Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 16
`
` Entered: October 19, 2016
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LOWER DRUG PRICES FOR CONSUMERS, LLC,
`Petitioner,
`
`v.
`
`FOREST LABORATORIES HOLDINGS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2016-00379
`Patent 6,545,040 B1
`____________
`
`
`Before MICHAEL P. TIERNEY, LORA M. GREEN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`DECISION
`Denying Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 16
`
` Entered: October 19, 2016
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LOWER DRUG PRICES FOR CONSUMERS, LLC,
`Petitioner,
`
`v.
`
`FOREST LABORATORIES HOLDINGS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2016-00379
`Patent 6,545,040 B1
`____________
`
`
`Before MICHAEL P. TIERNEY, LORA M. GREEN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`DECISION
`Denying Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`
`
`INTRODUCTION
`
`Lower Drug Prices for Consumers, LLC (“Petitioner”) filed a Request
`for Rehearing (Paper 15, “Reh’g Req.”) of our Decision (Paper 14, “Dec.”)
`denying institution of an inter partes review of claims 1–6 of U.S. Patent
`No. 6,545,040 B1 (Ex. 1001, “the ’040 patent”).
`In our Decision, we concluded that substantially the same prior art and
`substantially the same arguments were presented to the Office previously.
`We, therefore, exercised our discretion to deny the Petition under 35 U.S.C.
`§ 325(d). Petitioner requests a rehearing of our decision, arguing that we
`erred in deferring to the Board’s prior allowance of the ’040 patent. Reh’g
`Req. 2.
`For the reasons stated below, Petitioner’s request is denied.
`STANDARD OF REVIEW
`
`Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition,
`a panel will review the decision for an abuse of discretion.” An abuse of
`discretion occurs when a “decision was based on an erroneous conclusion of
`law or clearly erroneous factual findings, or . . . a clear error of judgment.”
`PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567
`(Fed. Cir. 1988). The request must identify, specifically, all matters the
`party believes the Board misapprehended or overlooked, and the place where
`each matter was previously addressed in a motion, an opposition, or a reply.
`37 C.F.R. § 42.71(d).
`
`ANALYSIS
`
`As an initial matter, we note that, aside from a conclusory statement
`stating otherwise (Reh’g Req. 4), Petitioner does not argue that we erred in
`determining that the Petition presents substantially the same prior art as was
`
`1
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`previously presented to the Office. Nor could it in light of the fact that
`Petitioner relies primarily on the same prior art that the examiner relied on
`during examination. See Dec. 9 (noting Petitioner and examiner both relied
`on Van Lommen1). Because, under 35 U.S.C. § 325(d), we have discretion
`to reject a Petition if “the same or substantially the same prior art or
`arguments previously were presented to the Office,” Petitioner has not
`established that we abused our discretion in denying the Petition because
`substantially the same prior art was previously before the Office. See
`§ 325(d) (emphasis added).
`Nevertheless, we are not persuaded that we abused our discretion in
`concluding that substantially the same arguments were previously presented,
`either. Petitioner contends that it submitted expert testimony that was not
`previously before the Office during examination. Reh’g Req. 2–3. In
`particular, Petitioner argues that the Office “never considered whether
`discovery of the alleged ‘unexpected benefits’ . . . was itself ordinary and
`routine, and thus not sufficient to overcome the strong prima facie case that
`the ’040 Patent claims are obvious and unpatentable.” Id. Petitioner also
`claims that this evidence and “its implications” were discussed in the
`Petition. Id. at 3 (citing Paper 6 (“Pet.”), 11–13).
`Petitioner’s argument, however, does not appear on the cited pages of
`the Petition, which describe the “background science” of stereochemistry,
`new drug research, and β-blockers. See Pet. 11–13. Nor does it appear in
`the section arguing that the alleged unexpected results do not overcome the
`prima facie case of obviousness. See id. at 55–56. At most, the Petition
`
`
`1 Van Lommen et al., US 4,654,362, issued Mar. 31, 1987 (Ex. 1004).
`
`2
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`asserts that the claimed compounds would have been the intended and
`expected result of combining the references. See id. at 56 (stating “the
`compounds of Claim[s] 1 and 2 would be the intended and expected result of
`combining the prior art asserted herein”). That assertion differs from what
`Petitioner now argues in its Request—i.e., that the discovery of the alleged
`unexpected benefits would have been routine and ordinary. See Reh’g Req.
`3–4. Thus, because it was not made in the Petition, we could not have
`misapprehended or overlooked Petitioner’s new argument. See 37 C.F.R.
`§ 42.71(d).
`Regardless, as we noted in our Decision, “the examiner repeatedly
`stated that ‘the skilled artisan would have seen optical isomer separation as a
`routine procedure leading to the compounds claimed herein.’” Dec. 9 (citing
`Ex. 1002, 48, 73, 88, 113). We also noted that by accepting without
`deciding that the examiner established a prima facie case of obviousness, the
`Board assumed that a person of ordinary skill in the art would have
`considered separating and studying the stereoisomers of the prior art base
`compound to be ordinary and routine. Id. at 11–12. To the extent Petitioner
`contends that its argument in its Rehearing Request differs from that offered
`by the examiner during prosecution, both arguments rest on the same
`assertion that separating and studying stereoisomers would have been
`ordinary and routine. The Board considered that assertion to be true, but
`determined that the evidence of unexpected benefits outweighed that
`assertion. Given the similarity of Petitioner’s and the examiner’s arguments,
`we see no reason to second-guess the prior panel’s determination,
`particularly where § 325(d) only requires that the arguments be substantially
`the same, and not identical.
`
`3
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`Moreover, as explained in our Decision, the Petition failed to address
`the deficiencies in the examiner’s position that the prior panel expressly
`identified in its decision on appeal. See Dec. 12. That is, the Petition failed
`to address why an ordinary artisan “would have expected the RSSS
`stereoisomer to have such [potentiating] properties” or to show “that the
`potentiating property, described in the declaration, is insignificant.” Id.
`(quoting Ex. 1002, 200). In its Request, Petitioner claims that our Decision
`was incorrect because Petitioner addressed those deficiencies in the Petition.
`Reh’g Req. 3–4 (citing Pet. 55–56). But the cited pages of the Petition argue
`the secondary considerations evidence is irrelevant because there is no
`nexus, and because the claimed compounds would be the expected result of
`combining the references. Pet. 55–56. We did not, however, find those
`arguments persuasive, and the Petition was otherwise silent as to the
`examiner’s deficiencies.
`Petitioner also argues that the Decision “provides no explanation as to
`why the alleged ‘unexpected benefits’ evidence, even if taken at face value,
`is sufficient to overcome the strong prima facie showing of obviousness,”
`particularly in light of the argument in the Petition that the evidence of
`unexpected benefits has no nexus to the challenged patent claims. Reh’g
`Req. 4–5. Our Decision, however, explains that the prior panel rejected the
`examiner’s argument that there was no nexus between the unexpected
`benefits and the natural racemic mixture. Dec. 10-11. We also found that
`the prior panel implicitly determined there was a sufficient nexus by
`concluding the applicants’ evidence of secondary considerations was
`sufficient to overcome the prima facie case of obviousness. Id. To the
`extent Petitioner asserts that we should have provided a separate analysis of
`the unexpected benefits evidence, Congress permits us to exercise our
`
`4
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`discretion and expend our resources elsewhere where substantially the same
`arguments have been previously presented to the Office. See 35 U.S.C.
`§ 325(d).
`Petitioner also contends that the Board’s deference to the evidence of
`alleged unexpected results is “strongly at odds with the way the PTAB treats
`such evidence in other cases.” Reh’g Req. 5–7 (citing Redline Detection,
`LLC v. Star Envirotech, Inc., Case IPR2013-00106, slip op. at 30 (PTAB
`July 1, 2013) (Paper 17)). Notwithstanding that nonprecedential decision is
`not binding on us, Redline is easily distinguishable. In Redline, the panel
`determined that the petitioner presented different arguments regarding new
`combinations of references and new supporting evidence that were not
`before the Office. Redline, slip op. at 16–17. The panel then declined to
`exercise its discretion to deny the Petition under 35 U.S.C. § 325(d). Id.
`Moreover, the panel noted that Patent Owner “does not argue here that the
`previously-presented evidence of secondary considerations rebuts or
`outweighs the evidence presented by Petitioner supporting the
`unpatentability of [the challenged claims over the cited art].” Id. at 29–30.
`Here, we found that Petitioner has offered substantially the same art and
`arguments that were previously before the Office. Dec. 9–12. And, unlike
`the patent owner in Redline, Patent Owner here has argued persuasively that
`the previously presented evidence of unexpected benefits rebuts the evidence
`and argument presented by Petitioner. See Paper 12, 44–56.
`Petitioner also argues that because the ’040 patent is a “particularly
`bad patent,” evidence of secondary considerations cannot rebut the strong
`prima facie case of obviousness. Reh’g Req. 6–7. Petitioner’s arguments,
`however, are substantially the same as previously presented to the Board on
`appeal. To the extent Petitioner asserts that we should have instituted an
`
`5
`
`
`
`IPR2016-00379
`Patent 6,545,040 B1
`inter partes review because the patent is “used to reap monopoly prices from
`ordinary consumers,” we decline to consider such nonsubstantive arguments
`in this proceeding. See id. at 8.
`In sum, in our Decision, we exercised our discretion under § 325(d)
`and determined, in light of the specific facts and circumstances of this case,
`that our resources were best spent elsewhere rather than readjudicating
`issues that the Board has already considered. Having fully considered
`Petitioner’s arguments in its Request for Rehearing, we are not persuaded
`that we abused our discretion in doing so.
`CONCLUSION
`
`For the foregoing reasons, we conclude that Petitioner has not
`demonstrated that we abused our discretion under 35 U.S.C. § 325(d) by
`declining to institute an inter partes review of claims 1–6 of the ’040 patent.
`ORDER
`
`Accordingly, it is ORDERED that Petitioner’s Request for Rehearing
`is denied.
`
`6
`
`
`
`PETITIONER:
`Barry Bumgardner
`barry@nelbum.com
`Brent Bumgardner
`brent@nelbum.com
`
`
`
`
`
`PATENT OWNER:
`Jeffrey Kushan
`IPRNotices@sidley.com
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