Paper No. __
`Filed: October 21, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`PAR PHARMACEUTICAL, INC. and ROXANE LABORATORIES, INC.
`Petitioners,
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`v.
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`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
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`________________
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`Case CBM2014-00151
`Patent 7,668,730
`________________
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`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 35 U.S.C. § 323 and 37 C.F.R. § 42.207
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`Filed: October 21, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`PAR PHARMACEUTICAL, INC. and ROXANE LABORATORIES, INC.
`Petitioners,
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`v.
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`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
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`________________
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`Case CBM2014-00151
`Patent 7,668,730
`________________
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`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 35 U.S.C. § 323 and 37 C.F.R. § 42.207
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`Patent Owner Preliminary Response
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`TABLE OF CONTENTS
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`Page
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II.
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`BACKGROUND ............................................................................................. 3
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`A.
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`The Challenge of Restricting Access to a Dangerous But
`Efficacious Drug .................................................................................... 4
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`B.
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`The ’730 Patent ..................................................................................... 7
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`III. ARGUMENT ................................................................................................... 9
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`A.
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`The ’730 Patent Does Not Claim A Method or Corresponding
`Apparatus for Performing Data Processing or Other Operations
`Used in the Practice, Administration, or Management of a
`Financial Product or Service ................................................................. 9
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`1.
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`2.
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`Covered Business Method Review Eligibility ............................ 9
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`The Statute Precludes Expansion of CBM Review to
`Encompass All Methods “Used In Commerce” ....................... 10
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`(a)
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`(b)
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`(c)
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`Legislative History Does Not Support
`Petitioners’ Statutory Construction ...................... 13
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`Petitioners’ “Used in Commerce” Argument
`Improperly Expands the Scope of CBM
`Review To Cover Virtually All Method
`Patent Claims ........................................................ 17
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`Petitioners’ Argument Improperly Expands
`the Scope of CBM Review to Capture the
`Type of Invention Congress Expressly
`Stated Would Not Be CBM-Review Eligible ...... 18
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`3.
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`Petitioners Fail to Show that the Claims of the ’730
`Patent Cover a Financial Product or Service ............................ 19
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`(a) Claim 1 is Not Financial in Nature, or
`Incidental or Complementary to Financial
`Activities .............................................................. 20
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`(b)
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`Petitioners Improperly Read In Limitations
`That Are Not Encompassed by the Claims .......... 21
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`4.
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`Petitioners Fail to Show that Disclosures in the ’730
`Patent’s Specification Relate to The CBM-Eligibility of
`the Claims ................................................................................. 24
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`5. Mere Classification Within Class 705 Does Not Make a
`Patent Eligible for CBM Review .............................................. 28
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`6.
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`Prior Art Asserted Against the ’730 Patent, with No
`Relation of the Portions of the Prior Art Cited to the
`Claims of the ’730 Patent, Does Not Make the ’730
`Patent Eligible for CBM Review .............................................. 30
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`B.
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`The Claims of the ’730 Patent Are Directed To A
`Technological Invention ...................................................................... 32
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`1.
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`2.
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`The ’730 Patent Recites a Technological Feature that is
`Novel and Unobvious Over the Prior Art ................................. 32
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`The ’730 Patent’s Claims Solve a Technical Problem
`Using a Technical Solution ....................................................... 38
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`C.
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`Petitioners Fail to Prove that the ACA is Prior Art ............................. 41
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`1.
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`2.
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`Petitioners’ Wayback Machine Evidence Does Not
`Establish A Publication Date Prior to the ’730 Patent’s
`Priority Date .............................................................................. 43
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`Petitioners’ Other Materials Do Not Establish Public
`Accessibility .............................................................................. 48
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`IV. CONCLUSION .............................................................................................. 51
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`I.
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`INTRODUCTION
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`CBM2014-00151
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`Pursuant to 35 U.S.C. § 323 and 37 C.F.R. § 42.207(a), Patent Owner Jazz
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`Pharmaceuticals, Inc. (“Jazz”) submits this Preliminary Response to Par
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`Pharmaceutical, Inc. and Roxane Laboratories, Inc.’s (“Petitioners”) Petition for
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`Covered Business Method (“CBM”) review (the “Petition”) of U.S. Patent No.
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`7,668,730 (the “’730 patent”). For the reasons discussed below, the Petitioners fail
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`to meet the threshold requirement to show that the ’730 patent is a covered
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`business method patent under the statute and subject to CBM review. The Patent
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`Trial and Appeal Board (the “Board”), therefore, should not institute review of the
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`’730 patent. Petitioners also fail to show that the Advisory Committee Art
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`(“ACA”) materials constitute prior art to the ’730 patent. Accordingly, even if the
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`Board does not deny the Petition in its entirety, it should not institute Petitioners’
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`second (§ 102(b)) and third (§ 103(a)) grounds for unpatentability.
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`The claims of the ’730 patent cover methods of preventing the abuse,
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`misuse, and diversion of potentially dangerous prescription drugs, particularly
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`drugs containing gamma-hydroxybutyrate (“GHB”), a substance notorious for its
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`illicit use in drug-facilitated sexual assaults. The claims specifically cover the
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`methods ultimately approved by the Food and Drug Administration (“FDA”) to
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`ensure the safe administration of Jazz’s FDA-approved form of sodium GHB—
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`Xyrem®—to treat patients while preventing the abuse, misuse, and diversion
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`known to have occurred with illicit forms of this drug. Xyrem is the only approved
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`treatment for cataplexy, a debilitating symptom of narcolepsy, and excessive
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`daytime sleepiness in patients with narcolepsy. The technological solution to the
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`problem of how to get Xyrem to patients who need it, while mitigating the risk of
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`abuse, misuse or diversion of this drug, was critical to Xyrem’s approval by the
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`FDA. The solution resulted in the claimed methods which utilize an exclusive
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`computer database, which has numerous safety checks and/or controls, including
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`restriction of availability, extensive determination of patient and physician identity,
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`and identification of behavioral patterns that suggest illicit drug use.
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`By statute, a patent is subject to CBM review only if the patent “claims a
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`method or corresponding apparatus for performing data processing or other
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`operations used in the practice, administration, or management of a financial
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`product or service. . . . ” AIA § 18(d)(1); 37 C.F.R. 42.301(a) (emphasis added).
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`Petitioners cannot meet their burden to establish that the ’730 patent covers “data
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`processing or other operations used in the practice, administration, or management
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`of a financial product or service” because the ’730 patent has nothing to do with a
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`financial product or service. Here, the ’730 patent’s claims do not cover a
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`financial product or service, or any activities incidental to a financial product or
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`service. As a result of Petitioners’ improper attempt to expand the scope of CBM
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`review to include the ’730 patent, virtually all inventions would be encompassed
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`by the statute.
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`By statute, patents for technological inventions are also exempt from CBM
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`review. Id. Petitioners likewise cannot meet their burden of showing that the
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`claims of the ’730 patent are not directed to technological inventions. The ’730
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`patent claims a novel and nonobvious technological feature, that is a technical
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`solution to a technical problem. The ’730 patent is not eligible for CBM review,
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`and the Petition must be denied.1
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`II. BACKGROUND
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`Petitioners are each defendants in Hatch-Waxman lawsuits involving the
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`’730 patent; each is seeking approval of an Abbreviated New Drug Application
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`1 Patent Owner’s decision to challenge the Petition solely on the grounds set forth
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`in this Preliminary Response should not be construed in any way to be a waiver of
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`its rights to address other issues such as claim construction or patentability. Here,
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`Patent Owner respectfully submits that the Board need not reach such questions in
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`order to dispose of the present Petition for lack of CBM standing. If, however, the
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`Board does institute CBM review of the ’730 patent, Patent Owner reserves the
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`right to address, and will address, all remaining issues in its Patent Owner
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`Response.
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`(“ANDA”) to make a generic version of Xyrem®. Xyrem is a unique drug product.
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`It is the only FDA-approved treatment for cataplexy, a debilitating symptom of
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`narcolepsy, but its active ingredient is a sodium salt of gamma-hydroxybutyric acid
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`(“GHB”), a substance which has been legislatively defined as a “date rape” drug.
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`As a result of Xyrem’s combination of benefits and risks, it is one of the only
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`prescription drugs to be subject to a bifurcated schedule by Congress—in its
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`approved form, Xyrem is a Schedule III drug, but all other forms of GHB are
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`placed on Schedule I (the category for drugs like heroin).
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`Xyrem would never have been approved, however, without an adequate
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`method of restricting access to the drug that the FDA considered capable of
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`ensuring that the benefit of Xyrem would outweigh the risks to patients and third
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`parties. The ’730 patent represents the inventors’ solution to this challenge. Had
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`Jazz’s predecessor Orphan (hereafter “Jazz”) not developed methods for
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`preventing the abuse, misuse and diversion of GHB, Xyrem would not be available
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`to narcolepsy patients today.
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`A. The Challenge of Restricting Access
`to a Dangerous But Efficacious Drug
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`The FDA first recognized the dangers of GHB in the early 1990s when it
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`banned all domestic sales and importation of GHB. (See Ex. 2001; Ex. 2002.)
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`Despite this ban, throughout the following years, the Drug Enforcement
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`Administration, Centers for Disease Control, National Institute on Drug Abuse,
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`Office of National Drug Control Policy, the Substance Abuse and Mental Health
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`Services Administration, and the National Drug Intelligence Center reported
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`increasing problems with GHB, specifically noting its use in committing drug-
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`facilitated sexual assault. (See Ex. 2003; Ex. 2004 at 1-3; Ex. 2005; Ex. 2006 at 1-
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`5, 8-9; Ex. 2007; Ex. 2008 at 1-5.)
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`At the same time that concern about GHB’s illicit use was mounting,
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`however, there was a recognition that GHB had promise as a potential treatment
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`for narcolepsy, an orphan condition—in other words, a debilitating but rare
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`disease. At the FDA’s request, Jazz began developing GHB as a treatment for
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`narcolepsy in the mid-1990s. When the DEA urged Congress to categorize GHB
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`as a Schedule I-controlled substance, meaning that it would not have any FDA-
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`recognized legitimate medical use, advocacy groups for patients with sleep
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`disorders and the FDA itself opposed this plan. (See Ex. 2009 at 67-71; Ex. 2010
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`at 97-103.)
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`In 2000, Congress resolved the matter in favor of the FDA’s
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`recommendation, declaring GHB to be “an imminent hazard to public safety,” but
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`recognizing its potential as a treatment for narcolepsy and cataplexy. (See
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`generally Ex. 2011.) Of note, this legislative compromise, designed to
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`accommodate the concerns of advocates for development of GHB as a treatment
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`for narcolepsy on the one hand, and the concern over misuse of GHB on the other,
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`was premised on assuring that GHB-containing therapeutic products could not be
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`diverted from legitimate channels. As the legislative history makes clear, Congress
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`intended that the availability of GHB would “be strictly controlled to ensure that
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`only patients in need of [the] drug would have access.” (See Ex. 2012 at 4.)
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`Jazz developed the methods claimed in the ’730 patent (described below) to
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`further Congress’s initiative and to protect the public from abuse, misuse and
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`diversion of a drug containing GHB. When the FDA approved Xyrem for
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`treatment of cataplexy in July 2002, the approval letter reminded the sponsor that
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`Xyrem was being approved under a special regulation, 21 CFR 314.520 (“Subpart
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`H”), which allowed the FDA to approve drugs that were shown to be effective but
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`that could only be used safely under restricted conditions. (Ex. 2013 at 1.)
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`Specifically, the approval letter stated that Xyrem was being approved for use
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`under the Risk Management Program developed by Jazz. (Id.) When Xyrem was
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`approved for treatment of excessive daytime sleepiness in narcolepsy in 2005, the
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`FDA again maintained essentially the same restrictions on access to the drug.
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`These core requirements, reflected in the Xyrem label and the ’730 patent’s claims,
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`include various safety checks and controls that are applied to ensure that there is no
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`abuse. (See generally PAR1001; Ex. 2014.)
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`B.
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`The ’730 Patent
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`The methods of preventing abuse, misuse, and diversion of GHB by means
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`of various controls described and claimed in the ’730 patent permit the
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`administration of sodium GHB in order to treat patients. (See PAR1001 at 8:36-
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`12:44; see also id. at Abstract, 1:41-45.) More specifically, the independent claims
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`of the ’730 patent claim methods of:
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`•
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`(i) receiving in a computer processor, at an exclusive central
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`pharmacy, all prescriptions of all patients being prescribed the
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`prescription drug along with information identifying the patient and
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`prescriber;
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`(ii) entering the information into a exclusive computer database for an
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`analysis of potential abuse situations;
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`(iii) checking the prescriber’s credentials to ensure he/she is eligible to
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`prescribe the drug;
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`(iv) confirming with the patient that he/she has read educational
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`materials prior to shipping or providing the prescription drug;
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`(v) checking with the exclusive computer database to determine any
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`potential abuse by the patient and/or prescriber;
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`(vi) mailing or providing the prescription drug to the patient only if
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`the information in the exclusive computer database is not indicative of
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`potential abuse or if no abuse is found by the patient and prescriber;
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`(vii) confirming receipt by the patient of the prescription drug; and
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`(viii) generating periodic reports with the exclusive computer database
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`to evaluate potential prescription drug diversion patterns.
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`(See id. at Claims 1, 2, 6-11.)2
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`The dependent claims add various other limitations for further preventing
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`any possible abuse, misuse or diversion of pharmaceuticals, including GHB,
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`generally comprising: (a) the exclusive central pharmacy controlling the exclusive
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`computer database (id. at Claim 3) and (b) selectively blocking shipment of the
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`prescription drug to a patient. (Id. at Claims 4 and 5.)
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`No element of either the independent or dependent claims requires or covers
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`any element of a financial product or a financial service, or any activities incidental
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`to a financial product or service. The claims do not cover the sale of the
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`prescription drugs or the processing of any health care benefits or insurance claims.
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`Nor do they concern the transfer or accounting of funds. Instead, the claims are
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`2 Claim 6 is dependent upon claim 2, and further identifies the drug as GHB.
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`concerned with preventing the abuse, misuse and diversion of GHB, and other
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`potentially dangerous prescription drugs.
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`III. ARGUMENT
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`A. The ’730 Patent Does Not Claim A Method or
`Corresponding Apparatus for Performing Data Processing or
`Other Operations Used in the Practice, Administration, or
`Management of a Financial Product or Service
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`Petitioners propose five disparate arguments for why a patent on a drug
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`safety system can be said to cover a financial product or service, including: (1) the
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`claimed system “would be used in commerce;” (2) the claims cover activities that
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`are “financial in nature” and “also incidental and complementary to financial
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`activities;” (3) the ’730 patent’s specification contains information that is
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`“incidental to a financial activity;” (4) the PTO classified the ’730 patent within
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`Class 705; and (5) certain prior art references cited against the ’730 patent would
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`allegedly qualify it for CBM review. (Paper 1 at 12-15.) All of these arguments
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`lack merit, on the facts and the law. Taken to their conclusions, each of these
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`arguments would eviscerate the limitation that Congress placed on the CBM
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`review process, turning essentially any method patent into a “covered” business
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`method patent. The Board, therefore, should reject Petitioners’ arguments.
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`1.
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`Covered Business Method Review Eligibility
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`The burden is on Petitioners to establish that the ’730 patent is eligible for
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`CBM review. See 37 C.F.R. § 42.304(a) (“The petitioner must demonstrate that
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`the patent for which review is sought is a covered business method patent . . . .”);
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`see also 77 Fed. Reg. 48756, 48763 (Aug. 14, 2012) (same).
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`The AIA defines “a covered business method patent” as:
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`A patent that claims a method or corresponding apparatus for
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`performing data processing or other operations used in the practice
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`administration, or management of a
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`financial product or
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`service . . . .
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`AIA, § 18(d)(1) (emphasis added). Thus, the Board has consistently stated that
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`CBM eligibility turns on what the patent claims. See, e.g., Monster Worldwide
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`Inc. et al. v. Career Destination Dev., CBM2014-00077, Paper 9 at 7 (Aug. 20,
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`2014) (“The determination of whether a patent is eligible for [CBM] patent review
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`is based on what the patent claims.”); Int’l Sec. Exch., LLC v. Chicago Bd.
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`Options Exch., CBM2013-00050, Paper 16 at 9 (Mar. 4, 2014) (“For purposes of
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`determining whether a patent is eligible for [CBM] review, the focus is on the
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`claims.”). Here, the ’730 patent’s claims do not claim or cover a financial product
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`or service, or any activities incidental to a financial product or service. Petitioners’
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`efforts to avoid this fatal flaw have no merit.
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`2.
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`The Statute Precludes Expansion of CBM Review
`to Encompass All Methods “Used In Commerce”
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`Petitioners argue that the ’730 patent is eligible for CBM review because the
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`claimed inventions would be “used in commerce,” and describe “the core activities
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`of running the very business of a . . . pharmacy.” (Paper 1 at 12; see also id. at 14.)
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`Both of these assertions are unsupported and incorrect. In spite of the conclusory
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`statement that the “claimed system would be used in commerce,” Petitioners and
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`their expert do not identify a single element in the claims that would be used in
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`commerce. Nor do they explain what system they are referring to, much less how
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`it could be used in commerce. For this reason alone, Petitioners’ argument fails.
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`Moreover, if Congress had intended all patents that claim methods used in business
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`to be “covered” by CBM review it would have said so. It did not. The
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`unambiguous language of the statute establishes that the claimed subject matter of
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`the ’730 patent is outside the scope of CBM review.
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`Statutory construction begins with the language of the statute. See Duncan
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`v. Walker, 533 U.S. 167, 172 (2001); Crandon v. United States, 494 U.S. 152, 158
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`(1990). If the meaning of the statute is plain and clear from its language, then the
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`question of interpretation and legislative intent is never raised. See Conn. Nat’l
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`Bank v. Germain, 503 U.S. 249, 253-54 (1992) (“[I]n interpreting a statute a court
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`should always turn first to one, cardinal canon before all others . . . courts must
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`presume that a legislature says in a statute what it means and means in a statute
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`what it says there . . . When the words of a statute are unambiguous, then, this first
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`canon is also the last: ‘judicial inquiry is complete.’”).
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`The plain language of Section 18 of the AIA expressly includes the phrase
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`“financial product or service” within its definition of a CBM patent. See AIA, §
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`18(d)(1). Under the controlling law of statutory construction, this phrase cannot
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`simply be read out of the statute to make any patent that claims methods “used in
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`commerce” or “core to running a business” eligible for CBM review. In fact, the
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`statute does not include any reference to commercial use because virtually all
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`patented subject matter is intended to be used commercially in some sense. As the
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`Supreme Court has stated, “[a] statute should be construed so that effect is given to
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`all its provisions, so that no part will be inoperative or superfluous, void or
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`insignificant.” Corley v. United States, 556 U.S. 303, 314 (2009). The plain
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`language of the statute limiting CBM review to a patent that claims methods for
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`performing data processing or other operations “used in the practice,
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`administration, or management of a financial product or service” is conclusive.
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`Petitioners attempt to turn to the legislative history because the plain
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`language of the statute does not support their attempt to broaden the scope of CBM
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`review. (See Paper 1 at 11-12.) But, if a statute’s plain meaning is clear, then the
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`question of interpretation and legislative intent should never be raised. See Conn.
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`Nat’l, 503 U.S. at 253-54. There is, accordingly, no reason to look to the
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`legislative history to see whether a patent that claims a method for controlling
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`access to a dangerous drug should be subject to CBM review. While Petitioners
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`never state which words of the statute are allegedly ambiguous, a review of the
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`legislative history nevertheless reveals that when Congress limited CBM review to
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`patents that claim methods used in the practice, management or administration of a
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`financial product or service, it did so deliberately, and did not intend to include all
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`patents that are “used in commerce.”
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`(a) Legislative History Does Not Support
`Petitioners’ Statutory Construction
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`While an examination of legislative intent is not appropriate here due to the
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`plain statutory language, Petitioners recite only a sliver of that history in support of
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`their contention that the phrase “financial product or service” should be interpreted
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`broadly. (See Paper 1 at 11-12). When an adjudicator turns to legislative intent,
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`however, the Supreme Court has cautioned that the adjudicator must consider the
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`legislative intent as a whole—not just “isolated fragments” of congressional
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`comments. See New England Power Co. v. New Hampshire, 455 U.S. 331, 342
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`(1982) (“Reliance on such isolated fragments of legislative history in divining the
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`intent of Congress is an exercise fraught with hazards . . . .”); see also Offshore
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`Logistics, Inc. v. Tallentire, 477 U.S. 207, 220-21 (1986) (statements in the
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`legislative history must be read in light of the statutory language and legislative
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`history as a whole).
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`The legislative history of Section 18 of the AIA does not support the broad
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`application of the phrase “financial product or service” to a method, which restricts
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`access to sensitive pharmaceuticals. Petitioners invoke Senator Schumer’s
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`statements that CBM-eligibility is conferred if a patent’s claims are “broad enough
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`Patent Owner Preliminary Response
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`to cover a financial product or service” and that the “practice, administration, or
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`management” language of the CBM definition is “intended to cover any ancillary
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`activities related to a financial product or service.” (See Paper 1 at 12.) Even these
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`select statements do not permit construing claims to a method for restricting access
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`to a prescription drug as falling within the CBM statutory definition. The
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`legislative history “as a whole” makes Petitioner’s arguments even less tenable.
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`See New England Power, 455 U.S. at 342 (“Reliance on such isolated fragments of
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`legislative history in divining the intent of Congress is an exercise fraught with
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`hazards . . . .”).
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`In fact, Petitioners’ selected statements were made by Senator Schumer to
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`question Representative Shuster’s “understanding that the definition of a ‘covered
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`business method patent’ . . . is intended to be narrowly construed to target only
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`those business method patents that are unique to the financial services industry.”
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`157 Cong. Rec. H4497-98 (daily ed. June 23, 2011). A few months after Senator
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`Schumer’s and Representative Shuster’s exchange, on September 8, 2011, just
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`days before the AIA was signed into law and immediately before the Senate agreed
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`to the House amendment on the CBM provision of the AIA, Senator Leahy—the
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`co-sponsor of the AIA—clarified that the phrase “financial product or service” is
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`specifically intended to limit the scope of CBM review to the financial services
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`sector:
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`There has been some question about the scope of patents that may be
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`subject to the transitional program for covered business method
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`patents, which is section 18 of the Leahy-Smith American Invents
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`Act. This provision is intended to cover only those business method
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`patents intended to be used in the practice, administration, or
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`management of financial services or products, and not
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`to
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`technologies common in business environments across sectors and
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`that have no particular relation to the financial services sector . . . A
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`financial product or service is not, however, intended to be limited
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`solely to the operation of banks. Rather it is intended to have a
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`broader industry definition that includes insurance, brokerages,
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`mutual funds, annuities, and an array of financial companies outside
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`of traditional banking.
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`157 Cong. Rec. S5441 (daily ed. Sept. 8, 2011) (emphasis added).
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`Senator Kyl—Senator Schumer’s co-sponsor for Section 18 of the AIA—
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`further clarified that the definition of a CBM patent “is limited to data processing
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`relating to just a financial product or service (rather than also to an enterprise).”
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`157 Cong. Rec. S1367 (daily ed. Mar. 8, 2011) (emphasis added). As defined by
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`the USPTO, an enterprise is a “conventional business organization . . . .” See
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`Manual of Classification, United States Patent & Trademark Office (hereinafter,
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`the “USPTO Manual”) at Class 705. Consistent with Senator Leahy’s comments,
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`Section 18 does not apply to “technologies common in business environments
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`[enterprises] across sectors and that have no particular relation to the financial
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`services sector.” See 157 Cong. Rec. S5441 (daily ed. Sept. 8, 2011).
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`Based on these unambiguous statements by Senators Leahy and Kyl, it is
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`clear that Congress intended to limit CBM review to patents with claims that have
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`a “particular relation to the financial services sector” and not patents that cover
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`technologies common in business operations. This legislative history does not, and
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`cannot, support Petitioners’ attempt to broaden the CBM review to patents “used in
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`commerce.”
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`Congressional intent to limit CBM review is further confirmed in light of
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`attempts to broaden the scope of the CBM review after the AIA’s enactment. In
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`2013, multiple members of Congress, including Senator Schumer, proposed
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`amendments striking the “a financial product or” language from Section 18 of the
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`AIA and replacing it with: “an enterprise, product or.” (See Ex. 2015, Patent
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`Quality Improvement Act of 2013, S. 866, 113th Cong. §2(2) (2013) (introduced
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`by Sen. Schumer); Ex. 2016, Stopping the Offensive Use of Patents Act, H.R.
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`2766, 113th Cong. § 2(a)(2) (2013) (introduced by Rep. Issa and Rep. Chu).)
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`Congress members proposed the amendments because the definition of a CBM
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`patent does not extend beyond the financial services sector. Congress did not
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`adopt, and has never adopted, the more expansive language set forth in the
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`proposed bills.
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`(b) Petitioners’ “Used in Commerce” Argument
`Improperly Expands the Scope of CBM Review To
`Cover Virtually All Method Patent Claims
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`By arguing that the ’730 patent is subject to CBM-review, Petitioners
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`consequentially ask the Board to find that every claimed method or apparatus that
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`could potentially be used in commerce constitutes a CBM patent. This is an
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`interpretation that has never been the basis for a CBM review. Petitioners’ novel
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`interpretation of the statute is particularly disturbing since arguably every patented
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`method is intended to be used in commerce. For pharmaceutical products alone,
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`virtually every patented method for administration or treatment with a prescription
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`drug is used in commerce and would be subject to CBM review under Petitioners’
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`interpretation. This absurd result is clearly not the intended result of the statute
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`and is directly contrary to the Constitutional purpose of the patent system: “To . . .
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`promote the Progress of Science and useful Arts, by securing for limited Times
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`to . . . Inventors the exclusive Right to their respective . . . Discoveries . . . .” Art.
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`I, Sec. 8, Cl. 8. Congress provided the critical “exclusive Right” in the form of a
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`right to exclude others from using one’s invention. See Studiengesellschaft Kohle
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`mbH v. N. Petrochemical Co., 784 F.2d 351, 357 (Fed. Cir. 1986).
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`The U.S. patent system itself is fundamentally about commerce.3 Congress
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`recognized this and that is precisely why, while the scope of CBM review is not
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`narrow, it is also not unlimited. And it certainly cannot be extended to reach any
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`patent that claims methods “used in commerce.” Accordingly, the mere fact that a
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`claimed invention may be used at some point in commerce does not mean that
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`every patent contains the “financial product or service” requirement necessary for
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`CBM eligibility.
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`(c) Petitioners’ Argument Improperly Expands
`the Scope of CBM Review to Capture the Type
`of Invention Congress Expressly Stated
`Would Not Be CBM-Review Eligible
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`Petitioners’ position is also problematic because the unlimited review of
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`method patents would include the very patents that claim inventions Con
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