As with our previous reports covering IPR, Patent Prosecution, Patent Litigation, CAFC, Trademark Prosecution, and ITC Intelligence, we have diligently incorporated feedback from the esteemed ANDA community. By carefully considering their insights, we have devised the most equitable and accurate methods for assessing the performance of companies, attorneys, law firms, and judges involved in ANDA cases.
Similar to our past reports, we constantly strive for improvement and listen to our valued community’s feedback. Our ranking methodologies and formulas are subject to continuous testing, surveys, and evolution with each new edition. In the upcoming section, we will provide a detailed explanation of the scoring rationale and methodology adopted for this particular report.
General Considerations
Assuming readers possess a basic understanding of the ANDA cases landscape, in its simplest form, ANDA litigation, governed by the Hatch-Waxman Act, arises when a generic drug manufacturer (referred to as “Generic”) submits a Paragraph IV certification in their ANDA application. This certification asserts that the relevant patents listed in the Brand’s Orange Book are either invalid or will not be infringed by the Generic’s proposed drug. Upon receiving notice of all Paragraph IV ANDA filings, the Brand has a 45-day window to file a lawsuit, which triggers a 30-month stay on the ANDA approval process. However, if no suit is filed within the stipulated 45 days, the Food and Drug Administration (FDA) may proceed to approve the ANDA through customary procedures.
During our analysis of the numerous PACER categorizations for ANDA cases concluded, it became apparent that practical and effective outcomes were relatively scarce. Few decisions or outcomes could be definitively classified as conveying tangible and evaluable benefits (i.e., “wins”) to either the Plaintiff (Brand) or Defendant (Generic), making it challenging to assign scores or points, as done in our previous reports.
Indeed, many of the PACER outcome classifications in our analysis primarily encompass technical closures or terminations, resulting from case consolidations, transfers, ongoing parallel litigation, or similar logistical and administrative reasons. Such terminations often fall under various PACER classifications, leading to potential overlap. For instance, our case-by-case examination and consultations with ANDA attorneys revealed that ANDA case terminations due to case consolidations or ongoing parallel litigation can be categorized under ‘Statistical Closing,’ ‘Dismissed – Voluntarily,’ and/or ‘Dismissed – Other’ in PACER. Other PACER categories, such as ‘Transfer/Remand – MDL Transfer,’ ‘Non-reportable closing,’ and ‘Dismissed – Settled,’ are self-explanatory and have been directly represented in Table 1.
As mentioned above in Section 1, the ANDA cases analyzed in this report are represented by 12 official PACER statuses which are then reclassified into 10 outcomes by providing the real conclusion of the judgment statuses whether the generic or brand side won, or they settled during trial (Table 1).
Table 1 – ANDA Outcomes and Scores Applied
| Outcome | Plaintiff | Defendant | Plain. Atty/Firm | Def. Atty/Firm | Judge |
| Judgment – Defendant Wins | 0 | 1 | 0 | 1 | 0 |
| Judgment – Plaintiff Wins | 1 | 0 | 1 | 0 | 1 |
| Judgment – Settled | 0.5 | 0.5 | 0.5 | 0.5 | – |
| Dismissed – Settled | 0.5 | 0.5 | 0.5 | 0.5 | – |
| Dismissed – Voluntarily | – | – | – | – | – |
| Dismissed – Other | – | – | – | – | – |
| Transfer/Remand – MDL Transfer | – | – | – | – | – |
| Statistical Closing | – | – | – | – | – |
| Non-reportable closing | – | – | – | – | – |
Table 1 Notes:
The analyzed cases are represented by 12 official PACER outcome classifications:
- Dismissed – Other
- Dismissed – Settled
- Dismissed – Voluntarily
- Statistical Closing
- Transfer/Remand – MDL Transfer
- Transfer/Remand – Transfer
- non-reportable closing
- Judgment – Judgment on Consent
- Judgment – Other
- Judgment – Court Trial
- Judgment – Motion Before Trial
- Judgment – Judgment on Default
Seven of these PACER classifications (numbers 1 through 7) are listed directly in the Table above. The three other outcomes in the Table reflect a case’s practical outcome, as drawn from a case-by-case analysis of all cases within the remaining five (numbers 8 through 12) PACER “Judgment” categories. Of all categories of case closures in Table 1, only four are scorable. Blank entries (dashes) in any columns/rows indicate the respective participant was not scored for that particular outcome.
The termination of cases falling under the four PACER “Judgment” categories (numbers 8 through 12 in the aforementioned list) required comprehensive analysis. To simplify and establish a scoring framework, these cases were effectively re-categorized into three groups based on their net outcome: ‘Judgment – Defendant Wins,’ ‘Judgment – Plaintiff Wins,’ and ‘Judgment – Settled’. To determine the scoring for each case, we posed a straightforward question: Does the judgment outcome of the case, whether through consent order or court trial, leave the Defendant (Generic) in a more favorable position than they would have been under the terms of the Hatch-Waxman Act (HWA) alone? If the answer was affirmative, we awarded 1 point to the Defendant (Generic). Conversely, if the outcome did not favor the Defendant, we assigned 1 point to the Plaintiff (Brand). This scoring system enabled us to objectively assess the cases and evaluate the performance of the involved attorneys and law firms for our report.
Consider the terms of a typical consent order, where no explicit settlement agreement, findings, or acknowledgments of invalidity or non-infringement are stated: A) The Generic is restrained from selling the current ANDA-relevant product until the expiration of the litigated patents, and B) The Generic is permitted to continue making or maintaining Paragraph IV certifications on the currently litigated product or any other product, without any restrictions or limitations on the FDA’s authority to approve such ANDAs, as expected. In certain instances, the consent order may include provisions requiring the Generic to amend their ANDA filing to Paragraph III.
According to our assessment and a majority of surveyed attorneys, in cases where the judgment terms did not provide any significant advantage to the Generic (nor any disadvantage to the Brand) beyond what the HWA already allows before the litigation, they were categorized as ‘Judgment – Plaintiff Wins.’ In such instances, 1 point was assigned to the Plaintiff (Brand) company, their respective attorneys and firms, and the presiding Judge (Table 1), as all these parties played a role in the final decision and outcome of the case. On the other hand, if the judgment, whether through consent order or court trial, resulted in a finding or acknowledgment of invalidity, non-infringement, or unenforceability, and/or allowed the Generic to market their drug before the expiration of the Brand’s patents in question, these outcomes were considered a “win” for the Defendant (Generic). Accordingly, 1 point was assigned to the Defendant, their respective attorneys and firms, and the Judge in the case.
Due to the confidential nature of Settlements and the limited information available in the docket material, we adopted a standardized approach for scoring cases involving explicitly mentioned Settlements. Whether the settlement was verbally acknowledged in the Consent Order or reflected in the PACER nomenclature (e.g., ‘Judgment – settled’ or ‘Dismissed – settled’ in Table 1), both the Brand and Generic were scored 50/50. While we acknowledge that Settlements may not always result in an equal benefit for both parties, the lack of detailed information compelled us to maintain a consistent and fair scoring system across all cases. As a result, settlements were treated as an “equal win” for both the Brand and Generic, as well as their respective attorneys and firms. Judges, however, were not scored on settlements since no formal case outcome was adjudicated in such instances.
In contrast to cases in the ITC Section 337 Investigations and other types of litigation, the majority of ANDA cases typically involved only one Plaintiff and one Defendant. In instances where multiple parties were involved, the outcomes often aligned for all parties on the same side, or the cases were administratively divided into separate individual cases. This streamlined approach enabled us to accurately and effectively score each party based on their specific involvement and role in the litigation.
Developing a scoring system for ANDA cases inevitably faces challenges due to the limitations in available case information, including the lack of insight into underlying legal strategies and confidential settlement terms. While it is impossible to completely overcome these inherent limitations, our aim in this and all our Intelligence Reports is to create a scoring methodology that can be consistently and fairly applied to all parties, considering the constraints of available information, time, and resources. We strived not to unfairly penalize or credit participants who may not have had a direct impact on a specific outcome, and to provide partial credit where relevant details or circumstances were ambiguous or unknown, allowing each participant the opportunity to achieve their highest possible score.
In summary, the scoring metrics used in this report were carefully designed to ensure fair and consistent application across all participants, including companies, attorneys, firms, and judges, given the available case information. The cases that could be viably scored fell into two categories: those with a rendered judgment or trial verdict (scored for all parties) and those that were settled (scored for all parties except Judges) (see Table 1). This approach allowed us to provide a comprehensive and well-rounded assessment of the ANDA cases while acknowledging and addressing the limitations inherent in the scoring process.
Activity Score
The number of cases that companies, and their representing attorneys/firms and judges, were involved in as plaintiffs (Brands), defendants (Generics), or both, comprised their Activity Scores, as follows:
The Activity Score, which reflects the number of ANDA cases, is determined by tallying the total count of cases in which the company, attorney, or firm is engaged. This includes instances where they act as a Plaintiff (Plaintiff Cases), a Defendant (Defendant Cases), or a combination of both, along with any other representations like counter claimant, among others (Overall Cases). Judges’ Activity score follows a similar methodology, encompassing all cases presided over, without distinguishing between Plaintiff and Defendant cases. By adopting this comprehensive approach, we ensure that all relevant involvements in ANDA cases are considered, providing a holistic view of each entity’s active participation in the litigation landscape.
Each participant in the study was assigned activity scores (“Cases” in the Tables) and ranks (“Activity Rank” in the Tables) based on the total number of ANDA cases they were involved in, filed between July 1, 2019, and June 30, 2024. Success and Performance scores (see below) were determined by analyzing the participants’ ANDA cases filed during the same period, which also had a listed decision status or outcome in PACER as of July 3, 2024.
Considering that the majority of the ANDA community agreed that recent cases provide a more accurate measure of activity, we have made a slight adjustment to the weight assigned to older cases. This adjustment allows for the possibility that an entity with 5 cases filed in 2024 could achieve a higher rank than an entity with an equal number of cases dispersed across the entire study period. Additionally, to address potential disparities between entities with above-average case numbers, we opted to compute the activity score using a logarithmic function. By doing so, the comparison between entities with varying levels of activity becomes more straightforward and equitable.
Success Score
Plaintiffs (Brands) and defendants (Generics) were scored for various ANDA outcomes, as described above and shown in Table 1.
The “Plaintiff Success” score is derived from the sum of all points (full points for wins, and half-points for settlements) for cases in which the entity acted as the Plaintiff (Brand). This score is then divided by the total number of scorable cases, multiplied by 100, and expressed as a percentage. The same calculation is applied to companies, attorneys, and firms. Similarly, the “Defendant Success” score is determined in the same manner but for cases in which the entity was the Defendant. The “Overall Success” score is a combination of Plaintiff and Defendant cases. All entities are then ranked based on their respective scores (“Success Rank” in the Tables).
Attorneys and law firms, being intimately involved in the cases on behalf of their clients, significantly impact the outcome of the cases. As a result, they were scored and ranked for Success in the same manner as their clients (Plaintiff/Brand or Defendant/Generic) for all scorable outcomes, including settlements.
Judges were evaluated and scored for all adjudicated case outcomes, which includes cases where they have a direct and adjudicatory role in determining the outcome. This means that all categories listed in Table 1, except settlements, were considered for judging. Judges were assigned a score of either 0 for Defendant wins or 1 for Plaintiff wins, indicating how often they ruled in favor of the Brand. A score closer to 1 implies that the judge ruled more frequently in favor of the Brand.
We have developed a concept called the “confidence interval,” inspired by the valuable input from the ANDA community. Recognizing that entities with a higher number of cases may find it challenging to win every case, we have adjusted the performance score to consider both the success and activity levels of entities. This ensures a fair evaluation that reflects the balance between the number of cases handled and the rate of successful outcomes.
In our effort to be inclusive and involve as many participants as possible, we have extended the calculation of the Success Score to all attorneys, law firms, or companies that were involved in at least one terminated case. This approach allows us to recognize and acknowledge the contributions of entities with a smaller number of cases, ensuring a comprehensive evaluation of their performance in the ANDA landscape.
Normalization Using Machine Learning
The outcome of an ANDA litigation case is influenced by a range of critical factors, including the actions and arguments presented by the involved parties, the presiding judge’s decisions, the specific ANDA products under scrutiny, the patents in question, and the expertise of the attorneys representing each side. Additionally, the testimony provided by expert witnesses and other pertinent elements contributes significantly to shaping the final result of the litigation.
In the context of ANDA litigation, accurately assessing the success of an individual, be it an attorney or an expert, becomes a complex task due to various intertwined factors that influence the case’s outcome. Evaluating an individual’s success independently within a single case is challenging as it is difficult to disentangle their impact from other contributing factors. However, leveraging the vast data from multiple cases, we harness the prowess of advanced computational methods and the finesse of machine learning algorithms to mathematically analyze how individuals performed under diverse conditions in various cases.
We have taken a rigorous approach to evaluating the Success Score to ensure fairness and accuracy in our analysis. To eliminate the influence of external factors, such as other entities’ success or judges, we have implemented a robust analytical model rooted in advanced machine learning techniques. This model allows us to isolate the performance of each entity, be it a company, attorney, or law firm, from any potential effects caused by the actions of other parties involved in the ANDA cases. By doing so, we can provide a more precise and unbiased assessment of individual success in the litigation landscape. Our scoring methodology is designed to offer a transparent and reliable representation of each participant’s performance without undue influence from external factors.
In practice, we utilize advanced analytical techniques, including sophisticated adjustments, to recalibrate the scores of all parties and their representatives in consideration of various influencing factors. Once we obtain the adjusted success for each participant in an investigation, we calculate the average success score for each party or their representatives by considering their performance across all the cases they were involved in. This advanced approach provides a more accurate and fair assessment of the success of individuals within the complex landscape of ANDA litigation.
Performance Score
The incorporation of this additional scoring metric addresses a key aspect sought by most clients when evaluating an attorney’s performance—both extensive experience (indicated by high activity/caseload in relevant cases) and a strong success rate. Recognizing that high case numbers can potentially dilute performance over time due to the law of averages, we have devised the “Performance Score” to overcome this limitation and ensure fair comparisons across firms and attorneys with varying caseloads. With the Performance Score, we can now comprehensively assess and rank companies, attorneys, and firms based on their combined Activity and Success, providing a more holistic and informative evaluation of the ANDA landscape.
In summary, it is essential to recognize that the scoring metrics presented here are not meant to be indicative of the overall quality, expertise, or impartiality of any firm, attorney, company, or judge. Similar to how even the most skilled doctors may face unfavorable outcomes, attorneys may encounter cases that result in losses, often due to factors beyond their control. Additionally, the nature of their professional responsibilities may lead them to handle challenging cases with potential risks. Therefore, we strongly advise clients to conduct their own due diligence, thorough analysis, and interviews when selecting a firm or attorney. Making informed decisions based on the unique requirements and needs of each individual case will ensure the best possible legal representation.
