Trials@uspto.gov
`571-272-7822
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` Paper 11
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`Entered: August 17, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORY, INC.,
`Petitioner,
`
`v.
`
`HELSINN HEALTHCARE S.A.,
`Patent Owner.
`
`______________
`
`Case PGR2016-00008
`Patent 9,173,942 B2
`_______________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 324; 37 C.F.R. § 42.208
`
`
`
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`
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`571-272-7822
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` Paper 11
`
`
`Entered: August 17, 2016
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`
`
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`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORY, INC.,
`Petitioner,
`
`v.
`
`HELSINN HEALTHCARE S.A.,
`Patent Owner.
`
`______________
`
`Case PGR2016-00008
`Patent 9,173,942 B2
`_______________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 324; 37 C.F.R. § 42.208
`
`
`
`
`
`
`
`PGR2016-00008
`Patent 9,173,942 B2
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`I. INTRODUCTION
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`(collectively, “Petitioner” or “DRL”) filed a Petition on February 5, 2016
`(Paper 2; “Pet.”) requesting post-grant review of claims 1–19 of U.S. Patent
`No. 9,173,942 B2 (Ex. 1001; “the ’942 patent”). Helsinn Healthcare S.A.
`(“Patent Owner” or “Helsinn”) filed a Patent Owner Preliminary Response.
`Paper 9 (“Prelim. Resp.”).1
`We have authority to determine whether to institute a post-grant review.
`35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard is set forth in
`§ 324(a), which provides that a post-grant review shall not be instituted
`unless “the Director determines that the information presented in the petition
`filed under section 321, if such information is not rebutted, would
`demonstrate that it is more likely than not that at least 1 of the claims
`challenged in the petition is unpatentable.”
`After considering the Petition and the Preliminary Response, we
`determine that Petitioner has failed to demonstrate that it is more likely than
`
`
`1 Helsinn represents that
`Roche Palo Alto LLC, which was previously a co-assignee of
`U.S. Patent No. 9,173,942 . . . and a real party-in-interest in this
`proceeding, has assigned to Helsinn all right, title, and interest in
`and to the ’942 patent. Accordingly, for purposes of this
`proceeding, Helsinn is the only remaining real party-in-interest.
`Paper 8 (Updated Mandatory Notices, filed May 18, 2016), 2.
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`2
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`not that at least one claim of the ’942 patent is unpatentable. Accordingly,
`we do not institute a post-grant review.
`
`A. Related Proceedings
`The ’942 patent has been asserted against Petitioner in Helsinn
`
`Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., Civil Action No. 15-8662
`(D.N.J.), filed December 15, 2015. Pet. 2; Paper 7, 2.
`
`In addition, several parents of the ’942 patent and other related patents
`have been asserted by Patent Owner in a number of civil actions. For
`example, U.S. Patent No. 7,947,724 has been asserted in Helsinn Healthcare
`S.A. v. Dr. Reddy’s Labs., Ltd., Civil Action No. 12-2867 (D.N.J.); and U.S.
`Patent Nos. 7,947,724, 7,947,725, 8,518,981, 8,598,218, and 8,598,219 have
`been asserted in Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., Civil
`Action Nos. 11-3962, 11-5579, 13-5815 (consolidated) (D.N.J.). See Pet. 2–
`3; Paper 7, 2–3.
`
`Finally, Petitioner filed concurrently a Petition for post-grant review
`of claims 1–6, 10, and 11 of the ’942 patent, on obviousness grounds.
`PGR2016-00007.
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`B. The ’942 Patent (Ex. 1001)
`The ’942 patent is directed to formulations “for the treatment and
`prevention of emesis using palonosetron,” where the formulations “are shelf
`stable for periods greater than 24 months at room temperature.” Ex. 1001,
`2:65–3:1. According to the specification, “palonosetron can be formulated
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`in some instances at concentrations of only about 1/10th the amount of other
`previously known compounds for treating emesis, [which] surprisingly
`allows the use of concentrations of palonosetron far below those that would
`ordinarily be expected.” Id. at 4:54–58.
`[I]n one embodiment . . . a pharmaceutically stable solution for
`preventing or reducing emesis compris[es] a) from about 0.01
`mg/mL to about 5 mg/mL palonosetron or a pharmaceutically
`acceptable salt thereof; and b) a pharmaceutically acceptable
`carrier. . . . In alternative embodiments, the formulation includes
`palonosetron or a pharmaceutically acceptable salt thereof in a
`concentration from about 0.02 mg/mL to about 1.0 mg/mL, from
`about 0.03 mg/mL to about 0.2 mg/mL, and most optimally about
`0.05 mg/ml.2
`Id. at 4:58–5:6.
`In one particular embodiment the palonosetron is supplied in
`vials that comprise 5 ml. of solution, which equates to about 0.25
`mg of palonosetron at a concentration of about 0.05 mg/ml.
`Id. at 5:12–15.
`[F]urther . . . by adjusting the formulation’s pH and/or excipient
`concentrations it is possible to increase the stability of
`palonosetron formulations. Therefore, in another embodiment,
`. . . a pharmaceutically stable solution for preventing or reducing
`emesis compris[es] a) palonosetron or a pharmaceutically active
`salt thereof; and b) a pharmaceutically acceptable carrier, at a
`pH from about 4.0 to about 6.0. . . . In alternative embodiments,
`
`
`2 According to the specification of the ’942 patent, “[w]hen concentrations
`of palonosetron are given herein, the concentration is measured in terms of
`the weight of the free base. Concentrations of all other ingredients are given
`based on the weight of ingredient added to the solution.” Ex. 1001, 4:14–18.
`4
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`the pH is from about 4.5 to about 5.5, and most optimally about
`5.0.
`Id. at 5:16–30.
`[I]n another embodiment . . . a pharmaceutically stable solution
`of palonosetron compris[es] . . . from about 0.01 to about 5.0
`mg/ml palonosetron or a pharmaceutically acceptable salt thereof
`and (i) from about 10 to about 100 millimoles citrate buffer,
`and/or (ii) from about 0.005 to about 1.0 mg/ml EDTA.
`Id. at 5:40–46.
`[I]n another embodiment . . . a pharmaceutically stable solution
`of palonosetron compris[es]
`.
`.
`. a) palonosetron or a
`pharmaceutically
`acceptable
`salt
`thereof
`and
`b)
`a
`pharmaceutically acceptable carrier . . . compris[ing] a chelating
`agent and mannitol. . . . In various embodiments the mannitol is
`present in a concentration of from about 10.0 mg/ml to about 80
`mg/ml, from about 20 mg/mL to about 60.0 mg/ml, or from about
`40.0 to about 45.0 mg/ml.
`Id. at 6:4–18.
`Finally, the specification teaches that “palonosetron concentration was
`also a critical factor in chemical stability, with greatest stability seen at the
`lowest palonosetron concentrations.” Id. at 7:40–43.
`
`C. Illustrative Claim
`Of the challenged claims, claims 1 and 12 are independent. Claim 1,
`
`reproduced below, is illustrative.
`1. A formulation comprising a pharmaceutical sterile
`aqueous intravenous solution, wherein said pharmaceutical
`sterile aqueous intravenous solution comprises:
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`palonosetron hydrochloride or another pharmaceutically
`
`acceptable salt of palonosetron at a concentration of 0.05
`mg/mL based on the weight of the palonosetron free base; and
`from 10 mg/mL to 80 mg/mL mannitol;
`wherein the pharmaceutical sterile aqueous intravenous
`
`solution has a pH of 4.0 to 6.0.
`
`D. The Asserted Grounds of Unpatentability
`Petitioner asserts the challenged claims are unpatentable on the
`following grounds. Pet. 24–61.3
`
`Basis
`
`Claims Challenged
`
`§ 112(a) Written Description
`§ 102(a)(1) On-Sale Bar
`
`1–19
`1–19
`
`II. ANALYSIS
`A. Eligibility for Post-Grant Review
`The post-grant review provisions set forth in Section 6(d) of the AIA4
`apply only to patents subject to the first-inventor-to-file provisions of the
`AIA. See AIA § 6(f)(2)(A) (“The amendments made by subsection (d) . . .
`shall apply only to patents described in section 3(n)(1).”). Transitional
`provision AIA section 3(n)(1) is as follows:
`
`
`3 Petitioner also relies on the Declaration of Dr. Christopher Fausel (Ex.
`1038).
`4 Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”).
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`(n) EFFECTIVE DATE.—
`(1) IN GENERAL.—Except as otherwise provided in this
`section, the amendments made by this section shall take effect
`upon the expiration of the 18-month period beginning on the date
`of the enactment of this Act, and shall apply to any application
`for patent, and to any patent issuing thereon, that contains or
`contained at any time—
`(A) a claim to a claimed invention that has an effective
`filing date as defined in section 100(i) of title 35, United
`States Code, that is on or after the [March 16, 2013]
`effective date . . . ; or
`(B) a specific reference under section 120, 121, or 365(c)
`of title 35, United States Code, to any patent or application
`that contains or contained at any time such a claim.
`AIA § 3(n)(1), 125 Stat. 293.
`The term “effective filing date” for a claimed invention in a patent or
`application for patent means “the filing date of the earliest application for
`which the patent is entitled, as to such invention, to a right of priority under
`section 119, 365(a), or 365(b) or to the benefit of an earlier filing date under
`section 120, 121, or 365(c).” 35 U.S.C. § 100(i)(1); see also AIA § 3(a),
`125 Stat. at 285 (amending 35 U.S.C. § 100).
`Entitlement to the benefit of an earlier date under §§ 119, 120, 121,
`and 365 is premised on disclosure of the claimed invention in the manner
`provided by § 112(a) 5 (other than the requirement to disclose the best mode)
`
`
`5 Section 4(c) of the AIA redesignated 35 U.S.C. § 112 ¶ 1 as 35 U.S.C.
`§ 112(a). 125 Stat. at 296.
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`in the application for which the benefit of the earlier filing date is sought.
`See 35 U.S.C. §§ 119(e), 120.
`The ’942 patent issued on November 3, 2015, from U.S. Application
`No. 13/901,830 (“the ’830 application”), filed on May 24, 2013. Ex. 1001,
`[21], [22], [45]. The ’942 patent is a continuation of U.S. Application No.
`13/901,437 (“the ’437 application”), filed on May 23, 2013, now U.S. Patent
`No. 8,598,219 (“the ’219 patent”). Id. at [63]. The ’437 application, in turn,
`is a continuation-in-part of U.S. Application No. 13/087,012, filed on April
`14, 2011, now U.S. Patent No. 8,518, 981.6 Id. Petitioner contends that
`claim 9 of the ’437 application had support only in newly added Example 8
`of the ’437 application—i.e., claim 9 of the ’437 application was not
`disclosed in the manner provided by § 112(a) prior to May 23, 2013. Pet. 4–
`6. The record appears to support Petitioner’s contention, and Patent Owner
`does not dispute that the effective filing date of claim 9 of the ’437
`application is no earlier than May 23, 2013. See Ex. 1002 (Prosecution
`History of the ’830 application), 154–156 (Applicants of the ’942 patent
`discussing the AIA status of the ’830 and ’437 applications.). Under the
`provisions of AIA sections 3(n)(1)(A) and (B), then, both the ’219 patent
`
`
`6 In addition, U.S. Application No. 13/087,012 is a continuation of U.S.
`Application No. 11/186,311, filed on July 21, 2005, now U.S. patent No.
`7,947,724, which is a continuation of Application No. PCT/EP2004/000888,
`filed on January 30, 2004. Finally, Provisional Application No. 60/444,351
`was filed on January 30, 2003. Ex. 1001, [63], [64].
`8
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`and the ’942 patent (which claims benefit to the ’219 patent) are AIA first-
`inventor-to-file patents.
`An additional requirement for post-grant review eligibility is that “[a]
`petition for a post-grant review may only be filed not later than the date that
`is 9 months after the date of the grant of the patent.” 35 U.S.C. § 321(c); see
`37 C.F.R. § 42.202(a).
`The Petition was filed on February 5, 2016 (Paper 4, 1), within nine
`months of the grant of the ’942 patent. See 35 U.S.C. § 321(c). Petitioner
`further certifies that it has standing to seek a post-grant review of the ’942
`patent. Pet. 4.
`Accordingly, on this record, we determine that the ’942 patent is an
`AIA first-inventor-to-file patent and is eligible for post-grant review.
`
`B. Claim Construction
`In a post-grant review, the claims of an unexpired patent are
`interpreted using the broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.200(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under
`that standard, claim terms are given their ordinary and customary meaning,
`as would be understood by one of ordinary skill in the art in the context of
`the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007).
`We determine that no claim term requires express construction for
`purposes of deciding whether to institute a review in this case. See, e.g.,
`9
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`Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)
`(“[C]laim terms need only be construed ‘to the extent necessary to resolve
`the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999)).
`
`C. Claims 1–19—Asserted Unpatentability under the
`Written Description Provision of 35 U.S.C. § 112(a)
`1. Analysis
`Petitioner contends that “the broadly drafted claims of the ’942 Patent
`are not fully supported by the narrow specification,” because the
`specification “repeatedly and emphatically states that the invention is
`directed to stable formulations and methods, [yet] the inventors have
`procured claims that have no requirement of stability whatsoever.” Pet. 27
`(citing Ex. 1038 ¶¶ 22, 24). According to Petitioner, “[t]his is a classic
`violation of the written description requirement of 35 U.S.C. § 112(a).” Id.
`at 26.
`
`Patent Owner contends that an objective of the ’942 patent “was to
`provide a formulation of Palonosetron hydrochloride with increased
`pharmaceutical stability for preventing and/or reducing emesis,” and that the
`specification discloses the ingredients of formulations—as well as the
`amounts, concentrations, and combinations of the ingredients—that achieve
`this two-part objective. Patent Owner contends that these are the same
`ingredients required by the challenged claims, in the same amounts,
`concentrations, and combinations. Prelim. Resp. 21–22 (citing Ex. 1001,
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`10
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`2:50–52). For example, the formulation of claim 1 comprises palonosetron
`hydrochloride at a concentration of 0.05 mg/mL and 10-80 mg/mL mannitol,
`and has a pH of 4.0–6.0. Claim 2, which depends from claim 1, requires
`palonosetron hydrochloride in an amount of 0.25 mg. Patent Owner points
`out that the specification identifies “the optimal palonosetron concentration
`to be 0.05 mg/mL . . . and disclose[s] a vial with 0.25 mg of palonosetron in
`5 mL of solution (i.e., a 0.05 mg/mL concentration) as ‘one particular
`embodiment’ of the invention.” Prelim. Resp. 22 (citing Ex. 1001, 5:1–6,
`12–15). Similarly, Patent Owner points out that the specification discloses
`that it is possible to increase the stability of a palonosetron formulation by
`adjusting the formulation’s pH and/or excipient concentrations, and the
`specification discloses that the preferred pH of the formulation is from about
`4.0 to about 6.0, and the preferred concentration of mannitol is from about
`10.0 mg/mL to about 80 mg/mL. Id. at 24 (citing Ex. 1001, 3:16–18, 5:19–
`23, 6:14–16, Example 3).7 Patent Owner contends “because the ’942 patent
`claims are directed to these ingredients in amounts described as optimal,
`they are fully supported by the written description.” Id. at 21.
`The written description requirement is satisfied when the specification
`“set[s] forth enough detail to allow a person of ordinary skill in the art to
`understand what is claimed and to recognize that the inventor invented what
`
`
`7 Patent Owner additionally provides Appendix A to the Preliminary
`Response. Appendix A purportedly maps the requirements of claims 1–19
`to the specification.
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`is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d
`916, 928 (Fed. Cir. 2004). Here, it is undisputed that the specification
`describes formulations comprising the same ingredients, in the same
`amounts, concentrations, and combinations required by the challenged
`claims. Given this disclosure, one of ordinary skill in the art could hardly
`fail to recognize a description of the claimed formulations in the
`specification, whether or not the claims recite that the formulations are
`stable.
`We are not persuaded otherwise by Petitioner’s reliance on Cooper
`Cameron Corp. v. Kvaerner Oilfield Products., Inc., 291 F.3d 1317, 1323
`(Fed. Cir. 2002) for the proposition that “[a] ‘broad claim is invalid when the
`entirety of the specification clearly indicates that the invention is of a much
`narrower scope.’” Pet. 24. The Cooper Cameron court, in elucidating an
`earlier decision in Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473
`(Fed. Cir. 1998), made clear that the statement quoted by Petitioner was
`made in the context of the location of a structural element—i.e., controls for
`a recliner—where “[t]here was no description or support whatever in the
`Gentry patent of the controls being other than on the console.” Cooper
`Cameron, 291 F.3d at 1323. That circumstance is not relevant here, where
`the specification describes formulations comprising the same ingredients, in
`the same amounts and concentrations, required by the challenged claims.
`Nor are we persuaded by Petitioner’s contention that the inventors of
`the ’942 patent have engaged in “the very type of ‘overreaching’ that the
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`Federal Circuit warned against” in University of Rochester v. G.D. Searle &
`Co., 358 F.3d 916 (Fed. Cir. 2004). Pet. 27. In that case, the court reiterated
`that “the purpose of the written description requirement is to ‘ensure that the
`scope of the right to exclude, as set forth in the claims, does not overreach
`the scope of the inventor’s contribution to the field of art as described in the
`patent specification.’” University of Rochester, 358 F.3d at 920 (quoting
`Reiffin v. Microsoft Corp., 214 F.3d 1342 (Fed. Cir. 2000)). The claims at
`issue in University of Rochester, however, all required a COX-2 selective
`compound, but no COX-2 selective compound was disclosed in the patent.
`Id. at 930. Moreover, it was undisputed that there was no pre-existing
`awareness in the art of any compound having COX-2 selective activity. Id.
`Here, again, that lack of disclosure is not relevant because the specification
`describes formulations comprising the same ingredients, in the same
`amounts and concentrations, required by the challenged claims—and
`moreover, describes them as optimal or preferred for stability.
`Accordingly, we determine that Petitioner has failed to show that it is
`more likely than not that claims 1–19 are unpatentable for failure to meet the
`written description requirement of 35 U.S.C. § 112(a).
`
`D. Claims 1–19—Asserted Unpatentability under
`35 U.S.C. § 102(a)(1), On-Sale Bar
`
`1. Analysis
`Petitioner contends that claims 1–19 are “invalid by virtue of an
`on-sale bar” under 35 U.S.C. § 102(a)(1). Pet. 8. According to Petitioner,
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`“[t]o bar patentability under the on-sale provision § 102(a)(1), the claimed
`invention must be sold or be the subject of a commercial offer for sale, and
`be ready for patenting more than one year prior to the earliest effective filing
`date, which in this case, is January 30, 2003.”8 Id. at 9, 32 (citing Pfaff v.
`Wells Elec., Inc. 525 U.S. 55, 67 (1998) (holding that the on-sale bar applies
`when two conditions are satisfied before the critical date: “the product must
`be the subject of a commercial offer for sale” and “the invention must be
`ready for patenting”)). Petitioner contends that “those conditions are
`satisfied here.” Id.
`Specifically, Petitioner contends that Patent Owner’s subsidiary,
`Helsinn Birex Pharmaceuticals Ltd. (“HBP”), entered into a Supply and
`Purchase Agreement with MGI Pharma, Inc. (“MGI”). Pet. 30 (citing Ex.
`1042 (“Supply Agreement”)). According to Petitioner, the Supply
`Agreement required MGI to purchase exclusively from HBP, and HBP to
`sell to MGI, MGI’s entire requirements of “Products,” where those Products
`were defined as:
`[P]harmaceutical preparations for human use in I.V. dosage form
`containing the Compound . . . in the formulation that will be
`described in the Registration. The current formulation as
`submitted to the Food and Drug Administration of the United
`States of America in the IND 39,797 Amendment # 64 . . . is
`described in the First Appendix hereto.
`
`
`8 See supra page 8, note 6.
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`Id. at 30–31 (citing Ex. 1042, Art. 1.9). The “Compound” was identified as
`palonosetron hydrochloride. Id. at 31 (citing Ex. 1042, Art. 1.3).
`Petitioner contends that Patent Owner additionally “entered into a
`License and Distribution Agreement (‘License Agreement’) with MGI for
`exclusive rights in the United States and Canada for the sale of palonosetron
`formulations, which included the same ‘requirements’ contract terms” and
`“[i]n return, Patent Owner received a total of $11 million upon the signing of
`the License Agreement and a previous letter of intent, with additional
`payments promised at later milestones.” Pet. 31 (citing Ex. 1043, Art. 2.5).
`Petitioner contends that “[r]edacted versions” of both the Supply
`Agreement and the License Agreement “were made publicly available
`through MGI’s Form 8-K SEC Filings submitted on April 25, 2001.” Id. at
`31 (citing Ex. 1044). In addition, Petitioner contends that “the Supply
`Agreement . . . was clearly and deliberately made public through . . . press
`releases prior to the critical date.” Id. at 32 (citing Ex. 1047).
`Petitioner argues, in any case, “[u]nder longstanding law, the on-sale
`bar applies not only to . . . ‘public’ sales, but also to ‘private’ sales made
`before the critical date.” Id. at 39 (citing Woodland Trust v. Flowertree
`Nursery, Inc., 148 F.3d 1368, 1370 (Fed. Cir. 2002)). Petitioner contends
`that “[t]he AIA did not change this.” Id. Moreover, Petitioner contends that
`even if the on-sale bar is triggered only by public sales, “the Supply
`Agreement would remain proof of invalidating on-sale activity under 35
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`U.S.C. § 102[(a)(1)], because MGI was a member of the public and the
`agreement was publicly disclosed.” Pet. 39.
`Patent Owner contends that “[t]he AIA effected sweeping changes to
`the patent laws” and the plain language and legislative history of 35 U.S.C.
`§ 102(a)(1) confirm that “a confidential offer for sale no longer qualifies as a
`potentially invalidating activity; an offer for sale must have made the
`claimed invention ‘available to the public.’” Prelim. Resp. 33.
`Patent Owner acknowledges that it entered into the aforementioned
`Supply and License Agreements with MGI.9 Id. at 10. Patent Owner
`contends however, that “[t]he License and MGI Agreements both contained
`strict confidentiality provisions” and “MGI was . . . obliged to ‘treat as
`strictly confidential, and use solely for the purpose of and in accordance with
`this Agreement, the Know-how, Improvements and/or any information
`and/or document received hereunder. . . .’” Id. at 11–12 (citing Ex. 1042,
`Art. 9.1; Ex. 1043, Art. 14.1). Patent Owner contends that the SEC Form 8-
`K filings relied on by Petitioner were “heavily redacted and did not disclose
`any relevant formulation information, such as the palonosetron dose,
`concentration, or any excipients.”10 Id. at 50; see Ex. 1044. Patent Owner
`
`
`9 The “Supply Agreement” discussed by Petitioner is the same as the “MGI
`Agreement” discussed by Patent Owner.
`10 We note that the press release relied on by Petitioner (Pet. 32) announces
`a “definitive agreement granting MGI PHARMA exclusive North American
`license and distribution rights to palonosetron,” but is similarly devoid of
`detail. See Ex. 1047.
`
`16
`
`
`
`
`PGR2016-00008
`Patent 9,173,942 B2
`
`contends, “[s]ince the MGI Agreement did not make the claimed invention
`‘available to the public,’ as required by AIA § 102(a)(1), the ’942 patent
`claims are not unpatentable under the on-sale bar.” Prelim. Resp. 34.
`Thus, the facts surrounding the MGI agreements are undisputed, but
`Petitioner and Patent Owner disagree on the applicability of the post-AIA
`on-sale bar to those facts.
`Before the AIA was signed into law, § 102 of the Patent Act provided,
`in relevant part, that:
`A person shall be entitled to a patent unless . . . (b) the invention
`was patented or described in a printed publication in this or a
`foreign country or in public use or on sale in this country, more
`than one year prior to the date of the application for patent in the
`United States . . . .
`35 U.S.C. § 102, amended by 125 Stat. at 285–86.
`The Court of Appeals for the Federal Circuit has held that commercial
`sales, even if confidential, trigger the on-sale bar under the pre-AIA § 102.
`See, e.g., Medicines Co. v. Hospira, Inc., 2016 WL 3670000, at *10 (Fed.
`Cir. 2016) (en banc) (“[T]he confidential nature of the transactions is a
`factor which weighs against the conclusion that the transactions were
`commercial in nature. Again, this factor is not disqualifying in all instances
`. . . . Indeed, we, and our predecessors, have found confidential transactions
`to be patent invalidating sales under § 102(b).”); Special Devices, Inc. v.
`OEA, Inc., 270 F.3d 1353, 1357–58 (Fed. Cir. 2001) (in finding that on-sale
`
`
`
`
`17
`
`
`
`
`PGR2016-00008
`Patent 9,173,942 B2
`
`bar invalidated patent claims, stating that the on-sale bar applies to “sales for
`the purpose of the commercial stockpiling of an invention, even if they took
`place in secret”); Woodland Trust, 148 F.3d at 1370 (“Thus an inventor’s
`own prior commercial use, albeit kept secret, may constitute a public use or
`sale under § 102(b), barring him from obtaining a patent.”).
`The AIA enlarged the scope of prior art under § 102 with respect to
`territory, and also added the clause “otherwise available to the public.” In
`relevant part, § 102(a)(1) provides:
`A person shall be entitled to a patent unless—(1) the claimed
`invention was patented, described in a printed publication, or in
`public use, on sale, or otherwise available to the public before
`the effective filing date of the claimed invention . . . .
`As an AIA first-inventor-to-file patent, the ’942 patent is subject to
`AIA § 102(a)(1). Thus, the dispositive issue in this case is whether
`§ 102(a)(1) requires a public sale or offer for sale of the claimed invention to
`trigger the on-sale bar.
`This issue was recently addressed in Helsinn Healthcare S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11–3962, 2016 WL 832089, at *39 (D.N.J. March
`3, 2016), a case involving three pre-AIA patents, and one AIA first-inventor-
`to-file patent—specifically U.S. Patent No. 8,598,219, the immediate parent
`of the ’942 patent. The parties in that case, as in this case, disagreed as to
`“whether the last clause of § 102(a)(1), ‘otherwise available to the public,’
`modifies the section’s previous clauses or serves as its own category of prior
`art.” Helsinn Healthcare, 2016 WL 832089, at *40.
`
`18
`
`
`
`
`PGR2016-00008
`Patent 9,173,942 B2
`
`
`The court in Helsinn Healthcare, guided at least in part “by the
`Supreme Court’s ‘common sense’ approach to statutory interpretation,” the
`USPTO’s non-binding published “Examination Guidelines for Implementing
`the First Inventor to File Provisions of the [AIA],” and the legislative history
`of the AIA, determined that the phrase “otherwise available to the public”
`does indeed modify the section’s previous clauses. Id. at *40–*44, *51 n.52.
`Specifically, the court concluded “that § 102(a)(1) requires a public sale or
`offer for sale of the claimed invention” and “[t]he new requirement that the
`on-sale bar apply to public sales comports with the plain language meaning
`of the amended section, the USPTO’s interpretation of the amendment, and
`the legislative history of the AIA.” Id. at *45. Moreover, the court
`emphasized that “the post-AIA on-sale bar inquiry is not focused on the
`public disclosure of the sale or offer for sale; rather, the ‘sale’ prong of the
`on-sale bar requires that the sale make the claimed invention available to the
`public one year prior to its critical date.” Id. at *52.
`
`Having considered the parties’ arguments in this case, which are
`essentially the same as those in Helsinn Healthcare, we reach the same
`conclusion. That is, we agree with the district court that § 102(a)(1) requires
`a public sale or offer for sale of the claimed invention, and that the post-AIA
`on-sale bar inquiry is not focused merely on the public disclosure of the
`existence of a sale or offer for sale; rather, the sale must make the claimed
`invention available to the public in order to trigger the on-sale bar.
`
`19
`
`
`
`
`PGR2016-00008
`Patent 9,173,942 B2
`
`
`Here, as in Helsinn Healthcare, Petitioner has established that MGI’s
`Form 8-K SEC filings and Helsinn’s press releases made public the
`existence of the Supply and Licensing Agreements, but Petitioner has not
`shown that the heavily redacted SEC filings or the press releases, devoid of
`detail, made the claimed invention available to the public. Thus, we
`determine that the Supply and Licensing Agreements did not make the
`claimed invention available to the public one year prior to the critical date at
`issue here.11
`Accordingly, we determine that Petitioner has failed to show that it is
`more likely than not that claims 1–19 are in violation of the on-sale bar
`under 35 U.S.C. § 102(a)(1).
`
`III. CONCLUSION
`For the foregoing reasons, we determine that Petitioner has not
`established that it is more likely than not that claims 1–19 of U.S. Patent No.
`9,173,942 are unpatentable.
`
`IV. ORDER
`
`It is hereby
`ORDERED that the Petition is denied, and no trial is instituted.
`
`
`11 As we have determined that the Supply and Licensing Agreements did
`not make the claimed invention available to the public one year prior to the
`critical date, we need not determine whether the Agreements satisfied the
`“commercial sale” and “ready for patenting” prongs of the on-sale bar.
`
`
`20
`
`
`
`
`PGR2016-00008
`Patent 9,173,942 B2
`
`For PETITIONER:
`William L. Mentlik
`wmentlik.ipr@ldlkm.com
`Michael H. Teschner
`mteschner.ipr@ldlkm.com
`Maegan A. Fuller
`mfuller.ipr@ldlkm.com
`
`For PATENT OWNER:
`Eric W. Dittman
`Naveen Modi
`Michael A. Stramiello
`PH-drreddys-helsinn-PGR@paulhastings.com
`Thomas L. Irving
`tom.irving@finnegan.com
`Mark E. Waddell
`mwaddell@loeb.com
`
`
`
`
`
`
`
`21
`
`
`
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