indicated the parties are unlikely to reach agreement on this term. In order to
`frame the parties’ briefing efforts, please confirm which portion(s) of Teva’s proposed
`construction for “effective amount” is inaccurate.
`
`
`After consideration of Bayer’s positions concerning the ’107 patent terms proposed for
`construction during the parties’ meet-and-confers, Defendants agree to withdraw the terms they
`had previously proposed for construction at this time. In order to avoid redundant claim
`language, Defendants propose that the phrase “in an amount equal to or less than 0.05%,” rather
`than “contaminated with” should be construed, and propose a construction of: “in an amount
`from 0.0001% to a maximum of 0.05%.” See, e.g., ’107 patent, col. 7, ll. 26-28. Please let us
`know if this change alters Bayer’s position on this claim construction issue.
`
`
`
`
`
`
`Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A. 225 South Sixth Street, Suite 4200, Minneapolis, MN 55402
`
`

`

`Case 1:16-cv-01221-LPS Document 58-2 Filed 06/13/18 Page 3 of 4 PageID #: 542
`
`
`May 1, 2018
`Page 2
`
`
`
`Bayer’s Concerns with Teva Responses
`
`
`Decision to File ANDA
`
`Teva stands by its objections to this category of documents. If Bayer identifies caselaw
`
`concerning the purported relevance of such information, Teva will consider it.
`
`Commercialization, Marketing, or Competitive Product Analysis
`
`Teva will look into whether any of the categories of documents Plaintiffs are seeking
`
`even exist.
`
`Drug Substance and Communications with Drug Substance Supplier
`
`Teva is producing the opened portion of the DMF shortly. Review of these documents
`
`should alleviate Bayer’s concerns. Teva agreed to produce 2 grams of API, which we explained
`expires in October, and 2 bottles of Teva’s ANDA product from the sample batches identified in
`Teva’s ANDA, that we explained has already expired.
`
`Licenses
`
`Teva agreed to get back to Bayer concerning the existence of documents concerning any
`
`licenses to the asserted patents, or non-privileged documents concerning the decision to seek
`such licenses, and if they exist, whether it will produce them.
`
`
`Defendants’ Concerns with Bayer’s Responses
`
`
`
`The parties did not have adequate time to discuss Defendants’ concerns with Bayer’s
`discovery responses, and this letter addresses only some of the identified concerns. As discussed
`on the call, please let us know your availability for a final meet and confer on these issues this
`week.
`
`
`Research and Development Documents
`
`Bayer stated that “much” of the information Defendants seek in their narrowed requests
`
`on page 2 of Defendants’ April 25, 2018 letter can be found in the pharma reports. Bayer
`represented that the pharma reports are not “scrubbed” or reviewed for legal purposes before
`being placed in the repository. Defendants appreciate these representations, but we are not in
`position (and never will be) to confirm whether the pharma reports contain the specific
`information we identified. Please let us know if that is the case, and if not, the objective basis for
`Bayer’s burdensomeness objections.
`
`We can discuss the additional issues raised in our letter during the parties’ next meet and
`
`confer.
`
`

`

`Case 1:16-cv-01221-LPS Document 58-2 Filed 06/13/18 Page 4 of 4 PageID #: 543
`
`
`May 1, 2018
`Page 3
`
`
`INDs and NDAs
`
`Bayer confirmed it has produced all INDs and NDAs involving compounds covered by
`
`the asserted claims. Bayer represented that INDs and NDAs exist for two such compounds.
`
`Patent Prosecution Documents
`
`
`
`Bayer stated that it is willing to produce public file histories for related applications from
`the countries Defendants identified in their April 25 letter. This production resolves Defendants’
`concerns.
`
`Joint Development Agreements
`
`Bayer is producing joint development agreements between Bayer and Onyx with respect
`
`to sorafenib and regorafenib. Please confirm no other agreements exist.
`
`
`
`Sincerely,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Shelleaha L. Jonas
`
`Shelleaha L. Jonas
`
`
`
`
`
`
`
`
`
`
`

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