Congratulations, your medical device is a success! But don’t celebrate yet—patent litigation may be next (objectively speaking). Patents are a strategic asset in medtech, where proprietary innovation is key to improving patient outcomes, driving company growth, and securing investment. Since competitors, investors, and opportunistic non-practicing entities (NPE) are aware of the strategic advantages of patents, medical device companies should plan for patent litigation as though it’s inevitable.

Regardless of a company being a plaintiff asserting patents or a defendant accused of infringement, there are several concrete steps companies can take now to boost their chances of success before the gavel ever falls.

Patent Litigation is Rising  

Patent litigation activity within the United States and abroad continues to grow. RPX Corporation reported a 21.6% increase in U.S. NPE filings and a 16.8% jump in operating company filings in 2024, culminating in a 19.7% spike in total U.S. patent litigation filings compared with 2023.¹ Similarly, Unified Patents reported an 18.2% overall rise in U.S. patent disputes last year.² Medtech-specific data is difficult to ascertain, but according to Unified Patents, 13.3% of U.S. district court patent litigation filings in 2024 were medical-related.³ The percentage of medical-related case filings has grown since the early 2010s, going from 10.4% in 2021⁴ to 14.5% in 2023.⁵ This recent rise in the share of U.S. patent cases involving medical-related technologies clearly shows such litigation has become an increasingly important segment of the overall U.S. patent litigation landscape.

Evolving U.S. patent policy continues to shape domestic patent litigation in ways that will likely increase the frequency, length, and cost of U.S. district court proceedings. For nearly a decade after the America Invents Act, accused infringers often leaned on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings at the Patent Trial and Appeal Board (PTAB) as a more cost-effective alternative to district court litigation. These time- and subject matter-limited proceedings allowed accused infringers to challenge patent validity without simultaneously litigating infringement, damages, or other issues. Recently, however, the PTAB has increasingly relied on discretionary denials—refusals to institute PTAB proceedings without considering the merits of the challenge—which has made it harder to obtain PTAB review.⁶ The resulting rise in discretionary denials will push more patent disputes to resolution in district court, which will likely raise overall litigation costs and amplify business disruption.

Meanwhile in Europe, high-stakes medtech litigation is playing out in the new, popular Unified Patent Court (UPC). Officially opened on June 1, 2023, the UPC creates a central venue where a single case can affect patent rights across 18 EU member states. The UPC’s remedies—particularly the ability to grant both interim and permanent pan-European injunctions—make it a powerful, and therefore popular, forum. In its first full year of operation in 2024, the UPC handled roughly 600 cases and issued nearly 600 decisions, quickly establishing itself as a high-volume, precedent-shaping tribunal.⁷ By May 2025, the case count had climbed to 883 filings.⁸ 

Irrespective of venue, patent litigation’s financial burden is staggering. Median patent litigation costs in the United States hover around $3 million through trial and appeal for $10 million to $25 million at risk cases,⁹ but that number is misleadingly modest. In complex medtech disputes, litigation often costs multiples of that amount. As a defendant, settlements and judgments can skyrocket into the hundreds of millions and, in some cases, break the billion-dollar mark. And the damage doesn’t stop there: litigation drains leadership attention and jeopardizes a company’s stakeholder perception.

Whether companies are contemplating a lawsuit, bracing for one, or managing both simultaneously, several proactive steps can improve the odds of success.

Prudent Plaintiffs Act With Caution

Companies considering filing a medical device patent infringement suit should first think strategically. Litigation can be a powerful competitive tool, but it can also backfire if not approached with discipline and foresight.

Perhaps the most important aspect of patent litigation is knowing the goal. Before lawyers draft a single word of a complaint, companies must establish a business objective. Patent lawsuits are not one-size-fits-all. Consequently, medtech companies must decide whether they want to:

• Stop the infringement: The most common reason for a patent infringement lawsuit is to remove a competitor’s product from the market.
• Monetize a patent: Litigation can force competitors to take a license and pay royalties.
• Send a deterrent message: A high-profile win can discourage other potential infringers.
• Boost stakeholder value: For companies eyeing acquisition, a robust enforcement campaign can increase real or perceived IP value.

In practice, a single patent litigation can often accomplish several of these goals. Conversely, filing a lawsuit simply “because you can” without a well-defined objective seldom leads to a favorable outcome.

Patent lawsuit fallout must be considered. Since patent disputes are fought both in the courtroom and the court of public opinion, customers may hesitate to buy from a company perceived as distracted or litigious. Investors may demand higher returns to compensate for risk, while engineers and clinicians may resent being pulled from R&D or product trials to sit for depositions. In addition, adversaries may retaliate by bringing their own infringement claims, antitrust counterclaims, or regulatory complaints. For medtech companies, a miscalculated legal action can put more at risk than it protects.

Patent litigation financing should be planned in advance because court battles are costly. For early- and mid-stage companies, expenses can rival or exceed annual R&D budgets. For public companies, protracted disputes can compromise quarterly earnings. The primary decision is whether to fund litigation internally or externally. Internal funding preserves control but strains cash flow and diverts resources from other projects. Third-party funding spreads risk, but investors typically take a share of the proceeds and may seek influence over settlement decisions. No matter what path is chosen, the litigation budget should be aligned with a business’s corporate objectives. Companies seeking licensing revenue should build realistic models as part of the valuation process. For injunctive relief, organizations must weigh the cost of litigation against eliminating competition from the market. Without a clear financing plan, litigation can quickly shift from a strategic tool to corporate liability.

Discerning Defendants Proactively Safeguard Their Companies

More worried about being sued than suing? If so, know that preparation is key. The companies that best weather patent litigation are those that proactively adopt the following defensive measures into their daily operations.

Know all suppliers. Medical devices routinely integrate third-party components and each part is a potential litigation trigger. Thus, vetting suppliers from an indemnity standpoint is critical. Check a supplier’s history, financial stability, and prior litigation record. Investigate whether potential suppliers have honored their past indemnity obligations, and negotiate strong indemnity terms. Supplier indemnity clauses can be lifesavers but only if enforceable. Don’t assume boilerplate indemnity language is enough; companies should push for indemnity coverage that matches their product risk profile. Weak supplier indemnities can leave enterprises financing a dispute caused by someone else’s component.

Understand the market. Freedom-to-operate analyses should be standard practice, not an afterthought. Before product launch, medtech IP counsel should survey competitor patents and confirm their claims do not map to a company’s products. Additionally, counsel should prepare non-infringement or invalidity opinions for the “close calls” to help defeat future willfulness claims that could expose a company to treble damages and fee-shifting. Patent monitoring should be continuous because competitors file new patents and NPEs acquire portfolios every week. Once a demand letter lands, the options are limited. Early awareness creates leverage.

Keep strong development records. Companies that produce clear, well-organized records of independent development and design-around efforts hold a significant advantage in litigation. Invest in the right physical and IT infrastructure to preserve historical product development materials and ensure they are accessible when needed. Equally important is training employees to be thoughtful about what is put in writing, especially regarding competitor patents and products. In litigation, assume every email, note, or presentation is discoverable. Careful documentation protects the company while careless documentation can do the opposite.

Conclusion: Act Now

Don’t wait until litigation arrives—by then, it’s already too late. The medtech industry is too competitive and litigious to rely on reactive strategies. Instead, adopt the best practices for patent litigation outlined in this column. They are foundational to ensure medtech companies survive and thrive in patent litigation.

References

1. RPX Q4 in Review – January 2025
2. Patent Dispute Report_2024
3. Patent Dispute Report_2024.  Medical-related technologies include pharmaceuticals, medical devices, and other health related technologies. 
4. 2021 Patent Dispute Report: Year in Review — Unified Patents
5. Patent Dispute Report: 2023 in Review—Unified Patents
6. PTAB Institution Rate Dropped in Q2 After USPTO Removed Fintiv Restrictions—July 23, 2005
7. Patent Litigation 2025 | Global Practice Guides | Chambers and Partners
8. The UPC two years in: close to 900 cases and plenty of settlements – JUVE Patent
9. AIPLA Report of the Economic Survey 2023, 67.

MORE FROM GREENBERG TRAURIG: Building a Future-Proof IP Strategy for AI in Medtech

Matthew J. Levinstein is an experienced IP litigator and trial attorney who represents clients nationwide in federal district courts. He knows when to litigate and knows when to settle. Levinstein has secured early settlements and wins at summary judgment, trial, and on appeal. In the last year, he has obtained both plaintiff- and defendant-side jury verdicts for his clients. Levinstein’s diverse technical experience spans numerous industries and technologies including medical devices, remote controls, and wireless communications, among others. He also handles high-stakes proceedings before the Patent Trial and Appeal Board (PTAB) and the Trademark Trial and Appeal Board (TTAB). He can be reached at levinsteinm@gtlaw.com.

David J. Dykeman is co-managing shareholder of Greenberg Traurig’s Boston office and co-chairs the firm’s global Life Sciences & Medical Technology Group. A registered patent attorney with more than 25 years of experience in patent and intellectual property law, he focuses on securing worldwide IP protection and related business strategy for high-tech clients, with particular experience in life sciences, medical devices, robotics, materials, and information technology. Dykeman provides strategic patent portfolio development and IP advice for clients including major research institutions, multi-national corporations, and startup companies. He can be reached at dykeman@gtlaw.com.