Beyond Hikma: Patent Prosecution Strategies for Anticipating Skinny-Label Generics in Pharmaceutical Patent Portfolios

Introduction

The Supreme Court’s recent decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. has renewed attention on a persistent challenge facing innovative pharmaceutical companies: protecting patented methods of treatment in a regulatory framework that permits generic manufacturers to market products with “skinny” labels. [1] While the decision arose in the context of pleading induced infringement, it offers lessons beyond litigation.

For innovators, Hikma underscores the importance of thoughtfully integrating patent prosecution, portfolio development, and regulatory strategy. While a patent directed to a commercially valuable indication can provide substantial protection, Hikma highlights the importance of considering the impact of alternative therapeutic uses, treatment instructions, or labeling content that remains unprotected. Hikma serves as a reminder to obtain patent protection that meaningfully covers all of the product’s uses.

This article examines the lessons Hikma offers innovative drug companies exploring patent prosecution and portfolio development strategies that can help innovators reduce the risks associated with generic “skinny” label carve-outs.

Skinny Labels and The Hikma Decision

Hatch-Waxman and Section viii Carve-Outs

The Hatch-Waxman Act established the modern regulatory framework for generic drug approval in the United States. [2] It allows a generic manufacturer to seek approval of a generic version of a previously approved drug by filing an Abbreviated New Drug Application (ANDA), relying on safety and efficacy data submitted by the innovative drug companies.[3]

When the innovator’s previously approved drug is protected by patents identified in the FDA’s Orange Book, an ANDA applicant must address those patents through one of four statutory certifications:

1. Paragraph I certification states that no relevant patent information has been submitted to the FDA;

2. Paragraph II certification asserts that the relevant patents have expired;

3. Paragraph III certification acknowledges the patents and states that the generic product will not be marketed until patent expiration;

4. Paragraph IV certification asserts that the listed patents are invalid or will not be infringed by the manufacture, use, or sale of the generic product.[4]

By contesting validity or noninfringement via a Paragraph IV certification, generic manufacturers can seek FDA approval and market entry prior to patent expiration but have committed a statutory act of infringement.[5] An innovator, in turn, can institute litigation under the Hatch-Waxman Act to prevent generic approval prior to patent expiration.[6] Since the generic product is not yet on the market, the question is one of hypothetical future infringement. For patents claiming methods of treatment or use, the issue for induced infringement is typically whether following the generic product’s labeling instructions would lead physicians or patients to infringe.

The Hatch-Waxman framework, however, contains another mechanism for generic approval. Section 505(j)(2)(A)(viii) permits a generic applicant to omit from its proposed labeling indications for treatment or methods of use that are patent-protected, while seeking approval for other non-patented, FDA-approved uses.[7] This process, commonly referred to as a “Section viii” carve-out, allows approval of a generic product with a “skinny label” that excludes the patented indication.[8] Examples of skinny labeling that generics have targeted include:

• Removing a patented dosage regimen from the brand-name label while retaining other dosage regimens not covered by the asserted patents.[9]

• Removing patented indications from the brand-name label while retaining one or more non-patented indications.[10]

• Removing clinical trial information discussing superiority data and other associated data of the brand-name drug.[11]

Even where a generic manufacturer has attempted to carve out a patented indication, however, questions may remain regarding whether the generic manufacturer’s label, or other evidence, nonetheless encourages use of the product for the patented method. For example, where the generic manufacturer has carved out express language directed to a patented dosage regimen, the label may still at least implicitly instruct and encourage use of that dosage regimen and induce infringement by inevitably leading at least some patients to practice the patented method.[12]

Skinny label disputes most frequently arise in the context of Hatch-Waxman litigation prior to generic approval, where, as above, the question is hypothetical future infringement based on the generic’s label. [13] There have also been notable cases addressing actual—not hypothetical future—infringement in a post-launch, non-Hatch-Waxman. In the post-launch context, additional conduct by the generic—such as promotions or press releases—beyond the label can be relevant to inducement.[14] Most recently, the Supreme Court addressed both labeling and post-approval evidence in the Hikma decision.

The Hikma Decision

The Supreme Court’s Hikma decision addressed the unique post-launch, non-Hatch-Waxman litigation dispute concerning whether Amarin plausibly pled that Hikma’s skinny label and other related conduct induced infringement of Amarin’s patents. [15] Vascepa® was originally approved only for the treatment of severe hypertriglyceridemia (the “SH indication”) and, several years later, further approved for the reduction of cardiovascular risk of hypertriglyceridemia in patients taking statins (the “CV indication”). [16],[17] Amarin obtained separate patents directed to each of the SH and CV indications.[18] Among these were patents directed to reducing cardiovascular risk in certain patients with hypertriglyceridemia through administration of icosapent ethyl, marketed by Amarin as Vascepa®.[19]

Hikma sought approval for a generic version of Vascepa® for the SH indication, which was the only approved indication at the time of Hikma’s ANDA filing. [20] In its ANDA, Hikma filed a Paragraph IV certification challenging Amarin’s patents associated with the SH indication. [21] Amarin subsequently brought Hatch-Waxman litigation against Hikma, where Amarin’s asserted SH patents were held invalid as obvious. [22] After Amarin obtained FDA approval for the CV indication, Hikma supplemented its ANDA with a Section viii statement to carve out the patented CV indication such that its label only included the SH indication.[23] The FDA approved Hikma’s revised skinny labeling, allowing Hikma to launch its generic in November 2020.[24]

Following Hikma’s launch of its skinny labeled generic product, Amarin filed suit, alleging induced infringement of Amarin’s patents covering the CV indication. [25] Amarin contended in its complaint that the totality of Hikma’s conduct—including its product label, statements contained in the product leaflet, and website statements regarding the drug’s therapeutic use—encouraged health care providers to prescribe Hikma’s generic product for the patented CV indication even though Hikma had carved out the CV indication from its label.[26] The district court dismissed the complaint for failure to state a claim under Rule 12(b)(6), but the Federal Circuit reversed, holding that Amarin’s allegations were sufficiently plausible to survive a motion to dismiss.[27]

The Supreme Court, however, reversed the Federal Circuit, holding instead that Amarin’s complaint failed to plausibly plead that Hikma’s conduct induced the alleged infringement. [28]

The Supreme Court extended its jurisprudence for induced infringement to the post-approval generic context.[29] First, mere foreseeability of infringement was insufficient to plausibly plead inducement in the post-launch context on the Amarin facts.[30] Second, to plausibly plead inducement in the post-launch context, plaintiffs are not limited to the language of a generic drug label and may identify affirmative steps by the generic manufacturer that encourage infringement.[31]

Third, courts may consider obvious non-infringing explanations for the accused conduct, such as where a defendant’s statements or actions are equally consistent with lawful, non-infringing uses of the product. [32] Finally, on facts similar to Hikma, post-launch it may be insufficient to merely plead that a generic manufacturer is liable because its product is capable of infringing use.[33]

Taken together, under Hikma, the focus of post-launch inducement remains on the accused inducer’s conduct rather than the existence of downstream infringement.[34]

What Hikma Did Not Address

Although Hikma has generated significant discussion, it is important to be clear on what it did not address or change.

First, Hikma does not alter the legal framework governing traditional Paragraph IV litigation. The case arose in the distinct context of pleading post-launch inducement by a marketed, skinny-labeled generic product.

Second, Hikma does not preclude or eliminate induced infringement claims involving marketed generic skinny-labeled products. Such claims can still be pled and remain viable where one can plead facts to demonstrate that a generic manufacturer actively encouraged infringing use.

Third, the traditional elements of inducement remain unchanged. A patentee must still establish: (1) direct infringement, such as by a third party; (2) knowledge of the inducing party that the induced acts constitute patent infringement; and (3) active steps by the inducing party taken to encourage infringement.[35] Hikma is primarily concerned with the type of allegations that can be relied upon to plead the third requirement.

Fourth, circumstantial evidence remains relevant. The Court did not reject the use of circumstantial evidence to plead inducement. Rather, it emphasized that well-pled facts, circumstantial or otherwise, must “nudge a claim ‘across the line from conceivable to plausible’” to satisfy pleading standards. [36]

Finally, statements made outside the product label remain potentially significant.[37] Public communications, marketing statements, educational materials, and other conduct may still support inducement allegations. Physician behavior likewise remains relevant insofar as it may demonstrate the practical effect of the generic manufacturer’s actions.

Hikma thus does not eliminate or preclude pleading induced infringement, whether for an identical label or a skinny label, either pre-launch (Hatch-Waxman) or post-launch. Instead, it simply reinforces the applicable standards for plausibly pleading post-launch inducement. To try to avoid Amarin’s fate in Hikma, innovators can develop patent portfolios that minimize dependence on inducement theories that can be undercut by generic skinny labeling.

Patent Prosecution Strategies for Reducing Skinnylabel Run-Arounds

The central lesson of Hikma for innovative pharmaceutical companies is straightforward: the strongest patent portfolios leave generic competitors without non-infringing pathways to market. Hikma further underscores the importance of coordination between patent counsel and clinical teams to identify, evaluate, and protect the full scope of therapeutic innovations, including uses that may not ultimately appear as a formal indication on a future label.

Accordingly, patent prosecution strategy would be wise to consider protecting all indications that may appear on the product label as well as other information related to a drug’s safe and efficacious use. Leaving even one indication unprotected may pave the way for a generic skinny label, as in Hikma.

1. Align Patent Strategy with Future Labeling Strategy

As discussed above, Hikma underscores the importance of prosecution counsel developing a comprehensive understanding of how a drug may be used to treat and therapeutically benefit patients. Those insights should be reflected in the specification from the outset to ensure that those innovations can be claimed and protected later, without necessarily knowing in advance what will ultimately appear on the approved label.

For example, clinical studies may reveal that a drug produces a particular therapeutic benefit in a defined patient population or under specific treatment conditions. While it may not be possible to predict what aspects of the clinical trial will be incorporated into the label, patent counsel should build a foundation to protect the discoveries by ensuring that they are adequately described in the specification and pursued through claims across the patent family.

The closer a patent claim aligns with treatment instructions that must appear on the label, the more difficult it may be for a generic manufacturer to omit those instructions while still marketing its product for the approved use. This principle extends beyond the label’s specific indications. Treatment parameters that are central to safe and effective use may present particularly valuable opportunities for patent protection because they are often difficult to exclude from labeling.

To this end, the label should be viewed holistically from a patenting strategy. In other words, patented treatment instructions need not be confined to the Indications and Usage section. Claim limitations may also correspond to disclosures appearing in sections such as Dosage and Administration, Drug Interactions, Use in Specific Populations, Warnings and Precautions, or Adverse Reactions. To the extent those disclosures are necessary for the safe and effective use of the drug, a generic manufacturer may have greater difficulty omitting them from its labeling without undermining the approved use, thereby reducing carve-out opportunities. The more patented subject matter integrated throughout the label, the fewer opportunities exist for competitors to rely on carve-outs while preserving the product’s commercial utility.

For example, if clinical studies demonstrate that a cardiovascular benefit is observed only when patients maintain triglyceride levels below a specified threshold throughout treatment, an innovator may pursue claims directed to treatment methods requiring that parameter. If the threshold later becomes a necessary treatment instruction reflected in the approved labeling, a generic manufacturer may have difficulty carving out that instruction without undermining the approved use, potentially strengthening the innovator’s infringement position.

However, this does not mean that narrower species claims are always preferable. Overly restrictive claims may leave adjacent uses unprotected. For example, a claim limited to treating patients under eighteen years of age with elevated triglyceride levels may fail to cover the broader adult patient population, creating opportunities for competitors to market products for non-claimed uses while still capturing a significant portion of the market. Patent strategy therefore requires balancing specificity with meaningful commercial coverage.[38]

By coordinating patent and regulatory planning early in development, innovators may improve the likelihood that critical treatment instructions are protected with appropriate patent coverage reflecting their innovative contribution.

2. Pursue Broad and Overlapping Protection Across and Beyond Indications

One of the most effective ways to address potential skinny labels is to pursue patent protection covering the full range of clinically meaningful uses of a product. Innovators frequently focus prosecution efforts on lead indications supporting initial approval, but over time a product’s commercial value often extends far beyond its initial labeled use.

Accordingly, patent portfolios should include claims directed not only to important therapeutic indications, but also to other innovative ways in which the drug is administered and used in practice. The point is that even if a generic manufacturer can carve out a specific limitation, its skinny label may still induce claimed methods that apply to all possible indications.

For example, innovators should consider pursuing:

• Disease-independent treatment claims, such as methods of treating a patient using a particular dose or dosing regimen;

• Claims directed to methods of adjusting dosage for special patient populations, such as patients receiving concomitant medications or patients with impaired organ function;

• Titration, maintenance, loading-dose, or dose-escalation regimen claims;

• Claims directed to achieving particular therapeutic outcomes or clinical benefits resulting from treatment;

• Claims directed to patient subpopulations defined by clinical characteristics, biomarkers, or treatment response; and

• Combination therapy or treatment-sequencing methods involving a drug.

By protecting inventions relating to how a drug is administered to a patient independent of the specific indications, a skinny label may nonetheless fall squarely within the scope of the claims.

Conclusion

For innovative pharmaceutical companies, the Supreme Court’s decision in Hikma highlights the importance of integrating patent prosecution, portfolio management, regulatory planning, and labeling strategy from the earliest stages of product development. By securing protection for all therapeutic uses, building layered patent portfolios, aligning claim scope with anticipated labeling requirements, and minimizing unprotected label content, innovators may be able to reduce opportunities for meaningful carve-outs and strengthen their competitive position.

At the same time, there is no one-size-fits-all approach. Effective planning requires careful consideration of not only the factors discussed here, but also the overall strategies innovative pharmaceutical companies need to meet their bottom line.

Ultimately, Hikma is a lesson in preparation. The most effective response to skinny-label filers is best developed long before the innovator’s product reaches the market, through deliberate patent prosecution strategies designed to ensure that innovations stay protected.

Endnotes

1. Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391, 1397 (2026).

2. H.R. 3605, 98th Cong. (1983–1984), Congress.gov, https://www.congress.gov/bill/98th-congress/house-bill/3605 (last visited Aug. 7, 2026) (“Drug Price Competition and Patent Term Restoration Act of 1984… Amends the Federal Food, Drug, and Cosmetic Act to authorize abbreviated applications for the approval of a new drug.”). 

3. Id.; Food & Drug Administration, https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatchwaxman-letters (last visited July 15, 2026).

4. 21 U.S.C. §355.

5. 35 U.S.C. § 271(e)(2) (“It shall be an act of infringement to submit … an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent… if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug, veterinary biological product, or biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.”).

6. 35 U.S.C. § 271(e)(4) (“For an act of infringement described in paragraph (2) … the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed[.]”); Food & Drug Administration, https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions (last visited July 15, 2026)

7. 21 U.S.C. §355(j)(2)(A)(viii).

8. Id. (“if with respect to the listed drug referred to in clause (i) information was filed under subsection (b) or (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use.”).

9. AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1047 (Fed. Cir. 2010) (“Apotex also submitted a section viii statement asserting that it was not seeking approval for the once-daily method of use claimed in the ′603 and â€²099 patents and that its proposed generic label would contain no explicit mention of once-daily administration.”).

10. Grunenthal GMBH v. Alkem Lab’ys Ltd. , 919 F.3d 1333, 1339, 1340 (Fed. Cir. 2019) (“Hikma and Actavis each filed ANDAs seeking approval to market a generic version of tapentadol hydrochloride extended release tablets. Both parties filed ‘Section viii’ statements under 21 U.S.C. § 355(j)(2)(A)(viii), whereby Hikma and Actavis told FDA that they will not seek FDA approval for an indication directed to the treatment of DPN… both Hikma andActavis filed ‘Section viii’ statements with FDA specifically carving out the [claimed] indication.”).

11. H. Lundbeck A/S v. Lupin Ltd., 87 F.4th 1361, 1371 (Fed. Cir. 2023) (“Here, defendants’ ANDA labels ‘carved out’ the superiority data in the clinical studies portion of the label and the cross-reference to that data.”).

12. AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010) (“[T]he district court found that Apotex had the requisite specific intent to induce infringement because Apotex included instructions in its proposed label that will cause at least some users to infringe the asserted method claims…. Even if Apotex were correct that the downward-titration language may be applied to other dosing regimens, the language is still applicable to the recommended starting doses and, as correctly determined by the district court, would inevitably lead some consumers to practice the claimed method.”).

13. Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365–66 (Fed. Cir. 2003) (“The proper inquiry under §271(e)(2)(A) is whether, if a particular drug were put on the market, it would infringe the relevant patent.”).

14. GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020).

15. Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391 (2026).

16. Id. at 1398.

17. Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370, 1372-73 (Fed. Cir. 2024).

18. Id. at 1372, 1372 n.4.

19. Id. at 1372-73.

20. Id.

21. Id. at 1372 n. 4.

22. Id.

23. Id. at 1373.

24. Id. at 1374.

25. Id.

26. Id. at 1375.

27. Id. at 1375, 1377-81.

28. Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391, 1401-03 (2026)

29. Id. at 1399 (“Our well-established federal pleading standards are not up for debate in this case…This case requires us to apply these familiar pleading standards to the third element of an induced-infringement claim: that the inducer took ‘active steps ... to encourage direct infringement.’”).

30. Id. at 1400 n. 3.

31. Id. at 1402 (“So the question is not merely whether the statements could be ‘plausibly underst[oo]d’ to induce infringement, but whether they plausibly constitute ‘affirmative steps to bring about the desired result’ of infringement.”).

32. Id. at 1401 (“First, several of the relevant statements have an ‘obvious alternative explanation’…[i]t is true, as Amarin complains, that Hikma’s label omitted the CV Limitation of Use and retained information about a clinical study involving patients taking statins, just as Amarin’s label did. But that is because, by statute, Hikma’s label must be identical to Amarin’s except for the carved-out use, barring specified circumstances not applicable here.”).

33. Id. at 1399 (“If the complaint ‘pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.’”).

34. Id. at 1402 (“So the question is not merely whether the statements could be ‘plausibly underst[oo]d’ to induce infringement, but whether they plausibly constitute ‘affirmative steps to bring about the desired result’ of infringement.”).

35. Limelight Networks, Inc. v. Akamai Technologies, Inc., 572 U.S. 915 (2014); Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011); Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005).

36. Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391, 1399 (2026).

37. Id. at 1400 (citing Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 935 (2005)).

38. See generally H. Lundbeck A/S v. Lupin Ltd., 87 F.4th 1361 (Fed. Cir. 2023).