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`UNl'l"ED S'|'ATE'S DE PARTMENT 0 F‘ COMMERCE
`
`United States Patent and Trademark 0I'I'ic¢
`
`January 14, 2014
`
`THIS IS TO CERTIFY THAT ANNEXED IS ATRUE COPY FROM THE
`RECORDS OF THIS OFFICE OF THE FILE WRAPPER AND CONTENTS
`OF:
`
`APPLICATION NUTVIBER: 10I322,348
`FILING DATE: December 17’, 2002
`PATENT NUBIIBER: 76$73O
`ISSUE DATE: February 23, 2010
`
`Under Secretary of Com merce
`for Intellectual Property
`and Director of the United States
`Patent and Trademark Oflice
`
`PAR1002
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`CBM of U.S. Patent No. 7,668,730-
`Page 1 of 818
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`Page 1 of 818
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`PATENT APPLICATIONFEE DETERMINATION RECORD I I
`'
`EffectiveIJanuary 1, 2003
`i
`cLAIMsAs FILED - PART I
`« C0|Umn1
`
`SMALL ENTITY
`'
`' OTHER THAN
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`TYPE l:l
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`
`
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`NUMBER FILED
`
`.26 minus 20:
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`ASIC FEE 5750.
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`TOTAL CHARGEABLE CLAIMS
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`It the entry in column 1 is less than the entry in column 2, write ‘O’ in column 3.
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`‘* II the "Highest Number Previously Paid For" IN THIS SPACE is less than 20, enter '20.’
`"*"ll the “Highest Number Previously Paid For’ IN THIS SPACE is lessthan 3, enter '3.’
`The ‘Highest Number Previously Paid For" (Total or independent) is the highest number lound in the appropriate box in column 1.
`
`TOTAL
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`Patent and Trademark Ollice, U.S. DEPARTMENT OF CDMMFRCF
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`PAR1002
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`CBM of U.S. Patent No. 7,668,730
`Page 2 of 818
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`[/2 / / fl / 0 (‘L
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Dayton T. Reardan et al.
`In re Patent Application of:
`Title:
`SENSITIVE DRUG DISTRIBUTION SYSTEM AND METHOD
`101.031US1
`
`Attorney Docket No.:
`
`PATENT APPLICATION TRANSMITTAL
`
`BOX PATENT APPLICATION
`Commissioner for Patents
`
`Washington, D.C. 20231
`
`We are transmitting herewith the following attached items and information (as indicated with an "X"):
`
`X
`x
`
`l><
`
`Return postcard.
`Utility Patent Application under 37 CFR § 1.53(b) comprising:
`X Specification (_l§ pgs, including claims numbered L through E and 21 1 page Abstract).
`X Formal Drawing(s) ( _1g sheets).
`2{_ Unsigned Combined Declaration and Power of Attorney ( A pgs).
`Applicant claims small entity status under 37 C.F.R 1.27.
`
`
`
`The filing fee (NOT ENCLOSED) will be calculated as follows:
`MM
`25 - 20 :
`5
`X 9 =
`$45.00
`
`$42.00 TOTAL CLAIMS
`
`INDEPENDENT CLAIMS
`
`4 - 3 =-
`
`I
`
`x 42 =
`
`[
`
`] MULTIPLE DEPENDENT CLAIMS PRESENTED
`
`BASIC FEE
`
`I
`
`5457.00
`
`THE FILING FEE WILL BE PAID UPON RECEIPT OF THE NOTICE TO FILE MISSING PARTS.
`
`
`SCHWEGMAN LUNDBERG WOESSNER & KLUTH P.A.‘
`
`P.O. Box 2938, Minneapolis, MN 55402 (612-373-6900)
`
`Customer Number
`
`1
`
`
`
`Reg.-No. 30,837
`
`"Express Mail" mailing Iabcl number:
`
`Date of Deposit: December 17 2002
`This paper or fee is being deposiled on the date indicated above with the United States Postal Service pursuant to 37 CFR 1.10, and is addressed to
`The Commissioner for Patents, Box Patent Application, Washington, DC. 20231.
`
`EV I49 506 149 US
`
`
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`PAR1002
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`Sensitive Drug Distribution System and Method
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`Field of the Invention
`
`The present invention relates to distribution of drugs, and in particular to the
`
`distribution of sensitive drugs.
`
`Background of the Invention
`
`Sensitive drugs are controlled to minimize risk and ensure that they are not
`
`abused, or cause adverse reactions. Such sensitive drugs are approved for specific uses
`
`by the Food and Drug Administration, and must be prescribed by a licensed physician in
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`order to be purchased by consumers. Some drugs, such as cocaine and other common
`
`street drugs are the object of abuse and illegal schemes to distribute for profit. Some
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`schemes include Dr. shopping, diversion, and pharmacy thefts. A locked cabinet or safe
`
`is a requirement for distribution of some drugs.
`
`Certain agents, such as gamma hydroxy buterate (GH B) are also abused, yet also
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`are effective for therapeutic purposes such as treatment of daytime cataplexy in patients
`
`with narcolepsy. Some patients however, will obtain prescriptions from multiple doctors,
`
`and have them filled at different pharmacies. Still further, an unscrupulous physician
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`may actually write multiple prescriptions for a patient, or multiple patients, who use cash
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`to pay for the drugs. These patients will then sell the drug to dealers or others for pro lit.
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`There is a need for a distribution system and method that directly addresses these
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`abuses. There is a further need for such a system and method that provides education and
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`limits the potential for such abuse.
`
`l0
`
`15
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`20
`
`25
`
`Summary of the Invention
`
`A drug distribution system and method utilizes a central pharmacy and database
`
`to track all prescriptions for a sensitive drug. Information is kept in a central database
`
`regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving
`
`the drug. Abuses are identified by monitoring data in the database for prescription
`
`pattems by physicians and prescriptions obtained by patients. Further verification is
`
`Docket
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`101.03 lUSl
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`1
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`made that the physician is eligible to prescribe the drug by consulting a separate database
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`for a valid DEA license, and optionally state medical boards to determine whether any
`corrective or approved disciplinary actions relating to controlled substances have been
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`brought against the physician. Multiple controls beyond those for traditional drugs are
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`imposed on the distribution depending on the sensitivity of the drug.
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`Education is provided to both physician and patient. Prior to shipping the drug
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`for the first time, the patient is contacted to ensure that product and abuse related
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`educational materials have been received and/or read. The patient may provide the name
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`of a designee to the central pharmacy who is authorized to accept shipment of the drug.
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`Receipt of the initial drug shipment is confirmed by contacting the patient. Either a
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`phone call or other communication to the patient within a set time after delivery may be
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`made to ensure receipt. Further, a courier service’s tracking system is used to confirm
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`delivery in further embodiments. If a shipment is lost, an investigation is launched to
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`find it.
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`In one embodiment, the drug may be shipped by the central pharmacy to another
`pharmacy for patient pick-up. The second pharmacy’s ability to protect against diversion
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`before shipping the drug must be confirmed. This ability may be checked through NTIS
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`and State Boards of Pharmacy.
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`Prescription refills are permitted in the number specified in the original
`
`prescription.
`
`ln addition, if a prescription refill is requested by the patient prior to the
`
`anticipated due date, such refills will be questioned. A lost, stolen, destroyed or spilled
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`prescription/supply is documented and replaced to the extent necessary to honor the
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`10
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`15
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`20
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`prescription, and will also cause a review or full investigation.
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`The exclusive central database contains all relevant data related to distribution of
`the drug and process of distributing it, including patient, physiciah and prescription
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`25
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`information. Several queries and reports are run against the database to provide
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`information which might reveal potential abuse of the sensitive drug; such as early refills.
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`30
`
`FIG. 1
`
`is a block diagram of a computer system for use in implementing the
`system and method of the present invention.
`
`Brief Description of the Drawings
`
`Docket
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`101.03 1USl
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`2
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`PAR1002
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`FIG.s 2A, 2B and 2C are a flowchart describing a method for sensitive drug distribution
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`at least partially utilizing a computer system such as that shown in FIG. 1.
`
`FIG. 3
`
`is a flowchart of a physician success program at least partially
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`implemented on a computer system such as that shown in FIG. 1.
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`FIG.s 4A and 4B are a flowchart describing a method for handling refill requests at least
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`partially utilizing a computer system such as that shown in FIG. 1.
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`FIG. 5
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`is a flowchart of a process for requesting special reimbursement when a
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`patient is uninsured or undcrinsured at least partially utilizing a computer
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`10
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`FIG. 6
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`is a flowchart of a process for inventory control at least partially utilizing a
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`system as that shown in FIG. 1.
`
`FIG. 7
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`FIG. 8
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`FIG. 9
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`15
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`FIG. 10
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`computer system such as that shown in FIG. 1.
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`is a block diagram of database fields.
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`is a block diagram showing a list of queries against the database fields.
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`is a copy of one example prescription and enrollment form.
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`is a copy of one example of a NORD application request form for patient
`financial assistance.
`
`FIG. 11
`
`is a copy of one example voucher request for medication for use with the
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`20
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`25
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`30
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`NORD application request form of FIG. 10.
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`FIG. 12
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`is a copy ofcertificate ofmedical need.
`
`FIG.s 13A, 13B and 13C are descriptions of sample reports obtained by querying a
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`central database having fields represented in FIG. 7.
`
`Detailed Description of the Invention
`
`In the following description, reference is made to the accompanying drawings that
`
`form a part hereof, and in which is shown by way of illustration specific embodiments in
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`which the invention may be practiced. These embodiments are described in sufficient
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`detail to enable those skilled in the art to practice the invention, and it is to be understood
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`that other embodiments may be utilized and that structural, logical and electrical changes
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`may be made without departing from the scope of the present invention. The following
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`description is, therefore, not to be taken in a limited sense, and the scope of the present
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`invention is defined by the appended claims.
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`Docket
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`l01.03lUSl
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`PAR1002
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`The functions or algorithms described herein are implemented in software or a
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`combination of software and human implemcntcd procedures in one embodiment. The
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`software comprises computer executable instructions stored on computer readable media
`
`such as memory or other type of storage devices. The term “computer readable media" is
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`also used to represent carrier waves on which the software is transmitted. Further, such
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`functions correspond to modules, which are software, hardware, firmware of any
`
`combination thereof. Multiple functions are performed in one or more modules as
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`desired, and the embodiments described are merely examples. The software is executed
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`on a digital signal processor, ASIC, microprocessor, or other type of processor operating
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`on a computer system, such as a personal computer, server or other computer system.
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`A sensitive drug is one which can be abused, or has addiction properties or other
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`properties that render the drug sensitive. One example of such a drug is sodium oxybatc,
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`also known as gamma hydroxy butyrate (GHB C4H7NaO3) which is useful for treatment
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`of cataplexy in patients with narcolepsy. GHB is marketed under the trademark of
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`Xyrem® (sodium oxybate oral solution), which trademark can be used interchangeably
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`with GHB herein. Sensitive drugs also include narcotics or other drugs which require
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`controls on their distribution and use to monitor behaviors to prevent abuse and adverse
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`side effects.
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`In one embodiment, Xyrem® is subject to a restricted distribution program. One
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`aspect of the program is to educate physicians and patients about the risks and benefits of
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`Xyrem, including support via ongoing contact with patients and a toll free helpline.
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`Initial prescriptions are filled only after a prescriber and patient have received and read
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`the educational materials. Further, patient and prescribing physician registries are
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`maintained and monitored to ensure proper distribution.
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`In a further embodiment, bulk sodium oxybate is manufactured at a single site, as
`
`is the finished drug product. Following manufacture of the drug product, it is stored at a
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`facility compliant with FDA Schedule III regulations, where a consignment inventory is
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`maintained. The inventory is owned by a company, and is managed by a central
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`pharmacy, which maintains the consignment inventory. Xyrem® is distributed and
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`dispensed through a primary and exclusive central pharmacy, and is not stocked in retail
`
`10
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`25
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`30
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`Docket
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`pharmacy outlets. It is distributed by overnight carriers, or by US mail in one
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`embodiment to potentially invoke mail fraud laws if attempts of abuse occur.
`
`FIG. 1 is a simplified block diagram of a computer system 100, such as a personal
`
`computer for implementing at least a portion of the methods described herein. A central
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`processing unit (CPU) 110 executes computer programs stored on a memory 120.
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`Memory 120 in one embodiment comprises one or more levels of cache as desired to
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`speed execution of the program and access to data on which the programs operate. The
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`CPU is directly coupled to memory 120 in one embodiment. Both CPU 110 and memory
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`120 are coupled to a bus 130. A storage 140, 1/0 150 and communications 160 are also
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`coupled to the bus 130. Storage 140 is usually a long term storage device, such as a disk
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`drive, tape drive, DVD, CD or other type of storage device. In one embodiment, storage
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`140 is used to house a database for use with the present invention. I/O l5O comprises
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`keyboards, sound devices, displays and other mechanisms by which a user interacts with
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`the computer system 100. Communications 160 comprises a network, phone connection,
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`local area network, wide area network or other mechanism for communicating with
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`external devices. Such external devices comprise servers, other peer computers and other
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`devices. In one embodiment, such external device comprises a database server that is
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`used in place of the database on storage 140. Other computer system architectures
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`capable of executing software and interacting with a database and users may also be used.
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`Appropriate security measures such as encryption are used to ensure confidentiality.
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`Further, data integrity and backup measures are also used to prevent data loss.
`
`FIGS 2A, 2B and 2C represent an initial prescription order entry process for a
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`sensitive drug, such as Xyrem. At 202, a medical doctor (MD) sends a Rx/enrollment
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`form via mail, fax, email or other means to an intake/reimbursement specialist at 204,
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`who makes a copy of the RX/enrollment form that is stamped “copy”. The original fax is
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`forwarded to a pharmacy team. The enrollment form contains prescriber information,
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`prescription information, checkboxes for the prescriber indicating they have read
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`materials, educated the patient, understand the use in treatment, and understand certain
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`safety information, and also contains patient information.
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`The prescriber information contains standard contact information as well as
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`license number, DEA number and physician specialty. Patient and prescription
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`Docket
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`information includes name, social security number, date of birth, gender, contact
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`inforrnation, drug identification, patient’s appropriate dosage, and number of refills
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`allowed, along with a line for the prescriber’s signature. Patient insurance information is
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`also provided.
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`There are two workflows involved at the phannacy team, intake reimbursement
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`206 and pharmacy workflow 208, which may proceed in parallel or serially. The intake
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`work flow 206 starts with an intake reimbursement specialist entering the patient and
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`physician information into an application/database referred to as CHIPS, which is used to
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`maintain a record of a client home infusion program (CHIP) for Xyrem®. A check is
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`made to ensure the information is complete at 212. If not, at 214, an intake representative
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`attempts to reach the MD or prescriber to obtain the missing information. If the missing
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`information has not been obtained within a predetermined period of time, such as 24
`
`hours at 216, the Rx/Enrollment form is sent back to the MD with a rejection explanation.
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`A note is entered in CHIPS that the application was rejected.
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`If the information is complete at 212, the MD is contacted at 220 to verify receipt
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`and accuracy of the patient’s Rx. This contact is recorded in CHIPS. The intake and
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`reimbursement specialist then sends a consent form and a cover letter to the patient at
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`224. The insurance provider is contacted at 226 to verify coverage and benefits. At 228,
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`a determination is made regarding coverage for the drug. If it is not available, it is
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`determined at 230 whether the patient is willing and able to pay. If not, a process is
`
`performed for handling patients who are uninsured or underinsured. In one embodiment,
`
`the process is referred to as a NORD process.
`
`If the patient is willing and able to pay at 230, the patient is informed of the cost
`
`of the product and is given payment options at 234. At 236, once payment is received,
`
`the intake reimbursement specialist submits a coverage approval form with the
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`enrollment form to the pharmacy team as notification to process the patient’s
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`prescription. If coverage is approved at 228, the intake reimbursement specialist also
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`submits the coverage approval fonn with the enrollment form to the pharmacy team as
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`10
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`notification to process the patient’s prescription. Processing of the prescription is
`described below.
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`30
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`Docket
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