Re-Examination Proceedings Post- KSR in the Generic Medicine Industry

Significant changes to inter partes re-examination, as well as creation of a new post-grant cancellation proceeding, have been proposed in Congress at the time of submission of this article. One proposal before Congress would place responsibility for inter partes re-examination at the USPTO's Board of Patent Appeals and Interferences (BPAI); another would curtail its use.

See 35 U.S.C. § 304 (West, 2009).

See 35 U.S.C. § 301, 302, 311 (West, 2009).

id..

See 35 U.S.C. § 301 (West, 2009).

id.

See 35 U.S.C. § 302, 311 (West, 2009); see also 37 C.F.R. § 1.510 (West, 2009).

See 35 U.S.C. § 302, 311 (West, 2009).

See 37 C.F.R. § 1.515 (West, 2009).

See 35 U.S.C. § 304 (West, 2009).

See 35 U.S.C. § 305 (West, 2009).

See 37 C.F.R. § 1.501(b) (West, 2009); see also 305 U.S.C. § 302 (West, 2009); cf. 305 U.S.C. § 311(b) (West, 2009).

See 37 C.F.R. § 1.913 (West 2009); see also Manual of Patent Examining Procedure (MPEP) § 2611 (8th edition, rev. 5., 2006); see also Cooper Technologies Co. v. Dudas, 536 F.3d 1330 on that an original application for purposes of inter partes re-examination is any application, other than a reissue application, filed on or after 29 November 1999, and rejecting the view that the term original application refers to the first application in a chain of applications from which priority is claimed).

See generally In re Swanson, 540 F.3d 1368 (Fed. Cir. 2008).

See 35 U.S.C. § 282 (West, 2009).

For any inter partes re-examination proceeding commenced on or after 2 November 2002, the third-party requester may appeal to the Federal Circuit and may participate in the patent owner's appeal to the Federal Circuit.

See ‘To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy. A Report by the Federal Trade Commission, October 2003’, located at http://www.ftc.gov/os/2003/10/innovationrpt.pdf; see also Merrill, S.A., Levin, R.C. and Myers, M.B. (2004) A Patent System for the 21st Century. Washington, DC: The National Academies Press.

The applicability of KSR to certain chemical and biological arts has been recently questioned by the Federal Circuit in Eisai Co. Ltd. v. Dr Reddy's Laboratories, Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008); cf. In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009).

The time periods shown in Table 1 correspond to the start of public criticism of the Federal Circuit and the USPTO (fiscal year 2003); the period after such criticism had blossomed but before KSR (fiscal year 2006); and the first full year following KSR (fiscal year 2008).

‘Affirmed’ means that at least one rejection of every claim on appeal has been approved by the BPAI. ‘Affirmed in part’ means that at least one rejection of a claim has been approved. ‘Reversed’ means that no rejection by the examiner has been approved. ‘Dismissed’ generally means that the appellant has withdrawn the appeal.

Statistics on inter partes re-examinations can be found at http://www.uspto.gov (search ‘reexamination statistics’).

The nature of new drug development includes drug discovery, medicinal work and clinical studies, as well as other efforts, all of which generate a large amount of documentation. The number of documents generated by generic companies is generally not nearly so voluminous. As a result, the discovery process is generally much more expensive for brand companies than for generic companies.

See Procter & Gamble Co. v. Kraft Foods Global, Inc., 549 F.3d 842, 848 (Fed. Cir. 2008) (noting that while 35 U.S.C. § 318 ‘does not expressly provide for an automatic stay of parallel district court proceedings, the statute in no way impacts the inherent powers of the court to control the litigation before it, and to grant a stay in the interests of justice when so required’.) (internal citations omitted).

See Procter & Gamble Co., 549 F.3d at 849 (noting that ‘[Section] 318 must be read as enabling a patentee to obtain a stay of district court proceedings more readily than it could otherwise when its patent is subjected to inter partes re-examination by the PTO’, and also noting that an accused infringer may also move for a stay under the Court's inherent power).

See Sony v. Dudas, 2006 WL 1472462, *5 (E.D. Va. 22 May 2006) (‘[T]he PTO retains the authority to suspend or terminate inter partes re-examinations for “good cause”’.) (citing 35 U.S.C. § 314(c)).

See 21 U.S.C. § 355 (West, 2009).

See F.D.C.A. § 505(j)(5)(B)(iii) (West, 2009).

See 35 U.S.C. § 315(c) (West, 2009) (‘The estoppel does not prevent the assertion of invalidity based on newly discovered prior art unavailable to the third-party requester and the Patent and Trademark Office at the time of the inter partes re-examination proceedings’.); see also 35 U.S.C. § 317(b) (‘This subsection does not prevent the assertion of invalidity based on newly discovered prior art unavailable to the third-party requester and the Patent and Trademark Office at the time of the inter partes re-examination proceedings’.).

See 35 U.S.C. § 315(c), 317(a),(b) (West, 2009).

Sony Computer Entertainment America Inc. v. Dudas, 2006 WL 1472462, *6 (E.D. Va. 2006).

Cf. In re Swanson, 540 F.3d 1368 (Fed. Cir. 2008) (noting that ‘the determination of a substantial new question [can be] unaffected by [] court decisions’, because ‘the two forums [Courts and the USPTO] take different approaches in determining validity and on the same evidence could quite correctly come to different conclusions’ based on the burden of proof) (internal quotations omitted).

See 35 U.S.C. § 307(a), 316(a) (West, 2009); see also MPEP § 2687(I); 37 C.F.R. § 1.979(f) (West, 2009).