From Lab to Lawsuit:
Pharma’s Litigation Lifecycle in 2025

September 12, 2025

In 2025, the pharmaceutical industry finds itself in a courtroom drama that stretches from the laboratory bench to the pharmacy checkout line. The actors are familiar—AbbVie, Amgen, Kroger, Walgreens, CVS, Takeda—but the script has changed. Litigation is no longer confined to one corner of the market. Instead, lawsuits are surfacing at every stage of the drug lifecycle, revealing a continuum of risk that forces companies to think differently about how they innovate, compete, and sell.

Fragile Partnerships and the High Price of Talent Mobility

AbbVie’s lawsuit against Genmab highlights a recurring challenge in the age of high-value biotech collaborations: how to balance innovation with intellectual property security. At issue are alleged trade secrets surrounding antibody-drug conjugate (ADC) linker chemistry. Trade secret protection under the Defend Trade Secrets Act of 2016 (DTSA), 18 U.S.C. §1836, allows a federal cause of action for misappropriation of confidential know-how. Courts applying the DTSA have consistently emphasized that liability can attach even when information is carried in an employee’s memory (see Allstate Ins. Co. v. Fougere, 79 F.4th (1st Cir. 2023).

This isn’t AbbVie’s first such fight. In AbbVie Inc. v. Adcentrx Therapeutics, Inc. (N.D. Ill. 2021), it alleged misappropriation of ADC payload designs by a former scientist turned startup founder. These cases illustrate the legal tension between employee mobility—protected under state law public policy (e.g., PepsiCo, Inc. v. Redmond, 54 F.3d 1262 (7th Cir. 1995))—and the safeguarding of trade secrets. For acquirers like Genmab, the takeaway is stark: due diligence in M&A must extend beyond patents into the provenance of tacit knowledge that may later be challenged as stolen.

Procedure as Strategy: Amgen and the BPCIA

Amgen’s litigation campaign to protect denosumab (Prolia/Xgeva) shows how statutory frameworks can become tools of competition. The Biologics Price Competition and Innovation Act (BPCIA) of 2009 (42 U.S.C. §262(l)) requires biosimilar applicants to engage in a structured “patent dance,” exchanging manufacturing and patent information with reference product sponsors. Courts have underscored that failure to comply can itself form the basis for litigation leverage (Amgen Inc. v. Sandoz Inc., 877 F.3d 1315 (Fed. Cir. 2017); Sandoz Inc. v. Amgen Inc., 582 U.S. 397 (2017)).

By alleging that Biocon failed to meet these disclosure obligations, Amgen isn’t just defending patents—it’s invoking statutory procedure as a substantive weapon. Similar dynamics appear in Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896 (Fed. Cir. 2025), where disputes over disclosure timing under the BPCIA shaped the contours of the infringement case. The lesson is clear: in biologics, law and science move in tandem, and procedural missteps can cost as much as substantive ones.

The Transparency Reckoning in Pharmacy Pricing

Further downstream, lawsuits against Kroger, Walgreens, CVS, and Rite Aid reflect a different kind of legal exposure: consumer protection. Plaintiffs allege that these chains reported inflated “usual and customary” (U&C) prices to insurers, causing insured patients to pay higher copays than cash customers. Courts have repeatedly held that U&C prices reported to insurers must reflect the lowest cash price available to the general public (U.S. ex rel. Garbe v. Kmart Corp., 824 F.3d 632 (7th Cir. 2016)).

Walgreens agreed in late 2024 to a $100 million settlement resolving nationwide claims tied to its Prescription Savings Club, effectively conceding that the program was no longer sustainable under judicial scrutiny. CVS now faces claims from state attorneys general alleging false Medicaid submissions, while similar suits have been brought by private insurers such as Blue Cross plans (Blue Cross & Blue Shield of Ala. v. CVS Health Corp., No. 1:20-cv-00236, 2020, U.S. Dist. LEXIS___ (D.R.I. May 27, 2020). The Kroger case, with class certification granted in April 2025, marks the next wave of this litigation.

The trend line is unmistakable: consumer class actions and qui tam suits are converging on retail pricing practices, weaponizing both federal statutes (e.g., False Claims Act, 31 U.S.C. §3729) and state consumer protection laws.

Antitrust Crosscurrents: Retailers as Plaintiffs

In a striking role reversal, Kroger, Walgreens, and H-E-B are now plaintiffs in an antitrust lawsuit against Takeda, alleging exclusionary tactics that delayed generic entry for the acid reflux drug Dexilant. The claims echo the line of “pay-for-delay” cases that culminated in the Supreme Court’s landmark ruling in FTC v. Actavis, Inc., 570 U.S. 136 (2013), which held that reverse-payment settlements can violate the Sherman Act, 15 U.S.C. §1.

The significance is not just the legal theory but the optics: retailers, often cast as defendants in consumer suits, are reframing themselves as victims of manufacturer overreach. The litigation illustrates the multidirectional nature of antitrust law in pharma—today’s distributor can be tomorrow’s antitrust plaintiff, depending on where competitive harm is felt.

The Larger Pattern

Taken together, these lawsuits map onto a single continuum. Trade secret law protects the earliest stages of innovation but is strained by talent mobility. Statutory frameworks like the BPCIA shape mid-stage competition between biologics and biosimilars. Consumer protection and fraud statutes challenge the fairness of pricing at the retail level. And antitrust law polices the boundaries of competition in the marketplace.

What is striking is the simultaneity: never before have courts been asked to decide, almost in parallel, whether knowledge, procedure, price, and market conduct are lawful. The result is a system in which litigation has become structural, not episodic.

Looking Ahead: The Next Wave of Litigation

If these cases mark the present fault lines, where might the next ones appear? Several emerging areas suggest themselves:

• AI in Drug Discovery: As machine learning becomes embedded in target identification and clinical trial design, disputes are likely to arise over inventorship (cf. Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022)) and data ownership. Expect questions about whether proprietary training data constitutes a trade secret under the DTSA.

• PBM Reform and Transparency: With federal and state lawmakers scrutinizing pharmacy benefit managers, future litigation may focus on spread pricing and rebate structures—echoing the U&C pricing disputes but with higher stakes for the entire reimbursement chain.

• Cell and Gene Therapy Pricing: As payers balk at multimillion-dollar one-time treatments, manufacturers may face contract, fraud, or consumer protection claims tied to outcomes-based pricing models.

• Climate and ESG Litigation: Drug manufacturing’s environmental footprint could spur suits under environmental statutes, adding another flank to litigation risk.

The connective thread is this: as science, law, and markets converge, every innovation creates not only opportunity but new categories of legal exposure.

Why It Matters

For companies in life sciences and healthcare, litigation risk now travels with the molecule. From lab bench to retail shelf, every stage is a potential battleground. The challenge is not just to defend against isolated claims but to anticipate the continuum. Firms that treat litigation as siloed—patent here, pricing there, antitrust somewhere else—will be blindsided. Those that view litigation as structural will be positioned to innovate, compete, and endure in an industry where the courtroom has become as consequential as the clinic.