ANDA Applicant’s Pre-Litigation Obligations

ANDA Applicant’s Pre-Litigation Obligations

Joseph M. Reisman, Ph.D. ACI - Paragraph IV Disputes

April 24, 2012

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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. . . .


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.


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)


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)


Obtaining a Separate Opinion of Counsel

Is 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.


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.


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.


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.

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ANDA Applicant’s Pre-Litigation Obligations

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