27 Apr 2016

Pharma patent battles up 68 per cent in 2015, study finds

The IP landscape is heating up across the United States pharmaceutical market.


A new study published by legal analytics group Lex Machina has found that the number of 'ANDA' filings—patent litigation filings which relate to new drug applications before the US Food and Drug Administration—rose around 68 per cent for 2014-2015 when compared to the average for the last five years. Between 2009 and 2013, the average number of ANDA cases per year was 269. According to Lex Machina's report, which analyses data from 2,249 ANDA cases filed with US district courts between 1 January 2009 and 31 December 2015, this number jumped to 451 last year.

Biggest filers

Beyond highlighting overall growth, the report has noted which companies have most contributed to the groundswell and which law firms have been representing them. Generics drugmaker Sandoz has participated in the most ANDA cases since 2009 with 426, followed at some distance by Actavis (which includes Allergan and Watson Laboratories) with 359 and Tev Pharmaceutical Industries with 188. Pharma giants AstraZeneca, Novartis and Pfizer have been the claimant for 139, 133 and 130 ANDA filings respectively.

Favourite firms

New Jersey firm McCarter & English has been the favourite plaintiffs' firm for pharmaceutical companies engaging in ANDA litigation with 344 cases since 2009, with Washington DC-based IP specialist firm Finnegan, Henderson, Farabow, Garrett & Dunner weighing in second with 274 cases. For defendants, international firm Winston & Strawn has proven most popular with 151 cases, followed by Chicago boutique Rakoczy Molino Mazzochi Siwik with 138 and Goodwin Procter with 100.

Mounting pressure

According to Lex Machina director of analytics services Brian Howard, the steady growth in ANDA filings is symptomatic of mounting pressure and competition within the sector. Though ANDA cases make up fewer than 10 per cent overall patent filings, their growth rate has been steadier than for other patent litigation categories. '[2015] was a busy year for ANDAs, a sign that the pharmaceutical industry is feeling greater urgency and things are getting more intense,' Mr Howard commented.

Sources: Corporate Counsel; Lex Machina