[USC10] 26 USC 45: Electricity produced from certain renewable resources, etc.
§45. Electricity produced from certain renewable resources, etc.
(B) sold by the taxpayer to an unrelated person during the taxable year.
The 1.5 cent amount in subsection (a), the 8 cent amount in paragraph (1), the $4.375 amount in subsection (e)(8)(A), the $2 amount in subsection (e)(8)(D)(ii)(I), and in subsection (e)(8)(B)(i) the reference price of fuel used as a feedstock (within the meaning of subsection (c)(7)(A)) in 2002 shall each be adjusted by multiplying such amount by the inflation adjustment factor for the calendar year in which the sale occurs. If any amount as increased under the preceding sentence is not a multiple of 0.1 cent, such amount shall be rounded to the nearest multiple of 0.1 cent.
(B) the denominator of which is the aggregate amount of additions to the capital account for the project for the taxable year and all prior taxable years.
The amounts under the preceding sentence for any taxable year shall be determined as of the close of the taxable year. This paragraph shall not apply with respect to any facility described in subsection (d)(2)(A)(ii).
In the case of electricity produced and sold in any calendar year after 2003 at any qualified facility described in paragraph (3), (5), (6), (7), (9), or (11) of subsection (d), the amount in effect under subsection (a)(1) for such calendar year (determined before the application of the last sentence of paragraph (2) of this subsection) shall be reduced by one-half.
Except as provided in clause (ii) or clause (iii), in the case of any facility described in paragraph (3), (4), (5), (6), or (7) of subsection (d), the 5-year period beginning on the date the facility was originally placed in service shall be substituted for the 10-year period in subsection (a)(2)(A)(ii).
In the case of any facility described in subsection (d)(3)(A)(ii) placed in service before the date of the enactment of this paragraph, the 5-year period beginning on January 1, 2005, shall be substituted for the 10-year period in subsection (a)(2)(A)(ii).
Clause (i) shall not apply to any facility placed in service after the date of the enactment of this clause.
(C) in the case of any facility the construction of which begins after December 31, 2018, and before January 1, 2020, 60 percent.
(I) marine and hydrokinetic renewable energy.
The term "closed-loop biomass" means any organic material from a plant which is planted exclusively for purposes of being used at a qualified facility to produce electricity.
(III) agriculture sources, including orchard tree crops, vineyard, grain, legumes, sugar, and other crop by-products or residues.
Such term shall not include closed-loop biomass or biomass burned in conjunction with fossil fuel (cofiring) beyond such fossil fuel required for startup and flame stabilization.
The term "agricultural livestock waste nutrients" means agricultural livestock manure and litter, including wood shavings, straw, rice hulls, and other bedding material for the disposition of manure.
The term "agricultural livestock" includes bovine, swine, poultry, and sheep.
The term "geothermal energy" means energy derived from a geothermal deposit (within the meaning of section 613(e)(2)).
(B) the nameplate capacity rating of which is not less than 150 kilowatts but is less than 5 megawatts.
The term "municipal solid waste" has the meaning given the term "solid waste" under section 1004(27) of the Solid Waste Disposal Act (42 U.S.C. 6903), except that such term does not include paper which is commonly recycled and which has been segregated from other solid waste (as so defined).
(ii) which is steel industry fuel.
The term "qualified emission reduction" means a reduction of at least 20 percent of the emissions of nitrogen oxide and at least 40 percent of the emissions of either sulfur dioxide or mercury released when burning the refined coal (excluding any dilution caused by materials combined or added during the production process), as compared to the emissions released when burning the feedstock coal or comparable coal predominantly available in the marketplace as of January 1, 2003.
(II) is used as a feedstock for the manufacture of coke.
The term "coal waste sludge" means the tar decanter sludge and related byproducts of the coking process, including such materials that have been stored in ground, in tanks and in lagoons, that have been treated as hazardous wastes under applicable Federal environmental rules absent liquefaction and processing with coal into a feedstock for the manufacture of coke.
(ii) in the case of any nonhydroelectric dam described in subparagraph (C), the hydropower production from the facility for the taxable year.
For purposes of subparagraph (A), incremental hydropower production for any taxable year shall be equal to the percentage of average annual hydropower production at the facility attributable to the efficiency improvements or additions of capacity placed in service after the date of the enactment of this paragraph, determined by using the same water flow information used to determine an historic average annual hydropower production baseline for such facility. Such percentage and baseline shall be certified by the Federal Energy Regulatory Commission.
For purposes of clause (i), the determination of incremental hydropower production shall not be based on any operational changes at such facility not directly associated with the efficiency improvements or additions of capacity.
(iii) the hydroelectric project is operated so that the water surface elevation at any given location and time that would have occurred in the absence of the hydroelectric project is maintained, subject to any license requirements imposed under applicable law that change the water surface elevation for the purpose of improving environmental quality of the affected waterway.
The Secretary, in consultation with the Federal Energy Regulatory Commission, shall certify if a hydroelectric project licensed at a nonhydroelectric dam meets the criteria in clause (iii). Nothing in this section shall affect the standards under which the Federal Energy Regulatory Commission issues licenses for and regulates hydropower projects under part I of the Federal Power Act.
(ii) were held in trust by the United States for the benefit of an Indian tribe or its members.
For purposes of this paragraph, the term "Indian tribe" has the meaning given such term by section 7871(c)(3)(E)(ii).
(iv) differentials in ocean temperature (ocean thermal energy conversion).
Such term shall not include any energy which is derived from any source which utilizes a dam, diversionary structure (except as provided in subparagraph (A)(iii)), or impoundment for electric power production purposes.
In the case of a facility using wind to produce electricity, the term "qualified facility" means any facility owned by the taxpayer which is originally placed in service after December 31, 1993, and the construction of which begins before January 1, 2020. Such term shall not include any facility with respect to which any qualified small wind energy property expenditure (as defined in subsection (d)(4) of section 25D) is taken into account in determining the credit under such section.
(ii) owned by the taxpayer which before January 1, 2018, is originally placed in service and modified to use closed-loop biomass to co-fire with coal, with other biomass, or with both, but only if the modification is approved under the Biomass Power for Rural Development Programs or is part of a pilot project of the Commodity Credit Corporation as described in 65 Fed. Reg. 63052.
For purposes of clause (ii), a facility shall be treated as modified before January 1, 2018, if the construction of such modification begins before such date.
Such term shall include a new unit placed in service after the date of the enactment of this subparagraph in connection with a facility described in subparagraph (A)(i), but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit.
(ii) if the owner of such facility is not the producer of the electricity, the person eligible for the credit allowable under subsection (a) shall be the lessee or the operator of such facility.
(ii) in the case of any other facility, the construction of which begins before January 1, 2018.
Such term shall include a new unit placed in service after the date of the enactment of this subparagraph in connection with a facility described in subparagraph (A), but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit.
In the case of any facility described in subparagraph (A), if the owner of such facility is not the producer of the electricity, the person eligible for the credit allowable under subsection (a) shall be the lessee or the operator of such facility.
(B) in the case of a facility using geothermal energy, the construction of which begins before January 1, 2018.
Such term shall not include any property described in section 48(a)(3) the basis of which is taken into account by the taxpayer for purposes of determining the energy credit under section 48.
In the case of a facility using small irrigation power to produce electricity, the term "qualified facility" means any facility owned by the taxpayer which is originally placed in service after the date of the enactment of this paragraph and before October 3, 2008.
In the case of a facility producing electricity from gas derived from the biodegradation of municipal solid waste, the term "qualified facility" means any facility owned by the taxpayer which is originally placed in service after the date of the enactment of this paragraph and the construction of which begins before January 1, 2018.
In the case of a facility (other than a facility described in paragraph (6)) which uses municipal solid waste to produce electricity, the term "qualified facility" means any facility owned by the taxpayer which is originally placed in service after the date of the enactment of this paragraph and the construction of which begins before January 1, 2018. Such term shall include a new unit placed in service in connection with a facility placed in service on or before the date of the enactment of this paragraph, but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit.
(B) with respect to any other facility producing refined coal, any facility placed in service after the date of the enactment of the American Jobs Creation Act of 2004 and before January 1, 2012.
(ii) any other facility placed in service after the date of the enactment of this paragraph and the construction of which begins before January 1, 2018.
In the case of a qualified facility described in subparagraph (A), the 10-year period referred to in subsection (a) shall be treated as beginning on the date the efficiency improvements or additions to capacity are placed in service.
For purposes of subparagraph (A)(i), an efficiency improvement or addition to capacity shall be treated as placed in service before January 1, 2018, if the construction of such improvement or addition begins before such date.
The term "Indian coal production facility" means a facility that produces Indian coal.
(B) which is originally placed in service on or after the date of the enactment of this paragraph and the construction of which begins before January 1, 2018.
The Secretary shall, not later than April 1 of each calendar year, determine and publish in the Federal Register the inflation adjustment factor and the reference price for such calendar year in accordance with this paragraph.
The term "inflation adjustment factor" means, with respect to a calendar year, a fraction the numerator of which is the GDP implicit price deflator for the preceding calendar year and the denominator of which is the GDP implicit price deflator for the calendar year 1992. The term "GDP implicit price deflator" means the most recent revision of the implicit price deflator for the gross domestic product as computed and published by the Department of Commerce before March 15 of the calendar year.
The term "reference price" means, with respect to a calendar year, the Secretary's determination of the annual average contract price per kilowatt hour of electricity generated from the same qualified energy resource and sold in the previous year in the United States. For purposes of the preceding sentence, only contracts entered into after December 31, 1989, shall be taken into account.
In the case of a facility in which more than 1 person has an ownership interest, except to the extent provided in regulations prescribed by the Secretary, production from the facility shall be allocated among such persons in proportion to their respective ownership interests in the gross sales from such facility.
Persons shall be treated as related to each other if such persons would be treated as a single employer under the regulations prescribed under section 52(b). In the case of a corporation which is a member of an affiliated group of corporations filing a consolidated return, such corporation shall be treated as selling electricity to an unrelated person if such electricity is sold to such a person by another member of such group.
(ii) sold to a utility pursuant to a contract originally entered into before January 1, 1987 (whether or not amended or restated after that date).
(II) sold to a third party subject to a mutually agreed upon advance notice to the utility.
For purposes of this subparagraph, avoided cost prices shall be determined as provided for in 18 CFR 292.304(d)(1) or any successor regulation.
(II) during such 10-year period and such taxable year.
Rules similar to the rules of the subsection (b)(3) and paragraphs (1) through (5) of this subsection shall apply for purposes of determining the amount of any increase under this paragraph.
(II) in applying this paragraph to steel industry fuel, the modifications in clause (ii) shall apply.
Subparagraph (A) shall be applied by substituting "$2 per barrel-of-oil equivalent" for "$4.375 per ton".
In lieu of the 10-year period referred to in clauses (i) and (ii)(II) of subparagraph (A), the credit period shall be the period beginning on the later of the date such facility was originally placed in service, the date the modifications described in clause (iii) were placed in service, or October 1, 2008, and ending on the later of December 31, 2009, or the date which is 1 year after the date such facility or the modifications described in clause (iii) were placed in service.
Subparagraph (B) shall not apply.
The modifications described in this clause are modifications to an existing facility which allow such facility to produce steel industry fuel.
For purposes of this subparagraph, a barrel-of-oil equivalent is the amount of steel industry fuel that has a Btu content of 5,800,000 Btus.
The term "qualified facility" shall not include any facility which produces electricity from gas derived from the biodegradation of municipal solid waste if such biodegradation occurred in a facility (within the meaning of section 45K) the production from which is allowed as a credit under section 45K for the taxable year or any prior taxable year.
The term "refined coal production facility" shall not include any facility the production from which is allowed as a credit under section 45K for the taxable year or any prior taxable year (or under section 29,1 as in effect on the day before the date of enactment of the Energy Tax Incentives Act of 2005, for any prior taxable year).
In the case of a facility producing steel industry fuel, clause (i) shall not apply to so much of the refined coal produced at such facility as is steel industry fuel.
(II) during such 12-year period and such taxable year.
(II) $2.00 in the case of calendar years beginning after 2009.
In the case of any calendar year after 2006, each of the dollar amounts under clause (i) shall be equal to the product of such dollar amount and the inflation adjustment factor determined under paragraph (2)(B) for the calendar year, except that such paragraph shall be applied by substituting "2005" for "1992".
Rules similar to the rules of the subsection (b)(3) and paragraphs (1), (3), (4), and (5) of this subsection shall apply for purposes of determining the amount of any increase under this paragraph.
In the case of an eligible cooperative organization, any portion of the credit determined under subsection (a) for the taxable year may, at the election of the organization, be apportioned among patrons of the organization on the basis of the amount of business done by the patrons during the taxable year.
(ii) shall be included in the amount determined under subsection (a) for the first taxable year of each patron ending on or after the last day of the payment period (as defined in section 1382(d)) for the taxable year of the organization or, if earlier, for the taxable year of each patron ending on or after the date on which the patron receives notice from the cooperative of the apportionment.
shall be treated as an increase in tax imposed by this chapter on the organization. Such increase shall not be treated as tax imposed by this chapter for purposes of determining the amount of any credit under this chapter.
For purposes of this section the term "eligible cooperative" means a cooperative organization described in section 1381(a) which is owned more than 50 percent by agricultural producers or by entities owned by agricultural producers. For this purpose an entity owned by an agricultural producer is one that is more than 50 percent owned by agricultural producers.
The date of the enactment of this paragraph, the date of the enactment of this clause, the date of the enactment of this subclause, and the date of the enactment of the American Jobs Creation Act of 2004, referred to in subsecs. (b)(4)(B)(ii) and (d)(2)(C)(i), (3)(A)(i), (4) to (8), is the date of enactment of Pub. L. 108–357, which was approved Oct. 22, 2004.
The date of the enactment of this clause and the date of the enactment of this paragraph, referred to in subsecs. (b)(4)(B)(iii), (c)(8), and (d)(9)(A), are the date of enactment of Pub. L. 109–58, which was approved Aug. 8, 2005.
The Federal Power Act, referred to in subsec. (c)(8)(C), is act June 10, 1920, ch. 285, 41 Stat. 1063 . Part I of the Act is classified generally to subchapter I (§791a et seq.) of chapter 12 of Title 16, Conservation. For complete classification of this Act to the Code, see section 791a of Title 16 and Tables.
The date of the enactment of this subparagraph and the date of the enactment of this paragraph, referred to in subsec. (d)(2)(B), (3)(B), (11), are the date of enactment of Pub. L. 110–343, which was approved Oct. 3, 2008.
Section 29, referred to in subsec. (e)(9)(B)(i), was redesignated section 45K of this title by Pub. L. 109–58, title XIII, §1322(a)(1), Aug. 8, 2005, 119 Stat. 1011 .
The date of enactment of the Energy Tax Incentives Act of 2005, referred to in subsec. (e)(9)(B)(i), is the date of enactment of title XIII of Pub. L. 109–58, which was approved Aug. 8, 2005.
A prior section 45 was renumbered section 37 of this title.
2018-Subsec. (c)(6). Pub. L. 115–141, §401(a)(14), substituted "section 1004(27)" for "section 2(27)".
Subsec. (c)(7)(A)(i)(II). Pub. L. 115–141, §401(a)(15), substituted "for the purpose" for "for purpose".
Subsec. (c)(7)(A)(i)(III). Pub. L. 115–141, §401(a)(16), substituted ", or" for period at end.
Subsec. (d). Pub. L. 115–123, §40409(a), substituted "January 1, 2018" for "January 1, 2017" wherever appearing.
Subsec. (e)(10)(A)(i), (ii)(II). Pub. L. 115–123, §40408(a), substituted "12-year period" for "11-year period".
2015-Subsec. (b)(5). Pub. L. 114–113, §301(a)(2), added par. (5).
Subsec. (d)(1). Pub. L. 114–113, §301(a)(1), substituted "January 1, 2020" for "January 1, 2015".
Subsec. (d)(2)(A). Pub. L. 114–113, §187(a)(1), substituted "January 1, 2017" for "January 1, 2015" wherever appearing.
Subsec. (d)(3)(A)(i)(I), (ii). Pub. L. 114–113, §187(a)(2), substituted "January 1, 2017" for "January 1, 2015".
Subsec. (d)(4)(B). Pub. L. 114–113, §187(a)(3), substituted "January 1, 2017" for "January 1, 2015".
Subsec. (d)(6). Pub. L. 114–113, §187(a)(4), substituted "January 1, 2017" for "January 1, 2015".
Subsec. (d)(7). Pub. L. 114–113, §187(a)(5), substituted "January 1, 2017" for "January 1, 2015".
Subsec. (d)(9)(A)(i), (ii), (C). Pub. L. 114–113, §187(a)(6), substituted "January 1, 2017" for "January 1, 2015".
Subsec. (d)(10). Pub. L. 114–113, §186(b), amended par. (10) generally. Prior to amendment, text read as follows: "In the case of a facility that produces Indian coal, the term 'Indian coal production facility' means a facility which is placed in service before January 1, 2009."
Subsec. (d)(11)(B). Pub. L. 114–113, §187(a)(7), substituted "January 1, 2017" for "January 1, 2015".
Subsec. (e)(10)(A)(i). Pub. L. 114–113, §186(a), substituted "11-year period" for "9-year period".
Subsec. (e)(10)(A)(ii)(I). Pub. L. 114–113, §186(c), inserted "(either directly by the taxpayer or after sale or transfer to one or more related persons)" after "unrelated person".
Subsec. (e)(10)(A)(ii)(II). Pub. L. 114–113, §186(a), substituted "11-year period" for "9-year period".
Subsec. (e)(10)(D). Pub. L. 114–113, §186(d)(2), struck out subpar. (D). Text read as follows: "The increase in the credit determined under subsection (a) by reason of this paragraph with respect to any facility shall be treated as a specified credit for purposes of section 38(c)(4)(A) during the 4-year period beginning on the later of January 1, 2006, or the date on which such facility is placed in service by the taxpayer."
2014-Subsec. (b)(2). Pub. L. 113–295, §210(g)(1), substituted "$2 amount" for "$3 amount".
Subsec. (d). Pub. L. 113–295, §155(a), substituted "January 1, 2015" for "January 1, 2014" wherever appearing.
Subsec. (e)(10)(A)(i), (ii)(II). Pub. L. 113–295, §154(a), substituted "9-year period" for "8-year period".
2013-Subsec. (c)(6). Pub. L. 112–240, §407(a)(2), inserted ", except that such term does not include paper which is commonly recycled and which has been segregated from other solid waste (as so defined)" after "(42 U.S.C. 6903)".
Subsec. (d)(1). Pub. L. 112–240, §407(a)(3)(A)(i), substituted "the construction of which begins before January 1, 2014" for "before January 1, 2014".
Pub. L. 112–240, §407(a)(1), substituted "January 1, 2014" for "January 1, 2013".
Subsec. (d)(2)(A). Pub. L. 112–240, §407(a)(3)(B), inserted concluding provisions.
Subsec. (d)(2)(A)(i). Pub. L. 112–240, §407(a)(3)(A)(ii), substituted "the construction of which begins before January 1, 2014" for "before January 1, 2014".
Subsec. (d)(3)(A)(i)(I). Pub. L. 112–240, §407(a)(3)(A)(iii), substituted "the construction of which begins before January 1, 2014" for "before January 1, 2014".
Subsec. (d)(3)(A)(ii). Pub. L. 112–240, §407(a)(3)(C), substituted "the construction of which begins" for "is originally placed in service".
Subsec. (d)(4). Pub. L. 112–240, §407(a)(3)(D)(i), substituted "and which-", subpars. (A) and (B), and concluding provisions for "and before January 1, 2014 (January 1, 2006, in the case of a facility using solar energy). Such term shall not include any property described in section 48(a)(3) the basis of which is taken into account by the taxpayer for purposes of determining the energy credit under section 48."
Subsec. (d)(6). Pub. L. 112–240, §407(a)(3)(A)(iv), substituted "the construction of which begins before January 1, 2014" for "before January 1, 2014".
Subsec. (d)(7). Pub. L. 112–240, §407(a)(3)(A)(v), substituted "the construction of which begins before January 1, 2014" for "before January 1, 2014".
Subsec. (d)(9). Pub. L. 112–240, §407(a)(3)(E), designated introductory provisions as subpar. (A) and inserted heading, redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), realigned margins, added subpar. (C), and redesignated former subpar. (C) as (B).
Subsec. (d)(9)(B). Pub. L. 112–240, §407(a)(3)(A)(vi), substituted "the construction of which begins before January 1, 2014" for "before January 1, 2014".
Subsec. (d)(11)(B). Pub. L. 112–240, §407(a)(3)(A)(vii), substituted "the construction of which begins before January 1, 2014" for "before January 1, 2014".
Subsec. (e)(10)(A)(i), (ii)(II). Pub. L. 112–240, §406(a), substituted "8-year period" for "7-year period".
2010-Subsec. (d)(8)(B). Pub. L. 111–312 substituted "January 1, 2012" for "January 1, 2010".
2009-Subsec. (d)(1). Pub. L. 111–5, §1101(a)(1), substituted "2013" for "2010".
Subsec. (d)(2)(A)(i), (ii), (3)(A)(i)(I), (ii), (4). Pub. L. 111–5, §1101(a)(2), substituted "2014" for "2011".
Subsec. (d)(5). Pub. L. 111–5, §1101(b), substituted "and before October 3, 2008." for "and before the date of the enactment of paragraph (11)."
Subsec. (d)(6), (7), (9)(A), (B). Pub. L. 111–5, §1101(a)(2), substituted "2014" for "2011".
Subsec. (d)(11)(B). Pub. L. 111–5, §1101(a)(3), substituted "2014" for "2012".
2008-Subsec. (b)(2). Pub. L. 110–343, §108(b)(2), inserted "the $3 amount in subsection (e)(8)(D)(ii)(I)," after "subsection (e)(8)(A),".
Subsec. (b)(4)(A). Pub. L. 110–343, §102(d), substituted "(9), or (11)" for "or (9)".
Subsec. (c)(1)(I). Pub. L. 110–343, §102(a), added subpar. (I).
Subsec. (c)(7)(A). Pub. L. 110–343, §108(a)(1), reenacted heading without change and amended text generally. Prior to amendment, subpar. (A) defined "refined coal".
Subsec. (c)(7)(A)(i). Pub. L. 110–343, §101(b)(1), amended subsec. (c)(7)(A)(i) as amended by Pub. L. 110–348, §108(a)(1), by inserting "and" at end of subcl. (II), substituting period for ", and" at end of subcl. (III), and striking out subcl. (IV) which read as follows: "is produced in such a manner as to result in an increase of at least 50 percent in the market value of the refined coal (excluding any increase caused by materials combined or added during the production process), as compared to the value of the feedstock coal, or".
Subsec. (c)(7)(B). Pub. L. 110–343, §101(b)(2), inserted "at least 40 percent of the emissions of" after "nitrogen oxide and".
Subsec. (c)(7)(C). Pub. L. 110–343, §108(a)(2), added subpar. (C).
Subsec. (c)(8)(C). Pub. L. 110–343, §101(e), reenacted heading without change and amended text generally. Prior to amendment, subpar. (C) described a nonhydroelectric dam facility for purposes of subpar. (A).
Subsec. (c)(10). Pub. L. 110–343, §102(b), added par. (10).
Subsec. (d)(1). Pub. L. 110–343, §106(c)(3)(B), inserted at end "Such term shall not include any facility with respect to which any qualified small wind energy property expenditure (as defined in subsection (d)(4) of section 25D) is taken into account in determining the credit under such section."
Pub. L. 110–343, §101(a)(1), substituted "January 1, 2010" for "January 1, 2009".
Subsec. (d)(2)(A). Pub. L. 110–343, §101(a)(2)(A), substituted "January 1, 2011" for "January 1, 2009" in cls. (i) and (ii).
Subsec. (d)(2)(B), (C). Pub. L. 110–343, §101(d)(2), added subpar. (B) and redesignated former subpar. (B) as (C).
Subsec. (d)(3)(A). Pub. L. 110–343, §101(a)(2)(B), substituted "January 1, 2011" for "January 1, 2009" in cls. (i)(I) and (ii).
Subsec. (d)(3)(B), (C). Pub. L. 110–343, §101(d)(1), added subpar. (B) and redesignated former subpar. (B) as (C).
Subsec. (d)(4). Pub. L. 110–343, §101(a)(2)(C), substituted "January 1, 2011" for "January 1, 2009".
Subsec. (d)(5). Pub. L. 110–343, §102(e), which directed amendment of par. (5) by substituting "the date of the enactment of paragraph (11)" for "January 1, 2012", was executed by making the substitution for "January 1, 2011" to reflect the probable intent of Congress. See below.
Pub. L. 110–343, §101(a)(2)(D), substituted "January 1, 2011" for "January 1, 2009".
Subsec. (d)(6). Pub. L. 110–343, §101(a)(2)(E), substituted "January 1, 2011" for "January 1, 2009".
Subsec. (d)(7). Pub. L. 110–343, §101(c), struck out "combustion" before "facilities" in heading and substituted "facility (other than a facility described in paragraph (6)) which uses" for "facility which burns".
Pub. L. 110–343, §101(a)(2)(F), substituted "January 1, 2011" for "January 1, 2009".
Subsec. (d)(8). Pub. L. 110–343, §108(c), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "In the case of a facility that produces refined coal, the term 'refined coal production facility' means a facility which is placed in service after the date of the enactment of this paragraph and before January 1, 2010."
Subsec. (d)(9)(A), (B). Pub. L. 110–343, §101(a)(2)(G), substituted "January 1, 2011" for "January 1, 2009".
Subsec. (d)(11). Pub. L. 110–343, §102(c), added par. (11).
Subsec. (e)(8)(D). Pub. L. 110–343, §108(b)(1), added subpar. (D).
Subsec. (e)(9)(B). Pub. L. 110–343, §108(d)(1), designated existing provisions as cl. (i), inserted heading, and added cl. (ii).
2007-Subsec. (c)(3)(A)(ii). Pub. L. 110–172, §7(b)(1), struck out "which is segregated from other waste materials and" after "lignin material".
Subsec. (d)(2)(B)(i) to (iii). Pub. L. 110–172, §7(b)(2), inserted "and" at the end of cl. (i), redesignated cl. (iii) as (ii), and struck out former cl. (ii) which read as follows: "the amount of the credit determined under subsection (a) with respect to the facility shall be an amount equal to the amount determined without regard to this clause multiplied by the ratio of the thermal content of the closed-loop biomass used in such facility to the thermal content of all fuels used in such facility, and".
Subsec. (e)(7)(A)(i). Pub. L. 110–172, §9(a), substituted "originally placed in service" for "placed in service by the taxpayer".
2006-Subsec. (d)(1) to (7), (9). Pub. L. 109–432 substituted "January 1, 2009" for "January 1, 2008" wherever appearing.
2005-Subsec. (b)(4)(A). Pub. L. 109–58, §1301(c)(2), substituted "(7), or (9)" for "or (7)".
Subsec. (b)(4)(B)(i). Pub. L. 109–58, §1301(b)(1), inserted "or clause (iii)" after "clause (ii)".
Subsec. (b)(4)(B)(ii). Pub. L. 109–58, §1301(f)(1), substituted "January 1, 2005," for "the date of the enactment of this Act".
Subsec. (b)(4)(B)(iii). Pub. L. 109–58, §1301(b)(2), added cl. (iii).
Subsec. (c). Pub. L. 109–58, §1301(d)(4), substituted "Resources" for "Qualified energy resources and refined coal" in heading.
Subsec. (c)(1)(H). Pub. L. 109–58, §1301(c)(1), added subpar. (H).
Subsec. (c)(3)(A)(ii). Pub. L. 109–135, §402(b), substituted "lignin material" for "nonhazardous lignin waste material".
Pub. L. 109–58, §1301(f)(2), inserted "or any nonhazardous lignin waste material" after "cellulosic waste material".
Subsec. (c)(7)(A)(i). Pub. L. 109–135, §403(t), struck out "synthetic" after "solid".
Subsec. (c)(8). Pub. L. 109–58, §1301(c)(3), added par. (8).
Subsec. (c)(9). Pub. L. 109–58, §1301(d)(2), added par. (9).
Subsec. (d)(1) to (3). Pub. L. 109–58, §1301(a)(1), substituted "January 1, 2008" for "January 1, 2006" wherever appearing.
Subsec. (d)(4). Pub. L. 109–58, §1301(a)(2), substituted "January 1, 2008 (January 1, 2006, in the case of a facility using solar energy)" for "January 1, 2006".
Subsec. (d)(5), (6). Pub. L. 109–58, §1301(a)(1), substituted "January 1, 2008" for "January 1, 2006".
Subsec. (d)(7). Pub. L. 109–58, §1301(e), inserted at end "Such term shall include a new unit placed in service in connection with a facility placed in service on or before the date of the enactment of this paragraph, but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit."
Pub. L. 109–58, §1301(a)(1), substituted "January 1, 2008" for "January 1, 2006".
Subsec. (d)(8). Pub. L. 109–135, §412(j)(1), substituted "In the case of a facility that produces refined coal, the term" for "The term".
Subsec. (d)(9). Pub. L. 109–58, §1301(c)(4), added par. (9).
Subsec. (d)(10). Pub. L. 109–135, §412(j)(2), substituted "In the case of a facility that produces Indian coal, the term" for "The term".
Pub. L. 109–58, §1301(d)(3), added par. (10).
Subsec. (e)(6). Pub. L. 109–58, §1301(f)(3), struck out heading and text of par. (6). Text read as follows: "In the case of a facility using poultry waste to produce electricity and owned by a governmental unit, the person eligible for the credit under subsection (a) is the lessee or the operator of such facility."
Subsec. (e)(8)(C). Pub. L. 109–58, §1301(f)(4)(B), struck out "and (9)" after "paragraphs (1) through (5)".
Subsec. (e)(9). Pub. L. 109–58, §1322(a)(3)(C)(i), substituted "section 45K" for "section 29" wherever appearing.
Pub. L. 109–58, §1301(f)(4)(A), reenacted heading without change and amended text of par. (9) generally. Prior to amendment, text read as follows: "The term 'qualified facility' shall not include any facility the production from which is allowed as a credit under section 29 for the taxable year or any prior taxable year."
Subsec. (e)(9)(B). Pub. L. 109–58, §1322(a)(3)(C)(ii), inserted "(or under section 29, as in effect on the day before the date of enactment of the Energy Tax Incentives Act of 2005, for any prior taxable year)" before period at end.
Subsec. (e)(10). Pub. L. 109–58, §1301(d)(1), added par. (10).
Subsec. (e)(11). Pub. L. 109–58, §1302(a), added par. (11).
2004-Pub. L. 108–357, §710(b)(3)(B), inserted ", etc" after "resources" in section catchline.
Subsec. (b)(2). Pub. L. 108–357, §710(b)(3)(C), substituted "The 1.5 cent amount in subsection (a), the 8 cent amount in paragraph (1), the $4.375 amount in subsection (e)(8)(A), and in subsection (e)(8)(B)(i) the reference price of fuel used as a feedstock (within the meaning of subsection (c)(7)(A)) in 2002" for "The 1.5 cent amount in subsection (a) and the 8 cent amount in paragraph (1)".
Subsec. (b)(3). Pub. L. 108–357, §710(f), inserted "the lesser of ½ or" before "a fraction" in introductory provisions and "This paragraph shall not apply with respect to any facility described in subsection (d)(2)(A)(ii)" in concluding provisions.
Subsec. (b)(4). Pub. L. 108–357, §710(c), added par. (4).
Subsec. (c). Pub. L. 108–357, §710(a), amended heading and text of subsec. (c) generally. Prior to amendment, subsec. (c) defined "qualified energy resources", "closed-loop biomass", "qualified facility", and "poultry waste" for purposes of this section.
Subsec. (c)(3). Pub. L. 108–311 substituted "January 1, 2006" for "January 1, 2004" in subpars. (A) to (C).
Subsec. (d). Pub. L. 108–357, §710(b)(1), added subsec. (d). Former subsec. (d) redesignated (e).
Subsec. (e). Pub. L. 108–357, §710(b)(1), redesignated subsec. (d) as (e).
Subsec. (e)(7)(A)(i). Pub. L. 108–357, §710(b)(3)(A), substituted "subsection (d)(1)" for "subsection (c)(3)(A)".
Subsec. (e)(8). Pub. L. 108–357, §710(b)(2), added par. (8).
Subsec. (e)(9). Pub. L. 108–357, §710(d), added par. (9).
2002-Subsec. (c)(3). Pub. L. 107–147 substituted "2004" for "2002" in subpars. (A) to (C).
2000-Subsec. (d)(7)(A)(i). Pub. L. 106–554 substituted "subsection (c)(3)(A)" for "paragraph (3)(A)".
1999-Subsec. (c)(1)(C). Pub. L. 106–170, §507(b)(1), added subpar. (C).
Subsec. (c)(3). Pub. L. 106–170, §507(a), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "The term 'qualified facility' means any facility owned by the taxpayer which is originally placed in service after December 31, 1993 (December 31, 1992, in the case of a facility using closed-loop biomass to produce electricity), and before July 1, 1999."
Subsec. (c)(4). Pub. L. 106–170, §507(b)(2), added par. (4).
Subsec. (d)(6), (7). Pub. L. 106–170, §507(c), added pars. (6) and (7).
Pub. L. 115–123, div. D, title I, §40408(b), Feb. 9, 2018, 132 Stat. 149 , provided that: "The amendment made by this section [amending this section] shall apply to coal produced after December 31, 2016."
Pub. L. 115–123, div. D, title I, §40409(c), Feb. 9, 2018, 132 Stat. 150 , provided that: "The amendments made by this section [amending this section and section 48 of this title] shall take effect on January 1, 2017."
Pub. L. 114–113, div. P, title III, §301(b), Dec. 18, 2015, 129 Stat. 3038 , provided that: "The amendments made by this section [amending this section] shall take effect on January 1, 2015."
"(1) Extension.-The amendments made by subsection (a) [amending this section] shall apply to coal produced after December 31, 2014.
"(2) Modifications.-The amendments made by subsections (b) and (c) [amending this section] shall apply to coal produced and sold after December 31, 2015, in taxable years ending after such date."
Amendment by section 186(d)(2) of Pub. L. 114–113 applicable to credits determined for taxable years beginning after Dec. 31, 2015, see section 186(e)(3) of Pub. L. 114–113, set out as a note under section 38 of this title.
Pub. L. 114–113, div. Q, title I, §187(c), Dec. 18, 2015, 129 Stat. 3074 , provided that: "The amendments made by this section [amending this section and section 48 of this title] shall take effect on January 1, 2015."
Pub. L. 113–295, div. A, title I, §154(b), Dec. 19, 2014, 128 Stat. 4021 , provided that: "The amendment made by this section [amending this section] shall apply to coal produced after December 31, 2013."
Pub. L. 113–295, div. A, title I, §155(c), Dec. 19, 2014, 128 Stat. 4021 , provided that: "The amendments made by this section [amending this section and section 48 of this title] shall take effect on January 1, 2014."
Pub. L. 113–295, div. A, title II, §210(h), Dec. 19, 2014, 128 Stat. 4032 , provided that: "The amendments made by this section [amending this section and sections 45K, 168, 907, 1012, and 6045 of this title and provisions set out as a note under section 9501 of this title] shall take effect as if included in the provisions of the Energy Improvement and Extension Act of 2008 [Pub. L. 110–343, div. B] to which they relate."
Pub. L. 112–240, title IV, §406(b), Jan. 2, 2013, 126 Stat. 2340 , provided that: "The amendment made by this section [amending this section] shall apply to coal produced after December 31, 2012."
"(1) In general.-Except as provided in paragraphs (2) and (3), the amendments made by this section [amending this section, section 48 of this title, and provisions set out as a note under section 48 of this title] shall take effect on the date of the enactment of this Act [Jan. 2, 2013].
"(2) Modification to definition of municipal solid waste.-The amendments made by subsection (a)(2) [amending this section] shall apply to electricity produced and sold after the date of the enactment of this Act, in taxable years ending after such date.
"(3) Technical corrections.-The amendments made by subsection (c) [amending section 48 of this title and provisions set out as a note under section 48 of this title] shall apply as if included in the enactment of the provisions of the American Recovery and Reinvestment Act of 2009 [Pub. L. 111–5] to which they relate."
Pub. L. 111–312, title VII, §702(b), Dec. 17, 2010, 124 Stat. 3311 , provided that: "The amendment made by this section [amending this section] shall apply to facilities placed in service after December 31, 2009."
"(1) In general.-The amendments made by subsection (a) [amending this section] shall apply to property placed in service after the date of the enactment of this Act [Feb. 17, 2009].
"(2) Technical amendment.-The amendment made by subsection (b) [amending this section] shall take effect as if included in section 102 of the Energy Improvement and Extension Act of 2008 [Pub. L. 110–343]."
"(1) In general.-Except as otherwise provided in this subsection, the amendments made by this section [amending this section] shall apply to property originally placed in service after December 31, 2008.
"(2) Refined coal.-The amendments made by subsection (b) [amending this section] shall apply to coal produced and sold from facilities placed in service after December 31, 2008.
"(3) Trash facility clarification.-The amendments made by subsection (c) [amending this section] shall apply to electricity produced and sold after the date of the enactment of this Act [Oct. 3, 2008].
"(4) Expansion of biomass facilities.-The amendments made by subsection (d) [amending this section] shall apply to property placed in service after the date of the enactment of this Act."
Pub. L. 110–343, div. B, title I, §102(f), Oct. 3, 2008, 122 Stat. 3811 , provided that: "The amendments made by this section [amending this section] shall apply to electricity produced and sold after the date of the enactment of this Act [Oct. 3, 2008], in taxable years ending after such date."
Amendment by section 106(c)(3)(B) of Pub. L. 110–343 applicable to taxable years beginning after Dec. 31, 2007, see section 106(f)(1) of Pub. L. 110–343, set out as an Effective and Termination Dates of 2008 Amendment note under section 23 of this title.
Pub. L. 110–343, div. B, title I, §108(e), Oct. 3, 2008, 122 Stat. 3821 , provided that: "The amendments made by this section [amending this section and section 45K of this title] shall apply to fuel produced and sold after September 30, 2008."
Amendment by section 7(b) of Pub. L. 110–172 effective as if included in the provision of the American Jobs Creation Act of 2004, Pub. L. 108–357, to which such amendment relates, see section 7(e) of Pub. L. 110–172, set out as a note under section 1092 of this title.
Pub. L. 110–172, §9(c), Dec. 29, 2007, 121 Stat. 2484 , provided that: "The amendments made by this section [amending this section and section 856 of this title] shall take effect as if included in the provisions of the Tax Relief Extension Act of 1999 [Pub. L. 106–170] to which they relate."
Amendment by section 402(b) of Pub. L. 109–135 effective as if included in the provision of the Energy Policy Act of 2005, Pub. L. 109–58, to which such amendment relates, see section 402(m)(1) of Pub. L. 109–135, set out as an Effective and Termination Dates of 2005 Amendments note under section 23 of this title.
Amendment by section 403(t) of Pub. L. 109–135 effective as if included in the provisions of the American Jobs Creation Act of 2004, Pub. L. 108–357, to which such amendment relates, see section 403(nn) of Pub. L. 109–135, set out as a note under section 26 of this title.
"(1) In general.-Except as provided in paragraph (2), the amendments made by this section [amending this section and section 168 of this title and amending provisions set out as a note under this section] shall take effect on the date of the enactment of this Act [Aug. 8, 2005].
"(2) Technical amendments.-The amendments made by subsections (e) and (f) [amending this section and section 168 of this title and amending provisions set out as a note under this section] shall take effect as if included in the amendments made by section 710 of the American Jobs Creation Act of 2004 [Pub. L. 108–357]."
Pub. L. 109–58, title XIII, §1302(c), Aug. 8, 2005, 119 Stat. 991 , provided that: "The amendments made by this section [amending this section and section 55 of this title] shall apply to taxable years of cooperative organizations ending after the date of the enactment of this Act [Aug. 8, 2005]."
Amendment by section 1322(a)(3)(C) of Pub. L. 109–58 applicable to credits determined under the Internal Revenue Code of 1986 for taxable years ending after Dec. 31, 2005, see section 1322(c)(1) of Pub. L. 109–58, set out as a note under section 45K of this title.
"(1) In general.-Except as otherwise provided in this subsection, the amendments made by this section [amending this section and section 48 of this title] shall apply to electricity produced and sold after the date of the enactment of this Act [Oct. 22, 2004], in taxable years ending after such date.
"(2) Certain biomass facilities.-With respect to any facility described in section 45(d)(3)(A)(ii) of the Internal Revenue Code of 1986, as added by subsection (b)(1), which is placed in service before the date of the enactment of this Act, the amendments made by this section shall apply to electricity produced and sold after December 31, 2004, in taxable years ending after such date.
"(3) Credit rate and period for new facilities.-The amendments made by subsection (c) [amending this section] shall apply to electricity produced and sold after December 31, 2004, in taxable years ending after such date.
"(4) Nonapplication of amendments to preeffective date poultry waste facilities.-The amendments made by this section shall not apply with respect to any poultry waste facility (within the meaning of section 45(c)(3)(C), as in effect on the day before the date of the enactment of this Act) placed in service before January 1, 2005.
"(5) Refined coal production facilities.-Section 45(e)(8) of the Internal Revenue Code of 1986, as added by this section, shall apply to refined coal produced and sold after the date of the enactment of this Act."
Pub. L. 108–311, title III, §313(b), Oct. 4, 2004, 118 Stat. 1181 , provided that: "The amendments made by subsection (a) [amending this section] shall apply to facilities placed in service after December 31, 2003."
Pub. L. 107–147, title VI, §603(b), Mar. 9, 2002, 116 Stat. 59 , provided that: "The amendments made by subsection (a) [amending this section] shall apply to facilities placed in service after December 31, 2001."
Pub. L. 106–170, title V, §507(d), Dec. 17, 1999, 113 Stat. 1923 , provided that: "The amendments made by this section [amending this section] shall take effect on the date of the enactment of this Act [Dec. 17, 1999]."
Section applicable to taxable years ending after Dec. 31, 1992, see section 1914(e) of Pub. L. 102–486, set out as an Effective Date of 1992 Amendment note under section 38 of this title.


text:
JOY MANUFACTURING COMPANY and Charles D. Crickmer.
Civ. A. Nos. 70-H-259, 71-H-1278.
United States District Court, S. D Texas, Houston Division.
*825 Fulbright, Crooker & Jaworski, James F. Weiler, Houston, Tex. and Miketta, Glenny, Poms & Smith, Paul Adams, Los Angeles, Cal., for plaintiffs.
Chilton Bryan, Houston, Tex., Rose, Schmidt & Dixon, Raymond G. Hasley, and E. W. Breisch, Pittsburgh, Pa., for defendants.
R. V. Lupo, Associate Sol., Washington, D. C., for U. S. Patent Office.
Civil Action No. 70-H-259 is a suit for patent infringement. Civil Action No. 71-H-1278 is a suit seeking review of a decision of the Board of Patent Interferences of the United States Patent Office. By an order of this Court on February 24, 1972, further proceedings in Civil Action No. 70-H-259 were stayed, except for discovery, pending the outcome of Civil Action No. 71-H-1278. All discovery taken in either case was held to be admissible in the other.
"matters of fact and [they] must not go into hypothetical or speculative areas or the bases, reasons, mental processes, analyses or conclusions of the patent examiners in acting upon the patent applications maturing into the patent challenged herein." Civil Action No. 70-H-259, Memorandum and Order, August 12, 1970.
Some ninety-six questions propounded by Joy's attorneys to four patent examiners were objected to by the Plaintiff and by the Patent Office as being outside the scope of Judge Hannay's order. Joy filed a motion to compel answers on March 27, 1972, which was placed on the motion docket for May 15, 1972. On June 28, 1972, the motion was heard and oral arguments were presented by both sides and by the Patent Office. The Court requested post hearing briefs.
In summary, the Plaintiffs contend that all of the questions violate the order by inquiring into the thought processes of the examiners. The Patent Office no longer considers thirty-four of the questions improper and has very considerately listed all of the challenged questions on separate lists for the Court and parties, (DX-H1). The Defendants contend that in light of recent case law on the issue of fraud upon the Patent Office in the procurement of a patent the order should be broadened. Alternatively the Defendants contend that the questions are proper under Judge Hannay's order and that the information sought is essential to the presentation of their defense of invalidity of the patent.
The Court has reviewed the cases cited by the Defendants in support of expanding the scope of the protective order, Charles Pfizer & Co. v. FTC, 401 *826 F.2d 574 (6th Cir. 1968), Beckman Instruments, Inc. v. Chemtronics, Inc., 428 F.2d 555 (5th Cir. 1970), and United States v. Saf-T-Boom Corp., 431 F.2d 737 (8th Cir. 1970) and Monsanto Company v. Rohm & Haas Co., 312 F. Supp. 778, aff'd 456 F.2d 592 (3d Cir. 1972), and finds those cases inappropriate on that point. Undeniably each of these cases stands for the proposition that a patent applicant is under an absolute duty of full and complete disclosure of all matters reflecting adversely upon his patent, and that a failure to disclose or an affirmative misrepresentation may be asserted to prove the invalidity of the patent acquired, Beckman Instruments, supra, 428 F.2d at 560, and are actionable in antitrust as well. Id., at 566. These cases permit proof of misconduct in the Patent Office, but they provide little guide as to the appropriate scope of interrogation of Patent Office employees in cases where such misconduct is at issue. In the Charles Pfizer & Co. case the Court of Appeals had earlier remanded the case to the Federal Trade Commission for further consideration of the fraud issue and directed that certain questions be put to the patent examiner to clear up the record on that issue. American Cyanamid Company v. FTC, 363 F.2d 757, 777 (6th Cir. 1966). This appears however to have been an unusual situation and not really analogous to the case at bar. For the most part where fraud on the Patent Office has been an issue it has been proven by use of objective facts from the application file itself which when compared to other data in the possession of the applicant (correspondence, business documents and memos) or of the public generally prove to be misrepresentations, omissions, or understatements of adverse matters. Therefore, the scope of the order of August 12, 1970, will not be broadened.
The purpose of that order was to protect the integrity of the decision making processes of the patent examiners, for that reason little purpose would be served in not letting the examiners answer those questions which the Patent Office does not think will interfere with its functions or the ability of its examiners to give careful, but not overly cautious, consideration to patent applications. This is especially so when compared to the liberal discovery philosophy of the Federal rules. Therefore, the deponents will be directed to respond to those thirty-four questions listed on exhibit A to Defendant's Exhibit H-1.
Having examined the remaining sixty-two questions of exhibit B to Defendant's Ex. H-1 in light of Judge Hannay's limiting order the Court is of the opinion that all of those questions to which objection was made are speculative and probe matters outside the permissible scope of that order except for the questions listed below. The challenged questions are identified by the name of the deponent and the transcript page number where the question appears. Where more than one question appears on the same page they will be identified by arabic numerals in parentheses.
The Defendant is entitled to have the enumerated questions answered by the deponents.
All questions listed in exhibit A to Defendant Ex. H-1 and the enumerated questions from exhibit B to Defendant Ex. H-1 shall be answered by the deponents in writing within thirty days from today's date. The question should be repeated in full and be followed by the deponent's answer. Counsel will attempt to resolve any further discovery problems which the answers may provoke before seeking the aid of the Court. Local Rule 16G, So.Dist.Tex., July 1, 1972.

matches: V. v. v. v. v. v.


Pfizer Inc. v. Alkem Labs. Ltd.
PFIZER INC. and UCB PHARMA GMBH, Plaintiffs, v. ALKEM LABORATORIES LTD., et al., Defendants.
WHEREAS, at the close of the Plaintiffs' production of evidence concerning infringement, both parties moved pursuant to Federal Rule of Civil Procedure 52(c) for judgment on partial findings on the issue of infringement (D.I. 272, 273).
If a party has been fully heard on an issue during a nonjury trial and the court finds against the party on that issue, the court may enter judgment against the party on a claim or defense that, under the controlling law, can be maintained or defeated only with a favorable finding on that issue.
Fed. R. Civ. P. 52(c). Sandoz makes two procedural arguments concerning the propriety of Dr. Leonard Chyall's expert testimony for the Plaintiffs. (D.I. 272 at 2-3.) First, Sandoz argues that Dr. Chyall offered improper testimony that was beyond the scope of his expert report. Specifically, Sandoz contends that Dr. Chyall did not offer a standard for "one of ordinary skill in the art" in his infringement report, and therefore he could not render an opinion as to the plain and ordinary meaning of the claims. See Fed. R. Civ. P. 26(a)(2). Second, Sandoz asserts that Dr. Chyall's testimony amounts to an untimely claim construction argument.
The court finds Sandoz's procedural arguments unavailing. Such concerns about Dr. Chyall's testimony should have been raised during the final pre-trial conference. Sandoz cannot argue that the scope and content of Dr. Chyall's testimony was unknown to them until trial—his mfringement report was specifically identified among the evidentiary issues during the final pre-trial conference. (D.I. 256, Ex. 16, ¶ 3 ("Whether Plaintiffs should be precluded from making untimely claim construction arguments, such as those included in Dr. Chyall's infringement report.").) But when the court presented the defendants—including Sandoz—an opportunity to discuss this very issue during the conference, Sandoz said nothing. (D.I. 262 at 6 ("THE COURT: And Dr. Chyall's mfringement reports, who wants to talk about that? No one. Okay.").) Sandoz's failure to argue its positions at the proper time amounts to a waiver of its procedural protestations. Indeed, the court already overruled these very same objections during the course of trial. (Tr. at 105-06, 113-14.) "Trial judges are afforded wide discretion in making rulings on the admissibility of evidence." Quinn v. Consol. Freightways Corp. of Delaware, 283 F.3d 572, 576 (3d Cir. 2002). The court sees no reason to reconsider its ruling at this time.
Sandoz finally argues that the substance of Dr. Chyall's testimony was insufficient to establish, by a preponderance of the evidence, the infringement of the disputed claims. Conversely, the Plaintiffs contend that a judgment of infringement is warranted based on Dr. Chyall's testimony because Sandoz did not present any evidence to the contrary. The court agrees with the Plaintiffs that Dr. Chyall's testimony adequately establishes Sandoz's infringement of the disputed claims.
Dr. Chyall testified that the disputed claims covered fesoterodine generally—i.e., not limited to the free base—and that one of skill in the art would understand that a salt form of fesoterodine was within the scope of the disputed claims. (Tr. at 107, 112, 116.) Next, Dr. Chyall examined Sandoz's Abbreviated New Drag Application ("ANDA") filings and determined that Sandoz's ANDA product included fesoterodine as a hydrogen fumarate salt (Sandoz does not contest this fact). (Tr. at 109-11.) Thus, Dr. Chyall concluded that Sandoz infringes the disputed claims. See Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996) ("An infringement analysis entails two steps. The first step is determining the meaning and scope of the patent claims asserted to be infringed. The second step is comparing the properly construed claims to the device accused of infringing." (internal citation omitted)).
The court finds Dr. Chyall's testimony credible and persuasive, especially given the lack of contradictory evidence from Sandoz. The court examines each claim in turn. Claim 1 of the '980 Patent claims: "R-(+)-isobutyric acid 2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethylphenyl ester," or the R-isomer of fesoterodine. '980 Patent, claim 1. Importantly, claim 2 recites "a salt of R-(+)-isobutyric acid 2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethylphenyl ester with a physiologically acceptable acid," i.e., the salt form of claim 1. '980 Patent, claim 2.
not a hard and fast rule of construction. . . . Claims that are written in different words may ultimately cover substantially the same subject matter.
Seachange Int'l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1368-69 (Fed. Cir. 2005) (internal citations, alterations, and quotation marks omitted). While Sandoz may have had a colorable claim differentiation argument, it never asked the court to construe claim 1 as excluding salt forms of fesoterodine, nor did it present expert testimony that one skilled in the art would read claim 1 as excluding salt forms of fesoterodine. "When the parties raise an actual dispute regarding the proper scope of the claims, the court . . . must resolve that dispute." O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir. 2008). Here, the court was not presented with an actual dispute—the only opinion is that of Dr. Chyall, who testified that one of skill in the art would read claim 1 as covering salt forms, in addition to the free base form. (Tr. at 116 ("[The disputed claims] cover fesoterodine without any limitations of form. So fesoterodine fumarate would be covered by that.").) During cross-examination, Dr. Chyall consistently maintained that claim 1 covered salt forms of fesoterodine, despite the different characteristics of fesoterodine free base and the hydrogen fumarate salt. (Tr. at 116-36.) The court is satisfied that the Plaintiffs have proven by a preponderance of the evidence that Sandoz infringes claim 1 of the '980 Patent.
[compound 1], isobutyric acid 2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethylphenyl ester [i.e., fesoterodine], [compound 3], and [compound 4], including the racemic mixtures and individual enantiomers of said compounds, and a salt of said compounds with a physiologically acceptable acid.
The method according to claim 1, wherein the compound is R-(+) isobutyric acid 2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethylphenyl ester.
'230 Patent, claim 3. Thus, claim 3 selects fesoterodine from among the four possible compounds identified in claim 1. Moreover, whereas claim 1 is directed to "the racemic mixtures and individual enantiomers of said compounds," claim 3 specifies the R-isomer of fesoterodine. Claim 3 did nothing, however, to further narrow the final limitation of claim 1: "including . . . a salt of said compounds with a physiologically acceptable acid." See 35 U.S.C. § 112(d) ("[A] claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.").
Dr. Chyall testified that claim 3 of the '230 Patent covers a method of treating urinary incontinence using fesoterodine hydrogen fumarate, and therefore Sandoz's ANDA product infringes the claim. (Tr. at 113, 115, 134.) Sandoz did not provide an opposing expert opinion. The court finds Dr. Chyall's testimony highly convincing. Unlike claim 1 for the '980 Patent (discussed previously), claim 3 of the '230 Patent does not face any potential claim differentiation problem. Claim 1 of the '230 Patent specifically covers salt forms of the various named compounds. Claim 3—which depends from claim 1 and therefore incorporates the same limitations—includes salt forms as well.
3. To the extent the claims are valid, Sandoz INFRINGES (a) claim 1 of U.S. Patent No. 7,384,980 and (b) claim 3 of U.S. Patent No. 7,855,230.


text:
57 results found for resources beginning with 'B' sorted alphabetically.
Provides information about researchers in the field and the developments in fighting harmful microbes as well in using beneficial ones for medicines. Peggy Thomas, ed. Part of the Lucent Library of Science and Technology. Available through the Gale Virtual Reference Library (GVRL).
BASE (Bielefeld Academic Search Engine) is one of the world's most voluminous search engines especially for academic open access web resources. BASE is operated by Bielefeld University Library.
Explores Chinese history and culture today in nearly a thousand articles ranging from "Adoption" and "Banking" to "Wound Literature" and the "Zhou Dynasty." Berkshire Publishing. 5 vols. Available through the Gale Virtual Reference Library (GVRL).
Coverage of sustainability theories and practices that have shaped and challenged the concept of what is sustainable, to industries that impact it, and to methods and measurements, such as life cycle costing and material flow analysis, that assess sustainability's progress and chart its future. Focused on solutions, this interdisciplinary publication draws from the natural, physical, and social sciences.
v. 1. The spirit of sustainability -- v. 2. The business of sustainability -- v. 3. The law and politics of sustainability -- v. 4. Natural resources and sustainability -- v. 5. Ecosystems management and sustainability -- v. 6. Measurements, indicators, and research methods for sustainability -- v. 7. China, India, and East and Southeast Asia : assessing sustainability -- v. 8. The Americas & Oceania : assessing sustainability -- v. 9. Afro-Eurasia : assessing sustainability -- v. 10. The future of sustainability [Overviews, future views, and review essays].
Available through the Gale Virtual Reference Library (GVRL).
Full-text of 20 different versions, including 12 full Bibles, five New Testament texts, two versions of the Gospels only, and William Tyndale's translations of the Pentateuch, Jonah and the New Testament. Available from Literature Online (includes the MLA International Bibliography) under "Individual Collections."
Online version of the nine volume set from Yale University Press, 1955-1991. Provides nearly 40,000 references to the literary works of approximately 300 American writers from the period of the Revolution to 1930, including holding libraries of specific editions. Available from Literature Online (includes the MLA International Bibliography) under "Individual Collections."
To see if any item in the bibliography is in the University of Kentucky Libraries or other libraries worldwide, search InfoKat Discovery. If we do not own the item, and you are a UK-affiliate, you may request it through Interlibrary Loan.
Western-language database for research on East, Southeast, and South Asia. Covers a broad range of subjects with special focus on the humanities and social sciences.
Covers historical and current members of congress. Search by name, position, state, party, and year or congress.
To see if we own a paper copy of any resources cited and to find additional electronic resources, search the InfoKat Discovery Library Catalog. If we do not own the item in any format, and you are a UK-affiliate, you may request it through Interlibrary Loan.
Biographies from Wilson Biographies Plus Illustrated and many periodicals covered in Biography Index, including full-text articles, page images, and abstracts (including biographical profiles, feature articles, interviews, essays, book reviews, performance reviews, speeches, or obituaries). Covers over 500,000 people and includes over 36,000 images.
When you get a results list in BRB, select the person in whom you are interested and go to the descriptive record. Select Related Biographies: entries to see biographical full-text from selected publications.
Select the format(s) you wish to see to get to citations and full-text material.
Includes the renowned Biological Sciences, MEDLINE, and TOXLINE databases and provides full-text titles from around the world, including scholarly journals, trade and industry journals, magazines, technical reports, conference proceedings, and government publications. The database includes specialized, editorially-curated A&I resources providing access to the extensive variety of biology’s cutting edge research, with applications to medicine, technology and the environment.
Coverage includes molecular and cell biology, pharmacology, endocrinology, genetics, neurosciences, infectious diseases, ecology and organismal biology material in journals, books, reports, meetings, and U.S. patents. Indexing includes Enzyme Commission numbers and cross-references throughout to gene, disease, and organism names.
Presents a state-by-state history of African Americans in the 50 states and the District of Columbia. Alton Hornsby, Jr. Greenwood. 2 vols. Available through the Gale Virtual Reference Library (GVRL).
Provides brief biographical sketches of African Americans who were elected to Congress during the Reconstruction. Also includes excerpts from documents illuminating their activities in Congress. Stephen Middleton. Praeger. Available through the Gale Virtual Reference Library (GVRL).
Full-text database that provides access to over 1,300 plays, including works by more than 200 playwrights from North America, English-speaking Africa, the Caribbean, and other African diaspora countries. Additionally includes information on related productions, theaters, production companies as well as selected playbills, production photographs and other ephemera related to the plays. Some 500 of the plays are published here for the first time, including a number by major authors.
Coverage 1850 to present; 2nd ed.
Presents evidence and theories for black holes and discusses how they were first predicted, how they form, their physical properties, and how scientists detect them. Don Nardo, ed. Part of the Lucent Library of Science and Technology. Available through the Gale Virtual Reference Library (GVRL).
Focuses on writers and works published since 1950. The majority of the authors surveyed are African American, but representative African and Caribbean authors are also included. Jelena O. Krstovic, ed. Gale. 3 vols. Available through the Gale Virtual Reference Library (GVRL).
Full-text of stories, fables and folktales, including previously uncollected works and unpublished manuscripts by a wide variety of authors. Also includes complete runs of selected literary magazines that feature short stories, such as Kyk-Over-Al and The Beacon, as well as many early North American black-owned and edited journals and newspapers. Texts are in their original languages, including some, like the Gullah language of South Carolina, that have their origins in African countries and are still present in regions far from their source. Contains nearly 12,000 stories and folk tales published in more than 15 countries from the mid-1900s to the present.
Speeches, essays, articles, letters, leaflets, trials, interviews, monographs and periodicals written by leaders within the black community from 1700 to 2005. Over 100,000 pages illustrate the evolution of what it means to "be black." Authors include teachers, artists, politicians, religious leaders, athletes, war veterans, and entertainers. Find influences and read history in their words. The collection begins with the words of Frederick Douglass and includes the writings of W.E.B. Du Bois, Carter G. Woodson, Alain Locke, Paul Robeson, Booker T. Washington, Malcolm X, Marcus Garvey, Langston Hughes, Muhammad Ali, Sammy Davis, Jr., Ida B. Wells, Nikki Giovanni, Mary McLeod Bethune, Carl Rowan, Roy Wilkens, James Weldon Johnson, Audre Lorde, Thurgood Marshall, A. Philip Randolph, Constance Baker Motley, J. Saunders Redding, Sojourner Truth, Walter F. White, Amiri Baraka, Ralph Ellison, Martin Luther King, Jr., Richard Wright, Angela Davis, Jesse Jackson, Bobby Seale, Rosa Parks, Gwendolyn Brooks, Huey P. Newton, Dizzy Gillespie, Butterfly McQueen, Charles Mingus and a long list of others.
Approximately 20% of the content is previously unpublished and fugitive, such as the recovered transcript of the Muhammad Ali trial; a full run of The Black Panther newspaper, with full-color images of every page as well as searchable text; and 2,500 pages of Panther oral histories owned by the Dr. Huey P. Newton Foundation, published as text and also with selected audio files here for the first time.
Provides a great variety of search tools: as well as searching by author, title, subject, or full-text, you can also search by personal event, historical event, nationality, occupation, religion, etc.
BNA databases are comprehensive sources for news and analysis on a wide range of legal topics. Most resources also link to relevant laws, regulations, cases, and other research materials.
Connects references in selected research books to the greater citation index, covering the sciences, social sciences and humanities. Part of the Web of Science Core Collection.
Connects references in selected research books to the greater citation index, covering the sciences. Part of the Web of Science Core Collection. You can also search the complete Book Citation Index, which includes the Social Sciences and Humanities collection as well as the Science Collection.
Connects references in selected research books to the greater citation index, covering the social sciences and humanities. Part of the Web of Science Core Collection. Part of the Web of Science Core Collection. You can also search the complete Book Citation Index, which includes the Science collection as well as the Social Sciences and Humanities Collection.
Contains citations to more than 2 million reviews from scholarly journals, popular magazines and newspapers. Search fields include author, date, illustrator, audiobook reader, review length, reading level, review source and type, reviewer, work title, and review title.
Document-level hyperlinking allows upi to connect current articles in newspapers, magazines, and journals with contextual reference content found within eBooks on GVRL.Translate any article into 34 languages.Print, download, share, and email without restrictions.Easily generate persistent URLs.
This database does not provide links to fulltext of the articles cited. For electronic access options, use the button that appears below the citation in your search results (more information). To see if we own a paper copy of the journal, newspaper or magazine, search the title in InfoKat Discovery. If we do not own the item in any format, and you are a UK-affiliate, you may request the item through ILLiad.
Description: Provides background information about the countries and peoples of the Middle East as well as literature related to the region and to the major ethnic groups of the region. Tami C. Al-Hazzá and Katherine T. Bucher. Linworth Books. Available through the Gale Virtual Reference Library (GVRL).
Description: Contains discussions of the writings found in the Old and New Testaments. Provides interpretive essays that deal descriptively with the content, purpose, and theological perspective of each book of the Bible. Primary emphasis is on the Bible as literature. Bernhard W. Anderson, ed. 2 vols. Available through the Gale Virtual Reference Library (GVRL).
Covers the experiences and issues central to life between cultures along the Mexican-American border. Ilan Stavans. The Ilan Stavans Library of Latino Civilization. Greenwood Press. Available through the Gale Virtual Reference Library (GVRL).
The Latin American Microfilm Project (LAMP) at CRL has digitized executive branch serial documents issued by Brazil's national government between 1821 and 1993, and by its provincial governments from the earliest available for each province to the end of the Empire to 1889. The documents consist of Provincial Presidential Reports, Presidential Messages, Almanak Laemmert, and Ministerial Reports.
The full encyclopedia with additional E-Books, primary sources, videos and other media and quotations. Includes a country comparison tool ("Compare statistics, maps, flags, and multimedia about any two countries"), timelines, a world atlas and world data analyst. Also includes news feeds from the New York Times and BBC News, and the Merriam-Webster Dictionary.Part of the database collection.
Presents more than 2,000 primary source documents plus 700 multimedia elements related to the history of the United States. Arranged by date, author, and topics. Content is searchable.
Consists of two primary resources: Enciclopedia Moderna (for high school ages and up) and Britannica Escolar Online (for ages 6-12).
Interactive data tool that provides individual and comparative analysis of countries. Includes PDF country snapshots, table creation of current specific countries and comparisons of multiple countries, both across multiple statistical categories. Chronological comparisons are also possible as far back as 90 years. In addition, ranked statistics are available in tabular format.
Browsable access (by playwright) to the full text of 1017 volumes by 154 playwrights. Collection is also searchable. Part of Literature Online.
Includes some of the primary printed and secondary sources for the medieval and modern history of the British Isles. The site was created by the Institute of Historical Research and the History of Parliament Trust. Much of the content is available free online, but there are certain collections available only to those who subscribe to the premium content version.
This resource offers facsimile page images and searchable full text for nearly 500 British periodicals published from the 17th century through to the early 21st.
British Periodicals Collection I consists of more than 160 journals that comprise the UMI microfilm collection Early British Periodicals, the equivalent of 5,238 printed volumes. Topics covered include literature, philosophy, history, science, the fine arts and the social sciences.
British Periodicals Collection II consists of more than 300 journals from the UMI microfilm collections English Literary Periodicals and British Periodicals in the Creative Arts together with additional titles. Topics covered include literature, music, art, drama, archaeology and architecture.
Browsable access (by poet) to the full text of 1,311 volumes by 314 poets. Collection is also searchable. Part of Literature Online.
Browsable access (by author) to the full text of 590 volumes by 103 authors. Collection is also searchable. Part of Literature Online.
Includes all volumes in the Scribner British Writers series, including British Writers (the 7-vol. base set and all supplements), British Writers Retrospective, and British Writers Classics. The British Writers Supplements include authors who have never been featured in British Writers, while the retrospective volumes re-examine some of the most important and influential writers in the British canon already covered in British Writers. The classic volumes focus on famous works - many of which are required reading in schools and colleges. Each classics volume includes 20-25 accessible essays, each on a single work of British literature. Examples include Geoffrey Chaucer's The Canterbury Tales, Jane Austen's Emma, and Emily Brontë's Wuthering Heights. Charles Scribner's Sons. Available through the Gale Virtual Reference Library (GVRL).
Collection of documents that contains the budget message of the President, information about the President's budget proposals for a given fiscal year, and other budgetary publications that have been issued throughout the fiscal year. Other related and supporting budget publications, such as the Economic Report of the President, are included, which may vary from year to year. Includes archive back to 1996. Also includes a link to Fraser (Federal Reserve Archive), that provides full-texts of budgets from 1923 on.
Newspapers, pamphlets, broadsides and books from London, the British Isles and the colonies gathered by the Reverend Charles Burney (1757-1817): "the largest and most comprehensive collection of early English news media." The present digital collection totals almost 1 million pages and contains approximately 1,270 titles. Title list (in Excel). Also available in the Gale NewsVault, a searchable collection of historical newspapers.
Covers current topics in business and management. Written for use with business and management curricula and entrepreneurial research.
Reports are also linked to additional topic-related content such as encyclopedia entries, case studies, zip-code level data series, and videos.
Includes company and industry profiles, market research reports, and business videos. For general information about many larger companies (both public and private, foreign and domestic), search "Company Profiles." For articles about a particular company, do a keyword search using the company name. An enhanced interface for Business Source Complete.

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Federal Medicaid regulations define AAC as a state Medicaid agency’s determination of a pharmacy provider’s actual prices paid to acquire drug products marketed or sold by specific manufacturers. 42 C.F.R. § 447.502, 81 Fed. Reg. 5170, 5347 (Feb. 1, 2016). It is based on periodic surveys of pharmacy invoices.
Effective April 1, 2017, all state Medicaid programs are required by CMS regulation to use AAC as a basis for Medicaid drug payment rates. States will be permitted to use the NADAC (see below), conduct their own pharmacy invoice surveys, or use other reliable actual cost data to determine AAC.
Calculate Federal Upper Limits (FULs) under Medicaid.
AMP is calculated and submitted by drug manufacturers at monthly and quarterly intervals to the Centers for Medicare & Medicaid Services (CMS).
It is defined as the average price of a drug purchased, either directly from manufacturers or through wholesalers, a by retail community pharmacies, excluding federal government sales and certain other transactions. See 42 U.S.C. § 1396r-8(k)(1) and 42 C.F.R. § 447.505.
ASP is a price benchmark used by CMS to establish payment amounts for drugs under Medicare Part B, which covers drugs administered in the physician’s office and in the outpatient hospital department that are not usually self-administered, drugs infused through durable medical equipment used in the home; and certain other categories of drugs specified by statute.
Payment for most drugs under Medicare Part B is 106% of ASP.
ASP is defined as the total value of a manufacturer's sales to all purchasers in the United States for a drug in a calendar quarter divided by the total number of units, with exclusions for federal government sales and certain other transactions. See 42 U.S.C. § 1395w–3a(c); 42 C.F.R. § 414.804ASP is calculated and submitted by drug manufacturers quarterly to CMS.
AWP is a “list” price for a drug available in drug pricing publications. It was originally intended as an estimate of the average price charged for a drug by wholesalers to pharmacies. However, as it has evolved over decades, AWP no longer represents an average of actual transactions. AWPs published by a pricing publication may be based on prices reported by the manufacturer. If the manufacturer does not report an AWP, it is calculated by the pricing publication based on the WAC reported by the manufacturer, increased by 20%.
For drugs approved under an NDA or BLA, it is used along with AMP to calculate rebates owed by manufacturers under the Medicaid Drug Rebate Program.
BP is calculated and submitted by drug manufacturers quarterly to CMS.
Biologic drugs are drugs that are made from a combination of organic components typically manufactured in a microorganism, such as a living cell or tissue. The combination is not easily identified or characterized, compared to the chemical structure of traditionally synthesized drugs, which is known and clearly replicable.
Biosimilar drugs are follow-on versions of biologic drugs, not manufactured by the innovator. Functional equivalence in addition to safety and efficacy must be tested and verified in order to gain FDA approval.
Brand name drugs are trademark protected by the original innovating drug manufacturer. These drugs are typically granted a period of market “exclusivity,” during which they face no generic competition.
“Buy and bill” is a financial transaction in which healthcare providers purchase prescription drugs from wholesalers for administration to patients in outpatient offices or clinics. Reimbursement through the “buy and bill” transaction as outlined in Medicare Part B is 106% of ASP.
Chargebacks are payments from pharmaceutical companies to wholesalers, which are made when wholesalers sell drugs to purchasers at a lower price than they themselves pay the manufacturer for them. This most commonly occurs when manufacturers and purchasers enter into direct contracts that set a lower price than the price to the wholesaler, who is contractually obligated to sell them to the purchasers by the manufacturer.
Co-insurance is a percentage of the cost of a prescription or medical service paid by the patient (the health plan covers the remainder of the cost. Generic drugs frequently require little or no co-insurance by the patient, while specialty tier drugs may require that patients pay coinsurance of 30% (or more) of the drug’s price.
Copay coupons are supplied by manufacturers to reduce or eliminate patients’ “out of pocket” spending on the drug. This undermines the insurer’s efforts to steer utilization toward generic or lower priced medicines. The copay coupon amount generally contributes to the out-of-pocket limit in the plan agreement.
These are separate from patient assistance programs.
A co-payment is a fixed dollar amount per prescription paid by the patient (the health plan covers the remaining cost). The amount of the co-payment depends on formulary placement and varies across health plans.
Health plans purchased through an employer are commercial health plans.
A deductible is a determined payment threshold, up to which the patient contributes 100% of healthcare costs. After the threshold is met, the patient enters the coverage phase, during which the health plan covers a pre-determined portion of the cost. Deductibles vary across health plans.
Discounts, typically calculated as a percentage of a drug’s price, may be offered by pharmaceutical companies or wholesalers in exchange for sales volume and prompt payment.
The donut hole is the gap in coverage in Part D plans when a patient’s cumulative annual prescription costs exceed the deductible and coinsurance limits, while not yet reaching the threshold for the catastrophic coverage.
FCP is the maximum price that a manufacturer may charge for a covered drug sold to the “Big 4” Federal agencies that procure drugs — Department of Veterans Affairs, Department of Defense, Public Health Service (including the Indian Health Service) and the Coast Guard. The FCP is calculated annually based on the NFAMP. See 38 U.S.C. § 8126 (h)(5).
The FUL is the maximum amount that a state Medicaid agency may pay in the aggregate to pharmacies as reimbursement for a multiple source drug. CMS establishes an FUL where there are at least three therapeutically equivalent (A-rated) products on the market nationally. The FUL is 175 percent of the weighted average of the most recently reported monthly AMPs for the A-rated products. See 42 U.S.C. § 1396r–8(e)(5).
Formularies are ranked or tiered lists of prescription drugs that are covered by a health plan. Formularies may be managed by PBMs on behalf of health plans, or the health plans themselves. Prescription drugs are placed on formulary tiers based on clinical and pricing considerations. Formulary tiers typically carry different levels of cost sharing (e.g. copayments or coinsurance levels).
Generic drugs are chemical and biological equivalents to brand name drugs. They are released into market after the brand name product’s period of exclusivity ends.
Generic drugs go through an abbreviated new drug application (ANDA) pathway forgoing the preclinical and clinical steps. Rather, this pathway requires the applicant to scientifically demonstrate that performance equivalence with the innovator product.
Group purchasing organizations (GPOs) are third-party administrative organizations that aggregate purchasing volume across multiple healthcare providers and negotiate with pharmaceutical companies and wholesalers on providers’ behalf.
GPOs may receive discounts from manufacturers or wholesalers for volume purchases. In addition, they receive fees from provider clients for aggregating purchases and negotiating favorable pricing.
72% of purchase volume by hospitals is contracted through GPOs.
Health insurance exchange plan is a health insurance policy participating in the government run marketplace complying with the Patient Protection and Affordable Care Act (ACA).
A health plan is an insurance policy administered by a government program or commercial entity that reimburses beneficiaries for health services, including inpatient, outpatient and prescription drugs.
Inpatient care is hospital care for patients admitted overnight.
For Medicare beneficiaries, this is covered under Medicare Part A.
MAC is an optional state Medicaid program that sets the maximum amount that a state Medicaid agency or commercial plan will pay for generic drugs and brand name drugs that have generic equivalents. Some MACs are based on FULs, but there is no standardization in the industry as to the criteria for the inclusion of drugs on MAC lists or for the methodology as to how the MAC is determined, changed or updated.
The medical benefit provides insurance coverage for drugs administered by intravenous infusion or injection in a clinic or other outpatient setting.
Medicare is a federal social insurance program that provides health insurance for patients over the age of 65 and patients with certain disabilities. Medicare is funded through payroll and income taxes, as well as beneficiary contributions (deductible, co-insurance and premiums) which vary by Part.
Medicare is the single largest healthcare payer and the second largest drug payer.
NADAC is the average acquisition cost for a covered outpatient drug purchased by retail community pharmacies, based on invoice purchase prices from independent and chain retail community pharmacies collected through a national survey of retail pharmacies. It is published and updated monthly by CMS. States may, but are not required to, use the NADAC as a basis for determining AAC.
NFAMP is the weighted average price paid for a drug by U.S. wholesalers, excluding sales to the federal government and certain other transactions. See 38 U.S.C. § 8126(h)(5).
NFAMP is calculated and submitted by drug manufacturers annually and quarterly to the Department of Veterans Affairs (VA). The annual NFAMP is used to calculate the Federal Ceiling Price (FCP) for each calendar year.
Outpatient care, also known as ambulatory care, is health care delivered in a clinic, doctor’s office or hospital that does not require an overnight stay.
For Medicare beneficiaries, this is covered under Part B.
A payer is a public or private entity that provides health insurance to patients, covering healthcare services and products. For prescription drugs, the payer generally reimburses the pharmacy or provider for the majority of the medication’s price, with the patient responsible for the balance through a co-payment or co-insurance. After the negotiated price has been reimbursed to the pharmacy or provider, the payer often receives a substantial rebate from the manufacturer.
A pharmaceutical company develops, produces and markets prescription drugs. Their activities include research and development as well as sales and marketing, also known as “commercialization”.
The pharmacy benefit provides insurance coverage for drugs dispensed to patients by pharmacies.
Drugs are dispensed to patients at the pharmacy who pay out of pocket amount and a claim is filed to payer for reimbursement.
Pharmacy Benefit Managers are third party organizations that aim to reduce pharmacy and administrative costs for health plans (payers) by 1) managing formularies and 2) negotiating drug rebates and discounts. Some large PBMs also manage their own mail order pharmacies.
In 2016, the three largest PBMs in the US managed prescription coverage for 78% of patients.
For high cost specialty drugs, insurance companies may require prior authorization in order to provide coverage. This utilization management strategy ensures that providers or patients meet certain conditions before a product is prescribed.
A healthcare provider is any individual or institution certified to provide health care services, including administering or prescribing drugs.
Insurance companies may set a quantity limit that applies to certain drugs as a form of utilization management. These limits set a maximum limit of coverage for units dispensed for each prescription during a specific period of time based on dosing limits approved during the drug approval process.
Rebates are payments made after sales in exchange for meeting certain conditions set forth in contracts between pharmaceutical companies and payers. PBMs or payers themselves negotiate rebates from manufacturers in exchange for a favorable formulary position, which often has the effect of increasing sales volume and market share. Although the majority of these rebates (generally ~90%) are returned directly to the payers, the PBMs typically retain about 10%. Rebates are rarely disclosed at the product level and have been a focus of calls for greater transparency in drug pricing. Although payers argue that aggregated rebates serve to reduce members’ premiums, they are rarely shared with patients at the point of sale.
Retail pharmacies dispense generic and branded drugs directly to patients.
Specialty drugs address complex or rare diseases. They frequently require special care with regard to distribution, administration or patient monitoring/management. They are dispensed at specialty pharmacies, and may require prior authorization or other utilization controls before the prescription can be filled.
Specialty pharmacies dispense drugs where patient monitoring/ management or utilization restrictions are needed.
Step edit or step therapy is a form of utilization management that requires patients to try other treatments on the formulary prior to being prescribed the specific product (frequently a more expensive specialty drug).
Utilization management includes techniques put in place on behalf of health insurers that manage reimbursement costs and assess appropriateness of care for individual prescriptions.
WAC is a price benchmark used by certain state Medicaid programs and commercial insurers to establish drug reimbursement rates to pharmacies and other providers.
WAC is a manufacturer’s list price for a drug, to wholesalers or direct purchasers, not including discounts, rebates or other reductions in price. WAC is published by pricing publications based on information reported by manufacturers. See 42 U.S.C. § 1395w–3a©(6).
A wholesaler or distributor acts as a middleman between the pharmaceutical companies and the pharmacies and providers that dispense medicines to patients.
The three largest wholesalers account for 85% to 90% of the distribution market in revenue: AmeriSourceBergen Corp. (ABC) $147.3, McKesson Corporation (MCK) $133.7B, Cardinal Health, Inc. (CAH) $97.4B.
Eligible health care organizations receive discounted prices on outpatient drugs through the 340B Drug Discount Program, created in 1992. Eligibility is specified in Section 340B(a)(4) of the Public Health Service Act.
The 340B price (established under section 340B of the Public Health Service Act) is the maximum price that a manufacturer may charge for a covered outpatient drug sold to certain types of clinics receiving federal funding and safety net hospitals specified by statute (“covered entities”). The 340B price is determined quarterly by manufacturers using a statutory formula that is based on the manufacturer’s Average Manufacturer Price (AMP) and Best Price (BP) reported to CMS. See 42 U.S.C. § 256b.


Q: What are the laws about guns and weapons?
A: Laws protect us when dangerous instruments are involved. This applies to driving a car as well as to possession of guns. In Arizona, the law states that kids under the age of 18 are not allowed to carry guns (ARS §13-3111(A)). This law also provides some exceptions where kids are allowed to have and use a gun under certain restricted conditions. For example, a kid can carry a gun if he or she is with a parent, grandparent, qualiﬁed hunter, safety instructor, or qualiﬁed ﬁrearms safety instructor with permission from a parent or guardian. When involved in lawful hunting or shooting events or marksmanship practice, kids between the ages of 14 and 18 are allowed to be in possession of a ﬁrearm (ARS §13-3111). Because there are many exceptions and details to this law, you should read the law or consult a gun expert or lawyer before actually possessing a ﬁrearm.
Arizona law deﬁnes a ﬁrearm as “any loaded or unloaded handgun, pistol, revolver, riﬂe, shotgun or other weapon that will or is designed to or that may readily be converted to expel a projectile by the action of an explosive” (ARS §133101 (4)). Prohibited weapons include ﬁreworks, bombs, grenades, and nunchaku (ARS §13-3101 (8)). In Arizona, it is against the law for a person to sell or give a ﬁrearm to a minor without the written consent of the minor’s parent or legal guardian (ARS §13-3109(A)). Violation of this law is a class 6 felony.
Q: Who can own a gun or weapon?
A: Generally speaking, anything that disqualiﬁes you as a voter or a juror, such as conviction of a felony, also legally disqualiﬁes you as a gun owner. This is no coincidence – these three rights and duties are historically and philosophically related.
Has been found to be a danger to himself or others.
Has been convicted of a felony and whose rights have not been restored.
Is serving a term of probation for a conviction for domestic violence or a felony offense (ARS §13-3101 (7)).
Is under 18 years of age and does not fall within any of the exceptions in (ARS §13-3111(B)).
Q: Who can carry a concealed weapon?
Satisfactorily complete a ﬁrearms safety-training program.
Not be under indictment for, and not have been convicted of a felony unless that conviction has been expunged, set aside or vacated or the applicant’s rights have been restored and the applicant is currently not a prohibited possessor under state or federal law.
Not suffer from mental illness.
Not be in the United States unlawfully.
Q: What is misconduct involving a weapon?
Carrying a deadly weapon without a permit.
Carrying a concealed deadly weapon without a permit in any means of transportation.
Manufacturing, possessing, transporting, selling or transferring a prohibited weapon.
Possessing a deadly weapon if you are a prohibited possessor.
Discharging a ﬁrearm at an occupied structure in order to further the interests of a criminal street gang.
Unless speciﬁcally authorized by law, entering any public establishment or attending any public event and carrying a deadly weapon after a reasonable request to remove the weapon.
Selling or giving control of a ﬁrearm to another person if you know or have reason to know that the other person would use the ﬁrearm in the commission of any felony. There are more things that meet this deﬁnition. Take a look at (ARS §13-3102 (A)) to see the whole list.
Q: How and where can I do my target practice?
A: There are restrictions about where you can do target practice, but be careful wherever you shoot a ﬁrearm.
Local city ordinances should be consulted as cities and towns have the authority to regulate ﬁrearm possession in areas developed for public recreation or family activity, such as picnic areas, swimming areas, golf courses, horseback riding facilities and boat landings (ARS §13-3108).