On April 29, the Supreme Court will hear argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., a case that may determine whether the Section viii “skinny label” pathway remains viable for generic drug manufacturers. At issue is whether a generic company that fully carves out a patented indication from its label can nevertheless face induced infringement liability based on statements that do not instruct, mention, or promote the patented use.
Hikma’s opening brief frames the case as a straightforward application of 35 U.S.C. §271(b): inducement requires “active” encouragement of infringement, not passive market participation or truthful, legally required statements. The questions presented are equally direct: when a generic label fully carves out the patented use, are routine statements, such as calling the product a “generic version” or citing publicly available sales data, enough to plausibly plead inducement?
The amicus support has been unusually broad. The U.S. government, former Congressman Henry Waxman, the Association for Accessible Medicines (AAM), public interest groups, and academic scholars have all warned that the Federal Circuit’s decision threatens to undermine the Hatch-Waxman framework. The government’s position is blunt: none of Hikma’s allegedly culpable statements expressly urged or encouraged third parties to infringe, and allowing such a complaint to proceed risks chilling use of the skinny label pathway.
AAM’s brief emphasizes that Section viii exists precisely to allow generic entry where only method-of-use patents remain. The skinny label is not a loophole; it is a statutory mechanism designed to avoid inducement by carving out patented uses. AAM characterizes the Federal Circuit’s approach as an existential threat to this pathway, warning that routine, commonplace conduct during a skinny-label launch could now generate massive exposure.
What is notable, however, is that while many briefs carefully recount the history and policy of Hatch-Waxman, few squarely address what a plaintiff would have to plead to state a viable inducement claim in this context. My amicus brief focused on that missing piece: if the Court is concerned about preserving patent rights while protecting Section viii, it should clarify what a complaint must plausibly allege.
Inducement is not strict liability. Under Supreme Court precedent, inducement requires clear expression or other affirmative steps taken to foster infringement. A skinny label that omits the patented indication does not satisfy that standard. Nor do investor-facing press releases, public sales data, or regulatory equivalence statements. If inducement is to retain its traditional meaning, a plaintiff should have to plead specific, affirmative conduct that instructs or encourages the patented use, not speculation based on market realities or automatic substitution laws.
In practical terms, if a branded company believes inducement exists in a skinny-label scenario, the complaint should identify: (1) a specific communication; (2) directed to a relevant audience (e.g., prescribers); (3) that expressly or implicitly instructs the patented use; and (4) facts plausibly showing intent to encourage that use. Absent such allegations, the claim collapses into passive market participation, which is precisely what Congress sought to avoid when enacting Section viii.
For generic manufacturers, the case also offers practical lessons. First, what generics are allowed to do remains clear under existing precedent: they may file a Section viii carve-out consistent with the Orange Book; they may describe their product as a generic equivalent; they may comply with FDA’s sameness requirements; and they may provide truthful, non-promotional investor disclosures. Selling a lawful product suitable for non-infringing use is not enough to create inducement liability.
Second, generics should continue to exercise discipline around launch communications. Avoid messaging, especially sales or marketing materials, that could be construed as encouraging off-label or carved-out uses. Ensure commercial teams understand the scope of the carved-out indication. Carefully separate investor communications from any prescriber-directed messaging. Confirm that websites and promotional materials track the carved-out label. And document the internal compliance process surrounding the carve-out decision.
Third, generics should be mindful that context matters. Automatic substitution laws and therapeutic equivalence are features of the regulatory system, not evidence of inducement. But internal emails, sales strategies, or detailing efforts that blur the carved-out boundary could create avoidable risk. The safest path is consistency: regulatory, legal, and commercial teams aligned around the carved-out scope.
Fourth, perhaps the most important thing that a generic company could do to defang any inducement to infringe allegation, is to say little or nothing. It may eliminate any self-inflicted wounds. For example, in the typical solid oral dose commercial market, more than 80% of the products are sold to just a handful of companies. For injectables, most are sold in very limited distribution chains to selected buyers and group purchasing organizations. Does a generic company really need to advertise to these handful of sophisticated buyers that the generic product (named by the generic name only) is equivalent to Brand X? Is there a need for a generic company to advertise how much the Brand X drug product sells for? Are the few buyers at wholesalers or the like so uninformed about the generic marketplace that they must know the Brand X drug name and/or sales information.
That is, many times a company will say that Brand X has an annual value of $Y of sales. Would the generic marketing program collapse if a generic company simply said that is now offering [Generic Drug] for sale? And that’s it. There’s no need to even mention the Brand X drug name, any annual sales volume, etc.
Furthermore, to the extent that a press release is even needed, maybe the generic company should put further language in the release that the generic drug is not indicated for the same indications as Brand X. For specific intent, evidence of mitigation is very important.
Fifth, generic companies should sanitize internal documents. Let’s suppose that Brand X drug has 2 indications, one for oncology and one for foot fungus treatments. Further, assume that the oncology indication is still patented, whereas the fungal treatment is off-patent. For the brand company, it might need to know how the drug is prescribed so it can allocate resources to oncologists or dermatologists. If most of the uses are for oncology, then more resources will be allocated to the oncology sales program.
But generic companies do not need to know what percent of drug sales are for oncology versus dermatology. How or even whether the generic version will be used is largely irrelevant to the generic companies. While the patient and doctor may know that the intent of the drug prescription is to treat a patented indication, the generic drug company does not and cannot know. In fact, it might be callous (but true) to say that the generic drug company does not care how the patient uses its drug. All the generic drug company does is put its product at the top of the distribution chain and whatever happens to the product downstream does not matter. Whether a patient takes the drug for indication #1 as labeled or for carved-out indications #2, #3, or #4, or for a complete off-label use, is of no consequence to the generic company. A buyer may choose to buy generic product, not distribute it all, and hold it in inventory. The buyer could choose to resell the generic product in other countries. The point is, because the generic drug market is concentrated, the generic drug company doesn’t really know or care how the drug is later used and by whom. To this end, since a generic company does not need to know prescription share allocation amongst indications, there is zero point in housing such information internally.
Sixth, during ANDA development and initial planning, the legal department will advise regulatory affairs about label redactions and marketing about marketing communications. Now post-approval the FDA may request that the company update its label. Reflexively and perhaps unthinkingly, the regulatory affairs department may add back any carved language, without consulting the legal department. In sum, if during the ANDA development the legal department has advised on a course of action, no department should take contrary actions without checking with legal. Marketing departments, in cooperation with legal, should also review any commercial marketing literature, such as scrubbing slide decks; scrub any FAQ’s; scrub sales call scripts; review press releases; and avoid implying full equivalence for all uses; etc.
The activities raise the fundamental issue between marketing departments who want to say anything and everything versus the legal department who wants to ensure minimal legal exposure. And when necessary, marketing must yield to the law department.
Ultimately, the Supreme Court’s decision will likely determine whether Section viii remains economically viable. If passive, lawful conduct can trigger discovery and the threat of lost-profit or trebled damages, many generics may conclude that skinny labels are no longer worth the risk. That would tilt the balance of Hatch-Waxman, potentially extending de facto exclusivity for brand companies beyond what Congress intended.
Argument is scheduled for April 29, with a decision expected by the end of the Term. Generic manufacturers should monitor the case closely and evaluate their labeling strategy, ANDA planning, and launch communications accordingly.
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