Brian C. Howard Legal Data Scientist & Director of ......Lex Machina Patent Litigation Damages eport 63 iii Table of Contents ANDA Litigation by Court, Judge, and Year Figure 1: Top

Brian C. HowardLegal Data Scientist & Director of Analytics Services

Jason Maples Legal Data Analyst

Lex Machina – Patent Litigation Damages Report 63 i

Executive Summary

This report covers 1,671 cases, filed from 2009 through September 2014, with over 1,100 patents, and involving over 400 applications to the FDA. Of the 1,671 cases, less than 3% were based on paper NDAs.

The majority of ANDA litigation is concentrated in three districts: the District of Delaware (678 cases), the District of New Jersey (481 cases), and the Southern District of New York (148 cases). These three districts account for just under 80% of the total ANDA litigation, and no other district had more than 50 cases over this time period. Unsurprisingly, the judges of the District of Delaware lead in the number of cases they see (Sleet 195 cases, Robinson 187 cases, Stark 139 cases, Andrews 122 cases), followed by those of the District of New Jersey (Pisano 64 cases, Cooper 49 cases, Chesler 38 cases, Sheridan 34 cases). Judge Irene Kelly, of the Northern District of West Virginia is the only top 15 judge not from Delaware, New Jersey, or S.D.N.Y.

The number of ANDA cases filed each year has held steady between 239 and 293, although 2014 has already set a record with 323 new cases. Much of the increase in 2014 comes in the top two districts of Delaware and New Jersey, and at the expense of S.D.N.Y.

Far fewer ANDA cases are filed each year than non-ANDA patent cases, by roughly an order of magnitude. Reaching consent judgment is more than three times as frequent (occurring in 13.5% of terminated ANDA vs 4.0% otherwise). Summary judgments on patents is less common in ANDA cases (1.8% of terminated ANDA cases vs 3.1% otherwise). In ANDA cases reaching judgment, an injunction issues more often than not (70.3% of terminated ANDA cases vs 42.4%). ANDA cases granting costs have awarded a far higher median amount ($58,384) than non-ANDA case ($11,932).

Oxycontin (a pain relief medication) is the most litigated drug trade name by number of cases. By number of asserted patents, Metformin Hydrochloride (diabietes drug AvKARE) is the most frequently litigated ingredient. The vast majority of cases and litigated patents involve prescription drugs (98.2% of cases, 98.1% of patents). Although a majority of litigated patents have no listed therapeutic equivalence (TE) code, the most common among those that do is AB (“products meeting the necessary bioequivalence requirements”).

Since 2009, the median age of patents being litigated has generally declined, peaking at 10.4 years in 2011 before dropping to 5.1 in cases filed in 2014. Over the same time, the median time between approval and the filing of litigation for patents approved before litigation has risen, from 3.9 years in 2009 to 4.9 years in 2014. The median number of years left to expiration on patents at the time of approval (for those listing an expiration) has risen from 8.1 years in 2009 to 15.4 years today.

Introduction

This report surveys the landscape of patent litigation related to Abbreviated New Drug Applications (ANDAs) submitted to the FDA under the Hatch-Waxman Act.

The ANDA process expedites the FDA approval process for generic drugs, and allows drug companies to litigate any patent claims implicated by a new drug, often before the drug even gains FDA approval or reaches the market.

Integrating patent and drug informa-tion from the FDA’s Orange Book with Lex Machina’s intellectual property litigation database, this report provides insight into current trends in ANDA litigation as well as showing the ways in which ANDA litigation differs significantly from other, non-ANDA patent litigation.

Lex Machina – Patent Litigation Damages Report 63ii

Data and Methodolgy

This report considers the last 5 years of patent litigation related to Abbreviated New Drug Applications (ANDA) and paper New Drug Applications (paper NDA), including cases filed from 2009 through the end of September 2014.

Data derived from the Orange Book is current at the time of press (August 2014 update).

What is an ANDA case?

The sale of new drugs in the United States is controlled by the Food and Drug Administration (FDA). Pharmaceutical companies launching new, branded drugs must file NDAs (New Drug Applications). For all approved NDAs, the FDA lists patent data in the Approved Drug Products with Therapeutic Equivalence Determinations publication (known as the Orange Book).

The FDA also approves applications for new generic drugs and makers may file abbreviated applications, either an ANDA or paper NDA (hybrid of a full NDA and an ANDA, also known as a “Section 505(b)(2)” application). These abbreviated applications assert that the generic is a duplicate of a branded drug (ANDA) or differs from a branded drug but meets safety and efficacy standards based on published studies (paper NDA). Although ANDA and paper NDA cases differ in some important respects, this report considers them together as “ANDA cases” as they represent less than 3% of Hatch-Waxman litigation.

The Hatch-Waxman Act put in place the expedited approval processes for generics and in doing so launched a new type of patent litigation — cases with accused infringing products that are not yet on the market or even approved by the FDA at the time the lawsuit is filed. These cases are often tried by a judge and the generic maker frequently stipulates to infringement. The remedies sought often include injunctions with specific date bounds.

A prospective generic maker’s filing with the FDA may include a Paragraph IV certification, which states that the branded drug listed patents in the NDA that are invalid or will not be infringed by the generic version. The generic applicant must give the NDA holder and the patentee a notice letter regarding their application. Then, if the patentee sues within 45-days the FDA stays the generic’s application for 30 months. First-filers for an ANDA with a Paragraph IV certification may receive a 180-day exclusivity period wherein the FDA will not approve any other ANDAs; first-filers for paper NDAs with a Paragraph IV certification are entitled to exclusivity periods relating to an orphan drug, a new chemical entity, a new clinical study or a pediatric exclusivity.

Lex Machina identifies as ANDA cases those patent infringement cases prompted by the filing of an ANDA or paper NDA by a prospective generic maker. This definition, however, does not include cases involving investigational new drugs, over-the-counter drugs or any process or product not requiring FDA approval, therapeutic biologic applications (biosimilars), or generics authorized by the branded drug maker.

Lex Machina’s Data

Lex Machina maintains a specialized database containing information about intellectual property litigation in U.S. District Courts and in the U.S. International Trade Commission (ITC). On a daily basis, Lex Machina requests and receives data from the various courts’ PACER systems on new cases and docket entries filed. Lex Machina’s automated systems ensure the completeness and consistency of this data, before analyzing it in conjunction with other data sources, such as the FDA’s Orange Book data (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm).

Lex Machina – Patent Litigation Damages Report ii

Lex Machina – Patent Litigation Damages Report 63 iii

Table of Contents

ANDA Litigation by Court, Judge, and Year

Figure 1: Top 15 judges for ANDA cases 2Figure 2: Top 15 districts for Hatch-Waxman cases 2Figure 3: ANDA cases, by year (showing partial 2014 - already a record year) 3Figure 4: ANDA cases, by quarter 3Figure 5: Top districts over time, by quarter (2009-2012) 4Figure 6: Top districts over time, by quarter (2013-2014) 4

ANDA vs Non-ANDA cases

Figure 7: Total patent cases filed, by year 5Figure 8: Injunctions in terminated cases 5Figure 9: Outcomes in terminated cases 6Figure 10: Median Costs 7Figure 11: Median Attorneys’ Fees 7Figure 12: Word cloud of ingredients, sized by number of asserted patents and colored

by number of cases 8Figure 13: Word cloud of trade names, sized by number of cases and colored by num-

ber of asserted patents (omitting tradenames with less than 3 cases) 8Trade names, Ingredients and Other Orange Book Data

Figure 14: Relationship between number of cases filed and number of patents asserted, for top ingredients with more than 10 cases and more than 10 patents 9

Figure 15: Application types, by number of cases and number of asserted patents 9Figure 16: Therapeutic equivalence (TE) codes, by number and percentage of asserted

patents having each code 10Figure 17: TE codes, chart 11Figure 18: Orange Book TE code definitions 11Figure 19: Drug and product flags, by patent assertions 11

Patent Age, Case Timing, and Approval Dates

Figure 20: Median patent age at time of case filing, by year of case filing (omitting as-sertions where the patent was filed after the case) 12

Figure 21: Median FDA approval of NDA to case filing, by year of case filing 12Figure 22: Patent age at time of case filing, by years (omitting assertions where the pat-

ent was filed after the case) 13Figure 23: FDA approval of NDA to case filing, by year of case filing 14Figure 24: Time before expiration at approval, by year of case filing, based on reported

expiration 15Figure 25: Median time before expiration at approval, by year of case filing, based on

reported expiration 16

Lex Machina – Patent Litigation Damages Report 632

District

0 100 200 300 400 500 600 700 800ANDA cases filed

D.Del.D.N.J.

S.D.N.Y.N.D.Ill.

S.D.Ind.D.Md.

S.D.Fla.N.D.W.Va.

D.Nev.E.D.Tex.N.D.Cal.

M.D.N.C.E.D.Pa.

D.Mass.N.D.Tex.

678 cases481 cases

148 cases39 cases35 cases31 cases29 cases27 cases24 cases23 cases18 cases15 cases14 cases12 cases12 cases

ANDA Litigation by Court, Judge, and Year

Figure 2: Top 15 judges for ANDA cases

Figure 1: Top 15 districts for Hatch-Waxman cases

Judge District

0 20 40 60 80 100 120 140 160 180 200 220 240ANDA cases filed

Gregory Sleet D.Del.Sue Robinson D.Del.Leonard Stark D.Del.Richard Andrews D.Del.Joel Pisano D.N.J.Mary Cooper D.N.J.Stanley Chesler D.N.J.Peter Sheridan D.N.J.Sidney Stein S.D.N.Y.Susan Wigenton D.N.J.Freda Wolfson D.N.J.Esther Salas D.N.J.Irene Keeley N.D.W.Va.Dennis Cavanaugh D.N.J.Jerome Simandle D.Del.

D.N.J.

195 cases187 cases

139 cases122 cases

64 cases49 cases

38 cases34 cases33 cases31 cases29 cases28 cases27 cases26 cases

23 cases3 cases

Lex Machina – Patent Litigation Damages Report 63 3

Jul 1, 09 Jul 1, 10 Jul 1, 11 Jul 1, 12 Jul 1, 13 Jul 1, 14Quarter and year of case filing

0

20

40

60

80

100

120

140

AND

A ca

ses f

iled

139

117

7272

7171

76

69 6767 6663

83

6160

86

43

87

5646

5353

93

Figure 3: ANDA cases, by year (showing partial 2014 - already a record year)

2009 2010 2011 2012 2013 20140

50

100

150

200

250

300

AND

A ca

ses f

iled

291 293

264

323

261

239

Figure 4: ANDA cases, by quarter


Jan 1, 13 Apr 1, 13 Jul 1, 13 Oct 1, 13 Jan 1, 14 Apr 1, 14 Jul 1, 14quarter and year of case filing

0

20

40

60

80

AND

A ca

ses f

iled

80

4546

3532

2521

27

18

3939

571019

4

13 1010 4 2 3

DistrictD.Del.

D.Md.

D.N.J.

N.D.Ill.

S.D.Ind.

S.D.N.Y.

Figure 5: Top districts over time, by quarter (2009-2012)

Figure 6: Top districts over time, by quarter (2013-2014)

Oct 1, 09 Oct 1, 10 Oct 1, 11 Oct 1, 12quarter and year of case filing

0

10

20

30

40

AND

A ca

ses f

iled

3637

201919

2525

16

24 21

18

26

35

22

17

27

77

710

1616

666

28

88

2124

5

28

5

17

20 2020

32

12

25

23 3

554 2 2

4

18

1111

2 13

1 1

13

1

DistrictD.Del.

D.Md.

D.N.J.

N.D.Ill.

S.D.Ind.

S.D.N.Y.


ANDA cases Non-ANDA cases

854 cases57.59%

No injunction granted

629 cases42.41%

Injunction granted

65 cases29.68%

No injunction granted

154 cases70.32%

Injunction granted Percentages reflect only terminated cases reaching merit-based outcome

Figure 8: Injunctions in terminated cases

2009 2010 2011 2012 2013 20140K

1K

2K

3K

4K

5K

6K

Cas

es fi

led

291 264293 323261 239

3,5643,235

5,793

2,4232,243

5,167

2014 onlythroughSept. 30

ANDA CasesNon-ANDA Patent Cases

Figure 7: Total patent cases filed, by year

ANDA vs Non-ANDA cases


0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20%

Percentage (and # of cases) having at least one outcome ofthis type

Judgment ConsentJudgment

ANDA cases

Non-ANDAcases

DefaultJudgment

Non-ANDAcases

Judgment as aMatter of Law

ANDA cases

Non-ANDAcases

Judgment onthe Pleadings

ANDA cases

Non-ANDAcases

SummaryJudgment

ANDA cases

Non-ANDAcases

Trial ANDA cases

Non-ANDAcases

Procedural Consolidation ANDA cases

Non-ANDAcases

InterdistrictTransfer

ANDA cases

Non-ANDAcases

Stay ANDA cases

Non-ANDAcases

13.51%(160 cases)

4.04%(698 cases)

1.00%(172 cases)

0.08%(14 cases)

0.08%(1 cases)

0.13%(23 cases)

0.08%(1 cases)

3.08%(533 cases)

1.77%(21 cases)

0.86%(149 cases)

5.07%(60 cases)

16.13%(191 cases)

3.66%(632 cases)

5.68%(982 cases)

2.03%(24 cases)

4.74%(819 cases)

2.45%(29 cases)

Figure 9: Outcomes in terminated cases


ANDA Non-ANDACases

$0

$10,000

$20,000

$30,000

$40,000

$50,000

$60,000

Med

ian

Cos

ts

203 cases$11,932

7 cases$58,384

Figure 10: Median Costs

ANDA Non-ANDACases

$0

$50,000

$100,000

$150,000

$200,000

$250,000

$300,000

$350,000

$400,000

Med

ian

Atto

rney

s' Fe

es

1 cases$378,285

62 cases$21,950

Figure 11: Median Attorneys’ Fees

Single ANDA case is Pfizer Inc., et al v. Teva Pharmaceuticals USA, Inc., E.D.Va., 2:10-cv-00128, awarded in October, 2011

The costs shown above are the clerical costs (e.g. witness and deponent per-diems, costs of transcripts, photocopying expenses, etc.) provided for in 28 U.S.C. § 1920, which Fed. R. Civ. P. Rule 54(d)(1) allows a prevailing party to recover from its opponent.


Figure 13: Word cloud of trade names, sized by number of cases and colored by number of asserted patents (omitting tradenames with less than 3 cases)

OXYMORPHONE HYDROCHLORIDE DARUNAVIR ETHANOLATESODIUM OXYBATE

RITONAVIR

LOPINAVIR

ETHINYL ESTRADIOLDROSPIRENONE

BIMATOPROST

RITONAVIR ETHINYL ESTRADIOL

OXYCODONE HYDROCHLORIDE

FENOFIBRATE

EFAVIRENZ

TENOFOVIR DISOPROXIL FUMARATE

SIMVASTATIN EMTRICITABINE

ESOMEPRAZOLE MAGNESIUM

PIOGLITAZONE HYDROCHLORIDEMETFORMIN HYDROCHLORIDE

TESTOSTERONE

10 51# of cases

Figure 12: Word cloud of ingredients, sized by number of asserted patents and colored by number of cases

ZYMAXID

ZYMAR ZOMETA

ZOHYDRO ER

ZETIA

ZEMPLAR

ZEGERID OTC

ZEGERID

YAZ

YASMIN

XYREMXIMINO

XELODA

XARTEMIS XR

WELCHOLVYVANSE

VYTORINVIREAD

VIMPAT

VIMOVO

VIGAMOX

VIAGRA

VENLAFAXINE HYDROCHLORIDE

VELCADEVASCEPA

VANOS

VALCYTE ULORIC

TYVASO

TYGACIL

TRUVADA

TRIZIVIR

TRILIPIX

TRICOR

TREXIMET

TREANDA

TRAVATAN Z

TRAVATANTOVIAZ

TARCEVASUSTIVA

SUPREP BOWEL PREP KIT

SUBOXONE

STRIBILD

STAXYN

SOLODYNSIMCOR

SILENOR

SEROQUEL XR

SEASONIQUE

SAVELLA

SANCTURA XR

SAFYRAL

RYZOLT

RITALIN LA

REYATAZ

RENVELA

RENAGEL

REMODULIN

RECLAST

PULMICORT RESPULES

PROVIGIL

PROQUIN XR

PROLENSA

PRISTIQ

PRILOSEC OTCPRILOSEC

PREZISTA

PREVACID

PRECEDEX

PHOSLO GELCAPS

PHOSLO

PENNSAID

PATANOL

PATADAY

OXYCONTIN

OXECTA

OSENI

ORTHO TRI-CYCLEN LO

ORENITRAMORAPRED ODT

ORACEA

OPANA ER

ONGLYZA

OFIRMEV

NUVIGIL

NUEDEXTA

NUCYNTA ER

NUCYNTANORVIR

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATENIASPAN TITRATION STARTER PACK

NIASPAN

NEXIUM IVNEXIUM 24HR NEXIUM

NESINA

NAMENDA XRMYFORTIC

MULTAQ

MUCINEX DM

MUCINEX D

MUCINEXMOXEZA

MINASTRIN 24 FE

METADATE CD

MEGACE ES

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

LYSTEDA

LYRICA

LUMIGAN

LOVAZA

LOTRONEX

LOPROX

LOESTRIN 24 FE

LO MINASTRIN FE

LO LOESTRIN FE

LIVALO

LIPTRUZETLIPITOR

LIDODERM

LIALDA

LEVITRA

LATISSE

KOMBIGLYZE XRKAZANO

KALETRA JANUMET XR

JALYN

INTUNIV

INTERMEZZO

INTEGRILIN

HECTOROL

GRALISE

GLUMETZA

GLEEVEC

FUSILEV

FOSRENOL

FORTAMET

FOCALIN XR

FOCALIN

FENTORA

FEMCON FE

FAZACLO ODT

FASLODEX

EXJADE

EXELON

EVISTA

EPZICOM

ENABLEXEMTRIVA

EMEND

EFFIENT

EFFEXOR XR

DUETACT

DORYXDIPRIVAN

DEXILANT

DETROL LACUBICIN

CRESTOR

COREG CR

COPAXONE

CONCERTA

COMPLERA

COMBIGAN

COLCRYS

CLOBEX

CIALIS

CHILDREN'S ALLEGRA HIVES

CHILDREN'S ALLEGRA ALLERGY

CANCIDAS

CADUET BONIVA

BEYAZ

BEPREVE

BARACLUDE

BANZEL

AZILECT

AVODART

AVANDAMETATRIPLA

ATELVIA

APLENZIN

ANTARA (MICRONIZED)

ANGIOMAX

ANGELIQ

ANDROGEL

AMRIX

AMPYRA

ALOXI

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

ALLEGRA HIVES

ALLEGRA ALLERGY

ALLEGRA

ALIMTA

AGGRENOX

ADVICOR

ADENOSCAN

ADCIRCA

ACULAR LS

ACTOS

ACTOPLUS MET XR

ACTOPLUS MET

ACTONEL

ACETADOTE

ACANYA

ABILIFY

1 23# of patents

Trade names, Ingredients and Other Orange Book Data


0 500 1000 1500 2000 2500# of cases

Prescription

Discontinued

Over-the-counterOver-the-counter

2.6%41 cases

Discontinued22.9%

365 cases

Prescription98.2%

1,565 cases

Figure 15: Application types, by number of cases and number of asserted patents

0 2 4 6 8 10 12 14 16 18 20 22 24# of patents asserted (>10)

0

5

10

15

20

25

30

35

40

45

50

# of

cas

es (>

10)

ETHINYL ESTRADIOL

DROSPIRENONE

BIMATOPROST

RITONAVIR

ETHINYL ESTRADIOL TENOFOVIR DISOPROXIL FUMARATE

SIMVASTATIN

EMTRICITABINE

TESTOSTERONE

METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM

FENOFIBRATE

OXYCODONE HYDROCHLORIDE

SODIUM OXYBATE

DARUNAVIR ETHANOLATE

OXYMORPHONE HYDROCHLORIDE

Figure 14: Relationship between number of cases filed and number of patents asserted, for top ingredients with more than 10 cases and more than 10 patents

0 500 1000 1500# of patents

Prescription

Discontinued

Over-the-counterOver-the-counter

2.4%24 patents

Discontinued15.8%

155 patents

Prescription98.1%

963 patents


Therapeuticequivalence

code

0 50 100 150 200 250 300# / % of patent assertions having TE code specified

AB

BX

AP

AT

AB2

AB1

AN

BT

AA

AB3

276 patents76.7%

36 patents10.0%

26 patents7.2%

13 patents3.6%

10 patents2.8%

6 patents1.7%

4 patents1.1%

3 patents0.8%

2 patents0.6%

1 patents0.3%

Figure 16: Therapeutic equivalence (TE) codes, by number and percentage of asserted patents having each code

A patent may be cited by more than one Orange Book NDA application. When a patent corresponds to multiple categories of Orange Book information (e.g. one application contains a AB code, while the other contains a BT code) that patent is counted once for each applicable category.


Figure 19: Drug and product flags, by patent assertions

Therapeuticequivalence code

AA

AB

AB1

AB2

AB3

AN

AP

AT

BT

BX

No code specified 725 patents1,166 cases

36 patents51 cases

3 patents6 cases

13 patents24 cases

26 patents73 cases

4 patents6 cases

1 patents1 cases

10 patents16 cases

6 patents25 cases

276 patents562 cases

2 patents3 cases

Figure 17: TE codes, chart

Drug-Substance flags

Both No flags Productflag only

Substanceflag only

0

50

100

150

200

250

300

350

400

450

# of

pat

ents

445 cases136 patents



290 cases58 patents

Figure 18: Orange Book TE code definitions

A patent may be cited by more than one Orange Book NDA application. When a patent corresponds to multiple categories of Orange Book information that patent is counted once for each applicable code. For example, if a patent had two applications, one with no flags, and the other with both, it would be represented in the “Both” and “No flags” counts above.

AA Products in conventional dosage forms not presenting bioequivalence problems

AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements

AN Solutions and powders for aerosolizationAO Injectable oil solutionsAP Injectable aqueous solutions and, in certain instances,

intravenous non-aqueous solutionsAT Topical products

B* Drug products requiring further FDA investigation and review to determine therapeutic equivalence

BT Topical products with bioequivalence issuesBX Drug products for which the data are insufficient to

determine therapeutic equivalence


2009 2010 2011 2012 2013 20140

1

2

3

4

5

Med

ian

time

from

FD

A ap

prov

al o

f ND

A to

cas

efil

ing

4.44.34.3

3.9

4.94.7

Figure 21: Median FDA approval of NDA to case filing, by year of case filing

2009 2010 2011 2012 2013 20140

2

4

6

8

10

Med

ian

age

of p

aten

t at a

sser

tion

5.1

9.4

7.9

10.0 10.2 10.4

Figure 20: Median patent age at time of case filing, by year of case filing (omitting assertions where the patent was filed after the case)

Patent Age, Case Timing, and Approval Dates


Year ofcase filing Patent age at assertion (years)

1 3 5 7 9 11 13 15 17 19 21 23 25 27

2009

2010

2011

2012

2013

2014

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

sFigure 22: Patent age at time of case filing, by years (omitting assertions where the patent was filed after the case)

Outliers omitted.


Year ofcase filing FDA approval of NDA to case filing

-5 -3 -1 1 3 5 7 9 11 13 15 17 19 21

2009

2010

2011

2012

2013

2014

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

s

0

100

200

# of

pat

ent

asse

rtion

sFigure 23: FDA approval of NDA to case filing, by year of case filing

Negative times indicate case was filed before approval. Approval often happens before a case is filed, but does not necessarily have to. Negative numbers on the above chart represent the situations where approval was gained only after a case had been filed. Outliers omitted.


Year ofcase filing Years from FDA approval to reported patent expiration

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29

2009

2010

2011

2012

2013

2014

020

40

60

# of

pat

ents

020

40

60

# of

pat

ents

020

40

60

# of

pat

ents

020

40

60

# of

pat

ents

020

40

60

# of

pat

ents

020

40

60

# of

pat

ents

Figure 24: Time before expiration at approval, by year of case filing, based on reported expiration


2009 2010 2011 2012 2013 20140

2

4

6

8

10

12

14

16

Med

ian

year

s fro

m F

DA

appr

oval

to re

porte

dpa

tent

exp

iratio

n

11.8 years

11.1 years12.2 years

15.4 years

10.5 years

8.1 years

Figure 25: Median time before expiration at approval, by year of case filing, based on reported expiration

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Documents

Brian C. Howard Legal Data Scientist & Director of ......Lex Machina Patent Litigation Damages eport 63 iii Table of Contents ANDA Litigation by Court, Judge, and Year Figure 1: Top