Inter Partes Review in ANDA Litigation

• Author: Kenneth L. Dorsney
• Pages: 129-148

129

chapter 7

Inter Partes Review

inANDA Litigation

The Leahy-Smith America Invents Act (AIA)1 aimed to provide cost-

effective alternatives to district court litigation through expedited review

of issued patents in the United States Patent and Trademark Office

(USPTO) through post-grant review. One procedure in particular, inter

partes review (IPR), permits a petitioner to challenge an issued patent’s

validity under 35 U.S.C. §§ 102 and 103 based on patents and printed

publications.2 The unique statutory framework of Hatch-Waxman litiga-

tion, however, requires patent owners and challengers alike to carefully

consider the potential implications IPR has on current or anticipated

Abbreviated New Drug Application (ANDA) litigation. This chapter is

designed to provide an overview of the statute and regulations governing

IPR, explain the unique interplay between the Hatch-Waxman Act and

IPR proceedings, and provide helpful strategies for patent owners and

challengers contemplating or anticipating concurrent ANDA litigation

and post-grant review.

I. Introduction to the AIA and Inter Partes Review

In one of the most sweeping legislative overhauls of U.S. patent law, Con-

gress enacted the AIA, creating significant changes in the U.S. patent sys-

tem, including the conversion to a first-to-file system and the significant

expansion of post-grant review procedures. Specifically, Congress sought

to address criticisms of the former ex parte and inter partes reexamina-

tion procedures, which allowed the USPTO to review patent validity based

on substantial new questions of patentability not previously presented

Aaron Gleaton Clay, Mark J. Feldstein, Ph.D., and William B. Raich, Ph.D., Finnegan,

Henderson, Farabow, Garrett & Dunner LLP.

1. Pub. L. No. 112-29, 125 Stat. 284 (2011).

2.

H.R. REP. NO.

112-98, pt. 1, at 40, 45–48 (2011).

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during examination.3 While reexamination was intended to provide an

efficient alternative to district court litigation of patent validity,4 a number

of restrictive procedural limitations, coupled with lengthy and costly pro-

ceedings, hindered their actual usefulness for challenging issued patents.5

As a result, Congress amended the ex parte and inter partes reex-

amination procedures. While continuing ex parte reexamination with

some procedural modifications, Congress effectively replaced inter partes

reexamination with IPR. Rather than maintaining an examinational

proceeding, however, Congress created an adjudicative proceeding, which

permits greater input from challengers in presenting legal argument and

provides for limited discovery. As illustrated by the substantial and grow-

ing number of IPR petitions filed by patent challengers, the number of

IPR proceedings instituted by the Patent Trial and Appeal Board (PTAB),

and the sheer number of canceled claims, Congress has appeared to have

succeeded in creating a robust alternative venue to district courts for chal-

lenging patents. The proceeding’s procedures are unique, however, and

not simply expanded reexaminations or fast track district court litigation.

Even the most experienced USPTO and litigation practitioners should

consult with experienced IPR practitioners and pay careful attention to

the statute and regulations governing this expedited proceeding before the

Board, especially in ANDA cases. The next section is intended to provide

an overview of IPR procedures, although the final rules governing IPRs

should be consulted.6

II. Procedure

A. Filing an IPR Petition

1. Who Can File and When?

IPR permits any person other than the patent owner (including the origi-

nal inventor) to petition to cancel one or more claims of an issued patent

as anticipated or obvious under 35 U.S.C. §§ 102 and 103 on the basis

3. Id. at 45.

4. Id.

5. Id.

6. See generally Changes to Implement Inter Partes Review Proceedings, Post-Grant

Review Proceedings, and Transitional Program for Covered Business Method Patents, 77

Fed. Reg. 48,680 (Aug. 14, 2012); Rules of Practice for Trials before the Patent Trial and

Appeal Board and Judicial Review of Patent Trial and Appeal Board Decisions, 77 Fed. Reg.

48,612 (Aug. 14, 2012); General Administrative Trial Final Rules (77 Fed. Reg. 48,612, Aug.

14, 2012); Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756 (Aug. 14, 2012).

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