In the ever-raging war between generic drugmakers and branded pharma, patent litigation is a standard-issue weapon. It's a high-stakes business as generics makers aim to grow their sales by rolling out copies of blockbuster drugs—and branded drugmakers seek to protect the billions in sales at risk.
And last year, branded drugmakers went after would-be copycat rivals 30% more often than they did in 2016, according to a new report from Lex Machina.
In 2016 and 2017, Eli Lilly and Pfizer brought the most cases against potential generics rivals at 42 each, while Sanofi brought 35, according to the report. Allergan and Bristol-Myers Squibb each filed 32 cases during the period. After generic drugmakers file their abbreviated new drug applications (ANDAs) to challenge branded meds, pharma regularly files lawsuits to work through patent disputes in court.
In total, the number of ANDA lawsuits grew 30% in 2017 to 417, up from 324 in 2016, according to Lex Machina; only six ended in actual damages, though. Half of the cases ended in settlements that set dates for generics launch.
Top generic drugmakers led the list of the defendants in the report, of course, because they have the resources to roll out a broader range of meds. Teva, Mylan, Apotex and Aurobindo faced the most cases, in order.
Multiple sclerosis med Tecfidera from Biogen, new-age blood thinner Eliquis from Pfizer and Bristol-Myers, and Amgen's aging calcium reducer Sensipar were the most litigated drugs in 2016 and 2017, according to the firm. It's possible Sensipar will fall to generic competition this year after a March 8 patent expiration, but because of ongoing litigation, generic launch timing for the drug remains uncertain.
In a parallel issue to its Sensipar patent lawsuits, Amgen is also in a legal battle with the FDA over pediatric exclusivity for Sensipar. The agency previously rejected a bid for six months of extra patent protections, and Amgen sued by arguing that the FDA applied different standards to its review than it did during a previous process for a Johnson & Johnson drug. The argument fell short in district court, but Amgen is appealing.