In the world of Hatch-Waxman, the judge is the ultimate X-factor. Their individual philosophies on case management, their doctrinal leanings on issues like obviousness and claim construction, and their tolerance for procedural gamesmanship can dramatically alter the strategic calculus for both brand-name innovators and generic challengers. Choosing the right venue—and understanding the proclivities of the judge you’re likely to draw—has become the most critical strategic decision a company can make. This report is designed to be your definitive guide to that decision. We’re moving beyond surface-level statistics to provide a deep, analytical dive into the jurists who matter most. We will dissect their backgrounds, their landmark rulings, their case management styles, and their statistical track records to give you the actionable intelligence needed to turn judicial insight into a powerful competitive advantage.
More Than a Law, It’s an Ecosystem
To grasp the outsized importance of individual judges, we must first appreciate the unique ecosystem the Hatch-Waxman Act created. Enacted in 1984, the Drug Price Competition and Patent Term Restoration Act was a grand compromise.1 It sought to balance two competing interests: incentivizing the massive R&D investment required for new drug innovation and facilitating the swift market entry of low-cost generic alternatives once patents and exclusivities expired.2
The Act achieved this through a series of interlocking mechanisms that form the bedrock of the modern pharmaceutical industry. It created the ANDA pathway, allowing generic manufacturers to rely on the brand’s safety and efficacy data, dramatically lowering the barrier to entry.5 In exchange, it offered brand innovators patent term extensions to compensate for regulatory delays and periods of market exclusivity to protect their investment.5
Crucially, the Act designed a formal, structured process for patent disputes. A generic company wishing to launch before a brand’s patents expire files a Paragraph IV certification, asserting the patents are invalid or not infringed.10 This filing is deemed an “artificial” act of infringement, a legal construct that allows a patent dispute to be litigated and resolved
before a generic product hits the market and causes potentially irreparable harm to the brand.11 This act triggers a 45-day window for the brand to sue, which in turn imposes an automatic 30-month stay on FDA approval of the generic, creating a defined period for litigation.4
And for the generic challenger, there’s a powerful incentive: the first to file a successful Paragraph IV challenge is rewarded with 180 days of market exclusivity—a “golden ticket” that can be worth hundreds of millions of dollars, as it allows the first generic to compete only with the brand, not with a dozen other generics.3
The result? Litigation is not a bug in the Hatch-Waxman system; it’s a core feature. The framework was explicitly designed to encourage patent challenges and resolve them in court.5 This means that for any drug of significant commercial value, the question is not
if a lawsuit will be filed, but where it will be filed and, most importantly, before whom it will be decided. The artificial nature of the infringement act shifts the entire strategic focus away from the merits alone and squarely onto the procedural and judicial environment where those merits will be judged.
The Shifting Epicenter: Why Delaware and New Jersey Still Reign Supreme
For decades, the answer to the “where” question has been overwhelmingly simple: Delaware or New Jersey. This concentration is no accident. Many pharmaceutical and biotech companies are incorporated in Delaware due to its favorable corporate laws, making it a natural venue for litigation. New Jersey, meanwhile, is home to the headquarters and major operations of numerous global pharmaceutical giants, establishing a strong nexus for legal disputes.13 Data consistently shows these two districts handle the vast majority of all ANDA cases filed in the United States.14
For years, legal analysts predicted that the Supreme Court’s 2017 decision in TC Heartland, which tightened the rules for patent venue, would break this duopoly and disperse Hatch-Waxman cases across the country.13 The logic was that brands could no longer sue a generic company anywhere it planned to sell its product. Instead, venue would be restricted primarily to the generic’s state of incorporation or a district where it has a “regular and established place of business” and committed the “act of infringement”—the ANDA submission itself.
Initially, however, the great dispersal never happened. Delaware and New Jersey, by virtue of their deep-seated connections to the industry, remained the undisputed epicenters of ANDA litigation.14 But now, something is changing. The ground is shifting beneath our feet, not in the way analysts predicted, but in a far more strategically significant manner.
Recent data reveals a dramatic realignment between the two dominant venues. In 2024, the District of New Jersey saw an astonishing 100% year-over-year increase in ANDA case filings, surging from 85 to 170 cases. During that same period, the District of Delaware experienced an 18% decrease, from 142 to 116 cases.18 This is not a random fluctuation. It is a market-driven, strategic migration. Litigants are actively choosing one powerhouse venue over the other.
This shift is not being driven by a single court decision or a change in statutory law. It’s being driven by the perceived judicial climate in each district. As we will explore in detail, a series of aggressive, efficiency-focused standing orders from key judges in Delaware have made litigating there more demanding, more rigid, and, for some, more perilous. This “push” from Delaware, combined with the “pull” of New Jersey’s reputation for pragmatic and experienced case management, is creating a powerful current that is redirecting the flow of high-stakes pharmaceutical litigation. Understanding this dynamic—and the judges who are causing it—is the key to navigating the landscape in 2025 and beyond.
Meet the Gatekeepers: Introducing the Top 5 Most Active Judges
The concentration of cases in Delaware and New Jersey has created a small, elite group of federal judges who wield immense power over the pharmaceutical industry. A staggering 50% of all ANDA complaints filed in 2024 were assigned to just five judges.15 Their dockets are a who’s who of blockbuster drugs, and their decisions create ripples that affect business strategy, R&D investment, and M&A activity across the globe.
Based on the most recent case filing data from 2024 and early 2025, and considering their overall influence on the practice, this report will focus on the five jurists who currently form the core of the Hatch-Waxman judicial landscape 15:
The Honorable Richard G. Andrews (District of Delaware)
The Honorable Gregory B. Williams (District of Delaware)
The Honorable Maryellen Noreika (District of Delaware)
The Honorable Brian R. Martinotti (District of New Jersey)
The Honorable Michael A. Shipp (District of New Jersey)
In addition, we will dedicate a special analysis to The Honorable Colm F. Connolly, Chief Judge of the District of Delaware. While his volume of new ANDA cases has fluctuated, his historical caseload is massive, and more importantly, his transformative standing orders on case management are the single biggest factor reshaping litigation strategy in Delaware and driving the venue shift to New Jersey. To understand Delaware, you must first understand the “Connolly Effect.”
Let’s begin by dissecting the power brokers of the First State.
The Delaware Docket: A Deep Dive into the First State’s Power Brokers
The United States District Court for the District of Delaware has long been the premier battleground for patent law, and Hatch-Waxman litigation is its crown jewel. For over a decade, Delaware’s judges have presided over more ANDA cases than all other courts in the country combined.21 This deep well of experience has created a sophisticated and predictable legal environment. However, the recent appointments of new judges and the implementation of transformative procedural rules by its Chief Judge have turned this once-stable system into a dynamic and evolving landscape. Navigating it successfully requires a nuanced understanding of the key players on its bench.
The Veteran Jurist: Hon. Richard G. Andrews
If there is a dean of the Hatch-Waxman bench, it is Judge Richard G. Andrews. With a staggering 481 ANDA cases assigned to him since 2015—more than any other active judge in the nation—his influence is undeniable.19 He is the steady hand, the experienced veteran whose rulings on complex scientific and legal issues are closely watched and highly respected.
Judicial Profile and Path to the Bench
Judge Andrews’ path to the bench is that of a career public servant, a background that distinguishes him from some of his colleagues who hail from private patent litigation practice. After graduating from the University of California, Berkeley School of Law and clerking on the Third Circuit Court of Appeals, he spent over two decades as an Assistant U.S. Attorney for the District of Delaware before becoming the state’s top prosecutor in 2007.22
Nominated by President Barack Obama, he joined the federal bench in 2011.22 In late 2023, he took senior status, a form of semi-retirement for federal judges. However, in a testament to his work ethic and the court’s heavy caseload, he has opted to retain a full caseload, ensuring his continued influence for the foreseeable future.23
Case Management and Judicial Philosophy
Compared to the procedural activism of some other judges in his district, Judge Andrews employs a more traditional, though by no means passive, case management style. He is known for his meticulous preparation, sharp questioning during hearings, and thorough, well-reasoned opinions.
While not the originator of the trend, he has embraced the district’s move toward early and successive case narrowing, recognizing the need for efficiency. In one case, he noted that narrowing the asserted claims to 32 was “reasonable” and ordered further reductions before trial.14 His experience is not limited to small molecules; he has also managed complex discovery disputes in biologics litigation under the Biologics Price Competition and Innovation Act (BPCIA), demonstrating his versatility in the life sciences space.24
His approach to claim construction, the critical process of defining the meaning of patent terms, follows the standard legal framework established in Phillips v. AWH Corp. He relies heavily on the patent’s intrinsic evidence—the claims, specification, and prosecution history—and expects litigants to do the same. His opinions, such as in a dispute over the term “administering” in a weight-loss drug patent, show a deep engagement with the specific language of the patent to resolve disputes, rather than relying on broader, extrinsic dictionary definitions.25
Statistical Deep Dive: The Numbers Behind the Name
The sheer volume of Judge Andrews’ ANDA docket is the most telling statistic. Presiding over 481 such cases since 2015 places him in a class of his own.19 This unparalleled experience means there are few, if any, legal or technical issues in the Hatch-Waxman space that he has not encountered.
While judge-specific win/loss rates can be misleading without controlling for case complexity and settlement dynamics, district-wide trends provide important context. In Delaware, patent challenger (generic) wins at trial have been on an upward trend, climbing from 6% of terminated cases in 2021 to 10% in 2023. During the same period, patentee (brand) wins at trial remained relatively low, moving from 1% to 3%.19 This suggests a judicial environment that, while not overtly hostile to patents, is certainly willing to invalidate them when presented with strong evidence. Judge Andrews’ own record contributes significantly to this overall picture.
Landmark Rulings & Doctrinal Leanings: The Obviousness Expert
Perhaps the most critical area of Judge Andrews’ jurisprudence for pharmaceutical litigants is his sophisticated and evolving approach to the doctrine of obviousness. A patent cannot be granted if the invention would have been “obvious” to a person of ordinary skill in the art. For years, this was a difficult defense for generics to win, especially in cases involving chemical polymorphs—different crystalline forms of the same active ingredient. The Federal Circuit had repeatedly emphasized the unpredictability of polymorphism, making it hard to argue that discovering a new, stable form was merely “obvious”.27
Judge Andrews’ handling of Salix Pharmaceuticals v. Norwich Pharmaceuticals marked a potential turning point. In that case, which involved patents on a polymorphic form of the antibiotic rifaximin, he held the polymorph patent claims invalid as obvious. His reasoning was grounded in a practical, fact-based analysis: the prior art disclosed processes and solvent systems that, according to expert testimony, would have produced the claimed polymorph. He found that a skilled artisan would have been motivated to perform “routine characterization” experiments on the resulting product, which would have revealed its crystalline structure.29
The Federal Circuit, in a closely watched appeal, affirmed his decision. The appellate court emphasized the fact-heavy nature of the inquiry and found no clear error in Judge Andrews’ conclusion that there was a reasonable expectation of success, not in creating a new form out of thin air, but in characterizing the form that resulted from a known process.30 Legal commentary immediately noted that this decision “breathes new life into polymorph claim obviousness arguments”.31
This was not an isolated event. In another case, Judge Andrews again found a patent invalid for obviousness based on the combined teachings of a published clinical study protocol and a journal article, despite arguments about the low success rate of clinical trials generally.32 The Federal Circuit affirmed here as well, agreeing that the combination of references provided a reasonable expectation of success.30
These rulings do not mean that Judge Andrews is reflexively anti-patent. Rather, they reveal a jurist who is deeply engaged with the factual record and expert testimony. He has developed a nuanced framework for obviousness that moves beyond broad generalizations about “unpredictability” and instead focuses on what a real-world scientist would have been motivated to do with the tools and knowledge available at the time.
Strategic Considerations for Litigants
Appearing before Judge Andrews requires a strategy grounded in factual and scientific rigor.
For Brand-Side Litigants: Defending a patent, particularly a polymorph patent, against an obviousness challenge is now a more difficult task in his courtroom. It is no longer enough to simply argue that the field is unpredictable. You must be prepared to affirmatively demonstrate, with strong expert testimony and documentary evidence, why the path to your invention was not a matter of “routine characterization” or logical combination of known elements. Simply put, the bar for demonstrating non-obviousness is higher.
For Generic-Side Litigants: Judge Andrews’ courtroom has become a more favorable venue for well-supported obviousness challenges. A case built on clear prior art references that teach a process, combined with credible expert testimony that characterization of the result would be routine, will receive a very serious hearing. He is a judge who will credit the evidence and is not afraid to invalidate a patent if the facts support it, even in technically complex areas.
The New Power Player: Hon. Gregory B. Williams
Appointed to the bench in September 2022, Judge Gregory B. Williams has wasted no time in establishing himself as a central figure in Delaware’s patent docket. In a court defined by its experience, he brings a unique and valuable perspective from his time in private practice and as a special master, and he is rapidly accumulating one of the heaviest Hatch-Waxman caseloads in the country.
Judicial Profile and Path to the Bench
Judge Williams’ background makes him uniquely suited for the Delaware bench. A graduate of Villanova University School of Law, he spent nearly three decades in private practice at the Wilmington office of Fox Rothschild LLP, where he rose to partner and specialized in commercial and patent law.33 This gives him a deep, practical understanding of the pressures and strategies involved in high-stakes IP litigation.
Even more uniquely, from 2020 to 2022, he served as a special master for the very court where he now sits, assisting the district judges with managing complex civil cases.34 This role gave him an insider’s view of judicial decision-making and case management before he ever donned the robe himself. Nominated by President Joe Biden, he has quickly become a go-to judge for patent disputes.33
Case Management and Judicial Philosophy
From the outset, Judge Williams has demonstrated a commitment to active and efficient case management. He is not a passive observer; he engages with the parties and the issues to move his cases forward. Early in his tenure, he showed he was not afraid to make tough calls, such as granting a motion to strike a defendant’s written description defenses that he deemed to have been raised too late in the proceedings.23
His popularity with litigants is evident in the numbers. While he had been assigned 55 total ANDA cases by the end of 2024 19, he received another 11 in just the first quarter of 2025, making him the single busiest judge for new ANDA filings on our list during that period.20 This flood of cases indicates that litigants on both sides see his courtroom as a fair and desirable venue to resolve their disputes.
Statistical Deep Dive: An Emerging Track Record
While his tenure is still relatively short, preventing a long-term statistical analysis, the early data points are compelling. The sheer volume of his new cases suggests he will soon rival Judge Andrews in terms of total ANDA experience. His decisions will be a major factor in shaping Delaware’s district-wide statistics, where, as noted, patent challengers have seen their win rate at trial climb to 10% in recent years.19
His early rulings on motions to dismiss and for summary judgment are being closely watched by the Delaware patent bar. In one notable decision, he granted a motion to dismiss a patent infringement case with prejudice after finding the patents invalid under 35 U.S.C. § 101 for claiming an abstract idea, a decisive ruling that ended the case at the earliest stage.35 This demonstrates a willingness to dispose of cases early if the legal flaws are clear, a trait that can save litigants millions in discovery costs.
Landmark Rulings & Doctrinal Leanings: The Amgen v. Lindis Saga
No case better illuminates Judge Williams’ emerging judicial philosophy than the high-profile patent dispute between Amgen and Lindis Biotech over Amgen’s blockbuster leukemia drug, Blincyto. His handling of this case from start to finish provides a rich case study in his pragmatic, substance-over-form approach.
The case began with a motion to dismiss from Amgen, arguing that Lindis’s complaint failed to plausibly allege infringement because it included no specific facts showing that Blincyto met a key “trifunctional” limitation present in the patent claims. This is a common tactic in Delaware, where judges often require a limitation-by-limitation analysis in the complaint for complex technologies. Judge Williams, however, denied the motion on this point. He held that it was sufficient that Lindis “drew significant parallels between” and “connected elements from” the claims and the accused product in a more general sense.36 This ruling was seen by some practitioners as a potential shift away from the district’s stricter pleading standards, making it easier for patentees to survive an early motion to dismiss.36
The case proceeded through discovery and a jury trial, which resulted in a stunning $50.3 million verdict for Lindis, with a finding of willful infringement that could have tripled the damages.38 However, the story was far from over.
Post-trial, Amgen made a powerful argument: that the Lindis patents were unenforceable due to “inequitable conduct.” They alleged that the named inventor had provided false information in his patent application to the U.S. Patent and Trademark Office (USPTO). In a dramatic reversal, Judge Williams agreed. He issued a post-trial decision concluding that the patents were, in fact, unenforceable due to this misconduct. This single ruling completely negated the jury’s $50.3 million verdict and handed Amgen a decisive victory.38
At first glance, these two rulings might seem contradictory. One appears lenient to the patentee at the pleading stage, while the other is a severe, case-ending sanction against the same patentee for misconduct. But taken together, they reveal a remarkably coherent judicial philosophy. The first ruling demonstrates a preference for letting cases be decided on their merits, avoiding dismissal on procedural technicalities. The second ruling shows that once he has examined those merits and the conduct of the parties, he will not hesitate to use the court’s full power to remedy what he sees as a fraud on the patent system. He is a pragmatist focused on substantive justice, not a formalist focused on procedural gatekeeping.
Strategic Considerations for Litigants
Judge Williams’ courtroom is a high-risk, high-reward environment that demands careful strategic calculation.
For Patentees: You can be more confident that your case will survive an early motion to dismiss, even if your complaint doesn’t tick every box of a limitation-by-limitation analysis. Judge Williams is likely to let you get to discovery.
For All Litigants: Do not misinterpret his approach to pleading standards as a sign of a universally pro-patentee stance. The Amgen v. Lindis outcome is a stark warning. You must be prepared for intense scrutiny of your conduct, both during the litigation and, crucially, during the original patent prosecution. Any evidence of misrepresentations to the USPTO, failure to disclose material prior art, or other forms of inequitable conduct could be fatal. Before litigating a patent in his court, a thorough, independent vetting of the prosecution history for any potential misconduct is no longer just best practice—it’s essential for survival.
The IP Specialist on the Bench: Hon. Maryellen Noreika
In a field dominated by complex science and arcane legal doctrine, there is no substitute for experience. Judge Maryellen Noreika brings a quarter-century of front-line patent litigation experience to the bench, and she has leveraged that deep practical knowledge to become one of the most respected, and demanding, case managers in the country. For litigants in her courtroom, preparation is not optional, and procedural shortcuts are non-existent.
Judicial Profile and Path to the Bench
Before her appointment to the bench by President Donald Trump in 2018, Judge Noreika was a partner at Morris, Nichols, Arsht & Tunnell, one of Delaware’s most prestigious IP law firms.39 For 25 years, she represented clients in more than 500 cases involving complex technologies in pharmaceuticals, biotechnology, and medical devices.39 She has lived and breathed patent litigation from the practitioner’s side.
This background gives her a unique perspective. She understands the strategic thinking, the pressure points, and the procedural gamesmanship that define high-stakes litigation. Her judicial philosophy and case management practices are a direct and forceful response to the inefficiencies and strategic ambiguities she undoubtedly encountered as a lawyer.
Case Management and Judicial Philosophy: The Queen of Claim Construction
Judge Noreika is renowned for her rigorous, no-nonsense approach to case management, with a particular focus on the claim construction phase. She views claim construction not as a preliminary skirmish, but as the foundational event of a patent case, and she demands that the parties treat it with commensurate seriousness.
Her procedures are designed to force clarity and substantive engagement. She has little patience for parties who propose that a disputed term simply has its “plain and ordinary meaning” without explaining precisely what that meaning is. In multiple cases, she has issued orders requiring parties to amend their claim construction charts to provide specific definitions, forcing them to articulate their actual positions and highlight the true nature of their dispute.41
Perhaps her most famous procedural intervention came in a 2023 case, Continuous Composites, Inc. v. Markforged, Inc. After finding that the parties’ initial 20-minute meet-and-confer on ten disputed claim terms was woefully insufficient, she issued a blistering order. Finding their “lack of effort shows a lack of respect for this Court,” she ordered lead trial counsel to meet in person in her courtroom and to continue their good-faith negotiations “until excused by the Court”.42 This extraordinary step sent a clear message to the entire Delaware bar: pro forma, check-the-box meet-and-confers will not be tolerated.
This philosophy is codified in her standing orders and form scheduling orders, which have been updated to streamline the process. For example, she now requires all intrinsic evidence to be submitted in a single joint appendix with the claim construction brief, avoiding piecemeal submissions.43 Her goal is singular: to strip away procedural clutter and force the parties to grapple with the substantive merits of their claim construction arguments based on the intrinsic evidence.
Statistical Deep Dive: Procedure as a Driver of Outcomes
Judge Noreika’s docket reflects her central role in the district. She has presided over 118 ANDA cases since 2015 19 and continues to receive a steady flow of new, complex pharmaceutical disputes.20
While it is difficult to isolate the statistical impact of one judge’s procedures, the logical effect of her management style is to accelerate the timeline to clarity. By front-loading the most critical legal work of the case—claim construction—and demanding that it be done thoroughly, she forces parties to confront the strengths and weaknesses of their positions much earlier than they might in other courtrooms. This can lead to more efficient resolutions, as a party that receives an unfavorable claim construction ruling may be more inclined to settle rather than proceed through years of costly discovery and trial with a weakened case. Her approach is a powerful tool for breaking litigation logjams.
Landmark Rulings & Doctrinal Leanings: Case Studies in Clarity
Judge Noreika’s written opinions reflect her procedural philosophy: they are clear, grounded in the intrinsic evidence, and focused on resolving the core of the dispute. In cases like Osteoplastics v. ConforMIS, her analysis of disputed terms like “anatomical landmarks” is a methodical march through the claims and specification to arrive at a construction that honors the patent’s own language.45 She consistently emphasizes that the specification is “the single best guide to the meaning of a disputed term”.46
Her rulings on other matters show a similar pragmatism. In one ANDA case, she granted a plaintiff’s motion to exclude expert testimony that was based on an “erroneous legal theory,” reinforcing the principle that infringement is assessed by comparing the patent claims to the ANDA specification itself, not to other extraneous materials.47 Yet, she is not quick to grant case-dispositive motions. In another matter, she denied a motion for attorneys’ fees after a bench trial, noting that even though the plaintiff lost on infringement, its arguments were not “objectively unreasonable or baseless.” She recognized that losing a “fact-intensive inquiry” after a hard-fought trial does not make a case “exceptional” under the law.48 This shows a balanced approach that respects the adversarial process while demanding it be conducted efficiently and in good faith.
Strategic Considerations for Litigants
Appearing before Judge Noreika is a demanding but predictable experience. Success requires abandoning procedural gamesmanship in favor of substantive preparation.
Master Claim Construction: Your entire case strategy must be built around a well-supported claim construction position. Do not wait until briefing to develop your arguments. They must be ready for the very first meet-and-confer.
Take Meet-and-Confers Seriously: A 20-minute phone call will not suffice. Lead trial counsel must be prepared for a substantive, detailed discussion aimed at genuinely narrowing the issues. Failure to do so risks a public rebuke and a court-ordered marathon negotiation session.
Define “Plain and Ordinary Meaning”: If this is your proposed construction, be prepared to provide a specific, clear definition of that meaning and explain why it is correct based on the intrinsic evidence. Relying on ambiguity is a losing strategy.
Focus on the Intrinsic Record: Ground every argument in the language of the claims, the text of the specification, and the file history of the patent. Expert testimony that attempts to contradict or rewrite the intrinsic record will be given little weight.
For parties who have strong, clear positions based on the patent’s own language, Judge Noreika’s courtroom is an ideal forum. For those whose cases rely on strategic ambiguity, it is a minefield.
The Wildcard: Hon. Colm F. Connolly and the Reshaping of a District
No analysis of the Delaware docket would be complete without a dedicated focus on its Chief Judge, the Honorable Colm F. Connolly. While he may not top the list of new ANDA filings in the most recent quarter, his historical caseload is immense, with 354 ANDA cases since 2015.19 More importantly, his series of standing orders issued since 2022 has fundamentally altered the rules of engagement for all patent litigants in his court, creating an impact that extends far beyond his own docket and is a primary driver of the strategic shifts we are seeing across the entire Hatch-Waxman landscape.
A former U.S. Attorney and partner at two major law firms, including the same Morris, Nichols, Arsht & Tunnell as Judge Noreika, Judge Connolly brings the perspectives of a prosecutor and a high-level practitioner to the bench.49 Appointed by President Trump in 2018, he has used his position as Chief Judge to implement a sweeping reform agenda aimed at increasing transparency, deterring meritless litigation, and improving judicial efficiency.
His influence is best understood through his standing orders:
The Litigation Funding Disclosure Order: In April 2022, Judge Connolly issued a standing order requiring parties in his court to disclose the existence of any third-party litigation funding arrangements. This includes identifying the funder and stating whether the funder has the authority to make material litigation or settlement decisions.51 The impact was immediate and staggering. A University of Utah study found that in the two years following the order, patent lawsuit filings in Delaware dropped by 41%, compared to a 15% drop nationwide. Funded patent cases have “virtually disappeared” from his courtroom.52 This order was born from his concern that undisclosed funders could be the real parties in interest, raising issues of standing and professional ethics.
The Corporate Disclosure Order: Alongside the funding order, he mandated more extensive corporate disclosures, requiring entities like LLCs and partnerships to identify every owner, member, and partner, ensuring the court knows exactly who is behind the litigation.51 This transparency push culminated in a lengthy 2023 opinion where he found that the patent monetization firm IP Edge had perpetrated a “fraud” on his court by using a network of shell companies to hide its involvement in dozens of lawsuits. He referred the lawyers involved for disciplinary and criminal investigation.53
The Summary Judgment Ranking Order: Citing the “proliferation of meritless summary judgment motions,” Judge Connolly implemented a “one-and-done” rule. Parties filing multiple summary judgment motions must rank them in order of preference. If the court denies the first motion, it will not, “barring exceptional reasons,” review any others filed by that party.55 This forces litigants to lead with their best argument and deters the common practice of filing numerous, weaker motions in the hope that one might stick.
The Case Narrowing Order: Judge Connolly has also been a leader in forcing early case narrowing. His form scheduling order for Hatch-Waxman cases now limits plaintiffs to asserting no more than 10 claims per patent and 32 claims total against any one defendant. Defendants are similarly limited to 12 prior art references per patent and 30 total.14 These numbers are further reduced after claim construction, forcing both sides to focus their resources on their strongest positions from the very beginning of the case.
The cumulative effect of these orders has been to create a “shadow doctrine” that has a greater practical impact on day-to-day litigation strategy than many Federal Circuit precedents. Judge Connolly is actively using his case management authority to curb what he perceives as systemic abuses in patent litigation. While many of these orders were prompted by the business models of non-practicing entities (NPEs), their application is universal in his court. For Hatch-Waxman litigants, this means that appearing before Judge Connolly now involves a series of demanding procedural hurdles and transparency requirements not found in other courts. This increased burden and risk, particularly for plaintiffs, is a significant factor—perhaps the single most significant factor—driving the strategic flight of new case filings from Delaware to the more traditional procedural environment of New Jersey.
The New Jersey Juggernauts: Efficiency and Pragmatism in the Garden State
As litigants increasingly look beyond Delaware, the U.S. District Court for the District of New Jersey has emerged as the primary beneficiary. With its deep historical ties to the pharmaceutical industry and a bench of experienced, pragmatic judges, it offers a compelling alternative. In 2024, New Jersey became the nation’s busiest district for Hatch-Waxman litigation, a trend driven by the work of two key jurists who have become titans of the ANDA docket.
The Case Management Maven: Hon. Brian R. Martinotti
If the surge in New Jersey’s caseload has an epicenter, it is the courtroom of Judge Brian R. Martinotti. In 2024, he presided over more new ANDA cases than any other judge in the country, establishing himself as a pivotal figure in the national landscape.15 His popularity is rooted in a judicial philosophy that prizes efficiency, predictability, and the early resolution of disputes.
Judicial Profile and Path to the Bench
Judge Martinotti is a product of the New Jersey legal system. A graduate of Seton Hall University School of Law, he has a diverse background that includes time in private practice as well as extensive public service as a municipal public defender, prosecutor, and councilmember.58 Before his appointment to the federal bench by President Barack Obama in 2016, he served for 14 years as a judge on the New Jersey Superior Court.58 This long tenure in the state court system, particularly in its multi-county litigation program, honed his skills in managing large, complex dockets—experience that has proven invaluable on the federal bench.
Case Management and Judicial Philosophy: The Pre-Motion Conference
The hallmark of Judge Martinotti’s case management style is his mandatory pre-motion conference procedure.59 Before a party can file most types of dispositive motions (including motions to dismiss or for judgment on the pleadings), they must first submit a letter to the court, not to exceed three pages, outlining the basis for the anticipated motion and citing relevant legal authority. The opposing party then has seven days to submit a three-page response.
This simple requirement has a profound effect on litigation. It forces parties to distill their arguments to their essential core at a very early stage. The court can then assess the merits and, in many cases, resolve the dispute during a conference call without the time and expense of full-blown motion practice. If the issue cannot be resolved, the judge will then grant the party leave to file its motion.
This process is the embodiment of judicial efficiency. It weeds out weak or posturing motions before they consume significant resources, and it provides the parties with an early read from the court on the key legal issues in the case. For sophisticated litigants in the Hatch-Waxman space, this predictability and efficiency are highly attractive features, contributing significantly to the influx of cases into his court.
Statistical Deep Dive: A Rising Caseload
While Judge Martinotti’s historical ANDA caseload since 2015 is a respectable 90 cases 19, his recent activity is what tells the story. As noted in a 2024 year-in-review analysis, he was the single busiest judge for ANDA cases in the nation.15 A review of filings shows a steady stream of complex cases involving major drugs being assigned to his docket.20
The key metric to watch for Judge Martinotti will be the impact of his pre-motion process on case timelines and settlement rates. By forcing an early confrontation on the legal merits, his procedure likely encourages earlier settlements. Parties who see their core legal theories questioned by the judge in a pre-motion conference may be more inclined to negotiate, rather than invest heavily in a motion they are likely to lose. This proactive management style stands in contrast to a more traditional model where parties might wait until after claim construction or the close of discovery to have a serious assessment of their case’s strength.
Strategic Considerations for Litigants
Litigating before Judge Martinotti requires a front-loading of legal analysis and a commitment to concise, powerful advocacy.
The Pre-Motion Letter is Key: Do not treat this as a mere formality. The three-page letter is your first, and perhaps best, opportunity to frame the dispositive legal issues for the court. A well-reasoned, persuasive letter can win the day without a full motion. A weak, conclusory letter may result in the court denying you the opportunity to file the motion at all.
Focus on the Core Dispute: His process is designed to cut through procedural clutter. Your arguments, both in letters and in conferences, should be focused on the central, outcome-determinative legal questions.
Be Prepared to Negotiate: The pre-motion conference often functions as an early, judge-guided settlement discussion. Parties should come to these conferences not just with their legal arguments, but with a clear understanding of their settlement posture and with representatives who have the authority to make decisions.
For litigants seeking a fast, efficient, and predictable path to resolution, Judge Martinotti’s courtroom has become a premier destination.
The Pragmatic Jurist: Hon. Michael A. Shipp
A long-serving and deeply respected member of the New Jersey bench, Judge Michael A. Shipp brings a wealth of experience in complex litigation to his substantial Hatch-Waxman docket. His background as a “big law” commercial litigator, a U.S. Magistrate Judge, and a high-level attorney in the New Jersey Attorney General’s office has shaped him into a pragmatic and even-keeled jurist known for his fair-minded approach and steady management of his cases.
Judicial Profile and Path to the Bench
Appointed to the District Court in 2012 by President Barack Obama, Judge Shipp had already served for five years as a U.S. Magistrate Judge, giving him extensive experience in managing the day-to-day realities of federal litigation, including discovery disputes and settlement conferences.60 Before joining the bench, his career included eight years in the complex commercial litigation group at Skadden, Arps, Slate, Meagher & Flom LLP, one of the world’s most powerful law firms.61 There, he handled a wide range of high-stakes disputes, including products liability and contract cases. He also served as Assistant Attorney General and Counsel to the New Jersey Attorney General, advising on significant litigation matters.60
This combination of elite private practice and high-level public service experience is evident in his judicial demeanor. He is known for his professionalism, impartiality, and respect for the litigants who appear before him.62 He is also one of a select group of judges chosen to oversee large, complex multi-district litigations (MDLs), a testament to his ability to manage sprawling and contentious cases.61
Case Management and Judicial Philosophy
Judge Shipp’s approach to case management is best described as pragmatic and resolution-oriented. He is not known for implementing idiosyncratic procedural rules like some of his Delaware counterparts. Instead, he relies on the Federal Rules of Civil Procedure and the district’s local rules to guide his cases in a predictable and orderly fashion.
His experience with MDLs makes him particularly adept at handling the typical Hatch-Waxman case structure, which often involves a brand innovator suing multiple generic filers in a series of consolidated or related cases. He understands how to coordinate discovery, manage overlapping legal issues, and guide multiple parties toward a global resolution. His docket is consistently filled with major ANDA litigations, such as the numerous cases filed concerning the blockbuster drug Caplyta.63
Statistical Deep Dive: A Decade of Data
With a tenure stretching back to 2012, Judge Shipp has one of the most extensive and established track records in Hatch-Waxman litigation. He has presided over at least 100 ANDA cases since his appointment 65, with a total of 142 cases since 2015 alone.19 This deep well of data allows for a reliable analysis of his judicial tendencies.
One of the most notable trends in his court, and in ANDA litigation generally, is the rarity of summary judgment. Data from recent years shows that very few Hatch-Waxman cases are decided at this stage.15 The technical complexity and the battle of expert witnesses almost always create the “genuine dispute of material fact” that precludes summary judgment. This means that cases in Judge Shipp’s court are overwhelmingly resolved in one of two ways: settlement or a full bench trial.
His trial rulings are thorough and well-respected. In one key case, Amgen v. Sandoz, he presided over a bench trial and issued a detailed opinion finding Amgen’s patent for a crystalline form of apremilast to be not invalid for obviousness. His fact-intensive analysis, which credited the secondary considerations of non-obviousness like unexpected results and long-felt need, was subsequently affirmed in its entirety by the Federal Circuit.67 This demonstrates a careful, evidence-based approach to the merits that gives both sides confidence in a fair hearing.
Strategic Considerations for Litigants
Success before Judge Shipp hinges on clear, credible, and well-supported arguments, particularly from expert witnesses.
Prepare for the Long Haul: Given the low probability of a case-ending summary judgment ruling, you should operate under the assumption that your case is heading toward either a trial or a late-stage settlement. Your budget and litigation strategy should reflect this reality.
Expert Witnesses are Paramount: As the Amgen v. Sandoz case illustrates, the outcome of a bench trial will often turn on the credibility and persuasiveness of your expert witnesses. Judge Shipp is adept at weighing competing scientific testimony, so your experts must be not only credentialed but also excellent communicators who can explain complex science in a clear and compelling way.
Leverage Settlement Opportunities: Judge Shipp’s background as a magistrate judge, where facilitating settlement is a key function, suggests he is likely to be an active and effective participant in settlement conferences. Be prepared for substantive discussions and come to the table with a realistic assessment of your case and clear settlement authority.
For litigants looking for a seasoned, impartial, and predictable jurist to handle their complex pharmaceutical dispute, Judge Shipp represents a gold standard on the federal bench.
Synthesis and Strategic Imperatives for 2025 and Beyond
Analyzing these five key judges in isolation provides valuable insight. However, the real strategic advantage comes from synthesizing this information, comparing their approaches, and understanding how their individual judicial philosophies interact with the broader trends shaping the pharmaceutical industry. The choice of where to file or defend a Hatch-Waxman suit is a multi-variable equation, and the judge is the most important variable of all.
Comparative Analysis: The Judge-by-Judge Playbook
The differences between the key judges in Delaware and New Jersey are not merely matters of personality; they represent fundamentally different approaches to the role of a judge in managing complex litigation. Delaware, particularly under the influence of Chief Judge Connolly and Judge Noreika, is trending toward a more interventionist, procedurally demanding model. New Jersey, as represented by Judge Martinotti and Judge Shipp, embodies a more traditional, pragmatic model focused on efficient application of established rules.
The following table provides a high-level comparative snapshot to aid in strategic decision-making:
Feature
Hon. Richard G. Andrews
Hon. Gregory B. Williams
Hon. Maryellen Noreika
Hon. Brian R. Martinotti
Hon. Michael A. Shipp
District
D. Delaware
D. Delaware
D. Delaware
D. New Jersey
D. New Jersey
Appointed By / Year
Obama / 2011
Biden / 2022
Trump / 2018
Obama / 2016
Obama / 2012
Total ANDA Cases (Since 2015)
481+ 19
55+ 19
118+ 19
90+ 19
142+ 19
2024 ANDA Cases
High
Very High
High
Very High (Nation’s Busiest)
High
Brand vs. Generic Win Rate (Trial)
Reflects D. Del. trend: ~10% generic win rate 19
Emerging record; will influence D. Del. trend
Reflects D. Del. trend: ~10% generic win rate 19
Reflects D.N.J. trend: historically more patentee-friendly 19
Reflects D.N.J. trend: historically more patentee-friendly 19
Summary Judgment Tendency
Low (consistent with ANDA litigation norms) 15
Willing to grant on clear legal issues (e.g., § 101) 35
Low (consistent with ANDA litigation norms) 48
Low; pre-motion process weeds out weak motions 59
Very Low (consistent with ANDA litigation norms) 27
Key Case Mgt. Feature
Traditional, fact-focused management
Pragmatic; allows cases to proceed but punishes misconduct
Extreme procedural rigor, especially on claim construction
Mandatory pre-motion conference letters
Pragmatic management of complex, consolidated cases
Noteworthy Doctrinal Focus
Obviousness (polymorphs, clinical trials) 29
Inequitable Conduct; Pleading Standards 36
Claim Construction Clarity & Intrinsic Evidence 41
Judicial Efficiency; Early Dispute Resolution 59
Obviousness; Secondary Considerations 67
This table makes the strategic trade-offs clear. Do you have a novel obviousness argument based on “routine characterization” of a prior art process? Judge Andrews’ courtroom is the place to test it. Is your opponent’s patent potentially tainted by misconduct during prosecution? Judge Williams has shown he will use the ultimate sanction. Is your case’s success entirely dependent on a favorable claim construction that is crystal clear from the patent’s own words? Judge Noreika’s process is designed for you. Are you seeking the fastest, most efficient path to a resolution or settlement? Judge Martinotti’s pre-motion conference is your best bet. Do you have a complex case against multiple filers that will turn on a classic battle of the experts at trial? Judge Shipp has the experience to manage it.
Connecting the Dots: Judicial Interpretation of Macro Trends
These judges do not operate in a vacuum. They are on the front lines, interpreting and applying the law in response to major shifts in the industry and regulatory landscape. How they are likely to handle these emerging macro trends is a critical question for any long-term strategist.
The FTC’s War on “Patent Thickets”: The Federal Trade Commission (FTC) has become increasingly aggressive in challenging what it deems “improper” Orange Book listings and the use of “patent thickets” to delay generic competition.14 The FTC can send warning letters and challenge listings, but the ultimate authority to order a patent delisted or to rule on its validity and infringement rests with the federal courts. A judge like Chief Judge Connolly, with his demonstrated focus on rooting out “fraud on the court” and abuse of the legal process, may be more philosophically aligned with the FTC’s goals and more receptive to arguments that certain listing practices constitute anti-competitive behavior. Conversely, a judge with deep, traditional patent law experience like Judge Noreika may be more inclined to view the issue through the strict lens of the statutory text, which governs what can be listed, leaving broader competition concerns to antitrust law. The success of the FTC’s new activist posture will likely be decided not in Washington D.C., but in the courtrooms of these five judges.
The “Skinny Label” Conundrum: The viability of the “skinny label”—where a generic carves out a patented use from its label to avoid infringement—has been thrown into question since the Federal Circuit’s controversial decision in GSK v. Teva. How judges interpret the standard for induced infringement in these cases is a billion-dollar question. A recent Federal Circuit decision in Amarin v. Hikma found that a generic’s press releases and public statements could be used as evidence of intent to induce infringement of the carved-out use, even with a skinny label.15 A pragmatist like Judge Shipp or Judge Williams, focused on the real-world context of a drug’s marketing, may be more inclined to follow this holistic approach. A more formalist judge might focus more narrowly on the four corners of the label itself.
Obviousness-Type Double Patenting (OTDP): The Federal Circuit’s 2023 decision in In re Cellect sent shockwaves through the industry by holding that patent term adjustments (PTA) are considered when analyzing OTDP, potentially invalidating later-expiring patents in a family.14 Judge Andrews has already applied this ruling with a bright-line approach, refusing to consider equitable arguments to avoid its harsh effect.14 This indicates a judicial tendency in Delaware, at least, to apply this new precedent strictly, increasing the risk for innovators with large, overlapping patent portfolios.
Leveraging Data for Competitive Advantage
In the modern Hatch-Waxman landscape, litigating on instinct is a recipe for disaster. The days of simply assessing the merits of a patent in a vacuum are over. Success now requires a sophisticated, data-driven strategy that integrates a deep understanding of the specific judge who will decide your case.
This is where comprehensive litigation intelligence becomes indispensable. Services like DrugPatentWatch provide the foundational data that underpins this advanced, judge-aware analysis. By systematically tracking ANDA filings, Paragraph IV certifications, court dockets, and litigation outcomes, these platforms allow strategists to move beyond anecdote and build predictive models.10
This kind of high-level statistical insight is just the starting point. By combining this data with the qualitative analysis of judicial philosophy and case management style detailed in this report, you can begin to answer the critical questions: What is the likely timeline to a claim construction ruling in this judge’s court? What is their historical grant rate for summary judgment on obviousness? How have they ruled in cases involving similar technology? Answering these questions allows you to more accurately forecast litigation costs, model the probability of success, and make smarter decisions about when to litigate, when to settle, and how to allocate your resources for the highest possible return on investment. In this complex ecosystem, data is not just power—it’s survival.
Key Takeaways
The Judge is the Strategy: In modern Hatch-Waxman litigation, the single most important factor influencing case outcome, timeline, and cost is the assigned judge. A one-size-fits-all litigation strategy is obsolete; approaches must be tailored to the specific jurist.
The Great Venue Migration is Real: A major strategic realignment is underway, with a significant volume of new ANDA cases shifting from the District of Delaware to the District of New Jersey. This is a direct market response to the demanding procedural and transparency requirements being implemented by judges in Delaware, particularly Chief Judge Connolly.
Delaware Demands Rigor: Litigating in Delaware now requires extreme preparation. Judge Noreika demands substantive, good-faith engagement in claim construction. Judge Williams will punish any hint of inequitable conduct with case-ending sanctions. Judge Andrews has raised the bar for defending patents against obviousness challenges. The district rewards litigants with clear, well-supported positions but has become perilous for those relying on procedural ambiguity.
New Jersey Offers Pragmatic Efficiency: The surge in cases before Judge Martinotti and Judge Shipp is driven by their reputation for predictable, efficient, and pragmatic case management. Judge Martinotti’s pre-motion conference process can accelerate resolution, while Judge Shipp’s steady hand provides stability in complex, multi-party disputes.
Doctrine is Evolving from the Trial Bench: Key patent doctrines are being actively shaped at the district court level. Judge Andrews is at the forefront of a more flexible approach to obviousness, while Judge Williams’ rulings are setting new precedents for pleading standards and the consequences of misconduct. These trial-level trends are critical to watch, as they often precede shifts in Federal Circuit law.
Data-Driven Decisions are Non-Negotiable: Success requires integrating quantitative data on case filings and outcomes with qualitative analysis of judicial philosophies. Leveraging litigation intelligence platforms like DrugPatentWatch to track dockets and decisions is essential for building predictive models that inform venue selection, settlement strategy, and resource allocation.
Frequently Asked Questions (FAQ)
1. Given Chief Judge Connolly’s standing orders in Delaware, is it still a favorable venue for a well-funded patent holder?
It depends on the patent holder’s strategy and risk tolerance. For a plaintiff with a straightforward case, a clean prosecution history, and a willingness to comply with rigorous transparency and case-narrowing requirements, Delaware remains an excellent venue with unparalleled judicial expertise. However, for plaintiffs who rely on complex corporate structures, utilize third-party litigation funding, or prefer a strategy of asserting a large number of claims to maximize settlement leverage, Judge Connolly’s courtroom, in particular, has become a much higher-risk environment. His orders are specifically designed to curb these tactics, and the consequences for non-compliance are severe. The venue shift to New Jersey suggests that many litigants are deciding the risks now outweigh the rewards.
2. How should our litigation strategy change if we draw Judge Andrews in a case involving a polymorph patent versus another judge?
If you are the patent holder, your defensive strategy before Judge Andrews must be far more robust. You cannot simply rely on the general unpredictability of polymorphism. You must be prepared to present compelling expert testimony and evidence that the process to create the claimed polymorph was non-routine and that its characterization required more than standard, predictable techniques. If you are the generic challenger, your offensive strategy should focus heavily on finding prior art that discloses a process for making the active ingredient, and then using an expert to testify that a person of skill in the art would have been motivated to run that process and would have used routine methods to identify the resulting crystalline form. His Salix ruling provides a clear roadmap for a successful obviousness challenge in this context.
3. What are the most common mistakes counsel make when appearing before Judge Noreika for claim construction?
The most common mistake is underestimating her demand for substantive preparation. Two errors are particularly fatal: 1) Treating the meet-and-confer as a perfunctory, check-the-box exercise. She expects lead trial counsel to engage in a genuine, good-faith effort to narrow disputes, and she will sanction parties who fail to do so. 2) Proposing “plain and ordinary meaning” as a construction without providing a specific, detailed definition of that meaning. She will force you to articulate your position, and a failure to have a clear, well-supported definition ready suggests a lack of preparation and a weak legal position.
4. Is the surge in New Jersey’s caseload a temporary anomaly or a long-term trend we should factor into our five-year strategy?
All signs point to this being a durable, long-term trend. The shift is not based on a temporary factor like a single vacancy on the bench; it is a structural response to fundamental changes in procedure and judicial philosophy in Delaware. As long as Delaware judges continue to implement demanding, interventionist case management rules, and New Jersey judges continue to offer a more traditional and pragmatically efficient alternative, the strategic calculus for many litigants will favor New Jersey. This should absolutely be factored into any long-term litigation strategy, including decisions about where to locate key personnel or hire outside counsel.
5. With Judge Williams’ recent ruling in Amgen v. Lindis, what new diligence steps should we add to vet a patent portfolio for potential inequitable conduct issues before acquisition or assertion?
The Amgen v. Lindis decision, where a $50 million verdict was erased due to inequitable conduct, should serve as a major wake-up call. Standard patent diligence is no longer enough. Before acquiring or asserting a patent portfolio, especially in a high-value case, you should add a specific “inequitable conduct audit” to your process. This involves retaining independent counsel (separate from the deal or litigation team) to conduct a privileged, deep-dive review of the entire prosecution history of the key patents. This audit should specifically look for any potential misstatements in declarations, failures to disclose material prior art known to the inventors, or any other evidence that could suggest an intent to deceive the USPTO. The cost of this upfront audit is a fraction of the potential loss if an issue is discovered by your opponent before a judge like Gregory Williams.
Do Not Pass Go, Do Not Stop for Summary Judgment: The U.S. District Court for the District of Delaware’s Seemingly Disjunctive Yet Efficient Procedures in Hatch-Waxman Litigation – Scholarly Commons, accessed August 16, 2025, https://scholarlycommons.law.northwestern.edu/njtip/vol14/iss1/4/
