Generic Pharmaceutical Patentand FDA Law

2008 Edition

Shashank Upadhye

XMOIVISOISI^k,

WEST

For Customer Assistance Call 1-800-328-4880Mat #40615439

Table of ContentsCHAPTER 1. BASICS OF PATENT LAW

I. INTRODUCTION§ 1:1 In general§ 1:2 Basic patent process§ 1:3 Structural organization of a patent

II. PATENT CLAIMS§1:4 Importance of patent claims§ 1:5 Person of ordinary skill in the art§ 1:6 Organizational structure of the claim—Preamble§ 1:7 Transition phrase§ 1:8 Organizational structure of the claim—Body of the

claim§ 1:9 Common types of pharmaceutical claims—Base

chemical/compound claims§ 1:10 —Salts, esters, and solvates§ 1:11 —Enantiomers§ 1:12 —Polymorphs§1:13 —Combinations of APIs§ 1:14 —Formulations§1:15 —Methods of use§ 1:16 —Method of manufacture or process claims§ 1:17 —Product-by-process claims§ 1:18 —Release profiles§ 1:19 Conclusion

III. STATUTORY PROVISIONSA. IN GENERAL

§ 1:20 Common statutory provisions of the patent law

B. SECTION 101: SUBJECT MATTER

§ 1:21 Patentable subject matter

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G K N K K I C I ' H A K M A < I t ric AI I ' A T K . M A N D FDA LAW

C. SECTION 102: NOVELTY§ 1:22 Novelty and "new" inventions§ 1:23 Section 102iai§ 1:24 Section 102<bi§ 1:25 —On-sale bar§ 1:26 —Public use bar§ 1:27 Section 102<ci§ 1:28 Section 102ul>

§ 1:29 Section 102<e>- -Utopian-world p.-,t.-ni issuance in theUor 10

§ 1 : 3 0 ^ " ? u r s t a n < l i n K § l ( )*<" through example .-ind time

§1:31 Section 102(ft-..I,m.nt«,r is , , , ,nh. . i,iv.-,.l«,r§ 1:32 Sect.on 102iKi_lVi«,r irnvmi,,,, l,v another1 J o , ~ C o n t r a s t » n « section l()2(g.( 1 I versus 1()2(MH2)§ 1:34 Conclusion

D. SECTION 103: OBVIOUSNESS

1 t h 3 n t n v i a l variations?• ^ f a c t°™-Primarv obviousness factors

° f obviou«ness inquiry- "S m l ?ftft

hin^ht-Motivation. suggestion,8 1 qq Pn^L ' t 0 comb»ne prior art

- ^ b i n a h o n of references-Flowing from the prior§ 1:40 — Reference v§ 1:41 Secondary tiJ™? T"™ °f p r ° b l e m to be S ° l v e d

§ 1:42 Unexpected rosuLofib10118"1":-§ 1:43 Long-felt need tu invention§ 144 Failnr V t ° r t h e Inv*ntion

1;S SXl°S!w t k§ 1;S SXlS! r§ 1:46 -Active i n ^ d ^ ^ f a C t" r i n o b v i » u s n l * 8

§1:47 -Formulation1"1:48 Licensing by others

8 1:49 Commercial si§ 1:50 Skepticism h ^ s s ~ G e n e r i c drug infringement cases§ 1:51 Third-nart, ° r S a n d P r o o f o f nonobviousness§ 1:52 Chemical ^ r r i S e ^ d

§ 1:53 - ^ S S t y§ 1:54 - I s o ^ l ? ! 1 °bv , i ousness of chemical compounds§1:55 ConclusTon

d ° b v i 0 U S n

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E. SECTION 112: SPECIFICATION§1:56 Role of the specification§ 1:57 First paragraph§ 1:58 —Written description§ 1:59 —Enablement requirement§ 1:60 —Best mode requirement§ 1:61 —Conclusion§ 1:62 Second paragraph: claim precision and boundaries§ 1:63 Third and fourth paragraphs: dependent claims§ 1:64 Conclusion

F. SECTIONS 119, 120 AND 121: PRIORITIES§ 1:65 Priority and earliest filing dates§ 1:66 Section 119: claiming foreign priority§ 1:67 —Tool for evaluating prior art effect§ 1:68 —Section 102(b) prior art is not affected by section

§ 1:69 Claiming the benefit of earlier-filed applications§ 1:70 Continuation applications for a different invention

using the same specification§ 1:71 Divisional applications for examiner-mandated

restrictions to different inventions§ 1:72 —Safe harbor provision of section 121 for divisional

applications§ 1:73 —Continuation-in-part applications—Introducing new

matter

IV. PATENT TERM EXTENSION§ 1:74 Patent term extension and patent expiration§ 1:75 Embroilment in FDA—Sections 155, 155A, 156§ 1:76 —Congressional patent term extensions§ 1:77 —PTO delays§ 1:78 —Uruguay round term extensions§ 1:79 —Patent term restoration due to FDA approval

processes§ 1:80 Cap of five years§ 1:81 Patent term restoration is a USPTO and FDA

cooperation§ 1:82 —Single and combination ingredients

V. ENANTIONERS§ 1:83 History of enantiomer patentability

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GENERIC PHARMACEUTICAL PATENT AND FDA LAW

§ 1:84 Case study—Levofloxacin§ 1:85 —Levetiracetam§ 1:86 —Clopidogrel§ 1:87 Lessons learned

VI. COMBINATION PRODUCTS§1:88 Patentability of combination products§ 1:89 Case study—Sudafed§ 1:90 —Loperamide§ 1:91 —Vicoprofen§ 1:92 Lessons learnedAppendix 1A. Bibliography of Resources

CHAPTER 2. PATENT INFRINGEMENTRULES AND PROCEDURES

I. INTRODUCTION§2:1 Generally§ 2:2 Basic infringement test

II. CLAIM CONSTRUCTION§ 2:3 Generally

A. EVIDENCE§ 2:4 Evidence considered in claim construction§ 2:5 Intrinsic evidence must be considered first—Mandatory

evidence§ 2:6 Extrinsic evidence can be considered—Permissive

evidence§ 2:7 Dictionaries and treatises as sources of evidence of

claim meaning

B. RULES§ 2:8 Customary claim construction rules

C. NARROW CLAIM CONSTRUCTIONS§ 2:9 Tools for the generic company§ 2:10 Specification clearly defines claim term§ 2:11 Claim term is implicitly defined by consistent use

throughout specification

TABLE OF CONTENTS

§ 2:12 Pattern of examples in specification deduces claimmeaning

§ 2:13 Embodiment is the invention§ 2:14 Specification disavows particular meaning§ 2:15 Specification explicitly disclaims definition§ 2:16 Limiting the claim scope because consistent with

invention's purpose§ 2:17 Specification contains implicit disclaimer of definition§ 2:18 Specifications and underclaiming—Claiming less than

you could have§ 2:19 Prosecution history as intrinsic evidence—Mandatory

or permissive evidence§ 2:20 Prosecution history contains narrow definition when

ordinary meaning is unclear§ 2:21 Claim term is narrowed because of disclaimer of

ordinary meaning in prosecution history§ 2:22 Using prosecution history of parent application in

subsequent applications§ 2:23 Choosing narrow claim scope when competing scopes

exist

E. OTHER ISSUES§ 2:24 Claim differentiation and interpreting claims of

different scope§ 2:25 Inexact modifiers or relative terminology§ 2:26 Illustration regarding scope of "about"§ 2:27 Timing of claim construction in view of issued patent

III. LITERAL INFRINGEMENT§ 2:28 Generally§ 2:29 Litigating more than one claim construction at trial:

Federal Circuit review of record§ 2:30 Special case: inherent infringement under single

crystal theory§ 2:31 Special case: Inherent infringement under single

crystal theory—Impact of SmithKline v. Apotex oninfringement

§ 2:32 Proving literal infringement§ 2:33 Literal infringement as based on the generic drug

application

IV. DOCTRINE OF EQUIVALENTS§ 2:34 Doctrine of equivalents (DOE) infringement

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GENERIC PMARMACEI'TICAL PATENT AND FDA LAW

§ 2:35 Tests for DOF§2:36 —Insubstantial differences test tor equivalency

infringement§2:37 —Function way result test§ 2:38 —Elcment-by-elenient anal.vMs§2:39 Subject matter disclosed but not claimed "Dedication

to the public" rule§2:40 Doctrine of prosecution history estoppel 1PHF.1§2:41 —Amendment-based estoppel§2:42 Rebutting the presumption of estoppel§2:43 ——Festo IX: Federal circuit summary of equivalency

factors§2:44 Festo Test Part 7: Rebutting prosecution history

estoppel§ 2:45 Festo Test Part 7ui: Foreseeable changes§ 2:46 Foreseeability of drafting claim to equivalent: Is it

new matter§ 2:47 Festo Test Part 7<ii>: Tangential relationship§ 2:48 Festo Test Part 7( iii i: Some other unexplained

reason§ 2:49 —Argument-based estoppel§ 2:50 —Related applications may evoke estoppel8 2:51 —ScopeS ? : S ~ P r i o r a r t Preclusions—Hypothetical claim analysis§ Z.bd —Detailed structure test: An alternate to the

insubstantial differences and function way resulttests

§ 2:54 Case studies: SmithKlinc Beecham and Equivalency-t a i n e d rdt 'a 'sc> bupropion

8 2:55 Case studies: SmithKUne Beecham andEquivalency—Conclusion

V. INDIRECT INFRINGEMENT§ 2:56 Contributory and inducement infringement generally

f f " t mfnngement-Inducement under 35 U.S.C.A.8 J/Kb)

§2:58 Summaryy

2 : 5 9 C2 ° ^ u t o r y Patent infringement under 35 U.S.C.A. §

\ 2-6? -JpV>wing component is especially made

§ 2:63 Infringem ent under 35 U.S.C.A. § 27 Kg ̂ Importingdrugs made by patented process

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§ 2:64 —Hypothetical describing problem with § 271(g)

VT. CONCLUSION§ 2:65 Generally

CHAPTER 3. FOUNDATIONS OFPATENT INVALIDITY

I. INTRODUCTION§ 3:1 In general

II. PRIOR ART§ 3:2 Burdens of proof—Prior art—Considered or not

considered by examiner§ 3:3 Sources§ 3:4 Fully presented and vetted§ 3:5 Cited but not vetted§3:6 Not cited

III. ANTICIPATION§ 3.7 Invalidating patent because invention is not new§ 3:8 Element-by-element analysis, express and inherent

anticipation§ 3:9 Inherent anticipation§3:10 —Hypothetical§ 3:11 SmithKline v. Apotex revisited

IV. OBVIOUSNESS§ 3:12 Invalidity defense§ 3:13 USPTO guidelines§ 3:14 Combining prior art elements according to known

methods to yield predictable results§ 3:15 —Simple substitution of one known element for

another to obtain predictable results§ 3:16 Known techniques to improve similar devices,

methods, or products§ 3:17 Applying known technique to yield predictable results§ 3:18 "Obvious to try"—Choosing from finite number of

items§ 3:19 —Applicability to enantiomers, salt selection, and

extended release (ER) formulations

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GENERIC PHARMACEUTICAL PATENT AND FDA LAW

§ 3:20 Market forces and design considerations§ 3:21 Teaching, suggestion, or motivation in the prior art§ 3:22 Person of ordinary skill in the art < POSITA)§ 3:23 Structural obviousness—Breaking compound patents§ 3:24 —Lansoprazole versus rabeprazole§ 3:25 —Attacking of analogue of compound

V. "PRACTICING THE PRIOR ART"§ 3:26 Defense to infringement

VI. GENUS AND SPECIES§ 3:27 Interpretation§ 3:28 Case study—Genus and species: ZyprexaQO

(Olanzapine)§3:29 —Enantiomers, invalidity, and Plavix® (dopidogrel)

VII. SECTION 112§ 3:30 Patent invalidity theories§ 3:31 Written description invalidity§ 3:32 —Mechanics of written description challenge§ 3:33 Enablement§ 3:34 —Undue experimentation§ 3:35 —"How to make"§ 3:36 —"How to use"§ 3:37 —In vitro to in vivo teaching§ 3:38 —Effective amounts§ 3:39 Best mode requirement§ 3:40 Contrasting enablement and best mode§ 3:41 Written description, enablement, and best mode-

Breaking chains of priority to invalidate later patents§ 3:42 Rolling provisionals allow for chains of priority§ 3:43 Section 112, second paragraph: claim precision and

boundaries§ 3:44 Section 112, third and fourth paragraphs: dependent

claims

CHAPTER 4. INEQUITABLE CONDUCTAND PATENT UNENFORCEABILITY§ 4:1 Inequitable conduct—Fraud on the Patent Office3 4:2 Types of inequitable conduct test—Common situations8 4:3 Penalties for inequitable conductxxiv

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§ 4:4 —Unenforceability—Later patents through infectiousunenforceability

§ 4:5 Awarding attorney's fees and costs§ 4:6 Fraud-based damages (Walker Process fraud)§ 4:7 Private enforcement of fraud§ 4:8 Curing inequitable conduct§ 4:9 Asserting inequitable conduct—Not a game of gotcha§ 4:10 Materiality threshold—Current and past tests for

materiality§ 4:11 Information does not have to be claimed§ 4:12 Failure to comply with section 112(1)§ 4:13 —Information does not have to verbatim§ 4:14 False statements§ 4:15 Failure to disclose relationship of affiant to

applicant§4:16 Data is presumed material§ 4:17 —Failure to provide unfavourable test results§ 4:18 -Accurate description of test conditions§ 4:19 Claim for priority§4:20 Issues examiner focuses on§ 4:21 ——Affirmative misrepresentations§ 4:22 —Intent to deceive§ 4:23 Stressing importance of submitted prior art§ 4:24 Gross negligence§ 4:25 "Totality" can include gross negligence§ 4:26 Mere denial is never enough to overcome

inference of intent§ 4:27 Searching for prior art§ 4:28 Patterns of misrepresentations or omissions—

Single actions§ 4:29 Cultivated ignorance—Obtaining translations of

foreign language documents§ 4:30 "Burying" critical reference§ 4:31 Failure to disclose prior art and foreign office

actions from foreign searches§ 4:32 False or misleading affidavits§ 4:33 Failure to name proper inventors§ 4:34 —Pitfalls for patent applicants and corrective

measures and practice tips§ 4:35 Conclusion

CHAPTER 5. EQUITABLE DEFENSESTO PATENT INFRINGEMENT§5:1 Introduction

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GENERIC PHAKMACKI THAI. PATEN I AND FDA LAW

§5:2 Issue preclusion, collateral estoppel/claim preclusionand res judicata

§ 5:3 Laches—General principles§5:4 —Quick comparison of laches and equitable estoppel§ 5:5 —Factors§5:6 —Laches and Presumptions§5:7 Equitable estoppel - Factors§5:8 —Presumptions§5:9 —Prosecution laches§5:10 Recent developments

CHAPTER 6. BASICS OF BRANDDRUG APPROVAL PROCESS ANDORANGE BOOK LISTINGS§6:1 Introduction§ 6:2 Brand drug approval§6:3 Investigational New Drug application iINI)>—

Beginning clinical trials§ 6:4 —Contents§ 6:5 New Drug Application < NDA t§ 6:6 —Drug Master Files i DMF >§ 6:7 Types of new drugs in NDA§ 6:8 Internal FDA machinations§ 6:9 Patent information and the Orange Book§ 6:10 —Listable and nonlistable patents§ 6:11 —Patent listing as clerical not substantive§ 6:12 —Delisting patents§ 6:13 —Forcible listing of unlisted patents§ 6:14 When patents may be listed9 6:15 Who may list which patents9 6:16 Medical device patents and antibiotic patents—Status9 6:17 Polymorph patent listing9 6:18 Blinds and clinical testing| 6:19 -Clinical trial phases

S Ro? P u b l i c USe p a t e n t '"validityJ£el N D A s " - N e w Drug Applications/section505(b)(2) applications

9 6:22 NDA approval and approval dates

f. ABBREVIATED NEWLICATION (APROCESS

§ ' 1 Reference Listed Drug (RLD)XXVI

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§ 7:2 Suitability petitions to refer to different RLDs§ 7:3 Abbreviated New Drug Application (ANDA)§ 7:4 —Differences between the NDA and ANDA§ 7:5 —Bioequivalency of generic drug§ 7:6 Inner workings of the FDA§ 7:7 Labeling review§ 7:8 Chemistry and manufacturing controls (CMC)§ 7:9 Biopharmaceutical review and bioavailability§ 7:10 Classification system for biopharmaceutical properties§ 7:11 —Patents claiming pharmacokinetics§ 7:12 Microbiology review§ 7:13 Clinical review§7:14 cGMP review§7:15 Deficiency Letters§ 7:16 —Major Deficiency Letter§ 7:17 —Minor Deficiency Letter§7:18 Telephone Amendment§ 7:19 Approval matrix§ 7:20 Final approval versus tentative approval§ 7:21 Tentative approval—Reasons for getting it§ 7:22 Patent attorney involvement in answering deficiency

letters§ 7:23 Showing bioequivalency of generic versions§ 7:24 Bioavailability defined§ 7:25 Bioequivalency defined§ 7:26 Measuring bioequivalence of traditional solid oral

dosage forms—Immediate and extended release forms§ 7:27 —Extended release (ER) forms§ 7:28 Extended release types—Diffusion control system§ 7:29 —Dissolution control system§ 7:30 —Erosion control system§ 7:31 —Osmotic pump system§ 7:32 —Ion-exchange resin system§ 7:33 Proving bioequivalency§ 7:34 —In vitro dissolution studies§ 7:35 —Dissolution testing and standardized testing

protocols§ 7:36 —Particle size and dissolution testing§ 7:37 In vitro bioequivalency (BE) testing—Reasons for BE

testing and biowaivers§ 7:38 Biostudies in human subjects—Pilot and pivotal

biostudies§ 7:39 —Fasting and fed biostudies

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GENERIC PHARMACEITICAI. PATENT AND FDA LAW

§7:40 Food effect patents are not patentahle§ 7:41 Impurity specifications§ 7:42 Impurity levels as defined by a regulatory authority§ 7:43 Avoiding impurity patent claims may jeopardize

regulatory approval§ 7:44 Metered and powder dose inhalers§ 7:45 Dry powder dose inhalers i DPI t§7:46 Nasal sprays and inhaled solutions, sprays§7:47 Samples and patent issues in samples§ 7:48 Changes to the Abbreviated New Drug Application§ 7:49 —Major changes§ 7:50 —Moderate changes Changes being effected in 30

days(CBE-30i§ 7:51 —Minor change—Minimal impact change documented

in annual report§ 7:52 Changes to the ANDA and patent issues§ 7:53 Review of ANDA approval process

CHAPTER 8. "PAPER NDA" ANDSECTION 505(B)(2) APPLICATIONS§ 8:1 Section 505(b)(2) application—General principles§ 8:2 Contrasting 505(bK2) applications with Abbreviated

New Drug Applications (ANDA)§ 8:3 Similarities between 505(b><2> application and ANDA§ 8:4 General types of applications§8:5 Information needed to support the application§ 8:6 Strategic uses§ 8:7 —Use of a 505(b)(2) application to circumvent the 180-

day exclusivity§ 8:8 Conclusion

CHAPTER 9. PATENT INFRINGEMENTSAFE HARBOR EXEMPTIONS§9:1 Introduction§ 9:2 Genesis of safe harbor exemption—Roche v. Bolar§ 9:3 Hatch Waxman Act/Safe harbor exemption—Scope of

exemption§ 9:4 "Information" development and "information"

submission to FDA§ 9:5 Reasonable scope of exemption§ 9:6 —Medical devices and other ostensibly unrelated

activities

TABLE OF CONTENTS

§ 9:7 —Effect of Congressional action on scope of exemption§ 9:8 —Chain of exemption§ 9:9 Generic drug development§9:10 Ancillary activities§9:11 Recourse for patent holders§ 9:12 Common law research exemption and de minimis

infringement

CHAPTER 10. MECHANICS OFORANGE BOOK PATENTCERTIFICATIONS AND NOTICELETTERS§ 10:1 Introduction§ 10:2 Patent certifications and Orange Book listing§ 10:3 —Paragraph I, II, III, or IV certifications§ 10:4 —Impact on ANDA approval§ 10:5 —Hypothetical patent certifications—Case study on

Viagra§ 10:6 Section (viii) statements—Carving out patented

methods of use§ 10:7 —Working example on Section viii

Statements—Sertraline§ 10:8 —One and only indication§ 10:9 —Carving out indications to unlisted patents§ 10:10 Request Listing§ 10:11 Using Suitability Petitions to allow carve out§ 10:12 Combining Paragraph I certification in lieu of Section

viii Statement§ 10:13 —Paragraph IV certification and Notice Letter

requirements§ 10:14 —Identifying the patents in the Notice Letter§ 10:15 Content and sufficiency of the Notice Letter§ 10:16 How much detail is necessary§ 10:17 Details on claims that are not normally listable§ 10:18 Form of Letter and Detailed Statement§ 10:19 Admonishments—Appending Letter to a

complaint§ 10:20 Predicates to antitrust injury§ 10:21 How to send the Notice Letter§ 10:22 Where to send the Notice Letter§ 10:23 When to send the Notice Letter§ 10:24 Updating the FDA on Notice Letters

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GENERIC PMARMACEI TICAI. PATENT AND FDA LAW

§ 10-25 Hi-issue Patents- NYw puteiits «»r rollovers of oldpatents that require new patent certifications

§ 10:26 Roll-overs from original patent§ 10:27 New patent§ 10:28 —Summary§ 10:29 Offer for Confidential Acce>> i( K'.V§ 10:30 —Where invahditv i> alleged§ 10:31 —Issues with the Offer for Confidential Access tOLAl§ 10:32 Tracking Paragraph IV cert itu at ions on the FDA Web

site

CHAPTER 11. THE 30-MONTHINJUNCTION/STAY

I. GENERALLY§ 11:1 Introduction§ 11:2 Creating the 30-month stay and counting days§ 11:3 Who notifies the FDA of the lawsuit

II. TERMINATION OF THE 30-MONTH STAY§ 11:4 How the 30-month stay is normally terminated§ 11:5 Court decision§ 11:6 Generic company wins§ 11:7 Generic company wins on appeal§ 11:8 Patentee delays'

III. LENGTHENING, SHORTENING, ORREINSTATING THE STAY

§ 11:9 Extending stay because court made no decision§11:10 Reinstating if wrongfully terminated§ 11:11 Lengthening or shortening due to lack of cooperation§ 11:12 Cases extending the 30-month stay§ 11:13 Cases shortening the 30-month stay t§ 11:14 Cases where the stay was not altered despite rcques

to alter

IV. EFFECT OF DELAYS§ 11:15 Blowing the 45-day window—Can suit still be

brought?

V. EARNING NEW 30-MONTH STAYS§ 11:16 Generally

TABLE OF CONTENTS

§ 11:17 Repetitive 30-month stays under the old rules§ 11:18 Earning 30-month stays under the December 2003

rules§ 11:19 Effect of pop-up (newly issued) patents§ 11:20 Working examples of the 30-month stay

VI. STAGGERED EXPIRATIONS§ 11:21 Multiple applicants 30-month stay; staggered stay

expiries

CHAPTER 12. BRAND SIDEEXCLUSIVITIES§ 12:1 Filing and approval exclusivities§ 12:2 New Chemical Entity (NCE) exclusivity [five-year]§ 12:3 —When to file ANDAs with Paragraph IV

certifications§ 12:4 —Extensions of the 30-month stay§ 12:5 —Delisting patents from Orange Book right before

NCE-1 date§ 12:6 New product/clinical information/supplemental

exclusivity [three-yearl§ 12:7 —Requirements for the new clinical information

exclusivity§ 12:8 —Requirements—Working example for generic

approval of less than all indications§ 12:9 —Difference between NCE and three-year exclusivity§ 12:10 Three-year exclusivity for enantiomers§ 12:11 Orphan drug exclusivity [seven-year exclusivity]§ 12:12 Pediatric exclusivity [six months]§ 12:13 —Effect§ 12:14 —Tracking§ 12:15 —Effect on ANDA filings§12:16 —Effect on the 30-month stay§ 12:17 Working examples of pediatric exclusivity§ 12:18 Working examples—Ranbaxy v. FDA and Pfizer;

fluconazole§ 12:19 Alza v. Mylan/Mylan v. FDA; fentanyl patch§ 12:20 —Effects on the 30-month stay—Working examples—

Pfizer v. Apotex; amlodipine§ 12:21 —Pediatric exclusivity and combination products§ 12:22 Patent infringement implications§ 12:23 Key points about pediatric exclusivity

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GENERIC PHARMACEUTICAL PATEVI AND FDA LAW

CHAPTER 13. THE 180-DAYEXCLUSIVITY§ 13:1 Introduction§ 13:2 Creating the 180-day exclusivity§ 13:3 Against whom the 180-day exclusivity applies§13:4 FDA's product-by-product approach to patent

certifications§ 13:5 Product-by-product approach to exclusivity§ 13:6 180-day exclusivity naturally expires with the

underlying patent§ 13:7 Triggering the 180-day exclusivity clock§ 13:8 —Under pre-December 2003 MM A rules§ 13:9 —Under the post-MMA rules§ 13:10 Tracking the lHO-day exclusivity§ 13:11 Reissue patents and new 180day exclusivities§ 13:12 Authorized generics§ 13:13 —Curbing by Medicaid Best Price Law§ 13:14 Waiver or relinquishment of the 180-day exclusivity§ 13:15 —Mechanics of selective waiver and total

relinquishment

CHAPTER 14. FORFEITURE OF THE180-DAY EXCLUSIVITY§ 14:1 Introduction§ 14:2 Forfeiture provisions§ 14:3 —Failure to market§ 14:4 —No litigation pending; 30 months to approval, 75

days to market§ 14:5 —Litigation pending§ 14:6 —Rationalizing the failure to market provisions; no

patent litigation1 4 : ? C ° ^ r i v e d Patent litigation, possibility of suit to avoidforfeits

§ 14:8 Settling lawsuits but maintaining the Paragraph IVto avoid forfeits

U i n f thdrawal of applicationBil l? £ m e n d m e n t of certificationI ll\l v t 0 ° b t a i n tentative approval

"petition^ a p p r 0 V a 1 ' c h a n g e d conditions, and citizen

I ifu tFreements that violate antitrust laws§14.14 Expiration of patentsxxxii

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§ 14:15 No-rolling exclusivity§ 14:16 Forfeitures in general policy terms

CHAPTER 15. DECLARATORYJUDGMENT§ 15:1 Introduction: purpose of the Declaratory Judgment

Act (DJA)§ 15:2 When DJs are used in pharmaceutical patent cases§ 15:3 Traditional declaratory judgment standards§ 15:4 Post-Medlmmune declaratory judgment standards§ 15:5 —Famciclovir case and factors allowing a declaratory

judgment action§ 15:6 Declaratory judgments to trigger exclusivity§ 15:7 —Orange Book listing alone could confer DJ

jurisdiction§ 15:8 Patents listed but statutorily disclaimed do not

confer jurisdiction§ 15:9 Covenants not to sue; removing fear of suit§ 15:10 —Covenants divesting court's jurisdiction

CHAPTER 16. PATENTINFRINGEMENT DAMAGES ANDREMEDIES§ 16:1 Introduction§ 16:2 Potential remedies for patent infringement§ 16:3 Impact of the loss on the ANDA approval status and

redating the ANDA approval date§ 16:4 —ANDAs for old antibiotics should not have redated

approval dates§ 16:5 Injunctive relief to stop future infringement or

prevent at-risk launch§ 16:6 —Other factors to consider in whether to grant a

launch-prevention injunction§ 16:7 Awarding an injunction against future infringement

when generic company loses§ 16:8 Product recall of generic products in the marketplace§ 16:9 Money damages for patent infringement§ 16:10 —Money damages, reasonable royalty or lost profits§ 16:11 —Reasonable royalty§16:12 Hypothetical negotiations§ 16:13 Factors to consider in setting the royalty:

Georgia Pacific test

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( I K N K H K I ' l l A K M A i ' h l IK Al I ' A I I N I A M ) F D A LAW

§ 16:14 factor.- in relation to generic druginfringement

§16:15 —Kfleet on permanent injunction§ 16:16 —Lost profits§ 16:17 —Lost profit.- and market reconstruction§ 16:18 No lost profit- when substitutes exist§ 16:19 No lo.-t profit- when substitutes and authorized

generic.- exist§ 16:20 --Calculating lost profit- and bringing expenses into

the calculus§16:21 Kxpense deductions§ 16:22 F.nhanced damages and willful infringement§ 16:23 Willful infringement and factors to consider§ 16:24 Legal opinions and willful infringement§ 16:25 —Willful infringement for filing an ANDA§ 16:26 —Willfulness and the need to specify facts in the

pleading§ 16:27 Exceptional cases and attorney fees§ 16:28 —When can attorney fees be awarded§ 16:29 —Steps in awarding attorney fees§ 16:30 —Who is a prevailing party§ 16:31 —Attorney fee amounts§ 16:32 —Case study: Pioglitazone and attorney fee awarded

to patentee

Table of Cases

Index