Reproduced with permission from Leaders League. This article was first published on leadersleague.com.
Litigating second medical use claims is a common occurrence both before the UPC and the US courts. However, the legal landscape differs in the two most relevant pharma markets around the globe – which entails important practical consequences.
Before the UPC there are no statutory provisions regarding infringement of second medical use claims. Thus, it is a judicial task to define the limits of infringement of these claims and there is no harmonized approach yet, let alone one endorsed by the UPC Court of Appeal.
The nature of the second medical use claim is a purpose-limited product claim. Thus, these claims can be infringed like product claims, i.e. directly and indirectly (cf. Art. 25(a) UPCA, Art. 26 UPCA resp.). As of today, the UPC Court of First Instance has dealt with second medical use claims in a number of cases (UPC_CFI_552/2025, Gilead Sciences v Academy of Military Medical Sciences, 4 May 2026; UPC_CFI_146/2024, Sanofi v STADAPHARM GmbH, 12 December 2025; APL_24205/2025, ORD_33516/2025, BOEHRINGER v ZENTIVA, 13 August 2025). However, the question of the relevant infringement test for second medical use claims was only comprehensively dealt with in the landmark decision of the Local Division Düsseldorf delivered on May 13, 2025 (UPC_CFI_505/2024, Sanofi v Amgen). Here, the Court held that direct infringement of such claims is not limited to scenarios where the product is already or actually being used for the claimed therapeutic purposes. In the Court’s view this would unduly limit the protection of the patent proprietor.
For a finding of direct infringement of a second medical use claim, the alleged infringer must offer or place the medical product on the market in such way that it (i) either leads or (ii) at least may lead to the claimed therapeutic use of which the alleged infringer (i) either knows or (ii) at least reasonably should have known that it does. Thus, this test comprises an objective element, i.e. a governing prescription practice or at least circumstances which allow concluding that such a practice may be expected to occur. In addition, this test includes a subjective element, i.e. the infringer must (i) either know about the objective element or (ii) at least reasonably should have known.
Reducing this two-pronged test to practice requires a case-by-case analysis taking into account all the relevant facts of the case at hand. Pursuant to the Local Division Düsseldorf, the relevant facts may include:
For both the objective and the subjective element, the burden of pleading and proof rests with the plaintiff (cf. Art. 54 UPCA). In the absence of a proven prescription practice occurring to a relevant extent, as means of evidence, the manufacturing and putting on the market of the accused product as well the package insert and the Summary of Product Characteristics (SmPC) are of utmost relevance. The same holds true for marketing statements, press releases, and websites provided that information is presented in a way of a recommendation for using the accused product for the patented use. With respect to the SmPC, the section about the therapeutic indications plays a crucial role. In most cases, the accused product is marketed with a label explicitly carving out the claimed therapeutic use. For prescription medicines, this means that physicians prescribing the accused product for the claimed therapeutic use engage in “off-label” prescriptions. However, depending on the circumstances, e.g. the country where the accused product is prescribed, there may be different hurdles for the physician for an “off-label” prescription, such as a need for medical justification, or the risk of a refusal of reimbursement or recourse by the health insurance funds. Against this background, it is by no means an easy task to successfully assert second medical use claims before the UPC.
In the United States, methods of using a known drug are also patent eligible. As in Europe, these patents play an important role for generic companies wishing to enter the market. The Food and Drug Administration (FDA) keeps track of drug patents in the so-called “Orange Book”. Two options are available for marketing a generic version of a drug that is listed in the Orange Book. The first option is filing a “paragraph IV certification”. This certification contains the statement that the originator’s/brand manufacturer’s patent is invalid or will not be infringed by the manufacture, use, or sale of the [generic] drug. The second option is the more defensive one: the submission of a “section VII statement”. With such statement it is asserted that the generic drug will only be marketed for one or more method(s) of use not covered by the brand’s drug patents. A generic manufacturer that selects the section VIII option must file with its abbreviated new drug application (ANDA) a proposed “skinny label” that “‘carves out’ from the brand’s approved label the still-patented methods of use.”
Even though, the market entry is regulated in the above detailed manner in the U.S., this does not mean that the marketing of the generic drug will not interfere with a patented method of use. However, such interference is only possible under very limited circumstances, namely if the generic manufacturer “actively induces” infringement of the brand manufacturer’s patent (cf. 35 U. S. C. §271(b)). That said, it is irrelevant in the U.S. – absent such “active inducement” – whether the generic manufacturer knows (and perhaps even expects) that its generic product will be put to infringing use. This is likely to occur as all 50 states have substitution laws enacted requiring medical providers to substitute the brand-name drug with the generic version.
A claim for active inducement of infringement under §271(b) requires three elements:
1) direct infringement by a third party;
2) knowledge that “the induced acts constitute patent infringement,” and
3) and “active steps . . . to encourage direct infringement”.
The recent Supreme Court decision HIKMA PHARMACEUTICALS USA INC. ET AL. v. AMARIN PHARMA, INC., ET AL. of June 4, 2026 sheds light on the third element. In this regard the Court held that inducement cannot be based only on “vague” language combined with speculation about how others may act. It can either be express or implicit. But implicit or explicit, the necessary inducement must be “clear” to the relevant audience and “affirmative”. The following three categories do not meet this threshold:
In summary, the key question is therefore whether a defendant actively encouraged infringement through its statements, not merely how others may understand those statements.
It follows from the above that it is by no means an easy task to successfully assert second medical use claims before the UPC, but it is even more difficult to enforce these claims before U.S. courts. The current UPC infringement test for second medical use claims is more favorable for originators/brand manufacturers and differs from the governing U.S. infringement test in at least two important aspects:
1) The UPC acknowledges that the patent proprietor must be protected if the claimed therapeutic use is already occurring on the market (at least to a relevant extent). This criterion is irrelevant in the U.S. as such use may occur without any involvement of the alleged infringer. If this was the case, no argument can be made that the statutory requirements of 35 U. S. C. §271(b) are met and that the alleged infringer “actively encouraged” such use.
2) The UPC finds liability in scenarios where the alleged infringer places the product on the market in a way that it “may lead to the claimed therapeutic use” of which the alleged infringer “reasonably should have known that it does”. This approach appears much easier to be argued than an “active encouragement” by the alleged infringer to use its product for the patented therapeutic use.
Datum
Tobias Wuttke
Attorney-at-Law (Rechtsanwalt), Certified IP Lawyer, UPC Representative, Partner
Axel Berger
German and European Patent Attorney, UPC Representative, Partner
