Generic Drug Litigation Snowballed in 2017, With Del., NJ as Top Venues
Litigation over generic drug applications under the Abbreviated New Drug Application process increased 30 percent in 2017, according to a report by litigation analytics company Lex Machina.
May 03, 2018 at 09:00 AM
4 minute read
Litigation over generic drug applications under the Abbreviated New Drug Application process increased 30 percent in 2017, according to a report by litigation analytics company Lex Machina.
The ANDA process accounted for 417 filings in federal courts across the nation in 2017, up from 324 in 2016. But filings of ANDA cases still haven't reached 2015's blockbuster level of 475, according to Lex Machina's report, which was made public Thursday.
The dramatic increase in ANDA litigation in 2017 is part of a five-year upward trend. From a low of 237 in 2012, ANDA filings increased in 2013, 2014 and 2015 before declining in 2016 and rising again in 2017.
The District of Delaware continued its role as the top venue in the nation for ANDA litigation in 2017, with 241 cases filed. That volume represents a significant increase from the 151 ANDA cases filed in Delaware in 2016.
The District of New Jersey continued its role as the second most popular venue for ANDA suits in 2017, with 111 cases filed. That's virtually identical to the 112 ANDA cases New Jersey saw in 2016, according to the report.
ANDA litigation volume in other judicial districts is nowhere near that in Delaware and New Jersey. The Southern District of Indiana, the third-busiest venue for ANDA cases, saw nine suits in 2017 and while the Eastern District of Virginia, which came in fourth, saw two ANDA suits.
The top law firm nationwide for representation of ANDA plaintiffs in 2016 and 2017 was Morris, Nichols, Arsht & Tunnell in Wilmington, Delaware, with 218 cases. Next was Finnegan, Henderson, Farabow, Garrett & Dunner of Washington, D.C., McCarter & English of Newark, New Jersey, Saul Ewing Arnstein & Lehr of Philadelphia, and Fitzpatrick, Cella, Harper & Scinto of New York.
Two Newark, New Jersey, firms made the list for representing plaintiffs in ANDA suits in 2016-17: Walsh Pizzi O'Reilly Falanga at No. 14 and Gibbons at No. 15.
Phillips, Goldman, McLaughlin & Hall, of Wilmington, led in representation of defendants in ANDA cases in 2016-17, according to the report.
Other top defense firms in ANDA cases were Winston & Strawn of Chicago, Shaw Keller and Young Conaway Stargatt & Taylor, both of Wilmington, and Goodwin Procter of New York. Three New Jersey firms made that list: Budd Larner of Short Hills, Walsh Pizzi and Hill Wallack of Princeton.
The top five plaintiffs in ANDA filings for 2016 and 2017 are Eli Lilly (42 cases), Pfizer (42 cases), Sanofi-Aventis (35 cases), Allergan (32 cases) and Bristol-Myers Squibb (32 cases).
The top defendants were Teva Pharmaceuticals USA, with 73 cases; Mylan Pharmaceuticals, 46 cases; Teva Pharmaceutical Industries Ltd., 45 cases; Apotex Inc., 44 cases; and Aurobindo Pharma USA, 40 cases.
The most litigated trade names were Tecfidera, 32 cases; followed by Eliquis, 26 cases, and Sensipar, 22 cases.
Damages are rare in ANDA cases—the only recent case that resulted in patent damages was Brigham and Women's Hospital v. Perrigo, with a royalty award of $10 million. In that case, a federal jury in Massachusetts found that generic drug maker Perrigo of Ireland willfully infringed a patent for antacid Pepcid Complete.
Medicines leading in 2017 filings include treatments for multiple sclerosis, anticoagulants and anti-psychotics used by dementia patients, according to the report.
A generic drug company files an ANDA when it wants to make a version of a drug that is still under patent protection. Under the Hatch-Waxman Act, an ANDA applicant must give the patent owner notice about its new drug application. The owner then has 45 days to bring a suit to protect its rights, which might lead to a 30-month stay of ANDA approval of the new drug, according to the Lex Machina report.
ANDA cases brought in New Jersey are more likely to result in claimant wins, 23 percent, than in Delaware, 16 percent. But Delaware has more cases that reach trial, 12 percent, than New Jersey, 7 percent.
Time to trial takes longer in New Jersey, 795 days, than Delaware, 731 days, but overall time to termination in New Jersey is faster, 271 days, than Delaware, 486 days, Lex Machina said.
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