The Paragraph Four Report®
Frequently Asked Questions
Exactly what products are included in ParagraphFour.com?
Products include the universe of products that are currently under Paragraph IV Challenge (under 505(j) of the statute). We also include 505(b)(2) cases, DESI products, Biologics cases (filed after 2012 – the BPCIA cases), Inter Partes Reviews, and antibiotics drugs (though some are not technically filed under Paragraph IV.) Currently, there are over 800 products covered. The start date of the database is November 1, 2003 — so it includes every PIV case and product that was “active” on that date. By “active,” we mean the product had a PIV challenge, had a pending lawsuit, and was not available as a generic on November 1, 2003. We follow the case through completion (settlement, court of appeals, etc). Once a generic product enters the market after final termination of litigation in its favor (usually after appeal — or the litigation otherwise terminates), the product is removed from the list and sent to the “Old Cases” Section (so no product and its data/cases leaves the database.) The”Old Cases” Section includes products and cases closed after November 1, 2003.
How often is the information updated?
We check for new cases and products (and Court of Appeals opinions) 2-3 times per week. When adding new products and cases, the real time will depend on the court docket itself, and a new case can appear on the site as little as a day or two after a suit is filed but usually no later than every 1-2 weeks. As for updating the status of pending cases, it depends. If the Court is near a significant decision (such as after a Bench Trial or MSJ), then the docket is checked every other week; if the case is plodding along (discovery, for example), the docket is updated once a month. In addition, there is a Monthly Update of all activity.
In addition, note that we are not a newswire and do not have instant, up-to-the minute information on court decisions. There are technical reasons why we can’t. Typically, when a Court renders an important decision, often the parties and their attorneys will know before anyone else, and one (or both) of the companies involved will typically transmit a press release which a newswire service will pick up, making the information generally known. We are a research site, not a news bureau.
Are all of the court cases in ParagraphFour.com?
It is difficult to say with absolute certainty whether the research has captured every single case. Typically, if a case is missed, it is due to clerical error at the Clerk’s office. Occasionally, Clerks of the Court mis-categorize cases so they are not picked up in the search engines. Remember that these cases affect about 20 jurisdictions and span over fifteen years so there is a chance that a clerk out there has made an error. Sometimes, we may overlook a case as well. While we take effort to find these “missing” cases and have found about 10 such cases misfiled over the past fifteen years, there is a slight chance for error. As of December 2018, there are over 4,000 cases in the database, and we believe that they represent the universe of Paragraph IV cases. However, it would not surprise us if a case or two is floating out there that has not been captured.
What about situations where the brand does not sue the ANDA applicant?
About 15% of the time, a brand company will not file a suit against the generic. Typically, this occurs when the generic company has not certified against the molecule patent but has certified against others that the brand has chosen not to defend. For our purposes, after a product appears on the FDA PIV List, we wait about 3-4 months, and if we don’t see a suit on the product, we review the Orange Book to see if there is a logical reason why there is no suit. If there is, we will place it in the database and provide our opinion what the situation likely is and during monthly updating, see if tentative approvals have appeared. We state when we speculate. If the situation is not clear from the public data, we will not take a “wild guess” and will leave the product out of the database.
Do you offer downloads to all of the court documents and files?
No. As a courtesy to our subscribers, we have scanned the Complaints and/or Answers to each case. We also scan and included all court opinions and all Court of Appeals opinions. All of these documents are available for downloading at no additional cost. As of December 2018, we have over 11,500 document downloads. However, we are not a document retrieval service, and sometimes pleadings go missing from the clerk’s office or are sealed.
Does the site include Citizen Petitions or 'peripheral cases' such as those filed between generic companies over the 180-day exclusivity?
If a Citizen Petition has been filed on a PIV product after January 1, 2004, it is noted in the product topic and directs the subscriber to FDAPetitions.com. We make an attempt to find and include mention of “peripheral cases.” While we make attempts to direct the subscriber to all petitions and peripheral cases, these special notes may not be exhaustive.
Does the database include an in-depth analysis of the case itself and an opinion on which company might win the patent dispute?
No. While acknowledging that some case analysis can be helpful, but having actually tried cases in federal court, we firmly believe that cases are not something that can be accurately predicted. Moreover, the reality is that many court documents — the ones that would give a great deal of insight into a case — are typically “sealed” and not available for public view. We like to keep it to the facts and not speculate or evaluate on patent cases. We leave that up to our subscribers.
How is the data made available to subscribers?
ParagraphFour.com is available over the internet. Our goal is to have the site available every day, 24 hours a day. We have the site on a dedicated server, and the data is backed up daily. So, if there were ever a problem, an interruption of service might only be a few hours. Since launching in 2004, we have had about 20 hours of downtime, if that.
Can I get a free trial?
No. However, we demonstrate the site over the Internet. It takes about 20-30 minutes.
When I do a Search, I can't seem to find the product that I am looking for and that product is on the FDA List of Products with Paragraph IV Certifications. Where is it?
If the product you are searching for appears on the FDA List but you can’t find it here, there could be one of three reasons:
- Sometimes, a company won’t file a lawsuit for infringement so there is no reliable access to the information. We will wait for a PIV case to surface before adding it to the site. So, it might be a matter of time before it is added, or if no case is filed and we can’t verify through company or other reliable sources, we do not include it. We won’t speculate on data.
- FDA does not remove products from its list, so some of them have long gone generic (eg, FDA still lists fluoxetine though it has had generic competion since August 2001), and cases/products terminated before November 1, 2003 are not included (so products such as fluoxetine or omeprazole are not included).
- If the product’s case finally terminated after November 1, 2003, the product has been moved to the Old Cases section. For The Paragraph Four Report, we send products to the Old Cases section when there are generics available (after favorable judicial decision or the litigation otherwise terminates.)
I noticed that there are products in your Paragraph IV information that do not appear in the FDA List of those with Paragraph IV Certifications. Why?
Two reasons: (1) Through our research, we have found that the FDA List occasionally omits a product or product dosage. (If you don’t believe us, read the Complaints.) (2) We include antibiotic products that aren’t technically Paragraph IV cases so they don’t appear on the FDA List. A quick technical note on antibiotics — those with NDA’s filed after November 20, 1997 are subject to the Paragraph IV rules.
Why are some of the Patent Expiration dates omitted for a few products and their patents?
For Patent Expiration dates, we rely on the Orange Book. So, for patents not listed (antibiotics, process patents, for example), we do not make an independent judgment as to when they expire although we are certainly capable of figuring it out. After all, no one really knows when a company will claim the patent expires, so we leave it up to you.
How are amended pleadings researched and handled?
In general, while we review all dockets on a monthly basis, we do not review or collect amended pleadings. However, if the plaintiff files an amended complaint before the answer is filed, we will review it and include it as a download. On occasion, if there are a massive amounts of amended pleadings in a case, we will review these to see what, if anything, has changed from the case as initially filed.
Can you explain the litigation process and timing of court cases?
When cases are filed in the District Court, the companies (or “parties”) file Pleadings (Complaint and Answer) which briefly outline the legal dispute. After the parties file Pleadings, they conduct Discovery where they exchange documents and talk to each other’s witnesses. Technically, the Discovery phase should last about four months, but, because these cases are complex, it can last anywhere from 6-18 months.
After the parties have conducted Discovery and are preparing their cases, they enter the Pre-trial phase where the Judge and parties get together and outline what the case issues will be. Then, the actual Trial takes place. Pre-trial and the Trial itself can often take a few months. After the Trial ends, the Judge usually won’t make a decision right away; instead the Judge will conduct Post-trial proceedings to discuss and argue further points of law.
After Post-trial, the Judge then renders a Judgment. The Judge can take as long as he or she wants to, so the Final Judgment may take an additional 4-6 months. After the Judge renders its decision, the losing party will often file an Appeal which can take around 12-16 months to conclude.
The whole process from the Pleadings to a final decision can take 2-3 years, sometimes longer, not counting the appeal. The process will often outlast the 30-month stay provision. However, there are some procedures parties use to make it shorter, typically through a Summary Judgment where basically one party will say to the Judge, “Here are the facts we can all agree on, and given those facts and the law, we should win.” If a party wins a Summary Judgment, the case will end quickly, but, of course can be appealed.
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