Paper No. 15
`Filed: July 29, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LOWER DRUG PRICES FOR CONSUMERS, LLC
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`PETITIONER
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`V.
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`FOREST LABORATORIES HOLDINGS LIMITED
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`PATENT OWNER
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`___________________
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`CASE NO.: IPR2016-00379
`PATENT NO. 6,545,040
`FILED: JANUARY 24, 1992
`ISSUED: 4/8/2003
`INVENTORS: XHONNEUX AND VAN LOMMEN
`TITLE: METHOD OF LOWERING THE BLOOD PRESSURE
`___________________
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`REQUEST FOR REHEARING OF DECISION
`DENYING INSTITUTION OF INTER PARTES REVIEW [PAPER NO. 14]
`PURSUANT TO 37 C.F.R. §42.71(d)
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`Filed: July 29, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`LOWER DRUG PRICES FOR CONSUMERS, LLC
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`PETITIONER
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`V.
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`FOREST LABORATORIES HOLDINGS LIMITED
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`PATENT OWNER
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`___________________
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`CASE NO.: IPR2016-00379
`PATENT NO. 6,545,040
`FILED: JANUARY 24, 1992
`ISSUED: 4/8/2003
`INVENTORS: XHONNEUX AND VAN LOMMEN
`TITLE: METHOD OF LOWERING THE BLOOD PRESSURE
`___________________
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`REQUEST FOR REHEARING OF DECISION
`DENYING INSTITUTION OF INTER PARTES REVIEW [PAPER NO. 14]
`PURSUANT TO 37 C.F.R. §42.71(d)
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`Patent No. 6,545,040
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`The Board’s Decision Denying Institution of Inter Partes Review [Paper No.
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`14] – which defers entirely the USPTO’s previous allowance of the ’040 Patent
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`without any consideration of the substance of the arguments raised in the Petition -
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`is an abdication of the Board’s responsibility under the America Invents Act
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`(“AIA”) to reexamine the agency’s earlier patent examination in order to invalidate
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`bad patents that should never have issued. As the Supreme Court recently
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`explained:
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`[T]he purpose of the [IPR] proceeding is not quite the same as the
`purpose of district court litigation. The proceeding involves what used
`to be called a reexamination . . . . The name and accompanying
`procedures suggest that the proceeding offers a second look at an
`earlier administrative grant of a patent. Although Congress changed
`the name from “reexamination” to “review,” nothing convinces us
`that, in doing so, Congress wanted to change its basic purposes,
`namely, to reexamine an earlier agency decision. Thus, in addition to
`helping resolve concrete patent-related disputes among parties, inter
`partes review helps protect the public’s “paramount interest in
`seeing that patent monopolies . . . are kept within their legitimate
`scope.”
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`Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, ___ (2016) (emphasis added).
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`With this IPR Petition, Petitioner submitted evidence that was not previously
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`before the USPTO during examination. In particular, Petitioner submitted expert
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`testimony from Dr. Ronald W. Millard, Ph.D explaining that it would have been
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`Patent No. 6,545,040
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`obvious and ordinary for a POSITA at the time to use well-known and routine
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`laboratory protocols to discovery the alleged “unexpected benefits” that the
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`USPTO previously relied upon to allow the ’040 Patent claims. See Ex. 1052 at
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`¶¶67-69, 87, 93, 100. In its Decision Denying Institution, the Board mistakenly
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`stated that USPTO “assumed this to be true . . .” during prosecution. See Decision,
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`Paper No. 14 at 11-12. This is incorrect. The USPTO during prosecution never
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`considered whether discovery of the alleged “unexpected benefits” – after the
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`filing of the patent application - was itself ordinary and routine, and thus not
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`sufficient to overcome the strong prima facie case that the ’040 Patent claims are
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`obvious and unpatentable. See Ex. 1002 at 199-200; 248. Similarly, none of the
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`declarations submitted by Patent Owner in support of the alleged unexpected
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`benefits addressed whether the discovery of these unexpected benefits was
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`ordinary and routine. See Ex. 1002 at 39-45; 219-230.
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`Rehearing of the Board’s Decision Denying Institution is appropriate
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`because the Board misapprehended the nature and implication of this new evidence
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`submitted by Petitioner. See 37 C.F.R. §42.71(d). This evidence and its
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`implications were previously discussed in the IPR Petition. See Paper No. 6 at pp.
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`11-13. The Board was mistaken to state that “the Petition is silent” in addressing
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`the “deficiencies in the examiner’s position with respect to the evidence of
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`unexpected results . . . .” Decision, Paper No. 14 at 12. The Petition specifically
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`Patent No. 6,545,040
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`addressed the deficiencies in the unexpected results evidence. See Paper No. 6 at
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`pp. 55-56. Moreover, the Board was incorrect to determine that “the same or
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`substantially the same prior art or arguments previously were presented to the
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`Office” as is required before exercising the Board’s discretion to deny institution
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`under 35 U.S.C. §325(d).
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`The prima facie case that the ’040 Patent claims are obvious is particularly
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`strong. The Board’s Decision Denying Institution itself recites the critical
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`undisputed facts: (1) the Van Lommen reference teaches the claimed compounds,
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`including all position isomers inherent in the claimed compound; and (2) a person
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`of ordinary skill at the time of the invention would have viewed optical isomer
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`separation as a routine procedure leading to production of the claimed compounds.
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`See Paper No. 14 at pp. 6-8.
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`The Decision Denying Institution, however, provides no explanation as to
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`why the alleged “unexpected benefits” evidence, even if taken at face value, is
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`sufficient to overcome the strong prima facie showing of obviousness. The
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`Decision instead merely defers to the USPTO’s previous reliance on the alleged
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`unexpected results during the original ex parte patent examination. See Paper No.
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`14 at pp. 9-12. But, as stated above, the Petition presents new evidence that was
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`not considered by the USPTO during prosecution – evidence showing that the
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`discovery of the unexpected benefits was routine and ordinary. Moreover, as
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`Patent No. 6,545,040
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`argued in the Petition, the evidence of unexpected benefits has no nexus to the
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`challenged patent claims – none of which contain claim elements regarding
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`potentiating effects of the claimed compound. See Paper No. 6 at pp. 55-56.
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`The Board’s deference to the evidence of alleged unexpected results, and to
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`the USPTO’s previous reliance upon such evidence, is strongly at odds with the
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`way the PTAB treats such evidence in other cases. For example, the Board has
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`held:
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`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]. Moreover, the existence of previously-presented
`evidence of secondary considerations does not act as a bar to the
`institution of a trial or an additional burden which the Petitioner
`must overcome in demonstrating a reasonable likelihood that it would
`prevail in demonstrating the unpatentabilty of [the challenged claims].
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` Redline Detection, LLC v. Star Envirotech, Inc., Case IPR2013-00106, Paper 17 at
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`30 (July 1, 2013) (emphasis added).
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`It is well known that the PTAB will not consider evidence of secondary
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`considerations such as unexpected results unless there is an established nexus
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`between the secondary considerations and elements of the challenged patent
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`claims. See, e.g., Coalition for Affordable Drugs II LLC v. NPS Pharmaceuticals,
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`Inc., Case IPR2015-00990, Paper 28 at 9 (Oct. 23 2015) (“All types of objective
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`Patent No. 6,545,040
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`evidence of nonobviousness must be shown to have a nexus”); Seagate Tech.
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`Holdings, Inc. v. Enova Tech. Corp., Case IPR2014-00683, Paper 47 at 44 (Sept. 2,
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`2015) (“The burden of showing that there is a nexus lies with the Patent Owner”).
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`Moreover, even in cases where the PTAB considers evidence of secondary
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`considerations, the PTAB rarely (if ever) finds that such evidence outweighs a
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`strong prima facie showing of obviousness. See, e.g. Samsung Electronics Co.,
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`Ltd. v. Nvidia Corp., Case IPR2015-01029, Paper 8 at 21 (Oct. 13, 2015); Chums,
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`Inc. v. Cablz, Inc., Case IPR2014-01240, Paper 10 at 8 (Feb. 10, 2015); Conopco,
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`Inc. v. The Proctor & Gamble Co., Case IPR2013-00505, Paper 69 at 25-28 (Feb.
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`10, 2015); Corning Optical Commun’s RF, LLC v. PPC Broadband, Inc., Case
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`IPR2013-00340, Paper 79 at 49-50 (Nov. 21, 2014).
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`The PTAB’s typical treatment of secondary considerations is consistent with
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`Federal Circuit precedent. “[S]econdary considerations of nonobviousness . . .
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`simply cannot overcome a strong prima facie case of obviousness.” Wyers v.
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`Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010). “[W]here the inventions
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`represented no more than ‘the predictable use of prior art elements according to
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`their established functions,’ . . . the secondary considerations are inadequate to
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`establish nonobviousness as a matter of law.” Id. (emphasis added). See also Sud-
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`Chemie, Inc. v. Multisorb Techs., Inc. 554 F.3d 1001, 1009 (Fed. Cir. 2009)
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`(“[E]vidence of unexpected results and other secondary considerations will not
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`Patent No. 6,545,040
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`necessarily overcome a strong prima facie showing of obviousness . . .”); Leapfrog
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`Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (affirming
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`a finding of obviousness over “substantial evidence of commercial success, praise,
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`and long-felt need . . . given the strength of prima facie obviousness showing . . .”).
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`The ’040 Patent is a particularly bad patent, and the prima facie case of
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`obviousness is particularly strong. The patent represents nothing more than the use
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`of conventional and well-known chromatography separation techniques to achieve
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`an expected result – the purified stereochemical forms of a prior art known racemic
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`mixture. The subsequent discovery of the alleged unexpected benefits was
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`achieved through the use of well-known, standard laboratory test protocols. In its
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`Preliminary Response, Patent Owner disputes none of this. The USPTO’s previous
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`allowance of the ’040 Patent claims - on the basis of alleged unexpected results -
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`was plainly wrong, and should be reconsidered in light of new evidence presented
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`by the Petitioner.
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`The ’040 Patent is the only patent protecting the Patent Owner’s monopoly
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`over the hypertension drug Bystolic (nebivolol). In the United States alone, Forest
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`Labs sells more than $800 million per year of this drug at inflated monopoly
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`prices. Yet, the validity of the ’040 Patent has never been determined in an
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`adversarial proceeding. Forest Labs settled several prior lawsuits against would-be
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`Patent No. 6,545,040
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`generic manufacturers of nebivolol, thus preventing the validity of the ’040 Patent
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`from ever being tested in an adversarial proceeding.
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`When Congress passed the AIA and created Inter Partes Reviews, it did not
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`impose a standing requirement. It specifically intended that members of the public
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`be permitted file IPR Petitions challenging bad patents. See 35 U.S.C. §311(a).
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`This IPR Petition is one of those cases – filed by Lower Prices for Drug
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`Consumers to invalidate a bad patent that is being used to reap monopoly prices
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`from ordinary consumers who rely upon Bystolic to treat hypertension. There is no
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`other avenue available for American consumers to challenge this patent. Institution
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`of this IPR would not only be an “efficient use of Board resources” (Paper No. 14
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`at 12), but it would promote social health and make a meaningful difference in the
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`lives of tens of thousands of Americans who purchase Bystolic for their health care
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`needs.
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`Petitioner respectfully requests rehearing of the Decision Denying
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`Institution. Petitioner requests the Board to reverse its decision, and instead
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`institute this IPR for a full trial on the merits so that the validity of the ‘040 Patent
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`can finally be determined in an adversarial proceeding on a full evidentiary record.
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`Patent No. 6,545,040
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`Dated: July 29, 2016
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`Respectfully Submitted,
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`/s/ Barry J. Bumgardner
`Barry J. Bumgardner (Lead Counsel)
`Registration No. 38,397
`Brent N. Bumgardner (Back-up Counsel)
`Registration No. 48,476
`Attorneys for Petitioner
`NELSON BUMGARDNER, P.C.
`3131 W. 7th Street, Suite 300
`Fort Worth, Texas 76107
`Telephone: (817) 377-9111
`Facsimile: (817) 377-3485
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`Patent No. 6,545,040
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` CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing document was
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`electronically filed through the Patent Review Processing System on July 29, 2016,
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`thereby causing all counsel of record who have consented to electronic service to
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`receive an email notice of the filing. In addition, the following attorneys of record
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`were separately served by email with a copy of the foregoing document:
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`Jeffrey P. Kushan (jkushan@sidley.com)
`Todd L. Krause (tkrause@sidley.com)
`Sidley Austin LLP
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`Date: July 29, 2016
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` /s/ Barry Bumgardner
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`10
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