Patexia is planning to release its 1st ANDA Litigation Intelligence Report in August. Similar to our other IP reports, we plan to measure the activity and performance of all the stakeholders including attorneys and law firms to rank them in the report.

We also plan to provide statistics about the cost, staffing and workload for ANDA cases in the report. 

To make this possible, we need your input to create the most relevant and useful report for the ANDA community.

The information you provide will ONLY be used statistically and in aggregate form, presented using charts or tables. You or your firm will not be quoted in relation to your answers. Furthermore, your information will not be shared with anyone outside our company.

Estimation of Cost and Workload 
The following questions will help us estimate the cost and workload for each side (brand and generic) in different stages of an ANDA case. 

We understand that the cost estimation is not simple and is a function of many factors including number of patents, number of defendants, strategy, complexity, etc. But to keep things simple, we assume that a typical ANDA case has 2 to 3 patents and involves 2 to 3 defendants. We understand that the cost is usually higher on the brand side. We divide the process into the following 5 phases: (1) Pre-filing, (2) Filing to Markman, (3) Markman to trial, (4) Trial and (5) Appeal (if  filed)

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* 1. Can you estimate the workload related to each of the following 4 phases as a percentage of total work for a typical ANDA case (the sum should be 100%)?

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* 2. Can you estimate the total attorney hours related to each of the following 4 phases?

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* 3. What is the estimated cost for a typical ANDA case (pre-filing through trial)?

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* 4. What is the estimated total number of hours spent by the group (all attorneys representing one party) for a typical ANDA case from pre-filing through trial (We understand that the workload is usually higher on the brand side)?

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* 5. What is the estimated cost of Experts?

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* 6. What is the estimated cost of Appeal (if filed)?

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* 7. What is the average hourly rate for your litigation associates?

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* 8. What is the average hourly rate for your ANDA partners?

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* 9. Additional comments on cost and workload:

Staffing
We understand that law firms allocate their resources differently. In terms of staffing, how many partners and associates are assigned to a typical ANDA case by your firm:

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* 10. For partners, if we are representing the plaintiff (brand), there is usually:

1 3 5
Clear
i We adjusted the number you entered based on the slider’s scale.

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* 11. For associates, if we are representing the plaintiff (brand), there is usually:

1 4 7
Clear
i We adjusted the number you entered based on the slider’s scale.

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* 12. For partners, if we are representing a defendant (generic), there is usually:

1 2 5
Clear
i We adjusted the number you entered based on the slider’s scale.

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* 13. For Associates, if we are representing a defendant (generic), there is usually:

1 4 7
Clear
i We adjusted the number you entered based on the slider’s scale.

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* 14. How would the staffing be affected on the brand side, if the number of defendants grows to 10 (how many more partners or associates are needed)?

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* 15. Additional comments on staffing:

Performance Measurement
The following questions will help us calculate the points for each side (brand or generic) under different circumstances. For performance measurement, we plan to only consider cases with the judgment as settled cases seem to be complicated and we do not have access to the settlement terms.

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* 16. In your view, are there any reasons why an ANDA case outcome whereby the generic agrees to change their ANDA to a Paragraph III application, should NOT be viewed as a 100% win for the brand?

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* 17. In your view, what is the fair method to allocate points for voluntary dismissal of an ANDA case (by the brand)?

Consider these terms of a quite typical consent order, in the absence of any expressly indicated “Settlement Agreement,” and in the absence of any expressly indicated findings or acknowledgments of validity/invalidity or infringement/non-infringement:
A) Generic is enjoined from selling the current ANDA-relevant product until expiration of the ANDA-litigated patents, and
B) Generic is not prohibited from making or maintaining Paragraph IV certifications on the currently litigated or any other product, and FDA’s authority to approve such ANDAs is (naturally) not restricted or limited.

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* 18. In your view, is there any reason such a consent order should NOT be viewed as a 100% win for the brand?

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* 19. Under these terms and presuming the absence of any other unknown settlement terms, it would seem the generic is, in effect, no better off than they were under the terms of the HWA alone, before the lawsuit was filed. Do you agree? If not, WHY do you disagree?

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* 20. We plan to remove attorneys who only acted as the local counsel. To do this, if we see multiple attorneys from several states, we only consider those attorneys who are NOT located in the same state as the case venue. Do you agree with our method?

Your Email and Final Feedback
Your responses will only be used in aggregate form and will not be shared with anybody outside of Patexia. Your email is only to avoid counting the responses multiple times and also to contact you if something is unclear.

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* 21. Your work Email address:

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* 22. Any additional comments (other challenges, suggestions, ...)

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