In the two-year period ending December 31, 2017, there were 741 Abbreviated New Drug Application (ANDA) patent litigation cases and 196 Patent Trial and Appeal Board (PTAB) pharmaceutical petitions filed, according to a new report issued by Lex Machina, a LexisNexis company.

The fourth annual Hatch-Waxman/ANDA Litigation Report also showed that 843 ANDA cases and 246 PTAB pharmaceutical trials were completed during the period.

The report, which focuses on FDA Paragraph IV pharmaceutical patent litigation related to ANDAs filed in U.S. district courts under the Hatch-Waxman Act and PTAB cases involving FDA Orange Book patents, found that district court ANDA case filings rebounded nearly 30 percent, from 324 cases in 2016 to 417 cases in 2017, but remained below the 2015 record high of 475 cases.

The District of Delaware and the District of New Jersey remained the top two venues for ANDA cases. Filings in the Delaware district increased 60 percent in 2017, to 241 cases from 151 cases the prior year, while new case filings in the New Jersey district were flat with 111 cases last year versus 112 in 2016.

The next leading venue, the Eastern District of Virginia, saw a significant reduction in new case filings, from 17 cases in 2016 to two cases in 2017—a decline of more than 90 percent. 

Despite some shifts on the Delaware bench and a greater proportion of ANDA cases, the median time to trial in Delaware at 731 days was faster than that of New Jersey at 795 days.

But, ANDA cases tried during 2016-2017 reached termination faster in New Jersey at 271 days compared with 484 days in Delaware, according to the litigation report, which provides pharmaceutical companies and their law firms with data-driven insights into the legal matters, key participants, case timings, and resolutions.

The law firm Morris Nichols led plaintiffs’ cases filed in 2016-2017, while Phillips, Goldman, McLaughlin & Hall led in total cases representing the defendants.

Medicines leading in 2016-2017 filings included treatments for multiple sclerosis, anticoagulants, and anti-psychotics used by dementia patients.

Other Key Facts and Findings

• 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 percent or 417 cases) or procedural resolution (18 percent or 155 cases). Claimants won their cases more often than claim defendants (25 percent or 208 cases vs. 7 percent or 62 cases, respectively). In such cases, consent judgment was the most prevalent case resolution for both claimants and claim defendants (18 percent and 3 percent, respectively), followed by trial (6 percent and 2 percent, 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.

The Hatch-Waxman/ANDA Report draws on a combination of litigation data from the Lex Machina’s proprietary Legal Analytics platform and Orange Book data published by the U.S. Food and Drug Administration on ANDA applications and related patents.

Lex Machina offers a copy of the full report upon registration on its website.

(Source: Lex Machina)