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  • Hatch-Waxman ANDA LitigationReport 2018

  • Hatch-Waxman ANDA Litigation Report 2018

    By Geneva Clark Legal Data Expert - IP, J.D., M.A.

    Published April 2018

    Executive Summary

    Lex Machina’s fourth Hatch-Waxman / ANDA Litigation Report delivers the latest trends and insights into FDA Paragraph IV pharmaceutical patent

    litigation revealed through the power of Legal Analytics. By taking a “big data” approach, our comprehensive analytics enables Law Firms, Outside

    and In-House Counsel, and Corporations alike to make data-informed risk assessments that serve business interests and directly influences the

    bottom line.

    From precise timing metrics that can improve legal budgeting to trends in the top law firms and product classifications, Legal Analytics provides

    data-driven, customized insights that supplement traditional research and accumulated experience. In today’s world, leveraging this data gives

    companies and firms a competitive edge -- companies can choose better counsel based on their performance, and counsel can improve their

    performance by accessing and applying data to their decisions in many areas, including motion practice, damages demands, and settlement


    This report examines the key axes of legal data and their interactions, drawing upon Lex Machina’s platform. It focuses exclusively on ANDA

    litigation in the federal U.S. District Courts and PTAB trials involving Orange Book patents.

    Key Trends and Highlights

    Filing Trends

    •ANDA District Court filings rebound in 2017 to 417 filings, from 324 filings in 2016. They do not rise to the level of the 475 filings seen in 2015.

    •During 2017, the District of Delaware reaches new heights in filings, exceeding 240 new cases, with a surge to more than 100 filings in the second


    Courts and Judges

    •The Districts of Delaware and New Jersey remain the top two Courts. Delaware sees a significant increase in filings in 2017, while New Jersey’s

    filings are essentially flat.

    •The face of the District of Delaware’s judicial bench that prioritizes patent matters is changing with the retirement of Judge Robinson during 2017.

    Law Firms and Highly Litigated Ingredients

    •Law firm Morris Nichols leads plaintiffs’ cases filed in 2016-2017, while Phillips, Goldman, McLaughlin & Hall leads in total cases representing the


    •Medicines leading in 2016-2017 filings include treatments for multiple sclerosis, anticoagulants, and anti-psychotics used by dementia patients.

    Findings, Case Resolutions and Damages

    •Most ANDA cases in District Court terminate in a consent judgment, stipulated dismissal, or plaintiff voluntary dismissal.

    •Of PTAB trials involving Orange Book patents terminating in 2016-2017, 15% of the trials ended with all challenged claims being ruled


    •The singular ANDA lawsuit award of damages in late 2016 remains the only damage award from 2016 through 2017, which is Brigham and

    Women's Hospital, Inc. et al v. Perrigo Company et al, with a reasonable royalty award of more than $10MM.

    This report presents the power and effectiveness that Legal Analytics brings to key aspects of the business and practice of ANDA litigation. The full

    potential of Legal Analytics is revealed when subscribers engage with the Lex Machina platform, tailoring their analysis to produce the tactical or

    strategic insights particular to their circumstance. When subscribers can adjust and update searches to integrate their priorities into the analyses,

    the results provide a competitive advantage in landing clients, winning cases, and closing deals by making data-driven decisions.

    Hatch-Waxman ANDA Litigation Report 2018 Page 1 of 28


  • Table of Contents

    ▪ Executive Summary .........................................................................................................................................................................................1▪ Table of Contents ............................................................................................................................................................................................2▪ Data and Methodology....................................................................................................................................................................................2▪ District Court & PTAB Filings............................................................................................................................................................................6▪ Timing, Courts, and Judges ..............................................................................................................................................................................9▪ Top Law Firms and Leading Parties ...............................................................................................................................................................17▪ Highly Litigated Ingredients ...........................................................................................................................................................................20▪ Findings, Resolutions, and Damages For ANDA District Court Cases ............................................................................................................21▪ PTAB Trial Outcomes .....................................................................................................................................................................................26▪ Understanding Boxplots ...............................................................................................................................................................................28

    Data and Methodology

    This report draws on data from Lex Machina’s proprietary litigation database. Our data starts with information available from PACER (an electronic

    public access service provided by the United States Federal Judiciary). Lex Machina then applies additional layers of intelligence to enhance the

    consistency and completeness of that data. In addition, key areas of Lex Machina’s data are either human-reviewed or hand-curated by a

    dedicated team of attorneys to further enhance the data.

    This report analyzes trends in ANDA patent litigation. To determine whether a case is an ANDA patent case, it is not sufficient to trust the Nature of

    Suit (NOS) codes entered in PACER. Lex Machina actively analyzes complaints to ensure that cases filed under mistaken NOS codes or a NOS code

    corresponding to a different type of suit are not missed. This same system also allows Lex Machina to filter out spurious cases that have no ANDA

    patent issue despite bearing such a NOS code.

    Lex Machina supplements and corrects the foundational data from PACER in a variety of ways, including:

    •Correcting errors ranging from simple spelling mistakes to complex data problems

    •Normalizing data on judges, parties, law firms, and attorneys

    •Extracting records of law firms and attorneys not found in the basic data

    •Tagging and categorizing cases

    •Annotating case resolutions, damages, and dispositive rulings

    Lex Machina’s ANDA data is focused on trial court proceedings before the U.S. District Courts and PTAB Board, and does not include appeals, or

    modifications of judgments on appeal, or state court cases.

    What is an ANDA case?

    A patent infringement lawsuit brought in response to an ANDA filing that contains a relevant paragraph IV certification, pursuant to the Hatch-

    Waxman Act.

    Within the Lex Machina lexicon, an ANDA case refers to a lawsuit brought under the Hatch-Waxman Act (also known as the Drug Price Competition

    and Patent Term Restoration Act). The purpose of the Hatch-Waxman Act is to balance the need for new medicines and generic, non-patent

    violating medicines with the interests of patent owners who have patented, FDA approved medicines that are still legitimately protected.

    As part of the ANDA itself, the applicant certifies that it has given notice to relevant patent owners about the new drug and it being part of the

    application process. The patent owner then has 45 days to bring a lawsuit to protect its rights, and stay potential ANDA approval for 30 months,

    maintaining exclusivity and exercising patent rights as appropriate under the law. ANDA cases are lawsuits brought under this umbrella.

    The patents for the medicines that may be involved in this litigation are in a list produced by the FDA that combines the medicine-related

    information and patent information, called the Approved Drug Products with Therapeutic Equivalence Determinations publication (the “Orange


    How Does Lex Machina Identify ANDA Cases From PACER and other Data Sources?

    Lex Machina actively analyzes complaints to ensure that cases filed under the following NOS codes are appropriately included in the dataset.

    Hatch-Waxman ANDA Litigation Report 2018 Page 2 of 28


  • Lex Machina actively analyzes complaints filed under the following NOS codes to include within the dataset.

    Core PACER NOS codes for the ANDA Patent Case Type include:

    •830 Patent Cases

    •835 ANDA Patent Cases

    Note that the ANDA Case Type does not include:

    • Cases solely alleging patent infringement without an FDA paragraph IV claim or count

    • Contract disputes related to patent or FDA filings that do not include patent infringement

    • Cases related to ANDA disputes where claims lack an ANDA litigation dispute, and instead are about other issues such as licensing, patent misuse,

    patent ownership, or insurance.

    What is Lex Machina’s Orange Book Coverage?

    Lex Machina displays Orange Book data directly from the United States Food and Drug Administration's (FDA) website, and is updated on a

    monthly basis. This includes patents published in the Orange Book from March 2014 onward. Unlike the FDA approach to the Orange Book, Lex

    Machina does not remove patents that are no longer in updated versions of the FDA’s Orange Book. As a result, Lex Machina’s ANDA analytics

    include cases referencing some patents that are not currently in the FDA’s Orange Book.

    Lex Machina’s Data

    Lex Machina maintains a specialized database containing information about litigation in U.S. District Courts, the Delaware Court of Chancery, the

    U.S. Patent and Trademark Office’s Patent Trial and Appeal Board, and the U.S. International Trade Commission. 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, including FDA’s Orange

    Book data (found at the http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm).

    What is the Patent Trial and Appeal Board?

    The Patent Trial and Appeal Board (PTAB) is an administrative law body created by the America Invents Act, to review issues of patentability. There

    are two main branches of the Board: the Appeal Division and the Trial Division.

    The Trial Division reviews patents through four pathways including: inter partes review, post grant review, covered business method review, and

    derivation reviews. In each trial, a petitioner challenges the validity of the patent by filing a petition with supporting arguments and

    documentation, arguing that some or all the claims in a patent are invalid.

    Each pathway has several stages, including the initial petition, a patent owner’s response, and whether the Board agrees or denies to institute the

    petition for review. If the Board agrees that even one claim could be considered invalid, a trial is instituted, allowing further opportunities for

    written and oral argument. Thereafter, the Board will give its final decision.

    Throughout this process, the two parties may settle the matter, the patent owner may disclaim some or all the patent claims, or some or all the

    petitioned arguments may be dismissed on procedural grounds by the Board.

    Case Tags

    Case Tags are added to cases to identify aspects searching and faceting.

    What Case Tags Are Associated with ANDA Cases in District Court?


    A patent infringement lawsuit filed in response to a Paragraph IV Certification filing in an ANDA, or a paper NDA that includes a Paragraph IV

    Certification (incentivized by the Hatch-Waxman Act's first to file exclusivity provisions for prospective generic drug makers).

    Claim Construction Hearing

    A claim construction hearing, or “Markman” hearing, is a pretrial hearing in patent litigation where the judge evaluates the disputed meanings of

    words or phrases contained in the patent’s claims.

    Hatch-Waxman ANDA Litigation Report 2018 Page 3 of 28


  • What Findings and Remedies are annotated for ANDA patent litigation cases?



    • An action that violates a patent owner's right to exclude others from practicing the patented technology, which is enforced by federal law under

    the U.S. Constitution.


    • A defense against a claim of patent infringement, asserting that the patent claims do not meet patentability requirements, and should not have

    been issued. Since the finding applies when any claim of a patent is found invalid, it is possible that the same patent may have multiple findings of

    invalidity that reflect different claims.


    • A defense against a claim of patent infringement, asserting that the patent is not enforceable to due to inequitable conduct, laches, or patent



    Permanent Injunction

    • A permanent injunction order requires a party to do or refrain from a particular act.

    Preliminary Injunction

    • An injunction granted for some portion of the duration of a case.

    Temporary Restraining Order

    • An early-stage injunction for a short amount of time. These typically dissolve in one to two weeks' time unless a hearing for Preliminary

    Injunction occurs and additional injunctive relief is granted.

    What is a Claimant Win vs a Claim Defendant Win?

    At the close of a case, the claimant or claim defendant may be categorized as winning the case. This assessment comes from summarizing all the

    damages, remedies, and findings in the case together, and evaluating which party got the better outcome overall.

    Some examples of pertinent information include

    • Rulings in the claimant’s favor include infringement, no invalidity and no patent unenforceability

    • Rulings in claim defendant’s favor include non-infringement, patent invalidity, and patent unenforceability.

    What is a PTAB Trial at Lex Machina?

    The PTAB trials currently referenced in and analyzed through the Lex Machina database include all the trials that come from petitions for review of

    patents to the Trial Division of PTAB.

    What is Annotated within the PTAB Trials Process?

    PTAB Board filings are unusual in that the entirety of Court filings at the Trial level are available online. Lex Machina draws documentation from

    the USPTO’s publicly available material, including supporting exhibits, and derives data from decision points throughout the court process at the

    claims level. Documentation relating to parties and Counsel is also reviewed and annotated to provide high quality information about the entire

    review and consideration of each claim that the Board reviews.

    What is Annotated From PTAB Trial Filings?

    At PTAB, the petition, patent owner response, institution decision, joinder decision (if applicable), and final decisions, along with any settlement or

    procedural decision filings, are reviewed and annotated to provide a complete pathway for each claim:


    • The filing that initiates the process, a petitioner requests a review of one or more claims of a patent with a supporting argument that the claim or

    claims are invalid on substantive grounds.

    Hatch-Waxman ANDA Litigation Report 2018 Page 4 of 28

  • Patent Owner Response

    •Patent Owner’s response countering arguments presented by petitioner, also at times responding to petitioner’s argument(s) by disclaiming one

    or more claims.

    Patent Owner Disclaimed

    • The claim was disclaimed by the patent owner, rendering the claim invalid.

    Institution Decision

    • Judges’ decision regarding the arguments of petitioner and patent owner as to whether to review the patent, and which, if any, claims should be

    reviewed on which grounds. Possible rulings at institution decision include:

    Institution Decision, Granted (instituted)

    • When the Judges agree that at least one claim should be reviewed as to whether or not it is a valid claim, the claim or claims have been

    “instituted” for further review.

    Institution Decision, Denied (denied institution)

    • When the Judges decide on a substantive basis that a given claim should not be reviewed, that claim has been denied institution. If no claims

    move forward to further review, the PTAB trial terminates.

    Procedurally Dismissed:

    • When the court declines to institute all claims strictly for procedural reasons, the case terminates with a procedural dismissal.

    Joined to Other Trial

    • This trial has been instituted and joined to another trial.

    Final Decision

    • The Court fully reviews the arguments that were instituted regarding each claim and rules whether the claims are patentable in view of the

    arguments. In addition, amendments may be considered to substitute for the claims, although this is rarely argued, and even more rarely granted.

    Possible rulings at final decision include:

    All Claims Upheld:

    • All remaining claims were upheld as not unpatentable.

    Mixed Claim Findings:

    • There was a mix of results. Some claims were upheld as not unpatentable, or found unpatentable, or amended.

    All Claims Unpatentable:

    • All remaining claims were found unpatentable.

    Amended Claims:

    •All claims remaining were amended.


    • This trial ended due to a settlement of all remaining claims.

    Procedural Dismissal

    • This trial ended due to a procedural dismissal of all remaining claims.

    Hatch-Waxman ANDA Litigation Report 2018 Page 5 of 28

  • District Court & PTAB Filings

    2017 filing trends for ANDA cases differ from non-ANDA patent cases. ANDA case filings drop in 2016 but increase in 2017. By contrast, non-ANDA

    patent case filings decline in 2016 and also decline in 2017.

    In 2016 and 2017, the District of Delaware has the most ANDA cases filed among the district courts, followed by the District of New Jersey in

    second. These two leaders in filing are distantly followed by the District of Eastern Virginia. Case filings in Delaware in 2017 are a record number of

    cases, which surpasses its previous top year, 2014.

    Orange Book PTAB filings peak in 2015, followed by a drop in filings in 2016 and a flat level of filings in 2017. As expected, Orange Book PTAB filings

    continue to be dominated by USPTO Technology Sector 1600: Biotechnology and Organic Chemistry.

    Figure 1: ANDA District Court Patent Cases Filed Per Year, 2009 to 2017








    2009 2010 2011 2012 2013 2014 2015 2016 2017

    ANDA 260 293 296 237 266 437 475 324 417

    Figure 2: Non-ANDA District Court Patent Cases Filed Per Year, 2009 to 2017






    2009 2010 2011 2012 2013 2014 2015 2016 2017

    Patent 2313 2497 3300 5236 5864 4655 5350 4202 3633

    Orange Book Patent PTAB Petitions Filed Per Year, September 16, 2012 to 2017

    Hatch-Waxman ANDA Litigation Report 2018 Page 6 of 28


  • Figure 3: Trial Filings







  • Figure 7: Top Four Districts for ANDA Litigation by Cases Filed in 2016 and 2017








    2009 2010 2011 2012 2013 2014 2015 2016 2017

    D.Del. 104 107 91 93 127 206 188 151 241

    D.N.J. 67 84 95 72 66 144 199 112 111

    E.D.Va. 1 1 0 0 1 3 2 17 2

    S.D.Ind. 8 9 2 3 5 11 6 9 9

    Hatch-Waxman ANDA Litigation Report 2018 Page 8 of 28


  • Timing, Courts, and Judges

    Harnessing timing data is one of the optimal uses of Legal Analytics. Knowing how long a case is likely to last makes for better planning and

    decision-making: clients can know what to expect in their bills, lawyers can plan their schedules with greater confidence, and budgets can

    accurately account for the costs. Lex Machina’s legal analytics present timing to various key events in ANDA cases and PTAB trials. The median

    (shown above each bar in the middle, and at the left) is the middle-most value.

    Litigants on both sides are able to make better business decisions by understanding the timing of achieving favorable outcomes, such as injunctive

    remedies. Disputes over the legal right to sell a given medicine impacts the bottom line on a daily basis. In the 843 ANDA cases that terminated in

    2016 and 2017, 184 cases reached Permanent Injunction with a median time frame of 638 days from the date of filing, or approximately 1.75

    years. By contrast, in ANDA cases, preliminary injunctions and temporary restraining orders are rarely sought and rarely received.

    On the Lex Machina site, subscribers can combine various filters (for case filing or termination, case type, party or law firm involvement, and much

    more) and view the timing data specific to those cases. This level of control can provide new insights. For example, Lex Machina subscribers can

    compare the relative speediness of two law firms, or determine the likelihood of being in litigation a year from when a patent case is filed in a

    particular Court. In this report, we will use the Courts & Judge Comparator App to assess legal analytics for ANDA cases filed 2009 through 2017.

    Time to trial takes longer in the District of New Jersey (795 days) than the District of Delaware (731 days). Time to termination is overall faster,

    however, in the New Jersey (271 days) than in the Delaware (486 days). Cases in both the Eastern District of Virginia and the Southern District of

    Indiana terminate even more quickly (161 days and 193 days respectively) but have too few trials to glean a trend.

    ANDA cases in New Jersey more often resolve with Claimant Wins (23%) than in Delaware (16%) but the District of Delaware has proportionally

    more terminated cases that reach trial (12%) than New Jersey (7%).

    Many factors may contribute to the pace at which a case moves through the entire court process. Claim construction hearings are often an

    important milestone in ANDA cases. Having legal analytics for how a judge works with their caseload is highly informative, and practical for making

    business decisions. In Comparator App for Four District of Delaware Judges in ANDA Cases Filed 2009 through 2017, four judges’ cases can be

    directly compared to assess timing trends. Here, one can see the power of Lex Machina’s Judge Comparator by examining ANDA cases filed in 2009

    through 2017. Judge Andrews takes the least time (437 days) to reach a claim construction hearing, Judge Sleet take the most time (480 days), and

    Judge Stark and Judge Robinson fall in between (448 and 451 days, respectively).

    Judge Robinson is the quickest to trial (656 days) and Judge Stark has the longest median time to trial (772 days). Judge Robinson has, however,

    the greatest variation (half of the trials occur within 388 and 725 days) whereas Judge Andrews has less variation (652 and 799 days).

    The four judges have overlapping boxes in the boxplot, which indicates that median and upper and lower quartiles (taken together, half their

    respective cases) are similar. Judge Robinson’s upper quartile is, however, only 734 days whereas Judge Stark’s is 907 days. This quicker time to

    resolution for Judge Robinson could be in part because only 18% of Robinson’s cases terminate on a judgment (Claimant or Claim Defendant Win),

    which is less than Stark (29%); if more of Robinson’s cases terminate on settlement or procedural rulings then the time to resolution may be


    PTAB trial time frames are determined by a statutory maximum, but the ability to assess what the Board’s actual time frames for action are, and to

    what extent the Board has worked to the edge of the statutory time frame, is revealed through Lex Machina’s legal analytics. For the 236 Orange

    Book patents involved in 246 ANDA PTAB trials that terminated in 2016 and 2017, the median time from the filing date of a Petition to the Decision

    on Institution is just over 6 months at 187 days. The median time to reach a Final Decision is 552 days among 70 trials. The median time to any

    terminating event, however, is 194 days among 246 trials. By incorporating even more information about specific judges and relevant patent types

    known to counsel, effective, well-informed business decisions related to PTAB litigation can be made.

    See the section entitled “Understanding Boxplots” at the end of this report to get more from these charts.

    Hatch-Waxman ANDA Litigation Report 2018 Page 9 of 28

  • Figure 8: Time to Key Events in ANDA Cases Terminating 2016 to 2017

    0 days 3 years 6 years

    Temporary Restraining Order (Deny)11 Cases reached Temporary Restraining Order (Deny)Median: 209 days






    Permanent Injunction (Grant)184 Cases reached Permanent Injunction (Grant)Median: 638 days






    Claim Construction Hearing150 Cases reached Claim Construction HearingMedian: 468 days






    Summary Judgment54 Cases reached Summary JudgmentMedian: 640 days






    Trial98 Cases reached TrialMedian: 759 days






    Termination842 Terminated CasesMedian: 435 days






    0 days 3 years 6 years


    Cases Reaching

    Event Median Time from Case Filing to Event

    Preliminary Injunction (Grant) 3 n/a

    Preliminary Injunction (Deny) 5 n/a

    Dismiss (Contested) 80 222 days

    Hatch-Waxman ANDA Litigation Report 2018 Page 10 of 28

  • Comparator App for Top District Courts in ANDA Litigation

    Figure 9: Time To Trial

    0 days 1 year 2 years 3 years 4 years 5 years

    D.Del.125 Cases reached TrialMedian: 731 days






    D.N.J.61 Cases reached TrialMedian: 795 days






    E.D.Va.1 Case reached Trial

    S.D.Ind.3 Cases reached Trial

    Figure 10: Time to Termination

    0 days 1 year 2 years 3 years 4 years 5 years

    D.Del.1062 Terminated CasesMedian: 484 days






    D.N.J.839 Terminated CasesMedian: 271 days






    E.D.Va.27 Terminated CasesMedian: 161 days






    S.D.Ind.56 Terminated CasesMedian: 193 days






    Hatch-Waxman ANDA Litigation Report 2018 Page 11 of 28

  • Comparator App for Four District of Delaware Judges in ANDA Cases Filed 2009 through 2017

    Figure 11: Case Fillings for Patent Cases with ANDA Case Tag








    2009 2010 2011 2012 2013 2014 2015 2016 2017

    Leonard Philip Stark 16 20 18 22 30 46 44 40 91

    Gregory Moneta Sleet 35 26 24 17 44 58 64 63 65

    Richard Gibson Andrews 8 9 16 13 25 72 56 27 51

    Sue Lewis Robinson 26 27 29 41 32 42 38 38 2

    Hatch-Waxman ANDA Litigation Report 2018 Page 12 of 28


  • Figure 12: Time To Claim Construction Hearing for Patent Cases with ANDA Case Tag

    0 days 1 year 2 years 3 years

    Judge Stark (D.Del.)53 Cases reached Claim Construction HearingMedian: 444 days






    Judge Sleet (D.Del.)53 Cases reached Claim Construction HearingMedian: 480 days






    Judge Andrews (D.Del.)54 Cases reached Claim Construction HearingMedian: 437 days






    Judge Robinson (D.Del.)30 Cases reached Claim Construction HearingMedian: 451 days






    Hatch-Waxman ANDA Litigation Report 2018 Page 13 of 28

  • Figure 13: Time To Trial for Patent Cases with ANDA Case Tag

    0 days 1 year 2 years 3 years

    Judge Stark (D.Del.)24 Cases reached TrialMedian: 772 days






    Judge Sleet (D.Del.)35 Cases reached TrialMedian: 761 days






    Judge Andrews (D.Del.)43 Cases reached TrialMedian: 713 days






    Judge Robinson (D.Del.)29 Cases reached TrialMedian: 656 days






    Hatch-Waxman ANDA Litigation Report 2018 Page 14 of 28

  • Figure 14: Time To Termination for Patent Cases with ANDA Case Tag

    0 days 2 years 4 years 6 years

    Judge Stark (D.Del.)235 Terminated CasesMedian: 463 days






    Judge Sleet (D.Del.)324 Terminated CasesMedian: 567 days






    Judge Andrews (D.Del.)231 Terminated CasesMedian: 487 days






    Judge Robinson (D.Del.)241 Terminated CasesMedian: 497 days






    Figure 15: Case Resolutions for Patent Cases with ANDA Case Tag

    Stark (D.Del.) Sleet (D.Del.) Andrews (D.Del.) Robinson (D.Del.)

    Cases with Claimant Win Resolutions 55 (23%) 51 (16%) 40 (17%) 35 (15%)

    Cases with Claim Defendant Win


    11 (5%) 18 (6%) 13 (6%) 7 (3%)

    Cases with Likely Settlement


    129 (55%) 167 (51%) 133 (57%) 165 (68%)

    Cases with Procedural Resolutions 40 (17%) 89 (27%) 46 (20%) 34 (14%)

    Total Cases with Resolutions 235 (100%) 325 (100%) 231 (100%) 241 (100%)

    Hatch-Waxman ANDA Litigation Report 2018 Page 15 of 28


  • Figure 16: Orange Book Patent PTAB Timing for Trials Terminating in 2016 and 2017

    0 days 1 year 2 years

    Institution Decision199 Trials reached Institution DecisionMedian: 187 days






    Final Decision70 Trials reached Final DecisionMedian: 552 days






    Termination246 Trials reached TerminationMedian: 194 days






    0 days 1 year 2 years

    Hatch-Waxman ANDA Litigation Report 2018 Page 16 of 28

  • Top Law Firms and Leading Parties

    Morris, Nichols, Arsht & Tunnell is the top law firm representing plaintiffs in ANDA district court litigation for cases filed in 2016 and 2017 followed

    by Finnegan and McCarter & English. Phillips, Goldman, McLaughlin & Hall is the top firm representing defendants followed by Winston & Strawn

    and Shaw Keller.

    A small number of firms are leading counsel for ANDA filings in both PTAB trials and district court litigation. This group includes Winston & Strawn,

    Goodwin Procter, and Fitzpatrick Cella.

    Other firms specialize in PTAB ANDA trial representation: Wilson Sonsini and Carlson Caspers are among top firms representing PTAB Petitioners,

    and Williams & Connolly is a top firm for PTAB Patent Owners, although none of these firms are among the top 25 for ANDA case filings in district

    court during 2016 and 2017.

    Top Plaintiff parties in ANDA litigation include pharmaceutical companies known for producing brand name products, such as Pfizer, Eli Lilly and

    Sanofi-Aventis. Top Defendant parties include two entities of a leading generics provider, Teva, along with Apotex and Aurobindo Pharma. The

    various branches of Teva are leading litigants on both the plaintiff and defendant lists, making it a leading participant in ANDA litigation overall.

    Most leading defendants specialize in generic product development. Only a few, like Pfizer and Shire, lead in biopharmaceutical drug development

    along with generic or biosimilar drug development.

    Figure 17: Top Firms for Orange Book Patent PTAB Trials Filed in 2016 and 2017

    Top Law Firms Representing Petitioners

    Wilson Sonsini Goodrich & Rosati

    Alston & Bird

    Carlson, Caspers, Vandenburgh, Lindquist & Schuman

    Goodwin Procter

    Winston & Strawn

    Top Law Firms Representing Patent Owners

    Fish & Richardson

    Finnegan, Henderson, Farabow, Garrett & Dunner

    Williams & Connolly

    Fitzpatrick, Cella, Harper & Scinto

    Eli Lilly & Company

    Hatch-Waxman ANDA Litigation Report 2018 Page 17 of 28

  • Figure 18: Top Plaintiffs Firms by ANDA Cases Filed in 2016 and 2017

    Law Firm Plaintiff

    Morris, Nichols, Arsht & Tunnell 218

    Finnegan, Henderson, Farabow, Garrett & Dunner 134

    McCarter & English 81

    Saul Ewing Arnstein & Lehr 65

    Fitzpatrick, Cella, Harper & Scinto 59

    WilmerHale 49

    Quinn Emanuel Urquhart & Sullivan 48

    Covington & Burling 41

    O'Melveny & Myers 39

    Williams & Connolly 38

    Paul Hastings 37

    Farnan 36

    Ashby & Geddes 33

    Walsh Pizzi O'Reilly Falanga 30

    Gibbons 29

    McDonnell Boehnen Hulbert & Berghoff 26

    Pepper Hamilton 25

    RatnerPrestia 23

    Jones Day 22

    Latham & Watkins 22

    Amgen 21

    Barnes & Thornburg 17

    Goodwin Procter 17

    Fish & Richardson 16

    Sidley Austin 16

    Green Griffith & Borg 16

    Arnold & Porter Kaye Scholer 16

    Womble Bond Dickinson 13

    Figure 19: Top Defense Firms by ANDA Cases Filed in 2016 and 2017

    Law Firm Defendant

    Phillips, Goldman, McLaughlin & Hall 87

    Winston & Strawn 66

    Shaw Keller 50

    Young Conaway Stargatt & Taylor 46

    Goodwin Procter 40

    Richards, Layton & Finger 37

    Morris James 35

    Heyman Enerio Gattuso & Hirzel 33

    Locke Lord 32

    Smith, Katzenstein, & Jenkins 31

    Taft Stettinius & Hollister 30

    Budd Larner 29

    Axinn, Veltrop & Harkrider 25

    Schiff Hardin 24

    Alston & Bird 21

    Walsh Pizzi O'Reilly Falanga 21

    Polsinelli 20

    Sterne, Kessler, Goldstein & Fox 20

    Rakoczy Molino Mazzochi Siwik 19

    Withers Bergman 18

    Knobbe Martens Olson & Bear 18

    Cozen O'Connor 17

    Stamoulis & Weinblatt 17

    Duane Morris 16

    Wilson Sonsini Goodrich & Rosati 16

    Shank & Moore 15

    Hill Wallack 15

    Carlson, Caspers, Vandenburgh, Lindquist & Schuman 15

    Hatch-Waxman ANDA Litigation Report 2018 Page 18 of 28


  • Figure 20: Top Plaintiffs in ANDA Cases Filed in 2016 and 2017

    Party Cases as Plaintiff

    Eli Lilly & Co 42

    Pfizer, Inc 42

    Sanofi-Aventis U.S. LLC 35

    Allergan, Inc. 32

    Bristol-Myers Squibb Company 32

    Biogen MA Inc. 31

    Genzyme Corporation 28

    Janssen Pharmaceuticals, Inc. 27

    Sanofi S.A. 25

    Biogen International GmbH 24

    Astrazeneca AB 23

    Amgen Inc. 22

    Forest Laboratories Holdings Ltd. 22

    Aventisub LLC 21

    Forest Laboratories, LLC 21

    ICOS Corporation 21

    Mitsubishi Tanabe Pharma Corp. 18

    Otsuka Pharmaceutical Co., Ltd. 18

    Purdue Pharma L.P. 18

    Astrazeneca, UK Limited 17

    Astrazeneca Pharmaceuticals LP 16

    Janssen Pharmaceutica 16

    Janssen Research amp; Development LLC 16

    Onyx Therapeutics, Inc. 16

    Bayer Intellectual Property GMBH 14

    Wyeth LLC 14

    Figure 21: Top Defendants in ANDA Cases Filed in 2016 and 2017

    Party Cases as Defendant

    Teva Pharmaceuticals USA, Inc. 73

    Mylan Pharmaceuticals, Inc. 46

    Teva Pharmaceutical Industries Ltd. 45

    Apotex Inc. 44

    Aurobindo Pharma USA Inc. 40

    Zydus Pharmaceuticals (USA) Inc. 36

    Dr. Reddy's Laboratories, Ltd. 35

    Dr. Reddy's Laboratories, Inc. 34

    Sandoz, Inc. 32

    Amneal Pharmaceuticals LLC 29

    Lupin Ltd. 29

    Aurobindo Pharma Ltd. 28

    Mylan, Inc. 27

    Par Pharmaceutical Inc. 27

    Lupin Pharmaceuticals, Inc. 26

    Cadila Healthcare Ltd. 24

    Hetero Labs Limited 24

    Actavis Inc. 22

    Hetero USA Inc. 21

    Actavis Laboratories FL, Inc. 19

    Actavis Laboratories UT, Inc. 19

    Prinston Pharmaceutical Inc. 19

    Sun Pharmaceutical Industries, Inc. 19

    Breckenridge Pharmaceutical, Inc. 18

    Macleods Pharmaceuticals, Ltd. 18

    Sun Pharmaceutical Industries Ltd. 18

    Hatch-Waxman ANDA Litigation Report 2018 Page 19 of 28

  • Highly Litigated Ingredients

    A wide variety of medicines are involved in ANDA litigation at any given time. In 2016 and 2017 filings, the most litigated trade names are

    Tecfidera, a trade name for dimethyl fumarate used to treat multiple sclerosis; Eliquis, an anticoagulant used to reduce the risk of stroke during

    cardiac events; and Sensipar, a treatment to lower parathyroid hormone in people with renal disease.

    Figure 22: Top Orange Book Trade Names with Ingredients by District Court ANDA Cases Filed in 2016 and 2017

    Trade Name Ingredient ANDA Cases










    Hatch-Waxman ANDA Litigation Report 2018 Page 20 of 28

  • Findings, Resolutions, and Damages For ANDA District Court Cases

    Findings in ANDA cases include Infringement or No Infringement, Invalidity or No Invalidity, Unenforceability or No Unenforceability. In the 843

    cases that terminate in 2016 and 2017, most that reach a publicly recorded judgment do so through a Consent Judgment. There are 121 Consent

    Judgments of Infringement, 36 of No Infringement, 7 Consent Judgments of Invalidity and 77 of No Invalidity, and 71 Consent Judgments of No


    By contrast, there are 42 cases with Trial rulings of Infringement and 24 of No Infringement.

    Cases involving ANDAs differ in resolutions and findings from non-ANDA patent cases. ANDA patent cases have a lesser proportion of cases

    resolving in Stipulated Dismissal or Plaintiff Voluntary Dismissal and a greater proportion of cases resolving on judgments with a winner. Of the 843

    ANDA cases that terminate in 2016 and 2017, less than half (49%) resolve through a Stipulated Dismissal (39%) or Plaintiff Voluntary Dismissal

    (10%). Claimant Wins include Consent Judgment (18%) and Trial (6%), while Claim Defendant Wins include Consent Judgment (3%), Trial (2%), and

    Summary Judgment (1%).

    By contrast, of the 9,338 non-ANDA patent cases that terminate in 2016 and 2017, the majority (79%) resolve on either a Stipulated Dismissal

    (48%) or Plaintiff Voluntary Dismissal (31%). Only 7% of the cases resolve on either a Claimant Win (4%) or Claim Defendant Win (3%).

    Damages are rare in ANDA cases. Only one case that terminates in 2016 through 2017 results in patent damages, which is Brigham and Women's

    Hospital, Inc. et al v. Perrigo Company et al, with a reasonable royalty award of more than $10MM. There are also five cases with costs or

    attorneys’ fees awarded in them.

    Figure 23: ANDA Patent Findings by Judgment Event in Cases Terminating in 2016 and 2017


    Infringement 0 121 0 4 41 0 158

    No Infringement 0 36 2 9 23 1 68

    Invalidity 0 7 1 6 17 0 30

    No Invalidity 0 77 0 2 47 0 124

    Unenforceability 0 0 0 0 1 0 1

    No Unenforceability 0 71 0 1 1 0 73

    Default Judgment

    Consent Judgment

    Judgment on the Pleadings


    ary Judgment


    Judgment as a M

    atter of Law

    Any Judgment Event

    Hatch-Waxman ANDA Litigation Report 2018 Page 21 of 28


  • Figure 24: ANDA Patent Invalidity Reasons by Judgment Event Terminating in 2016 and 2017

    Invalidity Reasons

    101 Subject Matter 0 1 1 0 1 0 3

    102 Anticipation / Novelty 0 0 0 0 3 0 3

    102(f) Derivation (pre-AIA) 0 0 0 0 2 0 2

    102(g) Interference (pre-AIA) 0 0 0 0 0 0 0

    103 Obviousness 0 1 0 1 13 0 15

    112 Best Mode (pre-AIA) 0 0 0 0 0 0 0

    112 Definiteness 0 0 0 5 2 0 7

    112 Enablement 0 0 0 0 1 0 1

    112 Written Description 0 0 0 0 2 0 2

    133, 371 Application Abandonment 0 0 0 0 0 0 0

    171 Improper Design Patent 0 0 0 0 0 0 0

    132, 251, 255, 305 Defective Correction 0 0 0 0 0 0 0

    Obviousness-Type Double Patenting 0 0 0 0 1 0 1

    No Invalidity Reason Specified 0 5 0 0 0 0 5

    Figure 25: Non-ANDA Patent Cases Findings In Cases Terminating in 2016 and 2017


    Infringement 90 113 0 36 67 1 289

    No Infringement 4 75 17 205 59 5 325

    Invalidity 4 5 88 124 27 3 241

    No Invalidity 13 118 1 64 71 3 251

    Unenforceability 0 0 1 6 4 0 11

    No Unenforceability 13 99 0 24 13 3 152

    Default Judgment

    Consent Judgment

    Judgment on the Pleadings


    ary Judgment


    Judgment as a M

    atter of Law

    Any Judgment Event

    Default Judgment

    Consent Judgment

    Judgment on the Pleadings


    ary Judgment


    Judgment as a M

    atter of Law

    Any Judgment Event

    Hatch-Waxman ANDA Litigation Report 2018 Page 22 of 28

  • Figure 26: Non-ANDA Patent Invalidity Reasons by Judgment Event in 2016 and 2017

    Invalidity Reasons

    101 Subject Matter 1 0 85 36 0 1 121

    102 Anticipation / Novelty 1 1 1 29 17 1 47

    102(f) Derivation (pre-AIA) 0 0 0 1 1 0 2

    102(g) Interference (pre-AIA) 0 0 0 1 1 0 2

    103 Obviousness 1 0 1 13 16 2 33

    112 Best Mode (pre-AIA) 0 0 0 0 1 0 1

    112 Definiteness 0 3 1 42 1 0 45

    112 Enablement 0 0 0 8 1 0 9

    112 Written Description 0 0 1 5 1 0 7

    133, 371 Application Abandonment 0 0 0 0 0 0 0

    171 Improper Design Patent 1 0 1 2 0 0 4

    132, 251, 255, 305 Defective Correction 0 0 0 4 0 0 4

    Obviousness-Type Double Patenting 0 0 0 1 0 0 1

    No Invalidity Reason Specified 1 1 0 1 4 0 7

    Figure 27: ANDA Case Resolutions for Cases Terminating in 2016 and 2017

    Default Judgment

    Consent Judgment

    Judgment on the Pleadings


    ary Judgment


    Judgment as a M

    atter of Law

    Any Judgment Event

    Claimant Win 208 25%

    Default Judgment 0 0%

    Consent Judgment 154 18%

    Judgment on the Pleadings 0 0%

    Summary Judgment 4 0%

    Trial 50 6%

    Judgment as a Matter of Law 0 0%

    Decision on Bankruptcy Appeal 0 0%

    Claim Defendant Win 62 7%

    Default Judgment 0 0%

    Consent Judgment 26 3%

    Judgment on the Pleadings 3 0%

    Summary Judgment 12 1%

    Trial 20 2%

    Judgment as a Matter of Law 1 0%

    Decision on Bankruptcy Appeal 0 0%

    Likely Settlement 417 50%

    Plaintiff Voluntary Dismissal 85 10%

    Stipulated Dismissal 332 39%

    Procedural Resolution 155 18%

    Contested Dismissal 9 1%

    Dismissal 53 6%

    Consolidation 67 8%

    Severance 0 0%

    Interdistrict Transfer 9 1%

    Intradistrict Transfer 5 1%

    Stay 12 1%

    Multidistrict Litigation 0 0%

    No Case Resolution 0 0%

    Hatch-Waxman ANDA Litigation Report 2018 Page 23 of 28

  • Figure 28: Non-ANDA Patent Case Resolutions, Cases Terminating in 2016 and 2017

    Claimant Win 408 4%

    Default Judgment 86 1%

    Consent Judgment 209 2%

    Judgment on the Pleadings 0 0%

    Summary Judgment 36 0%

    Trial 76 1%

    Judgment as a Matter of Law 1 0%

    Decision on Bankruptcy Appeal 0 0%

    Claim Defendant Win 309 3%

    Default Judgment 7 0%

    Consent Judgment 45 0%

    Judgment on the Pleadings 90 1%

    Summary Judgment 136 1%

    Trial 28 0%

    Judgment as a Matter of Law 3 0%

    Decision on Bankruptcy Appeal 0 0%

    Likely Settlement 7,356 79%

    Plaintiff Voluntary Dismissal 2,890 31%

    Stipulated Dismissal 4,466 48%

    Procedural Resolution 1,264 14%

    Contested Dismissal 198 2%

    Dismissal 319 3%

    Consolidation 168 2%

    Severance 1 0%

    Interdistrict Transfer 374 4%

    Intradistrict Transfer 30 0%

    Stay 173 2%

    Multidistrict Litigation 1 0%

    No Case Resolution 0 0%

    Hatch-Waxman ANDA Litigation Report 2018 Page 24 of 28

  • Figure 29: ANDA Injunction Grant Rate, Cases Terminating in 2016 and 2017

    Permanent Injunction

    Judgment on Merits

    Deny: 0 (0%)Grant: 42 (100%)

    Default Judgment Consent Judgment Judgment on the Merits

    Grant 0 143 42

    Deny 0 0 0

    Total 0 143 42

    Preliminary Injunction

    Judgment on Merits

    Deny: 5 (62%)Grant: 3 (38%)

    Default Judgment Consent Judgment Judgment on the Merits

    Grant 0 0 3

    Deny 0 0 5

    Total 0 0 8

    Temporary Restraining Order

    Judgment on Merits

    Deny: 11 (100%)Grant: 0 (0%)

    Default Judgment Consent Judgment Judgment on the Merits

    Grant 0 0 0

    Deny 0 0 11

    Total 0 0 11

    Hatch-Waxman ANDA Litigation Report 2018 Page 25 of 28

  • PTAB Trial Outcomes

    From 2016 through 2017, 246 PTAB trials challenging 235 Orange Book patents are completed. In these cases, 151 result in a Patent Owner Win,

    (where all claims are Upheld, Amended, Denied Institution, Procedurally Dismissed or Settled), 1 results in a Partial Win with Mixed Claim Findings,

    and 42 result in a Petitioner Win, where all claims are found Unpatentable or Patent Owner Disclaimed. The remaining 52 trials are Joined to Other


    These results show 61% of PTAB trials with a patent owner win, 18% with a petitioner win, and the remaining 21% merged into other trials.

    During 2016 through 2017, the majority of grounds evaluated at institution decision in PTAB proceedings use an obviousness (§103) argument to

    challenge patentability. 307 grounds are Instituted on §103 and 201 grounds are Denied. By contrast, for anticipation (§102), 24 grounds are

    Instituted and 27 are Denied. §103 is the most successful basis for challenging validity before the PTAB with 74 grounds succeeding. Only four

    grounds based on §102 result in a final decision of Unpatentability.

    Figure 30: Orange Book Patent PTAB Trial Flow for Trials Terminating in 2016 and 2017

    Petitioner Win 42 17% Patent Owner Win 151 61% Partial 1 0%

    All %s out of 246 Petitioned trials

    Petition Institution Decision Final Decision

    Petition 246 100%

    Open Pre-Institution 0

    Procedurally Dismissed 24 10%

    Settled 23 9%

    Patent Owner Disclaimed 0

    Denied Institution 49 20%

    Instituted 150 61%

    Open Post-Institution 0

    Joined To Other Trial 52 21%

    Procedurally Dismissed 2 1%

    Settled 22 9%

    Patent Owner Disclaimed 4 2%

    All Claims Upheld 31 13%

    Mixed Claim Findings 1 0.4%

    All Claims Unpatentable 37 15%

    All Claims Amended 1 0.4%

    Hatch-Waxman ANDA Litigation Report 2018 Page 26 of 28

  • Figure 31: Orange Book Patent PTAB Resolutions for Trials Terminating in 2016 and 2017

    Figure 32: Orange Book Patent PTAB Grounds Breakdown for Trials Terminating in 2016 and 2017

    Statute Trials Grounds

    Institution Decision: Instituted

    § 101 0 0

    § 102 21 24

    § 103 149 307

    § 112 0 0

    Institution Decision: Denied Institution

    § 101 0 0

    § 102 23 27

    § 103 82 201

    § 112 2 2

    Final Decision: Unpatentable

    § 101 0 0

    § 102 3 4

    § 103 38 74

    § 112 0 0

    Final Decision: Upheld

    § 101 0 0

    § 102 0 0

    § 103 33 60

    § 112 0 0

    Petitioner Win 42 17%

    All Claims Unpatentable 37 15%

    All Claims Amended 1 0%

    Patent Owner Disclaimed (Pre-


    0 0%

    Patent Owner Disclaimed (Post-


    4 2%

    Patent Owner Win 151 61%

    All Claims Upheld 31 13%

    Denied Institution 49 20%

    Procedurally Dismissed (Pre-Institution) 24 10%

    Procedurally Dismissed (Post-Institution) 2 1%

    Settled (Pre-Institution) 23 9%

    Settled (Post-Institution) 22 9%

    Partial 1 0%

    Mixed Claim Findings 1 0%

    Joinder 52 21%

    Joined To Other Trial 52 21%

    No Trial Resolution 0 0%

    Hatch-Waxman ANDA Litigation Report 2018 Page 27 of 28

  • Understanding Boxplots

    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 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 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.

    Figure 33: 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.


    •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 are drawn to show the outside bounds of reasonable expectation, beyond which datapoints are considered outliers. By statistical

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

    Hatch-Waxman ANDA Litigation Report 2018 Page 28 of 28

    Hatch-Waxman ANDA Litigation Report 2018 (figure 8 final 2018-04-30)Hatch-Waxman ANDA Litigation Report 2018 (61)Hatch-Waxman ANDA Litigation Report 2018Executive SummaryKey Trends and HighlightsTable of ContentsData and MethodologyWhat is an ANDA case?How Does Lex Machina Identify ANDA Cases From PACER and other Data Sources?What is Lex Machina’s Orange Book Coverage?Lex Machina’s DataWhat is the Patent Trial and Appeal Board?Case TagsWhat Case Tags Are Associated with ANDA Cases in District Court?ANDAClaim Construction Hearing

    What Findings and Remedies are annotated for ANDA patent litigation cases?FindingsRemediesWhat is a Claimant Win vs a Claim Defendant Win?What is a PTAB Trial at Lex Machina?What is Annotated within the PTAB Trials Process?What is Annotated From PTAB Trial Filings?

    District Court & PTAB FilingsOrange Book Patent PTAB Petitions Filed Per Year, September 16, 2012 to 2017

    Timing, Courts, and JudgesComparator App for Top District Courts in ANDA LitigationComparator App for Four District of Delaware Judges in ANDA Cases Filed 2009 through 2017

    Top Law Firms and Leading PartiesHighly Litigated IngredientsFindings, Resolutions, and Damages For ANDA District Court CasesPermanent InjunctionJudgment on Merits

    Preliminary InjunctionJudgment on Merits

    Temporary Restraining OrderJudgment on Merits

    PTAB Trial Outcomes

    PetitionInstitution DecisionFinal DecisionUnderstanding Boxplots