Key takeaways
- The U.S. Court of Appeals for the Federal Circuit affirmed the denial of a preliminary injunction sought by Boston Scientific Corp. and Relievant Medsystems, Inc.
- The court found Stryker Corp. presented a sufficient case that its spinal ablation device does not cause physicians to infringe the asserted patent.
- The ruling allows Stryker to proceed with the launch of its back pain device while the underlying patent litigation continues in the District of New Jersey.
The Decision
On or about June 17, 2026, the U.S. Court of Appeals for the Federal Circuit issued a decision affirming a lower court order that allows Stryker Corp. to proceed with the launch of a new medical device. The appellate panel upheld a ruling originating in the U.S. District Court for the District of New Jersey, which denied a motion for a preliminary injunction filed by Boston Scientific Corp. and Relievant Medsystems, Inc.
The plaintiffs sought the injunction to block Stryker from introducing its new back pain device to the market, alleging that the product violated their intellectual property rights. The core of the dispute involves a patent related to spinal ablation treatment, a medical procedure used to alleviate chronic back pain by targeting specific nerves. Boston Scientific and Relievant Medsystems argued that Stryker's device would inevitably lead to infringement of this patent.
However, the Federal Circuit concluded that the district court properly evaluated the evidence at this early stage of the litigation. The appellate court determined that Stryker provided a sufficient case that its device does not cause physician patent infringement. Because the defendant presented a strong defense against the infringement allegations, the court ruled that the extraordinary remedy of a preliminary injunction was not warranted, allowing Stryker to continue its commercialization efforts. (See Boston Scientific Corp v. Stryker Corporation).
Why It Matters
Preliminary injunctions serve as high-stakes, early-stage filters in intellectual property disputes. When a competitor attempts to enter a lucrative medical device market, the incumbent patent holder often seeks an immediate court order to halt the product launch. Securing such an order requires the plaintiff to demonstrate a high likelihood of success on the merits of their claims, alongside a showing that they will suffer irreparable harm if the competitor is allowed to operate freely during the litigation.
By concluding that Stryker presented a sufficient defense against the claim of induced infringement, the court signaled that Boston Scientific's legal theory faces substantial hurdles. This determination matters because it shifts the immediate commercial balance of power. Stryker can now introduce a competing spinal ablation treatment to the market, potentially capturing market share and establishing relationships with medical providers before a final trial determines the patent's ultimate validity and infringement status.
Furthermore, the decision highlights the heavy burden plaintiffs carry when attempting to stop a product launch based on method claims. Proving that a device manufacturer actively causes a third party to infringe requires specific evidence of intent and instruction, which can be difficult to establish definitively before full discovery has occurred.
Who Should Care
For lawyers
Patent litigators representing medical device manufacturers should closely examine the court's focus on the mechanics of induced infringement. When a medical device is sold to healthcare professionals, the manufacturer itself rarely performs the patented method. Instead, the plaintiff must prove the manufacturer induces the physician to infringe the patent through product design, marketing materials, or surgical instructions. The Federal Circuit's affirmation demonstrates that presenting a credible, well-supported defense against the "inducement" element can successfully defeat a preliminary injunction motion, even if the new device operates in the exact same medical field as the patented technology. Defense counsel can use this standard to construct early defenses focused on the specific language in their clients' instructions for use.
For consumers and parties
Patients seeking treatment for chronic back pain and the medical providers who perform spinal ablation procedures will benefit from having access to Stryker's new device, increasing competition and potentially lowering costs or improving treatment options. For the corporate parties involved, the ruling dictates the financial reality of the next several years. Boston Scientific must now litigate the full case without the advantage of an early market block. Stryker can generate revenue from its device immediately, though it does so "at risk"—meaning the company could face substantial financial damages if a jury eventually determines that the device does, in fact, infringe the patent.
Legal Background
In patent litigation, a patent holder can allege direct infringement, which involves making, using, or selling the patented invention, or indirect infringement. Indirect infringement frequently takes the form of induced infringement. This occurs when a company provides a product and actively instructs, directs, or encourages a third party—such as a surgeon or physician—to use that product in a way that violates a patented method.
To secure a preliminary injunction against a competitor before a full trial, a plaintiff must satisfy a rigorous four-factor test. The plaintiff must establish that it is likely to succeed on the merits of its infringement claim, that it will suffer irreparable harm without court intervention, that the balance of equities tips in its favor, and that an injunction serves the public interest.
If the defendant raises a substantial question regarding either the infringement allegations or the underlying validity of the patent, the court will typically deny the injunction. Historically, courts are hesitant to grant preliminary injunctions in cases relying on induced infringement of method patents because the question of whether a manufacturer's instructions actually cause a physician to perform the exact patented steps is highly fact-intensive and usually requires extensive expert testimony.
What the Court Did
The Federal Circuit reviewed the decision from the U.S. District Court for the District of New Jersey under an abuse of discretion standard. The appellate panel evaluated whether the lower court made a clear error of judgment in finding that Boston Scientific and Relievant Medsystems failed to meet the demanding standard for extraordinary preliminary relief.
The court focused its analysis on the specific allegations that Stryker's device would cause physicians to infringe the spinal ablation patent. Evaluating the arguments presented by both sides, the Federal Circuit determined that Stryker provided a sufficient case that its device does not cause physician patent infringement. The appellate judges noted that the evidence presented at this preliminary stage did not definitively establish that Stryker's instructions or product design would force or actively encourage doctors to perform the specific steps outlined in Boston Scientific's patent claims.
Because Boston Scientific could not overcome this defense or prove a clear likelihood of success on the merits of its induced infringement claim, the appellate court affirmed the denial of the preliminary injunction. The decision leaves the district court's order intact and permits Stryker to proceed with its business operations.
How It May Be Applied
The case now returns to the District of New Jersey for standard discovery, claim construction, and eventual trial or settlement. The parties will likely engage in extensive expert discovery regarding how physicians actually use the Stryker device in clinical practice and whether the device's labeling actively encourages an infringing method.
While the denial of a preliminary injunction does not definitively resolve the ultimate question of infringement, it sets a challenging tone for the plaintiffs. Boston Scientific will need to uncover new evidence during discovery—such as internal Stryker communications or specific physician testimony—to prove its inducement theory at trial.
Other medical device manufacturers may view this outcome as a clear signal that they can defeat early injunctions by carefully designing their products and drafting their surgical instructions to avoid directly mapping onto competitors' method claims. By leaving ambiguity in how a procedure might be performed, a new entrant can create enough doubt to survive a preliminary injunction motion and secure market entry.
Litigation Stages and Market Impact
| Stage of Litigation | Plaintiff's Burden | Defendant's Strategy | Market Impact |
|---|---|---|---|
| Preliminary Injunction | Must prove high likelihood of success on the merits and irreparable harm. | Raise a substantial question of non-infringement or invalidity. | Market entry is blocked if the plaintiff succeeds; entry proceeds if the defendant succeeds. |
| Discovery Phase | Gather evidence of actual physician use and corporate intent. | Defend product labeling and demonstrate alternative non-infringing uses. | Competitor remains on the market, generating revenue and potential liability. |
| Full Trial | Prove infringement by a preponderance of the evidence. | Prove non-infringement, invalidity, or both to the fact-finder. | Final determination of market access and calculation of any financial damages. |
Understanding Induced Infringement
What is induced infringement? When a patent covers a specific medical procedure, the doctors performing the surgery are technically the ones using the patented method. Because patent holders rarely sue doctors, they instead sue the company that makes the medical tools. To win, the patent holder must prove the manufacturer "induced" the infringement—meaning the company intentionally encouraged or instructed the doctors to perform the patented procedure using its tools. If the manufacturer's instructions allow the doctor to use the tool without performing the patented steps, the court may find no inducement occurred.
This article is general legal information and commentary about legal developments. It is not legal advice, does not address your specific situation, and is not a substitute for advice from a licensed attorney. Reading this article and contacting us through this website do not create an attorney-client relationship.
Sources & authorities
- Boston Scientific Corp v. Stryker Corporation — source
Further reading
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