LexisNexis company Lex Machina released its fourth annual Hatch-Waxman/ANDA Litigation Report.
The report focuses on FDA Paragraph IV pharmaceutical patent litigation related to Abbreviated New Drug Applications (ANDAs) filed in US district courts under the Hatch-Waxman Act, and Patent Trial and Appeal Board (PTAB) cases involving FDA Orange Book patents.
It provides insight into ANDA and PTAB filings and decisions made between January 1, 2016 and December 31, 2017.
“During this time, 741 ANDA cases and 196 PTAB pharmaceutical petitions were filed, while 843 ANDA cases and 246 PTAB pharmaceutical trials were completed,” said Lex Machina.
“Among the report’s key findings is that district court ANDA case filings have rebounded nearly 30% over last year, from 324 cases in 2016 to 417 cases in 2017, but remain slightly below the 2015 record high of 475 cases.”
The report said the District of Delaware (D. Del.) and the District of New Jersey (D.N.J.) remained the top two venues for ANDA cases.
While new case filings in D.N.J. were flat in 2017 (111 cases, down from 112 in 2016), D. Del. filings surged 60%, from 151 cases in 2016 to 241 cases in 2017.
The next leading venue, the Eastern District of Virginia, saw a dramatic reduction in new case filings, from 17 cases in 2016 to two cases in 2017 – a decline of more than 90%.
“Lex Machina’s latest Hatch-Waxman/ANDA Litigation Report provides pharmaceutical companies and their law firms with invaluable, data-driven insights about the legal matters, key participants, case timings and resolutions that can shape or reshape business and legal strategies,” said Owen Byrd, General Counsel, Lex Machina.
“It also explores trends pertaining to top ANDA judges, parties and law firms, which can help litigators prepare legal strategies, select the best outside counsel and forecast litigation costs.”
Other findings in the report included:
- In combined 2016-2017 cases, the most litigated drugs were Tecfidera (32 cases), followed by Eliquis (26 cases), and Sensipar (22 cases).
- The top five plaintiffs in combined 2016-2017 ANDA cases include Eli Lilly (42 cases), Pfizer (42 cases), Sanofi-Aventis (35 cases), Allergan (32 cases) and Bristol-Myers Squibb (32 cases).
- The top five defendants in combined 2016-2017 ANDA cases include Teva Pharmaceuticals USA and Teva Pharmaceutical Industries (73 and 45 cases respectively), Mylan Pharmaceuticals (46 cases), Apotex (44 cases) and Aurobindo Pharma USA (40 cases).
- Only six ANDA cases terminated in 2016 or 2017 resulted in damages, including one case with patent damages in 2016 (Brigham and Women’s Hospital, Inc. et al v. Perrigo Company et al. for more than $10.2 million).
- For ANDA cases terminated in 2016 and 2017, the majority were the result of a likely settlement (50% or 417 cases) or procedural resolution (18% or 155 cases). Claimants won their cases more often than claim defendants (25% or 208 cases vs. 7% or 62 cases, respectively). In such cases, consent judgment was the most prevalent case resolution for both claimants and claim defendants (18% and 3% respectively), followed by trial (6% and 2%, respectively).
- The median time to a Markman hearing was 468 days from the case filing date.
- In 2016-2017, 246 PTAB trials challenging 235 Orange Book patents were completed, with 151 trials resulting in a patent owner win, 42 resulting in a petitioner win and one resulting in a partial win with mixed claim findings, and the remaining 52 cases were merged into other trials.