Pharmaceutical patent litigation filings have declined for the first time in three years, according to Lex Machina’s Hatch-Waxman/ANDA Litigation Report.
Lex Machina, a LexisNexis company and creator of the Legal Analytics platform, today announced the release of its third annual Hatch-Waxman/ANDA Litigation Report. The report, which focuses on patent litigation related to Abbreviated New Drug Applications (ANDAs) submitted to the FDA under the Hatch-Waxman Act, provides litigators with trends and data-driven insights from 2,646 ANDA cases filed in U.S. district courts between January 1, 2009 and March 31, 2017.
Among the report’s key findings is that ANDA patent litigation has declined for the first time in three years — from a high of 468 cases in 2015 to 316 cases in 2016 — which represents a nearly 32.5% decline. However, ANDA litigation in 2016 remained higher than the average number of filings from 2009 through 2013 — about 269 cases per year.
The two U.S. districts that have received an overwhelming majority of ANDA filings are Delaware, with 1,114 cases filed since 2009 (up nearly 22.3% since 2015), and New Jersey, with 850 cases (up more than 17.2% since 2015). The third largest ANDA district — Southern District of New York (159 cases filed since 2009) — saw a dramatic decline in ANDA filings over the last five quarters (only one case, down from a high of 41 in 2011). Both Delaware and New Jersey have seen more ANDA cases filed since 2009 than all other jurisdictions combined (682 cases).
“Lex Machina’s 2017 Hatch-Waxman/ANDA Litigation Report provides valuable insights into current trends in ANDA litigation, and illuminates the ways in which ANDA litigation differs significantly from other, non-ANDA patent litigation,” said Owen Byrd, Chief Evangelist and General Counsel, Lex Machina. “Understanding where to file a case, one’s exposure to damage awards, and average case timing for key legal milestones is key to helping practitioners make more informed decisions, which leads to better litigation strategy.”
Lex Machina’s third annual Hatch-Waxman/ANDA Report draws on a combination of litigation data from the company’s Legal Analytics platform and Orange Book data published by the FDA on ANDA applications and related patents. Together with traditional research and intuition gained from experience, the report’s insights can provide readers with a distinct advantage over their competition.
Other Facts and Report Findings:
- Abilify (an antipsychotic, 63 cases since 2009) has overtaken Oxycontin (a pain relief medication, 59 cases) as the most litigated trade name by number of cases. Vascepa (a cholesterol medication) leads by the number of asserted patents.
- Actavis (including Allergan and Watson Laboratories) has participated in the most ANDA cases since 2009 (427 cases), followed by Mylan (290 cases), and Teva Pharmaceutical Industries (232 cases).
- Among the top parties since 2009, AstraZeneca (156 cases), Pfizer (143 cases) and Novartis (144 cases) have the largest number of cases as claimant (the party that is asserting the patent, as opposed to claim defendant). Other top claimants include Takeda, Cephalon, Roche, Abbott Labs, Genzyme and Wyeth.
- Only six ANDA cases filed since 2000 have resulted in actual damages, including one case in 2016 (Brigham and Women’s Hospital, Inc. et al v. Perrigo Company et al. for more than $10.2 million)
- ANDA cases are less likely to end in a settlement (57.9%) than other patent litigation (77.8%), and more likely to be won by the claimant (15.9% in ANDA cases vs. 4.4% in other litigation).
- The median time to a Markman hearing was 453 days (about a year and three months) from the case filing date.
The report also explores data-driven trends and insights pertaining to case timing and outcomes, as well as top ANDA judges and law firms, which can help litigators prepare legal strategies and help corporations select the best outside counsel and forecast litigation costs.
A copy of the full report is available by request, according to the group.
(Source: PR Newswire)