Litigation-Ready IP: Why MedTech Companies Must Think Beyond Patent Filing

In the world of MedTech, intellectual property can sometimes be treated as little more than a box-ticking exercise: file a patent, secure protection, and move on. This is particularly true for start-ups who may want to use the existence of a patent portfolio primarily to help secure investment funding. However, the reality can be far more complex. Indeed, it is essential to pause and consider whether the patents in issue would in fact hold up under the intense scrutiny of litigation. A litigation-ready IP strategy goes beyond mere filing: it ensures that patents are enforceable, defensible, and aligned with the company’s commercial objectives. In the MedTech sector, disputes are frequent and the sums at stake can be very high; it is important to get things right.

As will be appreciated, MedTech is one of the most IP-intensive industries and, as such, patent litigation is common. Investors and prospective buyers routinely examine IP portfolios to determine litigation risk and the strength of the patents held. A weak portfolio can put investors off. Accordingly, for those companies seeking investment, a litigation-ready IP strategy is a key asset which can be promoted.

There are numerous potential pitfalls to avoid. For example:

• Overly broad and/or vague claims can fail under challenge leaving patents vulnerable to revocation.
• Inventorship and ownership issues frequently arise; this is particularly true in R&D collaborations with academics or consultants.
• Freedom-to-operate checks are sometimes overlooked which gives rise to avoidable infringement risks.
• It is important to consider where enforcement might occur as the costs of litigation in different jurisdictions can vary significantly.

A litigation-ready patent portfolio must be built on strong foundations. More specifically, patent claims must be clear, novel, inventive and supported by the specification. The prosecution history should be clean and consistent; it should be free from concessions that weaken enforceability. Inventorship and ownership must be properly documented and assigned. Further, there must be a clear path to proving infringement, supported by technical evidence and avoiding relying on inferences where possible. Competitor intelligence is key. Additionally, a strong portfolio can assist with defensive strategy. Indeed, having a potential counterclaim can assist and provide leverage if a MedTech company is accused of infringement.

To avoid the pitfalls noted above, and to ensure that companies have a litigation-ready portfolio which is attractive to investors, it is important to involve litigation counsel early in the process. Patent filings should be aligned with the commercial objectives taking into account anticipated products, competitors, and target markets. Additionally, IP audits, competitor patent filing, and litigation risk assessments should be conducted on a regular basis. Finally, it is important to be aware of and budget for potential disputes. This is particularly true when operating in jurisdictions with specialist patent courts where the cost of litigation can be high in this legally and technically complex field.

Ultimately, a litigation-ready IP strategy isn’t just about obtaining patents, it is about obtaining strong valuable patents which enable growth, attract investment, and defend market share. MedTech companies that build with litigation in mind are better positioned to succeed in what can be a very competitive landscape.