Growth in the biological field expected to prompt a rise in biosimilar litigation in multiple jurisdictions, finds new report

07 Dezember 2021
  • 94% of respondents expect biosimilar litigation to increase over the next five years and a third (32%) expect this type of litigation to go to trial more often.
  • Litigation is the first choice strategy for 25% of respondents but more than a third (37%) say they opt for exploring other avenues initially.
  • As many as 19% prefer to avoid litigation altogether and always try to come to an agreement, with the majority (53%) approaching this jurisdiction by jurisdiction.
  • Views were divided as to whether anything in the current patent system needs "fixing", but a number of suggestions were made around the regulatory regime and filing processes.

New research produced by Life Sciences IP Review and Gowling WLG has found that the majority of companies operating in the biologics and biosimilars field (94%) expect biosimilar litigation to increase, with the US remaining the key jurisdiction to watch.

Our report, 'Patent litigation trends: the future of biologic and next generation therapies' is based on a survey of those at the forefront of the biologics and next generation therapies industry. It shares their experiences, attitudes and opinions on patent litigation involving biosimilars, current strategies and what trends to expect in future patent disputes.

The research reveals that as commercial opportunities in the biologics and biosimilars market have expanded, a patent battleground has emerged globally. And with market growth forecast to continue, the trend towards litigation over biosimilars is only expected to continue. Similarly, 80% of respondents predict an increase in so-called innovator vs innovator litigation, as companies compete over work on the same target.

Reflecting on the trends of cases to date, 33% of respondents think that the current environment favours innovator companies, while 20% believe biosimilars have the advantage. So opinions are mixed, with 47% expressing there is no advantage to either - most likely reflecting the different standpoints and experiences of those surveyed.

When it came to considering litigation, respondents highlighted a variety of different approaches in their comments. Overall, a quarter (25%) stated litigation is their first choice strategy, whereas 37% prefer to explore other avenues initially and 19% would always seek to reach an agreement.

For those seeking to avoid litigation, suggestions included developing a strong and diverse patent portfolio, covering the innovator drug with a duration exceeding regulatory exclusivity. Others advised considering reasonable licensing terms for secondary patents early on, and exploring the use of "skinny labelling" to carve out particular patented indications for a biosimilar. However, for some, a more proactive approach to avoiding litigation later on is simply to engage in it up front, using "clear the path strategies".

Patrick Duxbury, partner and head of life sciences in the UK said: "The significant commercial gains for innovators in this market is increasing the volume of litigation. Once you have a biologic out there, competitors may develop a molecule with a different sequence, leaving you with the choice of taking a proactive litigation approach or exploring a negotiated resolution which may not be easy. There will be many factors that influence your decision on how to deal with the issue - not least your resources and IP position, but also the jurisdictions involved."

Looking ahead, respondents suggested what changes might facilitate biologic and biosimilar development. These largely focused on the US landscape, including addressing the interchangeability of biosimilars and the perceived need for an easier regulatory regime. In the same vein, the US is sighted as the key jurisdiction to watch for biosimilars litigation over the next five years, followed by China and Germany.

John Norman, partner and head of life sciences in Canada added: "We've seen significant recent biosimilar litigation around areas such as 'skinny labelling'. In many ways, this is not surprising given biologics tend to be approved for multiple indications and biosimilars may not carry out clinical trials on all of the approved indications. However, it does highlight the sheer value of biologics to originator companies and the move towards a proactive litigation approach here."

Download our full report to find out more.

Media contacts