BPCIA Litigation: Key District Courts And Judges Shaping The Biologics Landscape

By analyzing a decade's worth of BPCIA filings, we have gained insight into how venue strategy, repeat players, and specialized counsel are shaping the contours of this complex and competitive legal landscape.

To stay ahead of litigation trends in evolving industries, WIT regularly examines its core practice areas to identify patterns in past disputes and anticipate where future challenges may arise. In this follow-up to our previous analysis of BPCIA biologics litigation, we shift our focus from the products and patents at issue to the players driving the disputes: the courts hearing these cases, the judges overseeing them, the parties involved, and the law firms and attorneys leading the charge. By analyzing a decade's worth of filings, we're gaining insight into how venue strategy, repeat players, and specialized counsel are shaping the contours of this complex and competitive legal landscape.

Let's take a closer look.

Q: Which federal district courts are most frequently involved in BPCIA biologics litigation?

A: BPCIA litigation is highly concentrated in a few venues. The District of Delaware tops the list, handling over a third (37%) of all cases. The District of New Jersey follows at 24%, with all other courts falling well below 15%.

This venue concentration isn't surprising. Both Delaware and New Jersey are home to many U.S. pharmaceutical company headquarters or subsidiaries, giving rise to personal jurisdiction. These courts also have deep experience with complex patent cases and well-established local rules for managing Hatch-Waxman and BPCIA litigation. In particular, the judges in these districts are known for handling high-stakes pharmaceutical patent disputes efficiently, making them favored forums for both plaintiffs and defendants.

The Northern District of West Virginia — where Mylan was historically headquartered — also appears more frequently due to venue ties in specific biosimilar cases.

Q: Are certain judges consistently overseeing BPCIA cases, and what does that suggest about venue strategy?

A: A handful of judges have become recurring figures in BPCIA litigation, reinforcing the strategic pull of certain districts. Chief Judge Colm Connolly of the District of Delaware has presided over nearly a quarter of all cases (24%), far more than any other judge. In New Jersey, Judges Christine O'Hearn and Renée Bumb each account for about 7% of cases, followed by Judge Claire Cecchi at 6%. And in the Northern District of West Virginia, Judge Thomas Kleeh oversaw all six cases filed there.

This concentration suggests that parties are not only choosing districts with established pharmaceutical expertise, but are also becoming familiar with — and potentially planning around — the practices and preferences of specific judges. Knowing how a judge approaches scheduling, discovery disputes, and claim construction can be a meaningful advantage in high-stakes BPCIA litigation.

Q: Which parent companies are most active in BPCIA litigation and who represents them?

A: Unsurprisingly, Amgen dominates BPCIA litigation, appearing in over 20 cases, which is more than any other company by a wide margin. It frequently appears as both plaintiff and defendant, reflecting its early entry into the biosimilars market and robust patent portfolio. Amgen's litigation is spread across several major firms, including Paul Weiss, Sidley Austin, Proskauer Rose, and Dechert, showing a strategic approach that leverages multiple specialized teams depending on the case.

Other highly active companies include:

• Regeneron: involved in at least 7 cases, frequently represented by Kellogg Hansen, Williams & Connolly, and Weil Gotshal.
• Celltrion, Sandoz, and Samsung also appear repeatedly, often teaming with firms like Fish & Richardson, Goodwin, and Quinn Emanuel.

The data suggests that larger players are deploying a deep bench of outside counsel, often partnering with firms experienced in both life sciences IP and high-stakes litigation. The variation in firm selection — even within the same company — reflects the complexity and nuance of BPCIA disputes, where venue, judge familiarity, and specific scientific issues all factor into representation strategy.

Q: Which attorneys and law firms appear most frequently in BPCIA biologics litigation, and what can that tell us about who's leading the charge in this niche field?

A: The attorneys most active in BPCIA litigation cluster around a handful of powerhouse firms—many with deep IP benches and long track records in life sciences disputes. Unsurprisingly, in-house counsel at Amgen dominate the top of the list, with Wendy Whiteford leading all attorneys by appearing in 14 cases, followed closely by Kimberlin Morley, Lois Kwasigroch, and others from Amgen's experienced internal legal team. This underscores Amgen's central role in shaping BPCIA litigation strategy from the inside out.

Among outside counsel, three firms stand out:

• Williams & Connolly: Led by litigators like Thomas Fletcher and David Berl (each with 14 cases), this team is frequently tapped for its trial expertise and biotech depth.
• Paul, Weiss: Attorneys such as Jennifer Wu, Nicholas Groombridge, and Stephen Maniscalco appear across multiple high-profile matters, reflecting the firm's expanding biotech IP footprint.
• WilmerHale and Sidley Austin also field robust BPCIA teams, with multiple attorneys appearing in 5+ cases each—particularly William Lee (WilmerHale) and Sue Wang (Sidley).

These repeated appearances signal more than just client trust — they suggest deep familiarity with the procedural and scientific complexity of BPCIA cases. Many of these litigators are becoming go-to names in biosimilar litigation, shaping case law and influencing how future disputes will be tried.

Q: Which companies appear most often as plaintiffs and which as defendants in BPCIA biologics litigation, and what does that reveal about their roles in shaping the market?

A: The data shows a clear split between originator companies, who dominate as plaintiffs, and biosimilar manufacturers, who most often appear as defendants. Leading the charge is Amgen, which stands out as the most active plaintiff by far, with 20 appearances in that role (and 8 as a defendant), underscoring its dual position as both an aggressive enforcer of biologic IP and a key player in biosimilar development.

Other frequent plaintiffs include:

• Genentech (17 plaintiff appearances)
• Regeneron Pharmaceuticals (7)
• AbbVie (4)
• Janssen Biotech (3)

Meanwhile, biosimilar makers like Samsung Bioepis, Celltrion, and Sandoz appear more frequently on the defense side. For instance, Samsung Bioepis and Celltrion Healthcare have 4+ defendant-side appearances each, reflecting their active efforts to bring biosimilars to market, often into patent-heavy therapeutic areas.

This divide reflects broader market dynamics: originators are focused on defending exclusivity, while biosimilar developers are testing the boundaries of early entry. The heavy litigation activity on both sides speaks to the competitive pressure in high-value drug classes, especially as more biologics reach the end of exclusivity and the FDA's biosimilar pathway matures.

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