AIPLA 2010 Mid-Winter Institute: Winter Institute: Patent ... Documen… · AIPLA 2010 Mid-Winter Institute: Winter Institute: Patent Term Extensions Kurt R. Karst Hyman, Phelps &

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AIPLA 2010 MidAIPLA 2010 Mid--Winter Institute:Winter Institute: Patent Term ExtensionsPatent Term Extensions

Kurt R. KarstKurt R. KarstHyman, Phelps & McNamara, P.C.Hyman, Phelps & McNamara, P.C.700 Thirteenth Street, N.W., Suite 1200700 Thirteenth Street, N.W., Suite 1200

Washington, D.C. 20005, U.S.A.Washington, D.C. 20005, U.S.A.202202--737737--56005600 �� www.hpm.comwww.hpm.com

[email protected]@hpm.comJanuary 29, 2010January 29, 2010

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TopicsTopicsTopics

•• Patent Term Extension (Patent Term Extension (““PTEPTE””))BasicsBasics

•• Current PTE IssuesCurrent PTE Issues–– PhotoCurePhotoCure && LupinLupin CasesCases–– ANGIOMAX/ANGIOMAX/ ““Dog Ate My Homework ActDog Ate My Homework Act””–– Wyeth CYDECTIN CaseWyeth CYDECTIN Case–– MultipleMultiple PTEsPTEs–– Multiple Interim Multiple Interim PTEsPTEs

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PTE BasicsPTE BasicsPTE Basics

•• Under Title II of the Drug Price Competition Under Title II of the Drug Price Competition and Patent Term Restoration Act, Pub. L. No. and Patent Term Restoration Act, Pub. L. No. 9898--417, 98 Stat. 1585 (1984) (the 417, 98 Stat. 1585 (1984) (the ““HatchHatch--Waxman ActWaxman Act””), certain patents related to ), certain patents related to products regulated by FDA are eligible for products regulated by FDA are eligible for extension if patent life was lost during a period extension if patent life was lost during a period when the product was undergoing regulatory when the product was undergoing regulatory review.review.

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•• As applied to drugs, the patent extension law (35 As applied to drugs, the patent extension law (35 U.S.C.U.S.C. §§ 156(a)(1)156(a)(1)--(5)) provides that the term of a (5)) provides that the term of a patent claiming the drug (or a use of the drug or a patent claiming the drug (or a use of the drug or a method of manufacturing a drug) shall be method of manufacturing a drug) shall be extended from the original expiration date of the extended from the original expiration date of the patent if: patent if: –– (1) The term of the patent has not expired; (1) The term of the patent has not expired; –– (2) The patent has not been previously extended; (2) The patent has not been previously extended; –– (3) The extension application is submitted by the owner of (3) The extension application is submitted by the owner of

record within sixty days of New Drug Application (record within sixty days of New Drug Application (““NDANDA””))approval;approval;

–– (4) The product, use, or method of manufacturing claimed has (4) The product, use, or method of manufacturing claimed has been subject to a been subject to a ““regulatory review periodregulatory review period”” before it is before it is commercially marketed; and commercially marketed; and

–– (5) The NDA is the first permitted commercial use of the (5) The NDA is the first permitted commercial use of the product.product.

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•• A PTE application A PTE application ““may only be submitted may only be submitted within the sixtywithin the sixty--day period beginning on the day period beginning on the date the product received permission under date the product received permission under the provision of law under which the the provision of law under which the applicable regulatory review period occurred applicable regulatory review period occurred for commercial marketing or usefor commercial marketing or use”” of the drug of the drug productproduct �� not one day laternot one day later. 35 U.S.C. . 35 U.S.C. §§ 156(d)(1).156(d)(1).–– UnimedUnimed, Inc. v. , Inc. v. QuiggQuigg, 888 F2d 826; 12 USPQ2d 1644 , 888 F2d 826; 12 USPQ2d 1644

(Fed. Cir. 1989) ((Fed. Cir. 1989) (““[[S]ectionS]ection 156(d)(1) admits of no 156(d)(1) admits of no other meaning than that the sixtyother meaning than that the sixty--day period begins day period begins on the FDA approval date.on the FDA approval date.””).).

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–– The PTO, after being challenged as to the date The PTO, after being challenged as to the date on which the 60on which the 60--day period at 35 U.S.C. day period at 35 U.S.C. §§156(d)(1) begins, ruled in the context of one PTE 156(d)(1) begins, ruled in the context of one PTE application (for PRILOSEC OTC) that although application (for PRILOSEC OTC) that although the PTO had in some instances started counting the PTO had in some instances started counting the 60the 60--day period on the date after NDA day period on the date after NDA approval,approval, ““[[b]yb]y not counting the date of FDA not counting the date of FDA approval as one of the sixty days included in approval as one of the sixty days included in the time period for filing a PTE application, the the time period for filing a PTE application, the USPTO was failing to comply with section 156 USPTO was failing to comply with section 156 and case law.and case law.””

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•• TheThe ““regulatory review periodregulatory review period”” is composed of a is composed of a ““testing phasetesting phase”” and a and a ““review phase.review phase.””

•• For a drug product, the For a drug product, the ““testing phasetesting phase”” begins on begins on the effective date of an Investigational New Drug the effective date of an Investigational New Drug Application (Application (““INDIND””) and ends on the date an NDA ) and ends on the date an NDA is submitted to FDA. 35 U.S.C. is submitted to FDA. 35 U.S.C. §§ 156(g)(1)(B)(i).156(g)(1)(B)(i).

•• TheThe ““review phasereview phase”” for a drug product is the for a drug product is the period between the submission and the approval period between the submission and the approval of the NDA (usually six or ten months). 35 U.S.C. of the NDA (usually six or ten months). 35 U.S.C. §§ 156(g)(1)(B)(ii).156(g)(1)(B)(ii).

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•• The patent term may be extended for a period of The patent term may be extended for a period of time that is the sum of onetime that is the sum of one--half of the time in the half of the time in the ““testing phase,testing phase,”” plus all the time in the plus all the time in the ““reviewreviewphase.phase.”” 35 U.S.C. 35 U.S.C. §§§§ 156(c)(2) and (g)(1)(B).156(c)(2) and (g)(1)(B).

•• However, the total (calculated) regulatory review However, the total (calculated) regulatory review period may not exceed 5 years, and the extended period may not exceed 5 years, and the extended patent term may not exceed 14 years after the date patent term may not exceed 14 years after the date of approval of the marketing application. 35 U.S.C.of approval of the marketing application. 35 U.S.C.§§§§ 156(g)(6)(A), 156(c)(3).156(g)(6)(A), 156(c)(3).

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•• The PTE law defines the term The PTE law defines the term ““drug productdrug product”” totomeanmean ““the active ingredient of a new drug [as the active ingredient of a new drug [as defined in defined in §§ 201(p) of the FDC Act] . . . including 201(p) of the FDC Act] . . . including any salt or ester of the active ingredient, as a any salt or ester of the active ingredient, as a single entity or in combination with another active single entity or in combination with another active ingredient.ingredient.”” 35 U.S.C. 35 U.S.C. §§ 156(f)(2).156(f)(2).–– The PTO interprets of the term The PTO interprets of the term ““productproduct”” in 35 in 35

U.S.C.U.S.C. §§ 156(a)(5)(A) to mean 156(a)(5)(A) to mean ““active moietyactive moiety”” ((i.e.i.e.,,the molecule in a drug product responsible for the molecule in a drug product responsible for pharmacological action, excluding any salt, ester, or pharmacological action, excluding any salt, ester, or other nonother non--covalent derivative) rather than covalent derivative) rather than ““activeactiveingredientingredient”” ((i.e.i.e., the active moiety in a drug product, , the active moiety in a drug product, including any salt, ester, or other nonincluding any salt, ester, or other non--covalentcovalentderivative).derivative).

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•• With respect to the applicability of With respect to the applicability of PTEsPTEs totocombination drugs, the Federal Circuit ruled in combination drugs, the Federal Circuit ruled in 2004 that 2004 that ““the statute places a drug product with the statute places a drug product with two active ingredients, A and B, in the same two active ingredients, A and B, in the same category as a drug product with a single ingredient category as a drug product with a single ingredient . . . .. . . . To extend the term of a patent claiming a To extend the term of a patent claiming a composition comprising A and B, either A or B composition comprising A and B, either A or B must not have been previously marketed.must not have been previously marketed.”” ArnoldArnoldPartnership v. Partnership v. DudasDudas, 362 F.3d 1338, 1341 (Fed. , 362 F.3d 1338, 1341 (Fed. Cir. 2004).Cir. 2004).

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•• InterimInterim PTEsPTEs–– A patent that expires before the submission A patent that expires before the submission

of an application to the PTO for a patent of an application to the PTO for a patent term extension is not eligible for such term extension is not eligible for such extension,extension, unlessunless a patent has been granted a patent has been granted an interim extension under one of two an interim extension under one of two exceptions under the patent term extension exceptions under the patent term extension law.law. SeeSee 35 U.S.C. 35 U.S.C. §§ 156(a)(1).156(a)(1).•• (1) interim patent extensions granted during the (1) interim patent extensions granted during the

““review phasereview phase”” of the statutory of the statutory ““regulatoryregulatoryreview period;review period;”” andand

•• (2) an interim patent extension granted during (2) an interim patent extension granted during the PTOthe PTO’’s review of an application for patent s review of an application for patent term extension.term extension.

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–– The cumulative patent time granted under The cumulative patent time granted under either type of interim PTE cannot exceed the either type of interim PTE cannot exceed the patent term extension that a company might patent term extension that a company might obtain under regular patent extension obtain under regular patent extension provisions.provisions.

–– That is, interim patent extensions cannot That is, interim patent extensions cannot exceed what the PTO might ultimately exceed what the PTO might ultimately determine is the correct patent term determine is the correct patent term extension for which a particular patent extension for which a particular patent claiming a drug product is eligible.claiming a drug product is eligible.

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•• Private Patent Extensions Private Patent Extensions –– Although very rare, a PTE is possible Although very rare, a PTE is possible

through a private patent extension, through a private patent extension, under which the United States Congress, under which the United States Congress, with the approval of the President, with the approval of the President, passes a private law to extend the term passes a private law to extend the term of a specific patent.of a specific patent.•• E.g.E.g., H.R. 2508 , H.R. 2508 -- To extend patent numbered To extend patent numbered

5,180,715 for a period of 2 years; ELMIRON 5,180,715 for a period of 2 years; ELMIRON ((pentosanpentosan polyslfatepolyslfate sodium)sodium)

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Current PTE IssuesCurrent PTE IssuesCurrent PTE Issues

•• OrthoOrtho--McNeilMcNeil PharmaPharma v.v. LupinLupin PharmaPharma,,Case No. 2009Case No. 2009--1362 & 1362 & PhotoCurePhotoCure ASA v. ASA v. KapposKappos, Case No. 2009, Case No. 2009--13931393–– Both cases concern the proper interpretation of 35 Both cases concern the proper interpretation of 35

U.S.C.U.S.C. §§ 156(a)(5)(A), which states that the term of a 156(a)(5)(A), which states that the term of a patent claiming a drug shall be extended from the patent claiming a drug shall be extended from the original expiration date of the patent if, among other original expiration date of the patent if, among other things,things, ““the permission for the commercial marketing the permission for the commercial marketing or use of the or use of the productproduct . . . is the first permitted . . . is the first permitted commercial marketing or use of the commercial marketing or use of the productproduct underunderthe provision of law under which such regulatory the provision of law under which such regulatory review period occurred.review period occurred.”” (emphasis added) (emphasis added)

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–– LupinLupin -- U.S. District Court for the District of U.S. District Court for the District of New Jersey ruled that the PTE granted by the New Jersey ruled that the PTE granted by the PTO with respect to U.S. Patent No. 5,053,407PTO with respect to U.S. Patent No. 5,053,407covering Ortho McNeilcovering Ortho McNeil--JanssenJanssenPharmaceutical, Inc.Pharmaceutical, Inc.’’s LEVAQUIN s LEVAQUIN ((levofloxacinlevofloxacin) is valid. () is valid. (LevofloxacinLevofloxacin is an is an enantiomerenantiomer in the previously approved Ortho in the previously approved Ortho racemateracemate drug product FLOXIN (drug product FLOXIN (ofloxacinofloxacin).)).)

–– LupinLupin challenged the challenged the ‘‘407 patent PTE in the 407 patent PTE in the context of ANDA Paragraph IV patent context of ANDA Paragraph IV patent infringement litigation on the grounds that the infringement litigation on the grounds that the PTE is invalid because FDA previously PTE is invalid because FDA previously approvedapproved levofloxacinlevofloxacin when the Agency when the Agency approvedapproved ofloxacinofloxacin..

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–– PhotoCurePhotoCure -- PhotoCurePhotoCure challenged the PTO's challenged the PTO's denial of a PTE for U.S. Patent No. 6,034,267 denial of a PTE for U.S. Patent No. 6,034,267 covering METVIXIA (methyl covering METVIXIA (methyl aminoevulinateaminoevulinatehydrochloride). The U.S. District Court for the hydrochloride). The U.S. District Court for the Eastern District of Virginia granted Eastern District of Virginia granted PhotoCurePhotoCure’’ss Motion for Summary Judgment Motion for Summary Judgment and denied the PTOand denied the PTO’’s Motion for Summary s Motion for Summary Judgment.Judgment.

–– The decision, which struck down the PTO's The decision, which struck down the PTO's interpretation of interpretation of ““productproduct”” in the PTE statute, in the PTE statute, could have significant implications on PTE could have significant implications on PTE decisions if the decision is affirmed by the decisions if the decision is affirmed by the Federal Circuit.Federal Circuit.

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–– ““To adopt the active moiety approach would To adopt the active moiety approach would entail construing the term entail construing the term ‘‘active ingredientactive ingredient’’ ininsuch a manner that permits compounds to such a manner that permits compounds to qualify as ingredients of drugs even when those qualify as ingredients of drugs even when those compounds are not actually present in the drug.compounds are not actually present in the drug.To adopt such a construction would be To adopt such a construction would be permissible, in this Courtpermissible, in this Court’’s view, only if there s view, only if there was support in the legislative history. But the was support in the legislative history. But the Court could find no legitimate support for the Court could find no legitimate support for the active moiety approach in the active moiety approach in the §§ 156 legislative 156 legislative history. Therefore, the Court will not construe history. Therefore, the Court will not construe thethe ‘‘active ingredientactive ingredient’’ term against its plain term against its plain meaning by adopting a construction that meaning by adopting a construction that permits compounds not present in the drug to permits compounds not present in the drug to qualify as the active ingredient.qualify as the active ingredient.’”’”

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•• ““Dog Ate My Homework ActDog Ate My Homework Act”” UpdateUpdate–– The Medicines Company is continuing its push The Medicines Company is continuing its push

to obtain a PTE for U.S. Patent No. 5,196,404 to obtain a PTE for U.S. Patent No. 5,196,404 covering ANGIOMAX (covering ANGIOMAX (bivalirudinbivalirudin).).

–– The Medicines Company submitted a PTE The Medicines Company submitted a PTE application to the PTO 62 days after FDA application to the PTO 62 days after FDA approved the companyapproved the company’’s ANGIOMAX NDA s ANGIOMAX NDA -- 22days late!days late!

–– Legislation has been introduced and debated Legislation has been introduced and debated over the past several years that would amend over the past several years that would amend 35 U.S.C. 35 U.S.C. §§ 156 to permit the PTO to accept the 156 to permit the PTO to accept the late filing of a PTE application.late filing of a PTE application.

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•• Wyeth Holding Corp. v. United StatesWyeth Holding Corp. v. United States–– WyethWyeth concerns a PTE request for U.S. Patent concerns a PTE request for U.S. Patent

No. 4,916,154 covering WyethNo. 4,916,154 covering Wyeth’’s new animal s new animal drug CYDECTIN (drug CYDECTIN (moxidectinmoxidectin) Pour) Pour--On.On.

–– FDA approved CYDECTIN PourFDA approved CYDECTIN Pour--On on January On on January 28, 1998 under New Animal Drug Application 28, 1998 under New Animal Drug Application ((““NADANADA””) No. 141) No. 141--099. The NADA was 099. The NADA was reviewed under FDAreviewed under FDA’’s Phased Data Review s Phased Data Review Policy and Administrative NADA process (Policy and Administrative NADA process (i.e.i.e.,,a process permitting rolling submission and a process permitting rolling submission and review of marketing application sections).review of marketing application sections).

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–– FDA determined that the date NADA No. 141FDA determined that the date NADA No. 141--099 was 099 was ““initially submittedinitially submitted”” to the agency for to the agency for PTE purposes was January 13, 1998, when the PTE purposes was January 13, 1998, when the final NADA component was submitted to the final NADA component was submitted to the Agency, thus resulting in a 16Agency, thus resulting in a 16--day approval day approval period and a short PTE period for the period and a short PTE period for the ‘‘154154patent.patent.

–– Wyeth sued FDA and contended that a 16Wyeth sued FDA and contended that a 16--daydayapproval period approval period ““is unreasonable,is unreasonable,”” and argued and argued that the NADA was that the NADA was ““initially submittedinitially submitted”” to FDA to FDA on August 8, 1995 when the company on August 8, 1995 when the company submitted the first technical section to its submitted the first technical section to its application.application.

–– FDA won in the district court and Wyeth has FDA won in the district court and Wyeth has appealed to the Federal Circuit.appealed to the Federal Circuit.

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•• MultipleMultiple PTEsPTEs–– The PTE statute states (at 35 U.S.C. The PTE statute states (at 35 U.S.C. §§ 156(c)(4))156(c)(4))

thatthat ““in no event shall more than one patent be in no event shall more than one patent be extended . . . for the same regulatory review extended . . . for the same regulatory review period for any product.period for any product.”” The PTO interprets 35 The PTO interprets 35 U.S.C.U.S.C. §§ 156(c)(4) to permit multiple 156(c)(4) to permit multiple PTEsPTEsunder certain circumstances under certain circumstances –– specifically, for specifically, for a drug product covered by several patents the a drug product covered by several patents the PTO may extend a different patent for each PTO may extend a different patent for each NDA approved on the same first day (even NDA approved on the same first day (even when multiple when multiple NDAsNDAs share common share common ““testingtestingphasephase”” and a and a ““review phasereview phase”” dates). That is, dates). That is, the PTO considers each NDA the PTO considers each NDA ““regulatoryregulatoryreview periodreview period”” to be distinct and for which a to be distinct and for which a PTE is available. PTE is available.

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•• Multiple Interim Multiple Interim PTEsPTEs–– A recent decision from the PTO in which A recent decision from the PTO in which

the Office granted an interim PTE for U.S. the Office granted an interim PTE for U.S. Patent No. 5,407,914 but denied interim Patent No. 5,407,914 but denied interim extensions for U.S. Patent Nos. 5,260,273 extensions for U.S. Patent Nos. 5,260,273 and 5,789,381 covering the drug product and 5,789,381 covering the drug product SURFAXIN appears to be the first time in SURFAXIN appears to be the first time in which the PTO has had to address the which the PTO has had to address the issue of the availability of multiple interim issue of the availability of multiple interim PTEsPTEs..

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–– ““Based on the language of the statute, as a whole, Based on the language of the statute, as a whole, and the plain meaning of and the plain meaning of ‘‘a patent,a patent,’’ the statute only the statute only contemplated that a single patent is entitled to contemplated that a single patent is entitled to have the term extended for the same (single) have the term extended for the same (single) regulatory review period. Similarly, the explicit regulatory review period. Similarly, the explicit language of section 156(d)(5)(C) makes clear that language of section 156(d)(5)(C) makes clear that interim extension is applicable only for interim extension is applicable only for ‘‘a patent,a patent,’’stating,stating, ‘‘[[t]het]he owner of record of a patent, or its owner of record of a patent, or its agent, for which an interim extension has been agent, for which an interim extension has been granted under subparagraph (b), may apply for not granted under subparagraph (b), may apply for not more than 4 subsequent interim extensions under more than 4 subsequent interim extensions under this paragraph . . . .this paragraph . . . .’’ The plain language of The plain language of obtainingobtaining ‘‘an extensionan extension’’ forfor ‘‘a patenta patent’’ delineatesdelineatesthat the [PTE] statute contemplates that only one that the [PTE] statute contemplates that only one patent may be granted an interim extension.patent may be granted an interim extension.””

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•• With respect to cases in which a company might With respect to cases in which a company might ultimately be eligible for multiple ultimately be eligible for multiple PTEsPTEs once a once a drug product is approved, the PTOdrug product is approved, the PTO’’s interim PTE s interim PTE decision leaves the door open for multiple interim decision leaves the door open for multiple interim patent extensions.patent extensions.

•• Specifically, the PTOSpecifically, the PTO’’s statement that s statement that ““only a only a single interim PTE is available for the same single interim PTE is available for the same (single) regulatory review period,(single) regulatory review period,”” means that means that when separate when separate NDAsNDAs, each with its own , each with its own ““regulatory review period,regulatory review period,”” might be approved on might be approved on the same first day, more than a single patent the same first day, more than a single patent might qualify for an interim patent extension. might qualify for an interim patent extension.

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AIPLA 2010 Mid-Winter Institute: Winter Institute: Patent ... Documen… · AIPLA 2010 Mid-Winter Institute: Winter Institute: Patent Term Extensions Kurt R. Karst Hyman, Phelps &