By Donald Zuhn

GlaxoSmithKline - GSK Plaintiff-appellee Dr. Triantafyllos Tafas was not alone yesterday in filing a petition for a panel rehearing or rehearing en banc of the March 20 decision in Tafas v. Doll (see Patent Docs report).  Also seeking a rehearing of the Federal Circuit's decision in Tafas were plaintiffs-appellees SmithKline Beecham Corp., SmithKline Beecham PLC, and Glaxo Group Ltd. ("GSK"), which filed a petition for rehearing en banc on Wednesday as well.  In that petition, GSK posed the following questions of exceptional importance:

I.  Whether the Panel majority erred in rejecting the test for determining whether a Patent and Trademark Office ("PTO") rule is "substantive," as set forth in the controlling precedent of Chrysler, supra; Animal Legal Defense Fund, supra; and Cooper Technologies, supra.

II.  Whether the Panel majority erred in holding that the challenged Final Rules, 72 Fed. Reg. 46,716 (Aug. 21, 2007), fall within the PTO's limited, non-substantive rulemaking authority.

Noting that "[t]wo judges agreed that PTO has authority to issue Rules 114, 75, and 265, but disagreed on the applicable legal framework and rationale," GSK's petition contends that "[b]oth opinions that comprise the majority conflict with established precedent of this Court and the Supreme Court governing when a rule is substantive."  The petition asserts that "[t]he opinions also conflict with each other, leaving the PTO and patent applicants wholly uncertain about this Court's test for deciding whether PTO rules are lawful," and therefore argues that "[t]he conflict between the majority opinions and binding precedent, and the need to remove the uncertainty this has created as to the legal standard for measuring the legality of PTO rules, warrants en banc review."

Stating that "[t]he principal opinion improperly and incorrectly dismissed Chrysler Corp. v. Brown, 441 U.S. 281, 289 (1979), as irrelevant in the course of finding the Final Rules non-substantive," the petition contends that "the line between substantive and procedural rules delineated in Chrysler is particularly important to enforce, given the PTO's narrow rulemaking authority, and both the principal opinion and the concurring opinion erred in rejecting its use in this case."  The petition notes that in Chrysler, the Supreme Court defined a "substantive rule" as one "affecting individual rights and obligations," and asserts that "[t]his Circuit has repeatedly endorsed the Chrysler test to determine whether rules, including PTO rules, are substantive."  In support of this assertion, GSK cites Animal Legal Defense Fund v. Quigg, 932 F.2d 920, 927 (Fed. Cir. 1991); Cooper Technologies Co. v. Dudas, 536 F.3d 1330, 1336 (Fed. Cir. 2008); Tunik v. MSPB, 407 F.3d 1326, 1344 (Fed. Cir. 2005); Schism v. United States, 316 F.3d 1259, 1281 (Fed Cir. 2002) (en banc)); and Merck & Co. v. Kessler, 80 F.3d 1543,1550 (Fed. Cir. 1996).  With respect to Animal Legal Defense Fund, the petition states that:

In ALDF, this Court adopted the Chrysler standard in reviewing PTO rules, thereby serving the statutory goal of circumscribing the PTO's authority.  The PTO's power is limited to internal housekeeping matters; it cannot alter inventors' basic rights to receive patents if they otherwise satisfy the Patent Act's conditions.  Thus, it makes perfect sense to declare PTO rules ultra vires whenever they affect "individual rights and obligations."  Chrysler, 441 U.S. at 302.  Yet, neither the principal opinion nor the concurring opinion applied the Chrysler/ALDF test to determine whether the Rules are lawful.  That decision thus conflicts with Circuit precedent.

GSK next addresses how each of the four Final Rules at issue "drastically change the existing law and alter an inventor's rights and obligations under the Patent Act" (quoting Judge Rader's dissent in Tafas v. Doll).  With regard to the limit on RCEs imposed by Final Rule 114, the petition states that:

[I]f Rule 114 functions as the PTO intends, an applicant will never be able to file an RCE in any member of an application family if that applicant has previously filed an RCE in any other family member.  The effect of the Rule is that many applicants will not secure any patent rights, or not the full scope of rights, to which the inventor is constitutionally and statutorily entitled.

While acknowledging that "Final Rule 114 does permit an applicant to file additional RCEs by filing a petition that establishes that 'the amendment, argument or evidence could not have been submitted prior to the close of prosecution in the application,'" GSK nonetheless observes that "the very purpose of Rule 114 is to limit the number of requests for continued examinations that are made, and to thereby reduce the PTO's backlog."

As for Final Rule 265, which sets forth the requirements for the filing of an Examination Support Document (as a means of securing more than the 5 independent and 25 total claims permitted under Final Rule 75), the petition contends that "[t]he majority fails to appreciate the substantive impact that the ESD requirement will have on applicants," and further argues that "[t]he principal opinion also dismissed the implications of the ESD requirement on claim scope and inequitable conduct."  GSK also asserts that:

The approach reflected in the principal opinion of dealing with the fatal vagueness of the ESD regulation is to suggest that applicants prosecute and litigate patents at their peril based on their own self-imposed search limitations.  The fiction of this assumption is that it is reasonable to rely on a standard which relies on this Court to tell applicants, on a case-by-case basis, whether their ESD-mandated search was adequate or if they committed inequitable conduct in preparing, providing and continually updating that ESD during examination.  This is an unacceptable approach.  Industry needs business certainty at the front end of the examination process to make well reasoned decisions based on clear rules.  Patent applicants cannot play the high risk game of going forward with millions of dollars of investment without any assurance that the investment will be adequately protected.

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