ANDA Applicant’s Pre-Litigation Obligations

ANDA Applicant’s Pre-Litigation Obligations Joseph M. Reisman, Ph.D. ACI - Paragraph IV Disputes April 24, 2012The recipient may only view this work. No other right or license is granted.

The “Detailed Statement” of the Notice Letter 21 U.S.C. § 355(j)(2)(B)(iv)(II) 21 C.F.R. § 314.9(c) Contents of the notice. In the notice, the applicant . . . shall include, but not be limited to, the following information: ... (6) A detailed statement of the factual and legal basis of the applicant’s opinion that the patent is not valid, unenforceable, or will not be infringed. . . .© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2

The “Detailed Statement” of the Notice Letter 21 C.F.R. § 314.9(c)(6) (continued) . . . The applicant shall include in the detailed statement: (i) For each claim of a patent alleged not to be infringed, a full and detailed explanation of why the claim is not infringed. (ii) For each claim of a patent alleged to be invalid or unenforceable, a full and detailed explanation of the grounds supporting the allegation.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 3

Considerations Under Microsoft v. i4i “[A]n invalidity defense [must] be proved by clear and convincing evidence.” “Simply put, if the PTO did not have all material facts before it, its considered judgment may lose significant force. And, concomitantly, the challenger’s burden to persuade the [fact finder] of its invalidity defense by clear and convincing evidence may be easier to sustain.” In determining invalidity, the finder of fact may consider whether “it has heard evidence that the PTO had no opportunity to evaluate before granting the patent,” and may consider “whether the evidence before it is materially new.” - 131 S.Ct. 2238 at 2242, 2251 (2011)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 4

Considerations Under Therasense But-For Materiality: “[T]he court must determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference.” Specific Intent to Deceive: “In a case involving nondisclosure of information, . . . the accused infringer must prove by clear and convincing evidence that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it. . . . [T]he specific intent to deceive must be the single most reasonable inference able to be drawn from the evidence. Indeed, the evidence must be sufficient to require a finding of deceitful intent in the light of all the circumstances.” - 649 F.3d 1276 at 1290-91 (Fed. Cir. 2011)© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 5

Obtaining a Separate Opinion of CounselIs a Separate Written Opinion Needed? Filing of ANDA, standing alone, cannot support willful infringement Obtaining a separate Written Opinion is not necessary, but may be advisable. Consider extent and complexity of alternative arguments being considered. Consider whether there may be a launch-at-risk.Should the Written Opinion Be From In-House or Outside Counsel? In-house counsel can certainly provide a competent legal opinion. Judge/Jury may have basis to discount in-house opinion in some contexts.Use of a Single Firm or Multiple Firms / Benefits of a “Second-Look” Consider on a product-specific basis; thoroughness v. controlling costs.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 6

The Detailed Statement’s Role in Litigation Litigation Arguments May Be Broader (or Different) Than in the Notice “New” arguments are not barred, but will often raise concerns. Consider (Patent) Local Rules, which may limit timing of “new” allegations. Litigation Arguments Should Not Be Inconsistent with Those in the Notice Tactical Shifts in Position v. Baseless ANDA and Frivolous Litigation Takeda v. Mylan, 549 F.3d 1381 (Fed. Cir. 2008) Patentee’s Heavy Burden of Showing Willfulness / Exceptional Case Often asserted; rarely is it fully litigated, and more rarely is it successful. Burden of showing both objective and subjective bad faith is substantial.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7

Considerations of Privilege The Notice Letter, Per Se, Is Not Privileged The statute requires that Notice Letter include a Detailed Statement. Sending the Notice Letter Is Not a Waiver of Privilege Nycomed v. Glenmark, E.D.N.Y (Oct. 14, 2009). Pfizer v. Ranbaxy, D.Del. (June 18, 2004). Source of Law as to Privilege; Will Always be a Fact-Intensive Inquiry Regional Circuit law governs whether waver has occurred. Federal Circuit law governs scope of the waiver where “advice of counsel” is raised in response to an assertion of willfulness.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 8

Use of Consultants and Testifying Experts Changes to Federal Rules of Civil Procedure, Rule 26(b)(4) Communications between counsel and testifying expert now protected. Limited exceptions: compensation, facts & assumptions relied upon. Strategic Considerations in Preparing Notice Letter Consider retaining consultants for the sole purpose of the Notice Letter. Consider retaining a separate, secluded stable of testifying experts. Limit testifying experts’ access to earlier consultants, and their analyses. Counsel, alone, should be responsible for preparing all testifying experts.© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 9

Joseph.Reisman@knobbe.com Thank youANDA Applicant’s Pre-Litigation Obligations

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ANDA Applicant’s Pre-Litigation Obligations

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