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7/31/2019 Patents and the Polymorph
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www.LicensingLaw.Netwww.LicensingLaw.Net Pharmaceutical Patent Attys, LLCPharmaceutical Patent Attys, LLC 11
Patents and the PolymorphPatents and the Polymorph
Washington, DCWashington, DC(Henry Stuart(Henry Stuart publpubl., Feb. 2004)., Feb. 2004)
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Economic ImportanceEconomic Importancenn Revenue loss to innovator firms:Revenue loss to innovator firms:
$51,508,000,000$51,508,000,000nn Revenue gain to generic firms:Revenue gain to generic firms:
$19,117,000,000$19,117,000,000(Figures are for upcoming ten years, discounted at 7%)(Figures are for upcoming ten years, discounted at 7%)
New rule is expected to increase (iv) patentNew rule is expected to increase (iv) patent
certifications by 50%certifications by 50%
nn How to succeed within this new framework?How to succeed within this new framework?
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= Overview == Overview =nn How to draft polymorph patents for theHow to draft polymorph patents for the Orange BookOrange Book
nn Expressly permitted patentsExpressly permitted patents
nn Drug Substance & Drug ProductDrug Substance & Drug Product
nn ProductProduct--byby--processprocess
nn Method of UseMethod of Use
nn Conditionally permitted patentsConditionally permitted patentsnn Polymorphic formsPolymorphic forms
nn Certain patents may need to be reCertain patents may need to be re--issued to qualifyissued to qualifynnManufacturing Intermediates, Packaging, MetabolitesManufacturing Intermediates, Packaging, Metabolites
nnWhat happens when a patent is listed?What happens when a patent is listed?nn 3030--month Stay, 180month Stay, 180--day exclusivityday exclusivitynnDeclaratory Judgment resolutionDeclaratory Judgment resolution
2
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Drug Substance & ProductDrug Substance & Product
nn DeclarationDeclaration 2.1: Does the patent claim 2.1: Does the patent claimthe drug substance that is the activethe drug substance that is the active
ingredient in the drug product described iningredient in the drug product described in
the approved NDA or supplement?the approved NDA or supplement?
nnthe final rule does not open the door tothe final rule does not open the door to
submission of any patents claimingsubmission of any patents claiming
formulations [not] described in theformulations [not] described in the
NDA.NDA.nn I f at least one patent claim isI f at least one patent claim islistablelistable, the entire, the entire
patent becomes so.patent becomes so.
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Drug Substance & ProductDrug Substance & Productnn CombinationsCombinations
nn FDA Office of Combination ProductsFDA Office of Combination Products
nnExclusion of a patent claiming a drugExclusion of a patent claiming a drug
substance in conjunction with another activesubstance in conjunction with another activeingredient or method of using theingredient or method of using the
combinationcombination
nn This was considered, but ultimately was notThis was considered, but ultimately was not
adopted.adopted.nn I f at least one patent claim isI f at least one patent claim islistablelistable, the entire, the entire
patent becomes so.patent becomes so.
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Drug Substance & ProductDrug Substance & Product
ProductProduct--byby--processprocessnn Example: eating hardExample: eating hard--cooked eggs to treatcooked eggs to treat
low serum albumin.low serum albumin.
nn N.BN.B.: Raw eggs may contain bacteria.: Raw eggs may contain bacteria
BOIL
ASSUMING THAT THIS HASBEEN KNOWN FOR A LONGTIME, NEITHER THE
BOILING PROCESS NORTHE EGG IS PATENTABLE
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Drug Substance & ProductDrug Substance & Product
ProductProduct--byby--processprocessnn New combination of process and productNew combination of process and product
nn BothBoth processprocess andand productproduct might be oldmight be old
BOIL MICRO-WAVE
Faster, cheaper
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Drug Substance & ProductDrug Substance & Productnnwhen the PTO issues a patent, the PTOwhen the PTO issues a patent, the PTO
necessarily determines thatnecessarily determines that some aspectsome aspectof the patent claims is novel. We want toof the patent claims is novel. We want tomake sure that the NDA applicant ismake sure that the NDA applicant is
identifyingidentifying the product claimthe product claim asas thethe novelnovelaspect.aspect. CommentsComments at 18.at 18.nn CfCf.: It is illegal for PTO to determine that.: It is illegal for PTO to determine thatsome aspectsome aspect of the claim is or is not novel; of the claim is or is not novel;
the claim must be evaluated as a whole.the claim must be evaluated as a whole.nn CfCf.: Every.: Every product claimproduct claim is novel; it is illegalis novel; it is illegal
for PTO to issue any claim which is not.for PTO to issue any claim which is not.
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Method of UseMethod of Usenn Must claim a use that is described in the NDA;Must claim a use that is described in the NDA;
method of use that is in the labelingmethod of use that is in the labeling
nn CfCf. off. off--point patents need not be certifiedpoint patents need not be certified
nn DeclarationDeclaration 4: 4:
nn Does the patent claim one or more approved methodsDoes the patent claim one or more approved methods
of using the approved drug?of using the approved drug?
nn Identify the use with specific reference to theIdentify the use with specific reference to theapproved labeling for the drug productapproved labeling for the drug product
nn Issues: drafting and certification consequencesIssues: drafting and certification consequences
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Certification ConsequencesCertification ConsequencesnnI attest that this submission compliesI attest that this submission complies
with the requirements of the regulation. Iwith the requirements of the regulation. I
verify under penalty of perjuryverify under penalty of perjury
nn
No good faith belief qualifier, nor exceptionNo good faith belief qualifier, nor exceptionfor subsequent change infor subsequent change in lawlaw oror factfact..
nn If patent claim does not verbatim copy useIf patent claim does not verbatim copy use
codecodenn Where will Doctrine of Equivalents be in the future?Where will Doctrine of Equivalents be in the future?
nn If newlyIf newly--discovered prior art unexpectedlydiscovered prior art unexpectedly
limits claim scopelimits claim scope
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MethodsMethods -- Listing ImplicationsListing Implicationsnn Estoppel may be found in court.Estoppel may be found in court.
nnThe [] requirement to identify claims wasThe [] requirement to identify claims wasintended to help prevent arguments as tointended to help prevent arguments as towhether a particular claim claimed thewhether a particular claim claimed the
approved drug product.approved drug product.nn TensionTension
nnAvoid estoppel by comprehensive listing ofAvoid estoppel by comprehensive listing ofclaimsclaims and risk erroneous listingand risk erroneous listing
nnAvoid perjury potential with an overlyAvoid perjury potential with an overly--conservative listingconservative listing and be estopped fromand be estopped fromenforcing legal rights.enforcing legal rights.
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MethodsMethods Generic StrategyGeneric Strategynn Section (viii) CertificationSection (viii) Certification
nnwhen an ANDA applicant has sought towhen an ANDA applicant has sought to
duplicate the labeling for which the innovatorduplicate the labeling for which the innovator
has submitted the patent, and not tohas submitted the patent, and not to
specifically omit, or carve out labeling, wespecifically omit, or carve out labeling, we
require the ANDA applicant to submit arequire the ANDA applicant to submit a
certificationcertification
nn
PurepacPurepac v. Thompsonv. Thompsonnn Consider claiming the carvedConsider claiming the carved--up labelup label
nn Property & Infringement valueProperty & Infringement value
15
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= Overview == Overview =nn
How to draft patents for theHow to draft patents for the Orange BookOrange Booknn Expressly permitted patentsExpressly permitted patentsnnDrug Substance & Drug ProductDrug Substance & Drug Product
nn ProductProduct--byby--processprocess
nnMethod of UseMethod of Use
nn Conditionally permitted patentsConditionally permitted patentsnn Polymorphic formsPolymorphic forms
nn Certain patents may need to be reCertain patents may need to be re--issued to qualifyissued to qualifynnManufacturing Intermediates, Packaging, MetabolitesManufacturing Intermediates, Packaging, Metabolites
nn
What happens when a patent is listed?What happens when a patent is listed?nn 3030--month Stay, 180month Stay, 180--day exclusivityday exclusivitynnDeclaratory Judgment resolutionDeclaratory Judgment resolution
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Polymorphic FormsPolymorphic Formsnn Different physical form, yet equivalent toDifferent physical form, yet equivalent to
NDA active ingredientNDA active ingredient
nn crystalline structures, waters of hydration,crystalline structures, waters of hydration,
solvates, amorphous formssolvates, amorphous formsnn Example : hardExample : hard--cooked eggscooked eggs
CHICKEN
OSTRICH
BIG BIRD
STORK
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Polymorphic FormsPolymorphic Formsnn Listed if bioequivalence data existsListed if bioequivalence data existsnn Issues:Issues:
nn Having dataHaving data
nn Timing of dataTiming of data
nn Effect of dataEffect of data
nn Having dataHaving data
nn Manufacturing and packaging process controls,Manufacturing and packaging process controls,product specifications, analytical methods areproduct specifications, analytical methods are
requiredrequired
nn What if Holder doesnt manufacture / sell theWhat if Holder doesnt manufacture / sell thepolymorph?polymorph?
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PolymorphsPolymorphsnn The test data must exist when aThe test data must exist when a
polymorph patent Declaration is submittedpolymorph patent Declaration is submitted
to FDA.to FDA.
nn
CfCf. Patent must be submitted to FDA w/in 30. Patent must be submitted to FDA w/in 30
days after PTO issues it.days after PTO issues it.
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PolymorphsPolymorphsnn Potential Solution: severalPotential Solution: several--month delaymonth delay
between Notice of Allowance and patentbetween Not ice of Allowance and patent
Issue dateIssue date
nn
Cf. PTO can revoke a Notice of AllowanceCf. PTO can revoke a Notice of Allowance
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nn Bioequivalence data mayBioequivalence data may
show that the polymorph isshow that the polymorph is
legally an obvious (read:legally an obvious (read:minor or inconsequential)minor or inconsequential)
variant of the innovatorvariant of the innovator
nn Can make it difficult to obtainCan make it difficult to obtain/ retain a patent claim/ retain a patent claimcovering the polymorphcovering the polymorph
nn Patent attorneyPatent attorney mustmust bebegiven this bioequivalence datagiven this bioequivalence data
SubmitEquivalence
data
ObviousnessRejection
ChangeTarget
Compound
21
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= Overview == Overview =nn
How to draft patents for theHow to draft patents for the Orange BookOrange Booknn Expressly permitted patentsExpressly permitted patentsnnDrug Substance & Drug ProductDrug Substance & Drug Product
nn ProductProduct--byby--processprocess
nnMethod of UseMethod of Use
nn Conditionally permitted patentsConditionally permitted patentsnn Polymorphic formsPolymorphic forms
nn Certain patents may need to be reCertain patents may need to be re--issued to qualifyissued to qualifynnManufacturing Intermediates, Packaging, MetabolitesManufacturing Intermediates, Packaging, Metabolites
nn
What happens when a patent is listed?What happens when a patent is listed?nn 3030--month Stay, 180month Stay, 180--day exclusivityday exclusivitynnDeclaratory Judgment resolutionDeclaratory Judgment resolution
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PackagingPackaging
nn patents must notpatents must not
be submitted forbe submitted for
bottles or containersbottles or containers
and otherand other
packaging, as thesepackaging, as these
are not dosageare not dosage
forms.forms.
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Business MethodsBusiness Methodsnn Patient registries, titration / dosagePatient registries, titration / dosage
schedulesschedules
nn CelgenesCelgenes thalidomidethalidomide
nn Roches 13Roches 13--ciscisretinoic acidretinoic acid
nn Relate claim verbiage to matter withRelate claim verbiage to matter withwhich FDA is comfortablewhich FDA is comfortable
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Manufacturing IntermediateManufacturing Intermediate
We consider reagents to be inWe consider reagents to be in--processprocessmaterials rather than drugmaterials rather than drugHow does one list a softHow does one list a soft--cooked egg patent?cooked egg patent?
SOFT-COOKED HARD-COOKEDRAW
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MetabolitesMetabolitesnn
The final rule prohibits submission ofThe final rule prohibits submission ofpatents claiming metabolitespatents claiming metabolites
nn DeclarationDeclaration 2.5: Does the patent claim a 2.5: Does the patent claim a
metabolite of the approved active ingredient?metabolite of the approved active ingredient?
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MetabolitesMetabolites
nn If a patent claims an approved use of anIf a patent claims an approved use of anapproved drug to administer a metabolite,approved drug to administer a metabolite,
the patent may bethe patent may be listablelistable -- yet invalid.yet invalid.
nn Schering Corp. v. GenevaSchering Corp. v. Geneva PharmaPharma., Inc.., Inc. (Fed.(Fed.
Cir., Aug. 1 2003) (Cir., Aug. 1 2003) (loratadineloratadine metabolite ismetabolite is
inherently createdinherently created in vivoin vivo; the metabolite is; the metabolite is
therefore not new; the metabolite patenttherefore not new; the metabolite patent
claim is thus invalid).claim is thus invalid).
26
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= Overview == Overview =nn
How to draft patents for theHow to draft patents for the
Orange BookOrange Book
nn Expressly permitted patentsExpressly permitted patentsnnDrug Substance & Drug ProductDrug Substance & Drug Product
nn ProductProduct--byby--processprocess
nnMethod of UseMethod of Use
nn Conditionally permitted patentsConditionally permitted patentsnn Polymorphic formsPolymorphic forms
nn Certain patents may need to be reCertain patents may need to be re--issued to qualifyissued to qualifynnManufacturing Intermediates, Packaging, MetabolitesManufacturing Intermediates, Packaging, Metabolites
nn
What happens when a patent is listed?What happens when a patent is listed?nn 3030--month Stay, 180month Stay, 180--day exclusivityday exclusivitynnDeclaratory Judgment resolutionDeclaratory Judgment resolution
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3030--Month StayMonth Staynn
One full opportunity per ANDA or 505(b)(2)One full opportunity per ANDA or 505(b)(2)nn OneOne -- Change from prior practiceChange from prior practice
nn CfCf.. In re OmeprazoleIn re Omeprazole: the statute does not limit the number of: the statute does not limit the number ofstays availablestays available
nn CfCf. Continuation with a terminal disclaimer (. Continuation with a terminal disclaimer (cfcf.. PaxilPaxil,,FosamaxFosamax))
nn Only oneOnly one -- subsequent (iv) certifications need not be noticedsubsequent (iv) certifications need not be noticed
nn full opportunityfull opportunitynn 45 day response period45 day response period
nn Amending a (iv) to a (iii) certification before 45 day perioAmending a (iv) to a (iii) certification before 45 day period runs,d runs,before suit commences.before suit commences.
nn NoticeNoticenn (ii), (iii) certifications and 505(j)(2)(A)(viii) flings d (ii), (iii) certifications and 505(j)(2)(A)(viii) flings do noto not
require notice, thus may fail to provide a full opportunity forrequire notice, thus may fail to provide a full opportunity for a staya staynn ? What if notice is given in fact ?? What if notice is given in fact ?
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180180--Day ExclusivityDay ExclusivitynnEach patent listed in the Orange BookEach patent listed in the Orange Book
may form the basis for a claim to 180may form the basis for a claim to 180--dayday
exclusivity. Thus an increase or decreaseexclusivity. Thus an increase or decrease
in listed patents as a result of this finalin listed patents as a result of this finalrule could affect the number of exclusivityrule could affect the number of exclusivity
periods.periods.
nn With only one stay, there is less incentive toWith only one stay, there is less incentive to
list patentslist patents -- and each listed patent is an aidand each listed patent is an aidto a potential generic company.to a potential generic company.
nn Consider drafting patents toConsider drafting patents to precludepreclude listinglisting
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Declaratory JudgmentsDeclaratory Judgmentsnn
Holder need not sue on ANDA filing.Holder need not sue on ANDA filing.nn If Holder waits to sue until after genericIf Holder waits to sue until after generic
is launched, infringement may beis launched, infringement may bewillfulwillfulnn treble damages, attorneys fees, permanenttreble damages, attorneys fees, permanent
injunction, personal liabilityinjunction, personal liability
nn Declaratory judgmentDeclaratory judgment
nn
Jurisdiction requires:Jurisdiction requires:1)1) Current infringing activity 271(e)(2)Current infringing activity 271(e)(2)
2)2) Reasonable apprehension of being suedReasonable apprehension of being sued
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Declaratory JudgmentsDeclaratory Judgments
nn Dr. Reddys v. PfizerDr. Reddys v. Pfizer (New Jersey)(New Jersey)nn SertralineSertraline declaratory judgment petition dismisseddeclaratory judgment petition dismissed
on 11 July 03on 11 July 03
1)1) Pfizer alleged that it needed more time to assessPfizer alleged that it needed more time to assess
whether infringement exists.whether infringement exists.2)2) Dr. Reddys failed to show reasonable apprehensionDr. Reddys failed to show reasonable apprehension
of suitof suit
nn AnanthAnanth IyerIyer ofofExpressExpress PharmaPharma PulsePulse (Bombay)(Bombay)predicted this in an article published in the spring.predicted this in an article published in the spring.
nn Resolving patent disputes prior to ANDAResolving patent disputes prior to ANDA
product launch not always possibleproduct launch not always possible
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Declaratory JudgmentsDeclaratory Judgmentsnn CfCf.: a firms inability to predict whether it will.: a firms inability to predict whether it will
or will not be sued for patent infringement is aor will not be sued for patent infringement is amatter outside the scope of this final rule. * * *matter outside the scope of this final rule. * * *some patent infringement suits may be initiatedsome patent infringement suits may be initiatedafter the 45 day period available to obtain a 30after the 45 day period available to obtain a 30--month stay has expired. * * * the NDA holdermonth stay has expired. * * * the NDA holderor patent owner can bring suit at a later time,or patent owner can bring suit at a later time,but loses the opportunity to obtain a 30but loses the opportunity to obtain a 30--monthmonthstaystay
nn
CfCf.: an NDA holder who defers filing a lawsuit.: an NDA holder who defers filing a lawsuiton a lateron a later--filed patent until a 30filed patent until a 30--month stay hasmonth stay haselapsed may feel that the subsequent litigationelapsed may feel that the subsequent litigationis still timelyis still timely
31
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ToTo--DoDonn
CurrentlyCurrently--Listed method patentsListed method patentsnn Use of new declaration form is particularlyUse of new declaration form is particularly
advisable for methodadvisable for method--ofof--use patentsuse patents
nnvoluntary submission of new patentvoluntary submission of new patent
declarations will not bring patents within thedeclarations will not bring patents within thescope of the final rule with respect to noticescope of the final rule with respect to notice
and 30and 30--month stays.month stays.
nn But with respect to perjury and estoppelBut with respect to perjury and estoppel
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ToTo--DoDonn
=> Review existing method patents and=> Review existing method patents andconsider filing claimconsider filing claim--identifying Declarationsidentifying Declarations
nn Patents listed in the Orange Book as of August 17,Patents listed in the Orange Book as of August 17,
2003 are grandfathered in and enjoy benefits of2003 are grandfathered in and enjoy benefits ofthe old rule (e.g., multiple 30the old rule (e.g., multiple 30--month stays, etc)month stays, etc)
nn CfCf. in. in Glaxo v.Glaxo v.ApotexApotex, Glaxo asked the FDA (on 1, Glaxo asked the FDA (on 1
July 2003) to deJuly 2003) to de--list 3 patents from the Orangelist 3 patents from the OrangeBook.Book.
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ToTo--DoDo
Our long experience with administering theOur long experience with administering theHatchHatch--Waxman Amendments convinces usWaxman Amendments convinces us
that any advantage a party can find inthat any advantage a party can find in
manipulating the regulatory program willmanipulating the regulatory program will
be pursued. Despite our conviction thatbe pursued. Despite our conviction thatthe final rule will substantially reduce suchthe final rule will substantially reduce such
manipulation, we do not believe we canmanipulation, we do not believe we can
completely prevent attempts at creativecompletely prevent attempts at creativecompliance by the parties.compliance by the parties.
CommentsComments at 52.at 52.
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for further researchfor further research
nn
available onavailable on--line atline atwww.LicensingLaw.Netwww.LicensingLaw.Net//LibraryLibrary::
nn A color copy of this presentation together withA color copy of this presentation together with
the Federal cases cited; andthe Federal cases cited; and
nn
A paper on antitrust implications of patent listing,A paper on antitrust implications of patent listing,together with the Federal cases citedtogether with the Federal cases cited
Mark Pohl, Esq., Patent AttorneyPharmaceutical Patent Attorneys, LLCMorristown, New [email protected] Dial +1 (973) 984-0076