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Lex Machina Hatch-Waxman / ANDALitigation Report 2017

by Brian C. Howard J.D./M.AAssociate General Counsel & Legal Data ScientistPublished April 2017

Lex Machina – Hatch-Waxman ANDA Litigation Report 2017 3 i

Executive Summary

Lex Machina’s third Hatch-Waxman / ANDA Litigation Report demonstrates the power of Legal Analytics by revealing trends and insights into pharmaceutical patent litigation. With large amounts of money riding on litigation decisions, knowing the data landscape is essential to assessing risk and making informed cost/benefit decisions.

This report covers the 2,646 cases filed in U.S. district courts filed between January 1, 2009, and March 31, 2017, related to new drug applications before the U.S. Food and Drug Administration (FDA) pursuant to the Hatch-Waxman Act. These cases involve the assertion of 1,879 unique patents and about 600 applications. Of these cases, fewer than 3% were based on paper new drug applications under 505(b)(2) (often called “paper NDAs”); the vast majority were based on Abbreviated New Drug Applications (ANDAs).

Drawing on a combination of litigation data from Lex Machina’s platform and data published by the FDA on ANDA applications and related patents in the Orange Book, this report analyzes various aspects of ANDA litigation to provide data-driven insights. Together with traditional research and intuition gained from experience, these insights can provide practitioners, whether in-house or at a law firm, an edge over the competition.

From knowing where to file a case, to understanding exposure to damage awards, Legal Analytics helps practitioners make more informed decisions, leading to better litigation strategy. For example, the timing charts below provide a framework for estimating budgets based on how long previous cases have taken. Using our groundbreaking platform, it’s easy to narrow down the dataset to analyze only the most relevant cases (in a particular jurisdiction, for example, or involving a certain party).

This report surveys the landscape of pat-ent 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 pat-ent 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 and shows the ways in which ANDA litigation differs significantly from other, non-ANDA patent litigation.

Lex Machina – Hatch-Waxman ANDA Litigation Report 2017 3ii

Key findings from this report include:

Filing Trends:

• In 2016, 316 ANDA cases were filed - the first decline in 3 years.

• Litigation in 2016 remained higher than the average in 2009-2013 of about 269 cases per year.

Top Districts

• Since 2009, the District of Delaware (1,114 cases) and the District of New Jersey (850 cases) have more cases than all the other districts combined.

• The Southern District of New York, third by number of cases filed since 2009 (159 cases total), has seen a dramatic decline from a peak of 41 cases in 2011 to only a single case filed in the last five quarters.

Top Parties and Firms

• Since 2009, Actavis (including Allergan and Watson Laboratories) has participated in the most ANDA cases (427 cases), followed by Mylan (290 cases), and then by Teva Pharmaceutical Industries (232 cases).

• Among the top parties since 2009, Astrazeneca (156 cases), Pfizer (143 cases), and Novartis (144 cases) have the largest number of cases as claimant (i.e., where the party is asserting the patent, regardless of whether plaintiff or declaratory judgment defendant). Many other top claimants are exclusively claimants including Takeda, Cephalon, Roche, Abbott Labs, Genzyme, and Wyeth.

• In more recent cases filed since 2015, the top parties remain the same: Actavis (138 cases), Mylan (85 cases) and Teva (67 cases). Actavis remains the top claimant in the more recent cases, but Sanofi-Aventis is second (56 cases) and Horizon (41 cases) third.

• McCarter English is the leading plaintiff-side firm with 391 cases since 2009 and 150 since 2015. Other top plaintiff firms include Finnegan, Henderson, Farabow Garrett & Dunner (363 cases since 2009, 125 since 2015), and Fitzpatrick, Cella, Harper & Scinto (310 cases since 2009, 81 since 2015). Saul Ewing appears to be catching up though, with 80 cases since 2015.

• The leading firm representing plaintiffs overall is the Delaware firm of Morris, Nichols, Arsht & Tunnell, with 251 cases in that role during 2015-2017Q1, and an astounding 707 cases in that role since 2009.

• On the defense side, Winston & Strawn leads with 187 cases since 2009, followed by Chicago boutique Rakoczy Molino Mazzochi Siwik (136 cases), Goodwin Procter (127 cases), and Knobbe Martens (108 cases). Among the more recent cases, Winston & Strawn still leads (56 cases), followed by Goodwin Proctor (39 cases) and Budd Lamar (35 cases).

Lex Machina – Hatch-Waxman ANDA Litigation Report 2017 3 iii

ANDA vs Other Patent Litigation

• ANDA litigation is only about 10% of all patent litigation.

• ANDA cases are significantly more likely to involve injunctive relief (12.4% of ANDA cases vs 4.2% of other cases).

• ANDA cases are much less likely to end as a result of settlement (56.5%) than other patent litigation (77.8%), and more likely to be won by the claimant (15.9% in ANDA cases vs 4.4% in other litigation).

• 35 U.S.C. § 103 (obviousness) is the most frequent basis for invalidity in ANDA cases, appearing in 68.8% of the ANDA cases where invalidity has been found.

Orange Book Data

• Abilify (an antipsychotic, 63 cases since 2009) has overtaken Oxycontin (a pain relief medication, 59 cases) as the most litigated tradename by number of cases. Vascepa (a cholesterol medication) leads by number of asserted patents.

• In more recent cases since 2015, Pennsaid (29 cases, 17 patents), Vimovo (25 cases, 13 patents), and Xyrem (17 cases, 17 patents) have also been heavily litigated.

• The vast majority (97.5%) of applications are for prescription drugs; over-the-counter and discontinued drugs are a tiny minority.

• Most applications do not indicate any Therapeutic Equivalence (TE) code (67.9%), but the most popular code when indicated is the “AB” code, representing “products in conventional dosage forms not presenting bioequivalence problems.”

Timing and Injunctions

• The median time to a Markman hearing was 453 days (about a year and three months) from the case filing date.

• When a permanent injunction issues, the median time to its issuance is 591 days (just over a year and a half).

• Time from case filing to summary judgment is 662 days (about 1 year and 9 months) on median while time to trial is 761 days (just over 2 years) on median.

Damages

• Only six ANDA cases filed since 2000 have resulted in damages.

Lex Machina – Hatch-Waxman ANDA Litigation Report 2017 3iv

Table of Contents

New Feature: Viewing products and ingredients in Lex Machina vi

Lex Machina’s Data, Methodology, and Terminology vii

Overview

Figure 1: ANDA cases filed 2009-2016, by year 1Figure 2: ANDA cases filed 2009-2017Q1, by quarter 1Figure 3: ANDA cases filed 2009-2017Q1, by month 2

Top Districts and Judges

Figure 4: Top districts by cases filed 2009-2017Q1 3Figure 5: Top districts by cases filed 2015-2017Q1 3Figure 6: Districts of Delaware and New Jersey, cases filed 2009-2017Q1, by year 4Figure 7: Other top districts, cases filed in 2009-2016, by year 5Figure 8: Top judges, by cases filed 2009-2017Q1 5Figure 9: Top magistrate judges, by cases filed 2009-2017Q1 6

Parties and Law Firms

Figure 10: Top parties by cases filed 2009-2017Q1 7Figure 11: Top parties by cases filed 2015-2017Q1 8Figure 12: Top claimants by cases filed 2009-2017Q1 9Figure 13: Top claimants by cases filed 2015-2017Q1 9Figure 14: Top law firms by cases filed 2009-2017Q1 representing plaintiffs 10Figure 15: Top law firms by cases filed 2009-2017Q1 representing defendants 10Figure 16: Top law firms by cases filed 20015-2017Q1 representing plaintiffs 11Figure 17: Top law firms by cases filed 2015-2017Q1 representing defendants 11

ANDA vs Other Patent Litigation

Figure 18: Cases filed 2009-2017Q1, by quarter 12Figure 19: Injunctions granted in cases filed 2009-2017Q1, ANDA vs other patent litigation 13Figure 20: Resolutions of cases filed and terminated 2009-2017Q1 14Figure 21: Invalidity bases, by findings of invalidity in cases filed and terminated 2009-2017Q1

14Figure 22: Findings in cases filed and terminated 2009-2017Q1 15

Orange Book Data

Figure 23: Word cloud of tradenames (colored by number of cases and sized by number of as-serted patents) in cases filed 2009-2017Q1 16

Figure 24: Word cloud of tradenames (colored by number of cases and sized by number of as-serted patents) in cases filed 2015-2017Q1 17

Figure 25: Word cloud of ingredients (colored by number of cases and sized by number of as-serted patents) in cases filed 2009-2017Q1 17

Figure 26: Application type, by cases filed 2009-2017Q1 18

Lex Machina – Hatch-Waxman ANDA Litigation Report 2017 3 v

Figure 27: Therapeutic equivalence codes, by patents asserted 2009-2017Q1 18Figure 28: Therapeutic equivalence codes, by patents asserted 2009-2017Q1 18Figure 29: Top Ingredients (relationship between cases filed and number of patents asserted) in

cases filed 2009-2017Q1 19Figure 30: Top Ingredients (relationship between cases filed and number of patents asserted) in

cases filed 2015-2017Q1 20Figure 31: Drug substance and product flags, by patent assertions 2009-2017Q1 21Figure 32: IPR petitions filed 2009-2017Q1 on Orange Book patents 21


Figure 33: Time to key events in cases filed 2009 to 21017Q1 22Figure 34: Injunction grant rate and timing, injunctions decided 2009-2017Q1 (in cases filed

2005-2017Q1) 23

Damages

Using Boxplots to Understand Timing 25

Lex Machina – Hatch-Waxman ANDA Litigation Report 2017 3vi

New Feature: Viewing products and ingredients in Lex Machina

1. Start with any case list2. Click on Customize Columns3. Select OrangeBook Product(s) and OrangeBook Ingredient(s) at bottom

Lex Machina – Hatch-Waxman ANDA Litigation Report 2017 3 vii

Lex Machina’s Data, Methodology, and TerminologyThis report considers the last 7 years of patent litigation related to Abbreviated New Drug Applications (ANDA) and paper New Drug Applications (paper NDAs), focusing on cases filed from January 2009 through the end of March 2017, except where otherwise noted. Data derived from the Orange Book is current through March 2017.

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 paper NDAs 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 the patents in the branded drug 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, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) and the U.S. International Trade Commission (ITC). On a daily basis, Lex Machina requests and receives data from the various district 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 – Hatch-Waxman ANDA Litigation Report 2017 31

Overview

Figure 1: ANDA cases filed 2009-2016, by year

Note: All charts reflect patent litigation in the U.S. District Courts except where otherwise stated.

2009 2010 2011 2012 2013 2014 2015 20160

50

100

150

200

250

300

350

400

450

AND

A ca

ses f

iled 316

468

295293

433

264260

236

Figure 2: ANDA cases filed 2009-2017Q1, by quarter

2009 Q3 2010 Q3 2011 Q3 2012 Q3 2013 Q3 2014 Q3 2015 Q3 2016 Q3Quarter / Year

0

20

40

60

80

100

120

140

160

AND

A ca

ses f

iled

113115 114

5661

66

53

72

154

72

80

102

84

74

98

60

93

7166

71

70

95

85

45

64

86

52

67

43

7781

139

67

Lex Machina – Hatch-Waxman ANDA Litigation Report 2017 3 2

In the last five quarters, ANDA litigation declined for the first time in 3 years, but levels nonetheless remained higher than they were at the start of the decade.

In 2016, 316 ANDA cases were filed. Between 2009 and 2013, an average of around 269 ANDA cases were filed per year but, in 2014 and 2015 (through November) the average increased to 451 ANDA cases - a 68% increase from 2009 - 2013.

ANDA cases tend to be filed in clumps, in part because multiple lawsuits may be triggered by related ANDA applications on same drugs filed by various parties. However, in 2016 and so far in 2017 there has been greater consistency, with less variation in filings by quarter relative to the previous higher years of 2014-2015.

Figure 3: ANDA cases filed 2009-2017Q1, by month

2009 2010 2011 2012 2013 2014 2015 2016 2017Quarter / Year

0

10

20

30

40

50

60

70

AND

A ca

ses f

iled

67

3637

3938

34

62

35

30

22

3437

272429

59

37

33

38

19

24

20 2424

33

40

18

26

2926

19

25

32

17

2422

25 2525

23

10

26 30

18

31

16 161616

28

3535

47

9

25

11

49

19

32

15

53

15

2929

21

27

10

29

24

32

28

50

36

1416

2021 212119

28

11

18

3330

25

32

13

1719 191919

1920

12

34

27

14


Top Districts and Judges

Figure 4: Top districts by cases filed 2009-2017Q1

0 100 200 300 400 500 600 700 800 900 1000 1100 1200ANDA cases filed

D.Del.

D.N.J.

Districts other than topten (combined)

S.D.N.Y.

N.D.W.Va.

S.D.Ind.

N.D.Ill.

D.Md.

E.D.Tex.

D.Nev.

S.D.Fla.

1,114

159

850

220

55

39

38

60

30

30

51

Figure 5: Top districts by cases filed 2015-2017Q1

0 50 100 150 200 250 300 350 400ANDA cases filed

D.Del.

D.N.J.

Districts other than topten (combined)

N.D.W.Va.

E.D.Va.

S.D.Ind.

E.D.Tex.

N.D.Ill.

D.Md.

S.D.N.Y.

S.D.Fla.

387

324

15

39

17

30

20

12

5

8

8


ANDA litigation is heavily concentrated in the top districts: the District of Delaware (1,114 cases since 2009) and the District of New Jersey (850 cases) each easily have more cases than all the other districts combined (a combined total of 220 cases). Since 2009, a total of 2,646 ANDA cases have been filed.

The District of Delaware has historically been the most popular district for ANDA litigation and it remains so today. The District of New Jersey held the lead for much of 2015, but since then has been second to the District of Delaware by a fair margin.

Unsurprisingly, the top judges for ANDA cases all hail from these two districts.

The Southern District of New York, third by number of cases filed since 2009 (159 cases total), has seen a dramatic decline from a peak of 41 cases in 2011 to only a single case filed in the last five quarters.

Figure 6: Districts of Delaware and New Jersey, cases filed 2009-2017Q1, by year

2009 Q3 2010 Q3 2011 Q3 2012 Q3 2013 Q3 2014 Q3 2015 Q3 2016 Q3Year / Quarter

0

10

20

30

40

50

60

70

80

AND

A ca

ses f

iled

8380

58

343335

53

32

3631

63

37

3025 25 25

2828

28 28

23

2727

2727

22

4747

21

25

2020

43

2419

19

181818

45

17

46 46

21

1010

1616

36

2020

20

48

4037

19

12 12

17

39 38

18

13

DistrictD.Del.D.N.J.


Figure 7: Other top districts, cases filed in 2009-2016, by year

Rank Judge Home District

0 50 100 150 200 250 300 350ANDA cases

1 Gregory Sleet D.Del.

2 Sue Robinson D.Del.

3 Leonard Stark D.Del.

4 Richard Andrews D.Del.

5 Mary Cooper D.N.J.

6 Jerome Simandle D.N.J.

7 Stanley Chesler D.N.J.

8 Joel Pisano D.N.J.

9 Renee Bumb D.N.J.

10 Noel Hillman D.N.J.

Peter Sheridan D.N.J.

352

273

248

230

120

81

69

67

63

61

61

Figure 8: Top judges, by cases filed 2009-2017Q1

2009 2010 2011 2012 2013 2014 2015 2016 20170

5

10

15

20

25

30

35

40

AND

A ca

ses f

iled

2022

17

41

21

25

1

26

66

64 6

3

66

11

5

1111

2

88

5

2

88

3

7

1

9

4 33

DistrictN.D.Ill.N.D.W.Va.S.D.Ind.S.D.N.Y.

Note: Judges shown with home district, but case counts may include cases in other jurisdictions when sitting by designation.


Rank Magistrate Home District

0 20 40 60 80 100 120 140ANDA cases

1 Douglas E. Arpert D.N.J.

2 Tonianne J. Bongiovanni D.N.J.

3 Lois H. Goodman D.N.J.

4 Karen M. Williams D.N.J.

5 Cathy L. Waldor D.N.J.

6 Joseph A. Dickson D.N.J.

7 Madeline Cox Arleo D.N.J.

8 Ann Marie Donio D.N.J.

9 Joel Schneider D.N.J.

10 Mark Falk D.N.J.

Michael A. Hammer D.N.J.

131

124

108

99

87

77

67

62

57

56

56

Figure 9: Top magistrate judges, by cases filed 2009-2017Q1


Figure 10: Top parties by cases filed 2009-2017Q1

Entity Total cases % of cases asclaim defendant

0 500 1000 1500 2000Total ANDA cases filed

Other 1,978 29%Actavis / Allergan / Watson 427 85%Mylan 290 100%Teva 232 80%Sandoz 189 99%Apotex 180 98%Lupin 176 88%Astrazeneca 156 0%Pfizer 150 5%Novartis 143 1%Par 131 92%Amneal 105 100%Dr. Reddy's 100 100%Forest 98 3%Sanofi-Aventis 97 1%Sun 90 99%Takeda 87 0%Eli Lilly 85 4%PF Prism 85 4%Cephalon 79 0%Aurobindo 76 100%Fresenius 72 49%Merck 71 3%Roche 70 0%Otsuka 69 0%Roxane 68 99%Zydus 67 99%Abbott Labs 65 0%Hetero 65 95%Genzyme 63 0%Horizon 58 2%Wyeth 56 0%Impax 55 91%Cadila 54 100%Bayer 52 2%

Party roleClaim defendantClaimant

Parties and Law Firms


Figure 11: Top parties by cases filed 2015-2017Q1

Since 2009, Actavis (including Allergan and Watson Laboratories) has participated in the most ANDA cases (427 cases), followed by Mylan (290 cases), and then by Teva Pharmaceutical Industries (232 cases). The top parties most of the time appear in the role of a claim defendant (i.e. a defendant or declaratory judgment plaintiff), although Actavis is an exception in large part due to its Allergan cases.

Among the top parties since 2009, Astrazeneca (156 cases), Pfizer (143 cases), and Novartis (144 cases) have the largest number of cases as claimant (i.e., where the party is asserting the patent, regardless of whether plaintiff or declaratory judgment defendant). Many other top claimants are exclusively claimants including Takeda, Cephalon, Roche, Abbott Labs, Genzyme, and Wyeth.

In more recent cases filed since 2015, the top parties remain the same: Actavis (138 cases), Mylan (85 cases) and Teva (67 cases). Actavis remains the top claimant in the more recent cases, but Sanofi-Aventis is second (56 cases) and Horizon (41 cases) third.

Entity Total cases % of cases asclaim defendant

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

Other 712 32%Actavis / Allergan / Watson 138 83%Mylan 85 99%Teva 67 78%Astrazeneca 63 0%Apotex 60 95%Sanofi-Aventis 57 2%Amneal 53 100%Lupin 47 96%Par 45 87%Dr. Reddy's 41 100%Horizon 41 0%Eli Lilly 37 0%Novartis 36 0%Aurobindo 35 100%Otsuka 32 0%PF Prism 30 0%



Note: Judges shown with home district, but case counts may include cases in other jurisdictions when sitting by designation.

Figure 12: Top claimants by cases filed 2009-2017Q1

Entity # of claimantcases

% of cases asclaimant

Totalcases

0 500 1000 1500 2000# of ANDA cases

Other 1,399 71% 1,978Astrazeneca 156 100% 156Pfizer 143 95% 150Novartis 141 99% 143Sanofi-Aventis 96 99% 97Forest 95 97% 98Takeda 87 100% 87Eli Lilly 82 96% 85PF Prism 82 96% 85Cephalon 79 100% 79Roche 70 100% 70Merck 69 97% 71Otsuka 69 100% 69Abbott Labs 65 100% 65Actavis / Allergan / Watson 65 15% 427Genzyme 63 100% 63Horizon 57 98% 58Wyeth 56 100% 56Bayer 51 98% 52Teva 46 20% 232


Figure 13: Top claimants by cases filed 2015-2017Q1

Entity # of claimantcases

% of cases asclaimant

Totalcases

0 100 200 300 400 500 600 700# of ANDA cases

Other 486 68% 712Astrazeneca 63 100% 63Sanofi-Aventis 56 98% 57Horizon 41 100% 41Eli Lilly 37 100% 37Novartis 36 100% 36Otsuka 32 100% 32PF Prism 30 100% 30Genzyme 27 100% 27Takeda 25 100% 25Merck 24 96% 25Actavis / Allergan / Watson 23 17% 138Pfizer 23 82% 28Forest 21 100% 21Jazz 17 100% 17Roche 16 100% 16Bayer 15 100% 15Fresenius 15 52% 29Teva 15 22% 67



Figure 14: Top law firms by cases filed 2009-2017Q1 representing plaintiffsRank Lawfirm Name

0 50 100 150 200 250 300 350 400 450ANDA cases

1 McCarter & English2 Finnegan, Henderson, Farabow, Garrett & Dunner3 Fitzpatrick, Cella, Harper & Scinto4 Saul Ewing5 WilmerHale6 Paul Hastings7 Covington & Burling8 Pepper Hamilton9 Gibbons10 Williams & Connolly11 Fish & Richardson12 Goodwin Procter13 Quinn Emanuel Urquhart & Sullivan14 Ropes & Gray15 Arnold & Porter Kaye Scholer

391 cases363 cases

310 cases146 cases145 cases

138 cases133 cases

116 cases112 cases

103 cases100 cases

91 cases91 cases

85 cases77 cases

Figure 15: Top law firms by cases filed 2009-2017Q1 representing defendants

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

1 Winston & Strawn2 Rakoczy Molino Mazzochi Siwik3 Goodwin Procter4 Knobbe Martens Olson & Bear5 Duane Morris6 Budd Larner7 Saiber8 Wilson Sonsini Goodrich & Rosati9 Schiff Hardin10 Latham & Watkins11 Axinn, Veltrop & Harkrider12 Leydig, Voit & Mayer13 Merchant & Gould14 McGuireWoods15 Cozen O'Connor

187 cases136 cases

127 cases108 cases


85 cases82 cases

76 cases74 cases74 cases74 cases

65 cases63 cases

Solid data on law firm representation helps law firms communicate their experience to clients, and enables companies to choose the right firm for the job. Although this section only examines top firms overall, Lex Machina allows users to narrow in on the top law firms by particular districts, or that have achieved certain results (e.g. trial).

The top law firms for representing plaintiffs in ANDA cases have been relatively stable. McCarter English is the leading plaintiff-side firm with 391 cases since 2009 and 150 since 2015. Other top plaintiff firms include Finnegan, Henderson, Farabow Garrett & Dunner (363 cases since 2009, 125 since 2015), and Fitzpatrick, Cella, Harper & Scinto (310 cases since 2009, 81 since 2015). Saul Ewing appears to be catching up though, with 80 cases since 2015.

On the defense side, Winston & Strawn leads with 187 cases since 2009, followed by Chicago boutique Rakoczy Molino Mazzochi Siwik (136 cases), Goodwin Procter (127 cases), and Knobbe Martens (108 cases).

Among the more recent cases, Winston & Strawn still leads(56 cases), followed by Goodwin Proctor (39 cases) and Budd Lamar (35 cases).

Note: These charts exclude Delaware local counsel law firms - see box on next page.


Figure 16: Top law firms by cases filed 20015-2017Q1 representing plaintiffsRank Lawfirm Name

0 20 40 60 80 100 120 140 160ANDA cases

1 McCarter & English2 Finnegan, Henderson, Farabow, Garrett & Dunner3 Fitzpatrick, Cella, Harper & Scinto4 Saul Ewing5 Paul Hastings6 Covington & Burling7 Pepper Hamilton8 WilmerHale9 Quinn Emanuel Urquhart & Sullivan10 Green Griffith & Borg11 Williams & Connolly12 Gibbons13 Global Patent Group14 McDonnell Boehnen Hulbert & Berghoff15 Goodwin Procter

150 cases125 cases

81 cases80 cases

63 cases47 cases

46 cases46 cases



25 cases

Figure 17: Top law firms by cases filed 2015-2017Q1 representing defendants

0 5 10 15 20 25 30 35 40 45 50 55 60 65ANDA cases

1 Winston & Strawn2 Goodwin Procter3 Budd Larner4 Schiff Hardin5 Taft Stettinius & Hollister6 Fox Rothschild7 Knobbe Martens Olson & Bear8 Saiber9 Walsh Pizzi O'Reilly Falanga10 Steptoe & Johnson PLLC11 Wilson Sonsini Goodrich & Rosati12 Polsinelli13 Axinn, Veltrop & Harkrider14 Connell Foley15 Hill Wallack

56 cases39 cases

35 cases32 cases

31 cases28 cases

27 cases25 cases



20 cases

Of course, the leading firm representing plaintiffs overall is the Delaware firm of Morris, Nichols, Arsht & Tunnell, with 251 cases in that role during 2015-2017Q1, and an astounding 707 cases in that role since 2009.

Also notable, on the defense side, are the Delaware firms of Young Conaway Stargatt & Taylor (with 161 cases in that role since 2009, and 55 cases during 2015-2017Q1) as well as Philips, Goldman, McLaughlin & Hall (100 cases in that role since 2009, and 62 during 2015-2017Q1).


ANDA vs Other Patent LitigationFigure 18: Cases filed 2009-2017Q1, by quarter

2009 Q3 2010 Q3 2011 Q3 2012 Q3 2013 Q3 2014 Q3 2015 Q3 2016 Q3Quarter of Filed On

0

200

400

600

800

1000

1200

1400

1600

Cas

es fi

led

1,029 1,0461,025 1,020

1,056

1,014

1,163

883

1,564

528

857855

1,222 1,222

543

1,228

1,5261,524

588589

590

1,4791,454

768

631632

635

1,325

154

1,416

139

1,405

8081

77 8485

1,358

86

74

678

72727171

70

93

676743

6666

9545

11564

114

981136160

10252 5356

1,379

Case Type NEWANDA litigationOther patent litigation

ANDA litigation differs from other patent litigation in several key aspects. By examining and comparing filing rates, remedies, and case resolutions between these two kinds of cases, practitioners can ensure they are supported by data relevant to the specific kind of case at hand.

Although ANDA filings constitute only about 10% of all patent litigation in the U.S. district courts in recent years, it has remained more steady than filing rates for other patent litigation. While other patent litigation has risen and fallen dramatically, ANDA litigation has been comparatively stable with only a moderate rise in 2014 to 2015.

ANDA cases also differ significantly in the likelihood of gaining injunctive relief: while an injunction has issued in 12.4% of ANDA cases, the percentage for other patent litigation is only 4.2% (see below for more on injunctive relief in ANDA cases).

ANDA cases are much less likely to end as a result of settlement (56.5%) than other patent litigation (77.8%), and more likely to be won by the claimant (15.9% in ANDA cases vs 4.4% in other litigation). Procedural outcomes (such as transfer or consolidation) also account for a larger percentage of ANDA case resolutions (23.9%) than in other patent litigation (14.6%).


Figure 19: Injunctions granted in cases filed 2009-2017Q1, ANDA vs other patent litigationANDA litigation Other patent litigation

Injunction granted328 cases

12.4%

Injunction granted1,534 cases

4.2%

No injunction35,343 cases

95.8%

No injunction2,318 cases

87.6%

In ANDA cases, consent judgment is the most frequent vehicle for getting a patent finding (accounting for a finding in 229 cases) followed by trial (89 cases). In contrast, other patent litigation is more likely to result in a patent finding from summary judgment, or on default judgment.

When patents are found invalid, ANDA cases differ from other litigation in the bases for the invalidity. Among ANDA cases, 35 U.S.C. § 103 (obviousness) is the most frequent basis for invalidity, appearing in 68.8% of the ANDA cases where invalidity has been found. In contrast, other patent cases tend to rely more on § 102 (anticipation/novelty, 55.9% of invalid patents in non-ANDA cases ).


Figure 20: Resolutions of cases filed and terminated 2009-2017Q1

ANDA litigation Other patent litigation

0% 10% 20% 30% 40% 50% 60% 70%Cases

10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Cases

ClaimantWin

ClaimDefendant

Win

Procedural

LikelySettlement

56.5%(1,190 cases)

15.9%(335 cases)

23.5%(495 cases)

4.1%(87 cases)

77.8%(23,536 cases)

4.4%(1,330 cases)

14.6%(4,427 cases)

3.2%(977 cases)

Figure 21: Invalidity bases, by findings of invalidity in cases filed and terminated 2009-2017Q1

0% 10% 20% 30% 40% 50% 60% 70% 80%% of cases with invalidity finding (within type)

ANDAlitigation

Invalidity: 102 Anticipation / Novelty

Invalidity: 103 Obviousness

Invalidity: 112 Definiteness

Invalidity: 112 Enablement

Invalidity: 112 Written Description

Invalidity: Obviousness-Type Double Patenting

Otherpatentlitigation

Invalidity: 101 Subject Matter

Invalidity: 102 Anticipation / Novelty

Invalidity: 102(f) Derivation (pre-AIA)

Invalidity: 103 Obviousness

Invalidity: 112 Definiteness

Invalidity: 112 Enablement

Invalidity: 112 Written Description

68.8%(11 cases)

12.5%(2 cases)

12.5%(2 cases)

12.5%(2 cases)

12.5%(2 cases)

6.3%(1 cases)

55.9%(19 cases)

11.8%(4 cases)

5.9%(2 cases)

26.5%(9 cases)

23.5%(8 cases)

2.9%(1 cases)

2.9%(1 cases)

Note: “Claimant win” refers to the rights-holder - the plaintiff, or declaratory judgment defendant - winning over an accused infringer (the “claim defendant”).

Note: Cases may include multiple findings of invalidity.


Figure 22: Findings in cases filed and terminated 2009-2017Q1

0% 10% 20% 30% 40% 50% 60% 70%% of cases with patent finding (within type)

ANDAlitigation

295 cases witha finding

Consent Judgment 229 cases Infringement 197 casesNo Infringement 5 casesNo Invalidity 162 casesNo Unenforceability 157 cases

Judgment on thePleadings

2 cases Infringement 1 casesUnenforceability 1 cases

Summary Judgment 24 cases Infringement 8 casesInvalidity 3 casesNo Infringement 8 casesNo Invalidity 6 casesNo Unenforceability 4 cases

Trial 89 cases Infringement 64 casesInvalidity 12 casesNo Infringement 20 casesNo Invalidity 74 casesNo Unenforceability 20 cases

Judgment as a Matterof Law

2 cases Invalidity 1 casesNo Invalidity 1 cases

Otherpatentlitigation

925 cases witha finding

Consent Judgment 540 cases Infringement 377 casesNo Infringement 7 casesNo Invalidity 439 casesNo Unenforceability 376 casesUnenforceability 1 cases

Default Judgment 265 cases Infringement 263 casesInvalidity 2 casesNo Infringement 2 casesNo Invalidity 33 casesNo Unenforceability 27 casesUnenforceability 1 cases

Judgment on the Ple.. 1 cases Invalidity 1 casesSummary Judgment 121 cases Infringement 65 cases

Invalidity 21 casesNo Infringement 46 casesNo Invalidity 44 casesNo Unenforceability 20 casesUnenforceability 1 cases

Trial 107 cases Infringement 90 casesInvalidity 9 casesNo Infringement 30 casesNo Invalidity 82 casesNo Unenforceability 22 cases

Judgment as a Matterof Law

26 cases Infringement 6 casesInvalidity 4 casesNo Infringement 7 casesNo Invalidity 8 casesNo Unenforceability 5 cases

66.78%1.69%

54.92%53.22%

0.34%0.34%

2.71%1.02%

2.71%2.03%

1.36%21.69%

4.07%6.78%

25.08%6.78%

0.34%0.34%

40.76%0.76%

47.46%40.65%

0.11%28.43%

0.22%0.22%

3.57%2.92%

0.11%0.11%

7.03%2.27%

4.97%4.76%

2.16%0.11%

9.73%0.97%

3.24%8.86%

2.38%0.65%0.43%0.76%0.86%0.54%


Orange Book Data

Figure 23: Word cloud of tradenames (colored by number of cases and sized by number of asserted patents) in cases filed 2009-2017Q1

ZYTIGAZYMAXID

ZYMAR

ZUBSOLV

ZORTRESS

ZOMETA

ZOHYDRO ER

ZETIA

ZEMPLAR

ZEGERID OTC

ZEGERIDYOSPRALA

YAZ

YASMIN

XYREM

XIMINO

XELODA

XELJANZ XR

XELJANZ

XARTEMIS XR

XARELTO WELCHOL

VYVANSE

VYTORIN

VIREAD

VIMPAT

VIMOVO

VIIBRYD

VIGAMOX

VIEKIRA XR

VIEKIRA PAK (COPACKAGED)

VIAGRA

VENLAFAXINE HYDROCHLORIDE

VELCADE

VASCEPA

VANOS

VALCYTE

ULORIC

UCERIS

TYVASO

TYGACIL

TYBOST

TRUVADA

TRIZIVIR

TRIUMEQ

TRILIPIX

TRICOR

TRIBENZOR

TREXIMET

TREANDA TRAVATAN ZTRAVATAN

TRADJENTA

TOVIAZ

TOPICORT

TIKOSYN

THALOMID

TECHNIVIE

TAYTULLA

TARGINIQ

TARCEVATAMIFLU

SYNJARDY XR

SUSTIVA

SUPREP BOWEL PREP KIT

SUBOXONE

STRIBILD

STIVARGA

STAXYNSPORANOX

SOLODYN SIMCOR

SILENOR

SEROQUEL XR

SENSIPAR

SEASONIQUE SAVELLA

SAPHRIS

SANCTURA XR

SAMSCA

SAFYRAL

RYZOLT

RITALIN LA

REYATAZ

REVLIMIDRESTASIS MULTIDOSE

RESTASIS

RENVELA

RENAGEL

REMODULIN

RELISTOR

RECLAST

RAVICTI

QUILLIVANT XR

QUARTETTE

QTERN

QSYMIA

PULMICORT RESPULES

PROVIGIL

PROQUIN XRPROLENSA

PRISTIQ

PRILOSEC OTC

PRILOSECPREZISTA

PREZCOBIX

PREVACID

PRECEDEX

PRADAXA

POMALYST

PHOSLO GELCAPS

PHOSLO

PENNSAID

PAZEO

PATANOL

PATADAYOXYCONTIN

OXTELLAR XR

OXAYDOOSENI

ORTHO TRI-CYCLEN LO

ORENITRAM

ORAPRED ODT

ORACEAOPANA ER

ONSOLIS

ONGLYZA

ONEXTON

OFIRMEV

ODEFSEY

NUVIGIL

NUEDEXTA

NUCYNTA ERNUCYNTA

NOXAFIL

NORVIR

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

NIASPAN TITRATION STARTER PACK

NIASPAN

NEXIUM IV

NEXIUM 24HR NEXIUM

NEXAVAR

NESINA

NASONEXNAROPIN

NAMZARICNAMENDA XR

NAMENDAMYRBETRIQ

MYFORTIC

MULTAQ

MUCINEX DM

MUCINEX D

MUCINEX

MOZOBIL

MOXEZA

MINIVELLEMINASTRIN 24 FE

METADATE CD

MEGACE ES

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

LYSTEDALYRICA

LUMIGAN

LOTRONEX

LOPROX

LOESTRIN 24 FELO MINASTRIN FE

LO LOESTRIN FE

LIVALO

LIPTRUZET

LIPITOR

LIDODERM

LIALDA

LEVOTHYROXINE SODIUM

LEVITRA LETAIRIS

LATUDA

LATISSE

KYPROLISKUVAN

KOMBIGLYZE XR

KAZANO

KALETRA

JEVTANA KIT

JENTADUETO XR

JENTADUETO

JANUMET XR

JALYN

JADENU

ISTODAX

INVOKAMET XR

INTUNIV

INTERMEZZO

INTEGRILIN

HYSINGLA

HECTOROL

GRALISE

GLYXAMBIGLUMETZA

GLEEVECGILENYA

GIAZO

GENVOYA

FUSILEV

FOSRENOL

FORTAMET

FOCALIN XR

FOCALIN

FENTORAFEMCON FE

FAZACLO ODT

FASLODEX

FANAPT

EXJADEEXELON

EVOTAZ

EVISTA

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER

ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

EQUETROEPZICOM

EPIDUO FORTE

EPIDUO

ENABLEX

EMTRIVA

EMEND

EFFIENT

EFFEXOR XRDYLOJECT DUETACT

DORYX MPC

DORYX

DORIBAX

DIPRIVAN

DICLEGIS

DEXILANT SOLUTAB

DEXILANT

DETROL LADESCOVY

DELZICOL

DALIRESP

CUBICIN RF

CUBICINCRESTORCOREG CR

COPAXONECONCERTA

COMPLERA

COMBIGAN

COLCRYS

CLOLAR

CLOBEX

CIPRODEX

CIALIS

CHILDREN'S ALLEGRA HIVES

CHILDREN'S ALLEGRA ALLERGY

CANCIDAS

CANASA

CADUET

BYETTA

BYDUREON PEN

BYDUREON

BUTRANS

BUNAVAILBRISDELLEBRILINTABREVIBLOC IN PLASTIC CONTAINER

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

BREVIBLOC

BONIVA

BEYAZ

BEPREVEBENICAR HCT

BENICAR

BENDEKA BELBUCA

BARACLUDE

BANZEL AZOR

AZILECT

AXIRON

AVODARTAVANDAMET

AUBAGIO

ATRIPLA

ATELVIA

ASTEPRO

APRISO

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

AFINITOR DISPERZ

AFINITOR

ADVICOR

ADENOSCAN

ADDERALL XR 30

ADDERALL XR 25

ADDERALL XR 20ADDERALL XR 15

ADDERALL XR 10ADDERALL XR 5

ADCIRCA

ACULAR LS

ACTOS

ACTOPLUS MET XR

ACTOPLUS MET

ACTONEL

ACETADOTE

ACANYA

ABILIFY MAINTENA KIT ABILIFY

The U.S. Food and Drug Administration (FDA) publishes data on new drug applications in the “Orange Book.” Integrating that data into Lex Machina’s platform enables insight into how different parts of the application affect ANDA litigation.

Abilify (an antipsychotic, 63 cases since 2009) has overtaken Oxycontin (a pain relief medication, 59 cases) as the most litigated tradename by number of cases. Vascepa (a cholesterol medication) leads by number of asserted patents. In more recent cases since 2015, Pennsaid (29 cases, 17 patents), Vimovo (25 cases, 13 patents), and Xyrem (17 cases, 17 patents) have also been heavily litigated.

By constituent ingredients, oxycodone hydrochloride (the primary ingredient of Oxycontin) has the most cases, followed by aripiprazole (an anti-psychotic), although testosterone has been asserted in the most patents.

Prescription drugs are more common than over-the-counter or discontinued drugs by cases (97.5% of cases are prescription). Therapeutic Equivalence (TE) codes indicate information about bioequivalence and FDA testing. Most applications do not indicate any TE code (67.9%). The most popular TE code among applications indicating one is the “AB” code, representing “products in conventional dosage forms not presenting bioequivalence problems.” 538 patents, or just over one quarter of ANDA litigated patents bear this code.

Drug substance/product flags indicate whether the patent underlying the ANDA application claims the drug substance or the drug product. Most applications have only the product flag (applications linked to litigated 1,527 patents) followed by those with no flag (those linked to 1,436 litigated patents).


Figure 24: Word cloud of tradenames (colored by number of cases and sized by number of asserted patents) in cases filed 2015-2017Q1

ZYTIGA

ZUBSOLV

ZOMETA

ZOHYDRO ER

YOSPRALA

XYREM

XELJANZ XR

XELJANZ

XARELTO

VIMOVO

VIIBRYD

VIEKIRA XRVIEKIRA PAK (COPACKAGED)

VELCADEUCERIS

TYVASO

TYGACIL

TYBOST

TRUVADA

TRIBENZOR

TREANDA

TRADJENTA

TOVIAZTECHNIVIE

TARGINIQSUBOXONE

STRIBILD

STIVARGA

SPORANOX

SENSIPAR

RESTASIS MULTIDOSE

RESTASIS

REMODULIN

RELISTOR

QUILLIVANT XR

QSYMIA

PROLENSA

PRILOSEC OTC

PRILOSECPREZISTA

PREZCOBIX

PREVACID

PRADAXA

PENNSAIDPAZEOOXYCONTIN

OXTELLAR XR

ORENITRAM

OPANA ERONSOLIS

ONEXTON

ODEFSEY

NUCYNTA ER

NOXAFIL

NORVIR

NEXIUM 24HR

NEXIUM

NEXAVAR

NAMZARIC

NAMENDA XR

MYRBETRIQ MULTAQ

MUCINEX DM MUCINEX D

MUCINEX

MINIVELLE

MEGACE ES


LETAIRIS

LATUDA

KYPROLIS

KALETRA

JEVTANA KIT

JENTADUETO XR

JENTADUETOJADENUHYSINGLA

GLYXAMBI

GLEEVEC

GILENYA

GENVOYA

FOSRENOL

FASLODEX

FANAPT

EVOTAZ

EPIDUO FORTEEPIDUO

EMTRIVA

DYLOJECT

DEXILANT SOLUTAB

DESCOVYDELZICOL

DALIRESPCUBICIN RF

CUBICINCOPAXONE

COMPLERA

CLOLAR

CIPRODEX

CIALIS

CANASA

BUNAVAILBRILINTA

BENICAR HCT

BENICAR

BELBUCA

AZOR AXIRON

AUBAGIO

ATRIPLA

ANDROGEL

ALOXI

ALIMTA

AFINITORACANYA

ABILIFY MAINTENA KIT

ABILIFY

Figure 25: Word cloud of ingredients (colored by number of cases and sized by number of asserted patents) in cases filed 2009-2017Q1

ZOLPIDEM TARTRATE

ZOLEDRONIC ACID

VILAZODONE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE

VARDENAFIL HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDETROSPIUM CHLORIDE

TREPROSTINIL DIOLAMINE

TREPROSTINIL

TRAVOPROST

TRANEXAMIC ACID

TRAMADOL HYDROCHLORIDE

TOPIRAMATE

TOLVAPTAN

TOLTERODINE TARTRATE TOFACITINIB CITRATE

TIGECYCLINE

TICAGRELOR

THALIDOMIDETESTOSTERONE

TERIFLUNOMIDE

TENOFOVIR DISOPROXIL FUMARATE

TAPENTADOL HYDROCHLORIDE

TADALAFIL

TACROLIMUS

SORAFENIB TOSYLATE

SODIUM OXYBATE

SILDENAFIL CITRATE

SEVELAMER HYDROCHLORIDESEVELAMER CARBONATE

SAXAGLIPTIN HYDROCHLORIDE

SAPROPTERIN DIHYDROCHLORIDE

RUFINAMIDEROSUVASTATIN CALCIUM

ROPIVACAINE HYDROCHLORIDE

ROMIDEPSIN

ROFLUMILAST

RIVASTIGMINE TARTRATERIVASTIGMINE

RIVAROXABAN

RITONAVIR

RISEDRONATE SODIUM

REGORAFENIB

RASAGILINE MESYLATE

RALOXIFENE HYDROCHLORIDE

QUETIAPINE FUMARATE

PROPOFOL

PREGABALIN

PREDNISOLONE SODIUM PHOSPHATE

PRASUGREL HYDROCHLORIDE

POSACONAZOLE

POMALIDOMIDE

PLERIXAFOR

PITAVASTATIN CALCIUM

PIOGLITAZONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

PEMETREXED DISODIUM

PAROXETINE MESYLATEPARICALCITOL

PALONOSETRON HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

OXCARBAZEPINE

OSELTAMIVIR PHOSPHATEOMEPRAZOLE MAGNESIUM

OMEPRAZOLEOMBITASVIR

OLOPATADINE HYDROCHLORIDE

OLMESARTAN MEDOXOMIL

NIACIN

NAPROXEN SODIUM

NALOXONE HYDROCHLORIDE

MYCOPHENOLIC ACID

MOXIFLOXACIN HYDROCHLORIDEMORPHINE SULFATE

MOMETASONE FUROATE

MODAFINIL

MIRABEGRON MINOCYCLINE HYDROCHLORIDE

MILNACIPRAN HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

METHYLNALTREXONE BROMIDE

METFORMIN HYDROCHLORIDE

MESALAMINE

MEMANTINE HYDROCHLORIDE

MEGESTROL ACETATE

MAGNESIUM SULFATE ANHYDROUS

MAGNESIUM HYDROXIDE

LURASIDONE HYDROCHLORIDE

LOVASTATIN

LOPINAVIR

LISDEXAMFETAMINE DIMESYLATE

LINAGLIPTIN

LIDOCAINE


LEVOLEUCOVORIN CALCIUM

LENALIDOMIDE

LANTHANUM CARBONATE

LANSOPRAZOLELACOSAMIDE

KETOROLAC TROMETHAMINE

ITRACONAZOLE

IMATINIB MESYLATE

ILOPERIDONE

ICOSAPENT ETHYLIBANDRONATE SODIUM

HYDROMORPHONE HYDROCHLORIDE

HYDROCODONE BITARTRATE

HYDROCHLOROTHIAZIDE

GUANFACINE HYDROCHLORIDE

GUAIFENESIN

GLYCEROL PHENYLBUTYRATE

GLIMEPIRIDE

GLATIRAMER ACETATEGATIFLOXACIN

GABAPENTIN

FULVESTRANT FOSAPREPITANT DIMEGLUMINE

FLUTICASONE PROPIONATE

FLUOCINONIDE

FINGOLIMODFEXOFENADINE HYDROCHLORIDEFESOTERODINE FUMARATE

FENTANYL CITRATEFENOFIBRATE

FEBUXOSTAT

FAMOTIDINE

EZETIMIBE

EXENATIDE SYNTHETIC

EVEROLIMUS

ETHINYL ESTRADIOL

ESTRADIOL

ESOMEPRAZOLE SODIUM

ESOMEPRAZOLE MAGNESIUM

ESMOLOL HYDROCHLORIDEERLOTINIB HYDROCHLORIDE

EPTIFIBATIDE

EPINEPHRINEENTECAVIR

EMTRICITABINE

EMPAGLIFLOZIN

EFAVIRENZDUTASTERIDE

DROSPIRENONEDRONEDARONE HYDROCHLORIDE

DOXYLAMINE SUCCINATE

DOXYCYCLINE HYCLATE

DOXYCYCLINE

DOXERCALCIFEROL

DOXEPIN HYDROCHLORIDE

DORIPENEM

DONEPEZIL HYDROCHLORIDE

DOFETILIDE

DICLOFENAC SODIUM

DICLOFENAC POTASSIUM DEXTROMETHORPHAN HYDROBROMIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE

DEXLANSOPRAZOLE

DESVENLAFAXINE SUCCINATE

DESOXIMETASONE

DESONIDE

DEFERASIROX

DASABUVIR SODIUM

DASABUVIR SODIUM

DARUNAVIR ETHANOLATE

DARIFENACIN HYDROBROMIDE

DAPTOMYCIN

DAPAGLIFLOZIN PROPANEDIOL

DALFAMPRIDINEDABIGATRAN ETEXILATE MESYLATE

CYCLOSPORINE

CYCLOBENZAPRINE HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE

COLCHICINE

COBICISTAT

CLOZAPINE

CLOFARABINE

CLOBETASOL PROPIONATE

CLINDAMYCIN PHOSPHATE

CIPROFLOXACIN HYDROCHLORIDE

CIPROFLOXACIN

CINACALCET HYDROCHLORIDE

CICLOPIROX

CHOLINE FENOFIBRATE

CASPOFUNGIN ACETATE

CARVEDILOL PHOSPHATE

CARFILZOMIB

CARBIDOPA

CARBAMAZEPINE

CAPECITABINE

CANAGLIFLOZIN

CALCIUM ACETATE

CABAZITAXEL

BUPROPION HYDROBROMIDE

BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE

BUDESONIDE

BROMFENAC SODIUM

BRIMONIDINE TARTRATE

BORTEZOMIB

BIVALIRUDIN

BIMATOPROST

BEPOTASTINE BESILATE

BENZOYL PEROXIDE

BENDAMUSTINE HYDROCHLORIDE

BALSALAZIDE DISODIUM

AZELASTINE HYDROCHLORIDE

ATORVASTATIN CALCIUM

ATAZANAVIR SULFATE

ASPIRINASENAPINE MALEATE

ARMODAFINIL

ARIPIPRAZOLE

AMPHETAMINE ASPARTATE

AMLODIPINE BESYLATE

AMBRISENTAN

ALOSETRON HYDROCHLORIDE

ALOGLIPTIN BENZOATE

ALBUTEROL SULFATE

ADENOSINE

ADAPALENE

ACETYLCYSTEINE

ACETAMINOPHEN

ABIRATERONE ACETATE

ABACAVIR SULFATE

ZIDOVUDINE

TOPIRAMATE

TIMOLOL MALEATE


TENOFOVIR ALAFENAMIDE FUMARATE

TAMSULOSIN HYDROCHLORIDE

SUMATRIPTAN SUCCINATE

SODIUM SULFATE

SODIUM BICARBONATE SITAGLIPTIN PHOSPHATE

SIMVASTATIN

SAXAGLIPTIN HYDROCHLORIDE

ROSIGLITAZONE MALEATE

RITONAVIR

RILPIVIRINE HYDROCHLORIDE

QUINIDINE SULFATE

PYRIDOXINE HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE

POTASSIUM SULFATE


PARITAPREVIR


OMEPRAZOLE

OMBITASVIR

OLMESARTAN MEDOXOMIL

NORGESTIMATE

NORETHINDRONE ACETATE

NORETHINDRONE

NIACIN

NAPROXEN

NALOXONE HYDROCHLORIDE METFORMIN HYDROCHLORIDE


LINAGLIPTIN

LEVONORGESTREL

LEVOMEFOLATE CALCIUM

LEVODOPA

LAMIVUDINE

HYDROCHLOROTHIAZIDE

GUAIFENESIN

EZETIMIBE

ETHINYL ESTRADIOL

ESTRADIOL

EMTRICITABINE

ELVITEGRAVIR

DOLUTEGRAVIR SODIUM

DIPYRIDAMOLE

DEXTROAMPHETAMINE SULFATE

DEXTROAMPHETAMINE SACCHARATE

DEXAMETHASONE


COBICISTAT

CLINDAMYCIN PHOSPHATE

BENZOYL PEROXIDE

ATORVASTATIN CALCIUM

AMPHETAMINE SULFATE


The Orange Book allows for multiple entries in some data fields, like ingredients, Therapeutic Equivalence (TE) codes, or drug/product flags. When a case or patent corresponds to multiple Orange Book entries (e.g. one application contains a “AB” TE code, but the other contains a “BT” code) the case and patent count towards each TE code.

Figure 26: Application type, by cases filed 2009-2017Q1

Discontinued Over-the-counter Prescription0

500

1000

1500

2000

2500

AND

A ca

ses

97.5%2,503 cases

27.1%696 cases

2.8%71 cases

Figure 27: Therapeutic equivalence codes, by patents asserted 2009-2017Q1

0 200 400 600 800 1000 1200 1400 1600# / % of patent assertions having TE code specified

Nonespecified

AB

AP

AT

BX

AA

AB2

AB1

AB3

AT2

AN

BT

AT1

67.9%1,276 patents

28.6%538 patents

5.4%101 patents

2.8%53 patents

2.2%42 patents

1.7%32 patents

1.1%21 patents

0.5%9 patents

0.4%7 patents

0.3%5 patents

0.2%4 patents

0.2%3 patents

0.1%2 patents

Figure 28: Therapeutic equivalence codes, by patents asserted 2009-2017Q1Therapeutic equivalence code

None specified

AA

AB

AB1

AB2

AB3

AN

AP

AT

AT1

AT2

BT

BX 42 patents64 cases

3 patents6 cases

5 patents11 cases

2 patents7 cases

53 patents106 cases

101 patents275 cases

4 patents6 cases

7 patents10 cases

21 patents21 cases

9 patents39 cases

538 patents1,145 cases

32 patents85 cases

1,276 patents1,694 cases

• AA Products in conventional dosage forms not presenting bioequivalence problems• AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements• AN Solutions and powders for aerosolization• AO Injectable oil solutions• AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions• AT Topical products• B* Drug products requiring further FDA investigation and review to determine therapeutic equivalence• BT Topical products with bioequivalence issues• BX Drug products for which the data are insufficient to determine therapeutic equivalence


Figure 29: Top Ingredients (relationship between cases filed and number of patents asserted) in cases filed 2009-2017Q1

8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34# of patents asserted (>10)

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GLATIRAMER ACETATE

FENTANYL CITRATE

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EMTRICITABINE

EFAVIRENZ

DROSPIRENONE

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RITONAVIR RILPIVIRINE HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE


NAPROXEN




ETHINYL ESTRADIOL

EMTRICITABINE

ELVITEGRAVIR

TESTOSTERONE

SODIUM OXYBATE


OXYMORPHONE HYDROCHLORIDE



LINAGLIPTIN

ILOPERIDONEICOSAPENT ETHYL


EVEROLIMUS

ETHINYL ESTRADIOL

ESTRADIOL

DEXLANSOPRAZOLE


COBICISTAT


BUDESONIDE

ARIPIPRAZOLE



Figure 30: Top Ingredients (relationship between cases filed and number of patents asserted) in cases filed 2015-2017Q1

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Figure 31: Drug substance and product flags, by patent assertions 2009-2017Q1

Both No flags Product flag only Substance flag only0

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210 patents710 cases

77 patents434 cases

Figure 32: IPR petitions filed 2009-2017Q1 on Orange Book patents

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Figure 33: Time to key events in cases filed 2009 to 21017Q1

The timing of key events in a case often directly influence its cost. For lawyers who have to budget cases, whether at firms or in-house, having good information on how long it takes to reach these key events can be critical to an accurate budget.

Lex Machina helps users understand the timing of events, and this section shows a few of those events across all districts as an example. To better understand how to read these graphs, see the section on Understanding Boxplots at the end of this report.

The median time to the grant of a permanent injunction is 591 days (just over a year and a half), and is the least predictable of these events (as indicated by the wide box).

The time to claim construction is faster and is the most consistent of these events (as indicated by the smaller box), with a median time of only 453 days - about a year and a quarter.

Time from case filing to summary judgment is 662 days (about 1 year and 9 months) on median while time to trial is 761 days (just over 2 years) on median.

Lex Machina users can click the icon below to explore case timing for a particular district or judge, or for a different time-frame.

Subscribers can click to explore ANDA case timing on Lex Machina’s site!When viewing live analytics, please note that numbers may vary marginally from those captured in this report as a result of Lex Machina’s ongoing data quality improvement efforts.

https://law.lexmachina.com/cases/?status=all&case_types-include=27&case_tags-include=92&filed_on-from=2009-01-01&filed_on-to=2017-03-31&filters=true&tab=timing&view=analytics&cols=475&bplots_caselist_on=permanent_injunction*markman_hearing*summary_judgment*trial_date&bplot_caselist_controls=1


0 2 4 6 8 10 12 14 16 18 20 22 24 26# of ANDA cases

TemporaryRestrainingOrder

ConsentJudgment

Judicial

PreliminaryInjunction

ConsentJudgment

Judicial

79.2%19 case(s)

25.0%6 case(s)

100.0%1 case(s)

52.6%10 case(s)

52.6%10 case(s)

100.0%9 case(s)

Order StatusDeniedGranted

Figure 34: Injunction grant rate and timing, injunctions decided 2009-2017Q1 (in cases filed 2005-2017Q1)

In ANDA cases, injunctions are often the most important remedy, so grant rates matter. On seeking a temporary restraining order, only 25% of motions are granted. However, on preliminary injunction the grant rate rises to more than 50%.


Damages

Very few ANDA cases reach damages. In cases filed since 2000, only six cases have reached compensatory damages. Three were jury verdicts, one a summary judgment, one a consent judgment, and the last a mixture of consent and a bench trial. Damages theories include both lost profits and reasonable royalty. Of the three awards based on a reasonable royalty, one jury trial was based on a 25% rate, a second jury trial was based on a 35% rate, and the bench trial was based on a 50% rate.

Brigham and Women’s Hospital, Inc. et al v. Perrigo Company et al 1:13-cv-11640-RWZ | filed 2013-07-09 | D.Mass. Jury verdict $10,210,071.00 in reasonable royalty for patent 5,229,137 Reasonable royalty based on 35% rate in jury verdict Case is still open and currently in post-trial briefing

Meda Pharmaceuticals Inc. v. Perrigo Israel Pharmaceutical Ltd. et al 3:14-cv-01241 | filed 2014-02-25 | District of New Jersey Consent judgment that did not disclose damages amount.

Sanofi-Aventis Deutschland GmbH. et al v. Glenmark Pharmaceuticals Inc., USA, et al 2:07-cv-05855 | filed 2007-12-07 | District of New Jersey Jury verdict: $15.2m of lost profits for patent 5,721,244 $0.8m for price erosion Judgment affirmed on appeal

Sunovion Pharmaceuticals v. Dey Pharma et al 1:06-cv-00113 | filed 2006-02-22 | District of Delaware Jury verdict $17m in lost profits and $1m in reasonable royalty for patents 5,547,994, 5,362,755, 6,083,993, 5,844,002, and 5,760,090. Reasonable royalty based on 25% rate in jury verdict.

Sanofi-Synthelabo, et al v. Apotex Inc., et al 1:02-cv-02255 | filed 2002-03-21 | S.D.N.Y. Infringement and enforceability were tried, but damages were limited by consent and determined by summary judgment after appeal Damages were 40-50% of sales by Apotex by pre-agreement

Astrazeneca AB, et al v. Apotex Corporation, et al 1:01-cv-09351 | filed 2001-10-25 | S.D.N.Y. Summary judgment: $76m of reasonable royalty on patents 4,853,230 and 4,786,505 Reasonably royalty based on 50% rate in bench trial Judgment affirmed on appeal


Using Boxplots to Understand Timing

Lex Machina’s analytics use a data visualization known as the boxplot to convey information about the timing of significant events in a case. Knowing how to interpret this data gives you an advantage when it comes to strategy, budgeting, and setting expectations, as well as in other decisions that involve case timing.

Consider a newly filed case: Regardless of whether you’re an outside counsel, say, trying to determine how large of a flat fee to charge or trying to make sure two trials don’t overlap, or an inside counsel estimating legal spend and evaluating a firm’s proposed budget, case timing matters. Knowing the lower and upper bounds of how long it may reasonably take the case to reach injunction can give both kinds of counsel a strategic advantage over opponents lacking such nuanced information. Moreover, knowing the best and worst case scenarios for timing, or exactly how likely it is that a case will be active in 6 months enables more far-sighted contingency planning.

A boxplot summarizes a series of data points to help you understand the shape, or distribution of the values in those points. The boxplot is drawn based on five numbers: the median, the upper and lower quartiles, and the whiskers for a distribution.

Paying attention to these key parts of the plot will help you quickly understand what you need to know. Although boxplots provide a wealth of information, the four observations below, in order from simplest onwards, are all one needs to easily grasp the significance of a boxplot.

Median: the middle dividing line of the box splits the data points evenly so that 50% fall to either side. It’s a form of average that gives a single number representation of what to reasonably expect.

Box bounds: the box encloses the middle-most 50% of the datapoints (from the 25th percentile to the 75th), with 25% of the datapoints falling outside to either side. This makes the box a good representation of the range one can reasonably expect.

Box compressed or elongated: a more compressed box means that more datapoints fall into a smaller range of time and therefore are more consistent; in contrast a longer box means that the datapoints are spread out over a wider time period and are therefore less predictable.

Whiskers: Whiskers are drawn to show the outside bounds of reasonable expectation, beyond which datapoints are considered outliers.1

1 By statistical convention, boxplots define outliers as points beyond more than 1.5 times the width of the box (sometimes called the “interquartile range”).

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