How to Guard Against Biologics and Medtech Patents Litigation

Life sciences companies are increasingly looking to the courtroom to resolve their disputes which were simmering during the pandemic. Ching-Lee Fukuda explains why litigation in the fields of biologics and medtech is now particularly likely, and how companies can best prepare for claims in these areas.

Given the large number of biologic products that are currently being developed and marketed, both big pharma and bio-tech startups are likely to experience an upturn in litigation in the area of biologics. This is in part because the historic broad scope of biologics patents tends to generate bona fide patent invalidity issues. For example, under U.S. patent laws, patents must be ‘enabled,’ meaning that they must adequately describe how to make and use the claimed invention. If they do not, they are vulnerable to claims.

Given the inherent uncertainties in biological systems, and the tendency of litigants to make their claims as broad as possible in order to capture the maximum number of competitor products, many biologic patents have encountered effective challenges in litigation. Such challenges have not tended to go in favor of the patent holders. However, there are ways in which biotech patents can be made sufficiently robust to withstand challenges; for example, by ensuring that the patent is written in a manner that can withstand enablement scrutiny.

We are also likely to see an upturn in litigation in the field of medtech, particularly as innovation fuels competitiveness between originators over market share. This will impact both large, established players, and the smaller startup companies that are looking to gain a foothold in established markets with innovative, disruptor products which pose a challenge to established players.

In medtech, the patents battleground is shifting from mechanical devices toward inventions that rely heavily on software implementation; the area where most top-of-the-line innovation is now occurring. We are also likely to see some of the non-practicing entity litigation that has previously plagued the high tech industry. Medtech companies would be prudent to prepare for any claims against them by putting robust confidentiality provisions in their employment agreements and separation agreements. It would also be advisable to implement strict measures to protect software innovations as trade secrets, where possible. These could involve encrypting, where necessary, and ensuring that disclosure is made only on a need-to-know basis within the company.