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I. INTRODUCTION
In mid-June 2025, attorneys for plaintiffs Janssen Products and PharmaMar were reviewing their opponent's document production in a routine Hatch-Waxman patent case when they stumbled across something that shouldn't exist: their own clients' highly confidential regulatory filings. Not summaries. Not publicly available information. But instead, substantive portions of the proprietary specifications, testing methods, and manufacturing parameters their clients had submitted to the FDA under seal—documents containing over a decade of research and hundreds of millions of dollars in development work resulting in their Yondelis® pharmaceutical product for the treatment of advanced soft tissue sarcoma.
Their opponent, EVER Valinject GmbH, an Austrian pharmaceutical company, had somehow obtained this information. And as further investigation would reveal, EVER wasn't alone. Discovery uncovered what Janssen and PharmaMar allege was a years-long, international scheme involving entities in Austria, China, and the United States, all working together to misappropriate their confidential regulatory data to enable and expedite approval of a competing drug product.
The attorneys further discovered that EVER simply copied many of the purloined records into its own FDA submission to describe its drug and manufacturing process—even though EVER alleges the patent in suit is not infringed because EVER developed an entirely different drug formulation and manufacturing process. That discovery would soon raise a question that cuts to the core of Hatch-Waxman's purpose: can a court meaningfully adjudicate patent infringement without also adjudicating the alleged fraud to define what the accused product actually is?
On August 12, 2025—within the court-ordered deadline for amending pleadings—plaintiffs moved to amend their complaint to add new claims and join four additional defendants. Pls.' Mot. to Amend, Dkt. 204. The new claims include wire fraud, unfair competition, civil conspiracy, and violations of the Racketeer Influenced and Corrupt Organizations ("RICO") Act. See id. at Ex. A, Amended Complaint ("Ex. A"). The motion demonstrated diligence. Plaintiffs had discovered the documents only weeks earlier in massive late-stage productions by EVER, conducted a swift investigation, and promptly sought to amend. Pls.' Mot. to Amend, Dkt. 204 at 8-9.
On October 6, 2025, the district court denied the motion. Order, Dkt. 251. The court acknowledged plaintiffs' diligence and found good cause under Federal Rule of Civil Procedure 16(b)(4). Id. at 1. But the court concluded that allowing amendment would cause "undue prejudice" to the defendants by "expanding the scope of the case" and making it "impossible to close fact discovery by the current deadline." Id. at 3. The court characterized the new RICO and state law claims as "too distinct from the current patent case to belong in the same action." Id.
Rather than simply denying amendment, the court crafted an unusual remedy. Plaintiffs could file the new claims in a separate action, designated as related to the patent case, without paying a filing fee or re-serving already-served defendants. Id. Discovery from the patent case could be "shared and used" in the new case. Id.
The ruling is understandable as an exercise of discretion under Rule 15. Hatch-Waxman cases operate on compressed timelines due to the 30-month regulatory stay that prevents final FDA approval while litigation proceeds. But the court's reasoning—that the patent and RICO claims have insufficient factual overlap and that bifurcation serves efficiency—may be exactly backwards.
The district court's decision, while within the broad discretion afforded under Rule 15, creates more problems than it solves and may undermine the Hatch-Waxman framework's core purpose of ensuring complete pre-launch adjudication of all legal challenges to market entry.
II. BACKGROUND
A. The Yondelis® Story
Comprehending what's at stake requires understanding the drug at the center of this dispute. Yondelis® (trabectedin) treats rare and deadly soft tissue cancers—specifically liposarcoma and leiomyosarcoma. Ex. A ¶ 8. For patients whose cancer progresses after first-line chemotherapy, treatment options are severely limited. "Prior to Yondelis®, the treatment landscape for soft tissue sarcoma had been relatively stagnant for decades with few effective therapeutic choices." Id.When Yondelis® received FDA approval in 2015, it represented the first meaningful therapeutic advance in a generation for this vulnerable patient population. Id.
Getting Yondelis® to market required extraordinary investment. Janssen and PharmaMar "collectively spent more than a decade and more than half a billion dollars on research and development." Id. ¶ 9. Much of that investment focused on solving two difficult problems: manufacturing trabectedin at commercial scale and developing a stable formulation for the lyophilized injectable product. Id. Trabectedin is "an extremely complex small molecule compound" whose commercial-scale manufacturing "poses significant challenges." Id. ¶ 10.
The patent at issue, U.S. Patent No. 8,895,557 ("the '557 patent"), addresses formulation stability. The patent covers a formulation designed to prevent degradation of the active ingredient (ET-743) into an impurity (ET-701) during lyophilization and storage. See the '557 patent at claim 1. The claimed formulation uses a disaccharide—specifically sucrose—as a stabilizer. Id. This formulation "helps ensure that commercial quantities of Yondelis® with sufficient storage stability are available to meet the needs of the vulnerable population of cancer patients for which it is indicated." Ex. A ¶ 4.
Against this backdrop of scientific innovation and substantial investment, plaintiffs initiated their Hatch-Waxman litigation against EVER and its trabectedin drug product, during which discovery revealed something unexpected.
B. The Regulatory Context: Hatch-Waxman and Paper NDAs
1. The Hatch-Waxman Framework
The Drug Price Competition and Patent Term Restoration Act of 1984—the "Hatch-Waxman Act"—established a carefully balanced procedural framework. For innovator companies, the Act provides patent term restoration and a certain period of market exclusivity to recoup research investments and prolonged regulatory review of their New Drug Applications ("NDAs"). See 35 U.S.C. § 156. For generic manufacturers, it created the Abbreviated New Drug Application ("ANDA"), which, as the name implies, is an abbreviated approval pathway for "generic copies" of the original drug that doesn't require repeating costly clinical trials. See, e.g., 21 U.S.C. § 355(j).
The Act also provides for a hybrid approval pathway under p 505(b)(2) of the Federal Food, Drug and Cosmetic Act—often called a "Paper NDA"—for drug products that differ in some respects from an existing approved drug but can still rely on the agency's prior findings of safety and efficacy for aspects that remain the same. See 21 U.S.C. § 355(b)(2) (codification). The term "Paper NDA" reflects the pathway's documentary nature: applicants compile existing data from published literature and FDA's prior findings rather than conducting entirely new clinical trials, essentially building a regulatory dossier from existing sources. EVER seeks approval of its drug under p 505(b)(2).
The Act also created an important tradeoff in expediting patent disputes. Generic companies can challenge innovators' patents before FDA approves their products, but innovators get an automatic 30-month stay of FDA's approval of the generic drug while litigation proceeds. See 21 U.S.C. § 355(c)(3)(C) (for Paper NDAs); id. § 355(j)(5)(B)(iii) (for ANDAs). This stay serves a critical purpose—preventing the disruption caused by having a generic drug on the market for some period of time, only to have it withdrawn later due to a finding of patent infringement. See Ben Venue Labs., Inc. v. Novartis Pharm. Corp., 146 F. Supp. 2d 572, 579 (D.N.J. 2001) ("[ T]he purpose of the 30-month stay is . . . to create an adequate window of time during which to litigate the question of whether a generic will infringe the patented product, without actually having to introduce the generic product to the market") (citing 130 Cong. Rec. H9118 (daily ed. Sept. 6, 1984) (statement of Rep. Waxman); 130 Cong. Rec. S10504 (daily ed. Aug. 10, 1984) (statement of Sen. Hatch)).
This accelerated litigation timeline is made possible by the "artificial act of infringement" created by § 271(e)(2)(A). The act of filing an ANDA or Paper NDA with a "Paragraph IV certification"—asserting that listed patents are invalid, unenforceable, or not infringed—constitutes an act of patent infringement even though no commercial product yet exists. 35 U.S.C. § 271(e)(2)(A). If the patent holder sues within 45 days, the 30-month stay triggers automatically and remains in place as the litigation proceeds. See, e.g., 21 U.S.C. § 355(j)(5)(B)(iii).
2. The Glaxo "Hypothetical Product" Framework
This framework creates a unique challenge: how do courts determine infringement when no commercial product yet exists? For over a decade after Hatch-Waxman's enactment, courts struggled with this question. The Federal Circuit finally provided guidance in 1997: "The only difference [from a standard infringement analysis] is that the allegedly infringing drug has not yet been marketed and therefore the question of infringement must focus on what the ANDA applicant will likely market if its application is approved." Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997) (emphasis added).
Critically, the court explained that "this hypothetical inquiry is properly grounded in the ANDA application and the extensive materials typically submitted in its support." Id. "Therefore, it is proper for the court to consider the ANDA itself, materials submitted by the ANDA applicant in support of the ANDA, and any other relevant evidence submitted by the applicant or patent holder." Id. at 1570. Subsequent decisions reinforced this framework. See Bayer AG v. Elan Pharm. Res. Corp., 212 F.3d 1241, 1248-49 (Fed. Cir. 2000); Glaxo Group Ltd. v. Ranbaxy Pharm., Inc., 262 F.3d 1333, 1337-38 (Fed. Cir. 2001).
The Federal Circuit has made clear that the application's process and product specifications ordinarily control the infringement inquiry. Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1278 (Fed. Cir. 2013) ("if a product that an ANDA applicant is asking the FDA to approve for sale falls within the scope of an issued patent, a judgment of infringement must necessarily ensue"). Courts may also consider evidence about what will "necessarily" result from the manufacturing and storage conditions described in the application. SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1341 (Fed. Cir. 2005) (post-manufacture conversion to infringing crystal polymorph).
In summary, patent infringement in Hatch-Waxman cases requires examining the Paper NDA or ANDA application, the Drug Master Files (DMFs), the specifications, the manufacturing processes, and related regulatory submissions to determine what product will reach the market. This framework is central to understanding why bifurcating plaintiffs' patent and fraud claims creates problems in this case.
3. ANDA vs. 505(b)(2): The "Paper NDA" Pathway
Most Hatch-Waxman cases involve ANDAs under 21 U.S.C. § 355(j). An ANDA applicant must demonstrate that its product is identical to the reference drug in active ingredient, strength, dosage form, and route of administration, and prove bioequivalence to the reference drug. Id. § 355(j)(2)(A)(ii)-(iv). This is the "copycat" approval pathway. For this reason, FDA assumes the generic drug will have the same safety and efficacy as the reference drug.
But p 505(b)(2) allows an applicant to submit a "Paper NDA" for a drug product that differs from the reference drug while still relying on the reference drug's clinical findings for some purposes. 21 U.S.C. § 355(b)(2). The pathway is used for new formulations, new routes of administration, new dosage forms, or new combinations of approved drugs.
A 505(b)(2) applicant must provide new data or information to support any differences from the reference drug but can rely on FDA's prior findings for aspects that are the same. See FDA, Guidance for Industry: Applications Covered by p 505(b)(2) (Oct. 1999). In some instances, FDA may require clinical studies to demonstrate safety and efficacy. Thus, while Paper NDAs do not enjoy the same "abbreviated" review path as ANDAs, their regulatory requirements are much less stringent than the scrutiny applied to an innovator's NDA.
C. EVER's Paper NDA: The L-Arginine Substitution
EVER used the 505(b)(2) pathway because its product lacks sufficient identity to Yondelis® to qualify for abbreviated review as an ANDA. The critical difference for the patent case—EVER's formulation uses L-arginine as a stabilizer, while Yondelis® uses sucrose (a disaccharide sugar). Ex. A ¶ 119. Both are intended to prevent degradation of trabectedin during lyophilization and storage, but they are chemically different excipients. Id. ¶ 121.
This substitution also serves EVER's patent strategy. Asserted claim 6 of the '557 patent requires "a disaccharide selected from sucrose, lactose and a combination thereof." Id. ¶ 120. L-arginine is an amino acid, not a disaccharide. EVER argues non-infringement based on this substitution. Id. ¶ 119. Plaintiffs dispute this, arguing infringement under the doctrine of equivalents because L-arginine and sucrose "perform substantially the same function, in substantially the same way, with substantially the same results." Id. ¶ 120.
This claimed difference between the formulations becomes central to understanding why the alleged RICO violations create such problems for the patent infringement analysis. To rebut EVER's noninfringement defense that the L-arginine formulation does not literally infringe the '557 patent, plaintiffs must use the specifications, testing methods, and quality control procedures submitted in EVER's Paper NDA to prove the drug's equivalence to the claimed invention.
But EVER's Paper NDA may be of little practical use to plaintiffs if, as plaintiffs allege, the specifications, testing methods, and quality control procedures in EVER's Paper NDA were effectively copied from the Yondelis® NDA rather than independently developed and tailored to EVER's drug product. If proven, this would mean EVER's Paper NDA largely addresses the wrong product.
D. The Alleged International Scheme
In the two weeks preceding the June 20, 2025 deadline for substantial completion of document production, EVER produced over 370,000 pages of documents. Pls.' Mot. to Amend at 1. Buried within that production, plaintiffs discovered substantive portions of their own highly confidential regulatory filings—documents they had submitted to FDA under seal. Id. These were proprietary specifications for the trabectedin API, testing methods for identifying impurities, manufacturing parameters, and quality control procedures—the product of over a decade of research and hundreds of millions of dollars in investment. Ex. A ¶¶ 10-11.
Plaintiffs immediately investigated and quickly prepared their amended complaint. The amended complaint alleges that together with five other named entities and inpiduals, EVER formed an association-in-fact enterprise under 18 U.S.C. § 1961(4)—the "EVER NDA Enterprise." Plaintiffs further allege that the EVER NDA Enterprise acted with "the common purpose of preparing and submitting regulatory submissions in order to sell and profit from the NDA Product," including "using Plaintiffs' confidential information for their regulatory submissions and deceiving drug approval agencies to obtain regulatory approval" without disclosing the origins of that information. Ex. A ¶ 132.
The amended complaint describes a pattern of wire fraud spanning at least seven years, beginning around 2017. Ex. A ¶¶ 181-82. Enterprise members allegedly shared, discussed, and used the confidential information over years of wire communications. The amended complaint provides examples of email communications among the enterprise members in which they allegedly discussed using plaintiffs' specifications and testing parameters. Id. ¶ 140. These emails—sent across international borders among the Austrian, Chinese, and U.S.-based enterprise members—form the predicate acts of the alleged wire fraud in support of plaintiffs' RICO claims. Id. ¶¶ 139-40.
The alleged fraud consisted of both affirmative misrepresentations and material omissions. The defendants allegedly "deceived the regulatory authorities by withholding material information they were obligated to reveal." Id. ¶ 14. Specifically, they allegedly failed to disclose to FDA that their submissions "were only made possible through the unauthorized use of Plaintiffs' highly confidential information," and that they "did not have independent knowledge or know-how" of various aspects of those submissions. Id. ¶ 136. FDA regulations require applicants to include "data and information in sufficient detail to permit the agency to make a knowledgeable judgment about whether to approve the NDA." 21 C.F.R. § 314.50(d)(1).
The most significant aspect of the alleged fraud involves EVER's submission of specifications, testing methods, and other quality control methods that plaintiffs developed for their Yondelis® sucrose-stabilized formulation to support regulatory approval of EVER's L-arginine-stabilized product. This was no mere regulatory sleight of hand.
The significance of the alleged fraud is not simply that defendants misappropriated plaintiffs' confidential information—it's that using specifications developed for one formulation and manufacturing process to support approval of a different formulation and process creates a genuine risk that critical quality defects will go undetected. Ex. A ¶ 138. This risk arises because different formulations and manufacturing processes produce different degradation and residual impurity profiles, requiring tailored specifications. Id.
The amended complaint alleges defendants presented specifications and testing methods as if they had been developed independently, when in fact they had been copied or derived from Plaintiffs' confidential filings. Id. ¶ 136. This concealment prevented FDA from scrutinizing whether specifications developed for the Yondelis® sucrose-stabilized formulation were appropriate for EVER's L-arginine-stabilized formulation.
The alleged scheme has produced tangible results. EVER received European marketing authorization on October 2, 2024, and launched its trabectedin product shortly thereafter. Ex. A ¶ 149. PharmaMar currently suffers "lost profits and price erosion due to direct competition from EVER's version of Yondelis® in the E.U. market." Id. ¶ 150. In the United States, FDA granted tentative approval on April 9, 2025. Id. ¶ 148. Final approval is stayed due to the patent litigation, but the NDA has cleared all substantive regulatory hurdles.
E. The District Court's Ruling
Plaintiffs timely filed their motion to amend the complaint on August 12, 2025, the last day in the schedule for amending the pleadings. Pls.' Mot. to Amend, Dkt. 204 at 7 n.4 (citing Dkt. 186 at 4 (scheduling order)). The amended complaint sought to add several new causes of action: civil RICO under 18 U.S.C. § 1962(c), RICO conspiracy under § 1962(d), and state law claims for unfair competition and civil conspiracy.
Plaintiffs emphasized their diligence. EVER produced the critical documents only in mid-to-late June 2025, in productions totaling over 370,000 pages. Pls.' Mot. to Amend at 1. Upon discovering their own documents in EVER's possession, plaintiffs immediately investigated, took a deposition, consulted experts, and prepared the amended complaint and supporting motion—all within approximately seven weeks. Id. at 8-9.
The court acknowledged plaintiffs' diligence, finding they "exercised sufficient diligence and did not unduly delay the filing of the motion to amend the complaint." Order at 2, Dkt. 251. The court also found no bad faith. Id. But the court concluded that allowing amendment would cause undue prejudice to defendants for three reasons.
First, the "new claims concerning RICO and New Jersey state law are too distinct from the current patent case to belong in the same action." Id. at 3. The court found that "the new claims have no factual overlap to prove the elements of the current claims and the new counts." Id. The addition would "transform[] this case from a patent infringement case against four defendants to a much broader and complex RICO case involving four additional defendants." Id.
Second, the court emphasized timing pressures from the Hatch-Waxman framework. "This patent action, as a result of the 30-month stay, is on a fast track for a trial in September 2026, and adding these new claims will require additional discovery that will make it impossible to close fact discovery by the current deadline." Id. Extending discovery would delay summary judgment motions and trial, which would be "counter to the plan this Court set at the outset of this case." Id.
Third, such delays would "cause undue prejudice to Defendants, who will have adjudication of this case substantially delayed." Id. (citing Ferguson v. Roberts, 11 F.3d 696, 706 (7th Cir. 1993)).
Rather than simply denying amendment, the court granted plaintiffs leave "to file a new complaint with these claims, without the need to serve already served Defendants, and without the need to pay a filing fee." Id. The court directed the Clerk to open a separate case number and assign it as a related case. Id. Discovery from the patent case could be "shared and used in the other case." Id. The court reasoned this approach would "further judicial economy, avoid undue delay, and lessen any prejudice to current and new defendants." Id.
The court's order is notable for what it doesn't say. Although futility is a basis for denying amendment, the court expressly declined to reach defendants' futility arguments. The court's silence on futility suggests the RICO and state law claims are substantively viable—the only question is which action should adjudicate them, not whether they should be adjudicated at all. The bifurcation remedy thus rests entirely on timing and case management concerns, not on the merits of the new claims. Whether those concerns justify separating claims as factually and legally intertwined as plaintiffs contend is the subject of the analysis that follows.
III. ANALYSIS: WHY THE COURT'S RULING IS PROBLEMATIC
A. Shared Common Factual Issues: Same Regulatory Documents
The court's central finding—that "the new claims have no factual overlap to prove the elements of the current claims and the new counts"—overlooks how patent infringement is actually proven in Hatch-Waxman cases. Order at 3.
As explained, the Federal Circuit established in Glaxo that infringement analysis must focus on "what the ANDA applicant will likely market if its application is approved." 110 F.3d at 1569. Because no commercial product yet exists, "this hypothetical inquiry is properly grounded in the ANDA application and the extensive materials typically submitted in its support." Id. Courts must "consider the ANDA itself, materials submitted by the ANDA applicant in support of the ANDA, and any other relevant evidence submitted by the applicant or patent holder." Id. at 1570.
Under Glaxo and its progeny, the patent infringement case will necessarily require examining (1) EVER's "Paper NDA" application (NDA No. 219617) to determine what product EVER seeks to market; (2) the supporting Drug Master Files (DMF Nos. 36724 and 36899) describing the API and its manufacturing process (3) product specifications for the trabectedin API and finished drug product; (4) testing methods used to assess purity and degradation levels; and (5) quality control procedures ensuring batch-to-batch consistency.
These are precisely the documents whose creation and submission form the basis of the RICO and state law claims. The amended complaint alleges defendants acquired plaintiffs' specifications, testing methods, and manufacturing parameters (Ex. A ¶¶ 12-13); used this information to prepare the NDA application and supporting DMFs (id. ¶¶ 132); submitted these applications to FDA without disclosing their origins (id. ¶ 137); and used specifications developed for a different formulation and manufacturing process (id. ¶ 138).
Both cases require examining the same core documents. And both involve questions about the origin, reliability, and technical appropriateness of the specifications in the regulatory submissions. The court cannot determine "what EVER will market" under Glaxo without examining the NDA—and it cannot evaluate whether the NDA accurately describes an approvable product without determining whether the specifications were misappropriated and suited to EVER's formulation.
Thus, the patent case will examine what's in the NDA application—the specifications, methods, and parameters. The RICO case will examine whether those specifications were fraudulently obtained and potentially inappropriate to FDA's review and approval of EVER's drug product. These aren't separate inquiries that can be neatly bifurcated.
Moreover, both cases seek the same ultimate remedy: preventing the NDA Product from reaching the market. The patent case seeks an order preventing FDA from granting final approval until after the '557 Patent expires. 35 U.S.C. § 271(e)(4)(A). The RICO case seeks injunctive relief prohibiting defendants from marketing the NDA Product and ordering withdrawal of the fraudulent regulatory submissions. Ex., Prayer for Relief. The injury to plaintiffs is unified: loss of market exclusivity for Yondelis® due to competition from EVER's product.
The document overlap, however, runs even deeper than simply examining the same files.
B. The Fraud Case is Prerequisite to the Patent Case
The interp between the patent and RICO claims is not merely a matter of document overlap or factual similarity. The fraud allegations must be resolved to properly conduct the infringement analysis under Glaxo.
1. The Regulatory Significance of the Fraud Allegations
The alleged fraud has two layers. First, defendants purportedly used plaintiffs' specifications without authorization and without conducting the independent development work necessary to create appropriate specifications for their own process and product. Ex. A ¶ 136. Second, they allegedly concealed this from FDA, leaving the impression that those specifications were appropriately developed for EVER's process and product. Id. ¶ 137.
FDA's review assumes the applicant is providing specifications tailored to its own manufacturing process and formulation. That assumption breaks down if the specifications were borrowed wholesale from another product. The agency evaluates whether the proposed specifications adequately control quality for the described process and formulation. That evaluation is misdirected where the specifications were developed for an entirely different manufacturing process and formulation.
The regulatory significance goes beyond the alleged fraud itself. If the allegations are proven true—that EVER's specifications were copied from plaintiffs' regulatory filings for a sucrose-stabilized formulation and are being applied to EVER's L-arginine-stabilized formulation made by a purportedly different process—then EVER's NDA may not be approvable based on those specifications. Specifications that "risk[] failing to detect critical quality defects" because they test for impurities characteristic of a different formulation and process do not satisfy FDA's requirements for demonstrating product quality. Ex. A ¶ 138. An approval based on such specifications would rest on a fundamentally flawed foundation.
2. The Interp with the Glaxo Infringement Analysis
This lays bare the critical interp with the patent infringement analysis.
Under Glaxo and its progeny, infringement in Hatch-Waxman cases focuses on "what the ANDA applicant will likely market if its application is approved." Glaxo, 110 F.3d at 1569 (emphasis added). The question is not simply what the current application says, but what product FDA will actually approve when properly informed and what the applicant will market based on that approval.
But if EVER's current NDA specifications are inappropriate for its manufacturing process—as the fraud allegations contend—then the product described in EVER's current application is not the product that should be approved. FDA would either deny approval based on inadequate specifications or require EVER to develop and submit specifications tailored to its actual L-arginine formulation and manufacturing process. Either way, the "likely-to-be-approved product" under Glaxo is not the product currently specified in EVER's Paper NDA—it's whatever product EVER should present with appropriate, independently-developed specifications.
Plaintiffs therefore cannot prove infringement under Glaxo without first demonstrating the fraud. To establish what drug product EVER will "likely market if its application is approved," plaintiffs must show: (1) the current specifications are inappropriate because they were derived from a different formulation and process, (2) appropriate specifications for EVER's actual process would necessarily be different, and (3) a product meeting those appropriate specifications would (or would not) infringe the '557 Patent.
The doctrine of equivalents analysis makes this interp even more acute. EVER's non-infringement defense is straightforward: the '557 Patent requires "a disaccharide selected from sucrose, lactose and a combination thereof," and L-arginine is an amino acid, not a disaccharide. Ex. A ¶¶ 119-20. All concede there is no literal infringement. Plaintiffs therefore must prove infringement under the doctrine of equivalents, which requires demonstrating that L-arginine "perform[s] substantially the same function in substantially the same way to obtain the same result" as the claimed disaccharide stabilizer. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950).
To satisfy this test, plaintiffs must prove how L-arginine stabilizes the trabectedin formulation—the mechanism by which it prevents ET-743 degradation to ET-701, the conditions under which it maintains stability, and the degree of stabilization it achieves compared to sucrose. This requires examining EVER's specifications, testing methods, and stability data to prove the function, way, and result of L-arginine stabilization in EVER's actual product. But if those specifications, testing methods, and stability data were copied from the Yondelis® regulatory filings for a sucrose-stabilized formulation, they describe how sucrose works, not how L-arginine works.
Thus, specifications showing that sucrose prevents degradation under certain conditions, or testing methods validated for sucrose's stabilization mechanism, do not demonstrate that L-arginine performs substantially the same function in substantially the same way. Plaintiffs cannot meet their doctrine of equivalents burden without accurate specifications and data showing how EVER's L-arginine formulation actually functions—which requires first proving that EVER's current specifications are fraudulent and inappropriate for its formulation. The doctrine of equivalents analysis therefore may be frustrated without first resolving the fraud allegations.
The patent infringement analysis therefore cannot proceed in a vacuum—it requires first resolving whether EVER's regulatory submissions accurately describe an approvable product or whether they're based on fraudulent misappropriation of specifications unsuited to EVER's formulation.
3. The Factual Interdependency Undermines Bifurcation
This factual interdependency fundamentally undermines the court's bifurcation decision. The court found the claims had "no factual overlap" and were "too distinct" to proceed together. Order at 3. But the reality is precisely the opposite—the claims are so intertwined that the patent case cannot reach a proper conclusion without first resolving the fraud allegations.
Consider how this would play out at trial. Plaintiffs must prove what drug product EVER will market to establish infringement. EVER will point to its NDA specifications and argue its L-arginine formulation doesn't infringe. Plaintiffs must then prove those specifications don't support EVER's noninfringement defense because they were copied from and developed for a different drug formulation. That's the fraud case. Without proving the fraud, plaintiffs cannot establish what drug product EVER will actually manufacture and market. The infringement analysis stalls.
Defendants might argue that plaintiffs could proceed by assuming the NDA specifications are accurate and proving infringement based on those specifications. But Glaxo doesn't ask what the application says—it asks what the applicant will "likely market if its application is approved." 110 F.3d at 1569 (emphasis added). If the application shouldn't be approved because its specifications are fraudulent, then the Glaxo analysis cannot proceed based on those specifications.
Moreover, the Federal Circuit has emphasized that courts must examine any other "pertinent evidence provided by the parties" beyond just the application itself. Id. at 1570. Evidence that specifications were misappropriated and are inappropriate for characterizing the accused drug product is precisely the kind of "other relevant evidence" Glaxo contemplates. Courts cannot ignore such evidence simply because it also supports fraud claims.
The implications are striking. Bifurcation forces plaintiffs to prove the same facts twice in two different forums under two different legal standards, or worse, prevents them from proving the facts necessary for the patent case because those facts are locked in the separate RICO case. This is not judicial economy—it's judicial inefficiency compounded by potential impossibility of proper adjudication.
4. The Fraud Allegations Are Central, Not Peripheral
In this way, the fraud allegations are not peripheral to the patent case—they are prerequisite. The court's finding that the claims have "no factual overlap" (Order at 3) inverts the relationship between these claims. Far from being separate, the RICO case must be resolved to properly conduct the Glaxo analysis in the patent case.
This case can be distinguished from cases where fraud allegations are truly collateral to patent disputes. If, for example, a patentee alleged that a generic company bribed an FDA official to expedite approval, that fraud would be separate from the infringement analysis—the patent case could proceed based on the approved product specifications regardless of how approval was obtained. But here, the fraud allegations go directly to whether the specifications in the NDA are appropriate for the product EVER will manufacture.
Under Glaxo, that's not a collateral issue—it's the central question.
The court's "separate but related case" solution attempts to have it both ways: keep the cases separate while protecting the trial schedule and allow discovery sharing while acknowledging overlap. But this middle ground fails when the claims aren't merely overlapping but factually interdependent. How can plaintiffs prove infringement in the patent trial without presenting evidence that EVER's specifications are fraudulent? And if they present that evidence, haven't they necessarily litigated the fraud claims? The bifurcation creates a redundant, if not impossible, situation.
C. The 505(b)(2) Context Makes This Interp Even More Critical
The 505(b)(2) pathway makes the interp between the patent and fraud claims even more problematic than it would be in a typical ANDA case. The court characterized the RICO and state law claims as "too distinct from the current patent case to belong in the same action." Order at 3. But the Paper NDA context makes the fraud allegations more central to approvability—and to the infringement analysis—not less.
In a typical ANDA case, both the regulatory review and the patent infringement analysis operate within narrow constraints. The generic product must be identical to the reference drug in active ingredient, dosage form, strength, and route of administration. 21 U.S.C. § 355(j)(2)(A). FDA's review focuses primarily on bioequivalence—whether the generic produces the same blood concentration-time profile as the brand. Id. § 355(j)(2)(A)(iv). The generic drug specifications naturally resemble the brand's specifications, and the patent infringement analysis is likewise narrow. Often the generic manufacturer admits literal infringement of composition-of-matter patent claims, narrowing the dispute to patent validity.
But 505(b)(2) applications involve intentionally different products, which demands a fundamentally broader inquiry—both for FDA approval and for patent infringement. A Paper NDA applicant may change the formulation (as EVER did by substituting L-arginine for sucrose), alter the dosage form, modify the route of administration, or add new indications. 21 U.S.C. § 355(b)(2); see FDA, Guidance for Industry: Applications Covered by p 505(b)(2), at 2-4 (Oct. 1999). For each difference, the applicant must provide data or published literature demonstrating that the change doesn't adversely affect safety or efficacy. Id. This often requires FDA to conduct a more complex, multi-faceted review than for the typical ANDA submission.
The patent infringement analysis in 505(b)(2) cases is correspondingly broader and more complex. Because the accused product is intentionally different, literal infringement is often impossible to prove, as here, where L-arginine is chemically distinct from the claimed disaccharide. Ex. A ¶¶ 119-20. The analysis often turns on the doctrine of equivalents that requires proving functional and performance similarity to the claimed invention.
This creates a fundamental problem for plaintiffs here. The doctrine of equivalents demands exacting evidence about the accused product's function and performance. Yet EVER's NDA allegedly obscures that evidence by presenting false product specifications and data derived from misdirected testing methods. Plaintiffs may face difficulty in proving that L-arginine stabilizes trabectedin in substantially the same way as sucrose when the only available evidence—EVER's specifications and stability data—allegedly describe how sucrose rather than how L-arginine works. The alleged fraud doesn't run parallel to the patent case; it stands in its path.
The 505(b)(2) context not only complicates the interplay between the patent and fraud cases but also amplifies patient safety concerns arising from bifurcating the two cases. If, due to bifurcation, EVER is able to launch its product after a patent victory, only to have its approval later invalidated for fraud, vulnerable cancer patients may face mid-treatment complications. That complexity magnifies the danger of fragmenting judicial review between one court overseeing the patent case and another the fraud case based on the same regulatory record.
D. Patient Safety: Bifurcation and the Risk Hatch-Waxman Sought to Prevent
The Hatch-Waxman Act's 30-month stay serves a critical policy objective: ensuring that patent disputes are fully resolved before generic products enter the market, avoiding market disruption from having a generic launched only to be withdrawn later due to patent infringement. See Ben Venue Labs., Inc. v. Novartis Pharm. Corp., 146 F. Supp. 2d 572, 579 (D.N.J. 2001).
This policy concern is magnified in the 505(b)(2) context because federal and state law treat these products fundamentally differently from true generic drugs.
ANDA products that demonstrate bioequivalence receive an "AB" therapeutic equivalence rating in FDA's Orange Book, triggering automatic substitution under state pharmacy laws. See U.S. FOOD & DRUG ADMIN., APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS at viii-x. In all fifty states, pharmacists may—and in many states must—substitute an FDA-approved AB-rated generic for a brand-name drug unless the prescriber specifically indicates "dispense as written." See, e.g., Cal. Bus. & Prof. Code § 4073; N.Y. Educ. Law § 6816-a. If an AB-rated generic launches and is later withdrawn, patients can seamlessly return to the brand product. The disruption is primarily economic.
But 505(b)(2) products do not receive AB ratings and are not deemed therapeutically equivalent to the reference drug. See FDA, Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application, at 3 (Oct. 2017). The formulations may have different tolerability profiles, different injection site reactions, different stability characteristics in reconstituted form, or different handling requirements. They may have separate prescribing information that may contain different warnings, contraindications, or administration instructions. Pharmacists therefore cannot automatically substitute a Paper NDA product for the reference drug. A prescriber must write a new prescription specifically for the 505(b)(2) product. This is why most generic manufacturers avoid the 505(b)(2) pathway where possible—the lack of automatic substitution eliminates the primary commercial advantage of generic drugs. Paper NDA products must be actively marketed and promoted, much like brand-name drugs
Bifurcation creates acute risks in this context. Consider this sequence: (1) The patent case proceeds to trial in September 2026; (2) EVER prevails on non-infringement or invalidity grounds; (3) EVER's product launches and patients begin treatment; (4) The RICO case proceeds months or years later; (5) Plaintiffs prove the NDA was obtained through fraud; (6) FDA withdraws approval; (7) Patients mid-treatment must switch to Yondelis®.
This creates precisely the patient disruption Hatch-Waxman was designed to prevent—magnified by non-interchangeability. Patients with advanced soft tissue sarcoma who have exhausted first-line chemotherapy are a vulnerable population receiving palliative cancer treatment. Ex. A ¶ 8. Trabectedin is administered by intravenous infusion over multiple treatment cycles. If patients have begun therapy with EVER's L-arginine formulation and adapted to its specific characteristics, they cannot simply return to Yondelis® through automatic pharmacy substitution. Prescribers must write new prescriptions, re-educate themselves on different prescribing information, and counsel patients about mid-treatment formulary changes. For patients receiving palliative care, this is not seamless—it is meaningful disruption at a vulnerable time.
The irony is stark: The court cited Hatch-Waxman's "fast track" as justification for denying amendment (Order at 3), but bifurcation may undermine Hatch-Waxman's core purpose. By deferring fraud claims that go to the approval's legitimacy while proceeding with the patent trial, the court creates a scenario where EVER's non-substitutable Paper NDA product might launch after a patent victory—even though its regulatory approval remains under fraud challenge. When that fraud is later proven and the product withdrawn, vulnerable cancer patients face disruptive mid-treatment formulary changes that state pharmacy laws and FDA's regulatory framework do not accommodate seamlessly. Thus, a bifurcation designed for speed could endanger the very patients Hatch-Waxman was enacted to protect.
E. The Bench–Jury pide Further Undermines Bifurcation
The district court's bifurcation order creates an additional structural problem: a potential bench–jury pide that further complicates the proceedings and increases the risk of inconsistent findings.
In a standard Hatch-Waxman case under 35 U.S.C. § 271(e)(2), the patentee's remedies are equitable—orders under § 271(e)(4) delaying FDA approval or enjoining product launch. Courts have consistently held there is no Seventh Amendment right to a jury on such claims seeking only injunctive relief. See, e.g., Pfizer Inc. v. Novopharm Ltd., No. 00-C-1475, 2001 WL 477163, at *4 (N.D. Ill. May 3, 2001). The patent case will therefore proceed to a bench trial.
By contrast, plaintiffs' RICO claims seek both equitable relief under 18 U.S.C. § 1964(a) and treble damages under § 1964(c). See Ex. A at Prayer for Relief. The treble damages claim is legal in nature and ordinarily entitles defendants to a jury trial. See Sedima, S.P.R.L. v. Imrex Co., Inc., 473 U.S. 479, 489–90 (1985) (predicate act can be found by jury under preponderance standard). Unless defendants waive their jury right, separating the cases means two different factfinders will hear the same evidence regarding how the Paper NDA was prepared and whether plaintiffs' regulatory data were misappropriated. That pision increases—not reduces—the risk of inconsistent findings on the same core facts.
Courts confronting mixed legal and equitable claims have long recognized that when jury rights exist, the jury's factual determinations must take precedence on overlapping factual issues. See Beacon Theatres, Inc. v. Westover, 359 U.S. 500, 510–11 (1959) (action in equity must be tried with jury-entitled claims to preserve Seventh Amendment rights); cf. In re Innotron Diagnostics, 800 F.2d 1077, 1085 (Fed. Cir. 1986) (discussing sequencing of patent and antitrust proceedings with overlapping evidence). If the RICO case proceeds separately to a jury trial, factual findings from the bench-tried patent case could influence—or potentially preclude through collateral estoppel—jury consideration of those same facts, contrary to Beacon Theatres' directive to preserve jury rights. Conversely, if the cases were consolidated, the court could structure the proceeding to preserve jury rights through appropriate sequencing, bifurcated trial procedures under Rule 42(b), or advisory jury mechanisms under Rule 39(c). Any of these approaches would allow a single evidentiary record with coordinated factual findings.
But the bench–jury complication is not insurmountable if plaintiffs were to withdraw their treble damages claim under § 1964(c) and proceed solely on the equitable relief available under § 1964(a), which includes injunctive relief prohibiting defendants from marketing the NDA Product and ordering withdrawal of the fraudulent regulatory submissions. See 18 U.S.C. § 1964(a) ("district courts . . . shall have jurisdiction to prevent and restrain violations of p 1962"). With both the patent and RICO claims seeking only equitable relief, all issues could be tried in a single, consolidated bench trial before the same judge examining the same evidence—eliminating the risk of inconsistent findings, avoiding duplicative proceedings, and preserving the comprehensive pre-launch resolution that Hatch-Waxman contemplates. The existence of this straightforward path to consolidation underscores that bifurcation was not compelled by the structure of the claims but was instead a discretionary choice that created rather than resolved procedural complications.
F. The Timing and Prejudice Findings Invite Scrutiny
The court's basis for finding prejudice was that "adding these new claims will require additional discovery that will make it impossible to close fact discovery by the current deadline." Order at 3. But the timelines and the nature of the required discovery undercut rather than support this finding.
Eleven months remained until trial when the court issued its October 6, 2025 ruling. While Hatch-Waxman cases move quickly, eleven months is substantial time—not an eve-of-trial scenario where amendment would be particularly disruptive. Cf. Ferguson v. Roberts, 11 F.3d 696, 706 (7th Cir. 1993) ("new complex and serious charges" when trial was imminent).
Under these circumstances, it appears the court could have adjusted discovery deadlines without delaying trial. The court assumed additional discovery would "make it impossible" to close discovery in December 2025, forcing delays to summary judgment and trial. But the court lost sight of the fact that the additional discovery would be relevant to both the patent claims and the RICO and state law claims.
Moreover, bifurcation itself creates timing problems. The court's solution—file a separate but related case—doesn't eliminate timing pressures; it merely redistributes them. Now there are two cases with two discovery tracks, two summary judgment schedules, and two trial dates. Managing parallel cases involving substantially overlapping facts creates more work for both the court and the parties, not less. The risk of inconsistent outcomes increases, and the likelihood that one case will be rendered moot by the other means the "efficiency" gained by bifurcation is illusory.
Finally, plaintiffs acted as expeditiously as possible. The court acknowledged this, finding plaintiffs "exercised sufficient diligence and did not unduly delay." Order at 2. EVER produced the critical documents only in mid-June 2025. Plaintiffs investigated, took a deposition, consulted with experts, and filed their motion within seven weeks. The timing pressures stem from EVER's delayed production schedule—producing over 370,000 pages in the final two weeks before the deadline. Pls.' Mot. to Amend at 3. Penalizing plaintiffs for timing problems created by defendants' discovery practices is fundamentally unfair.
IV. CONCLUSION
The district court faced a difficult and rare situation: serious fraud allegations discovered late in a time-sensitive case. The court's bifurcation solution—separate but related cases with shared discovery—charted a middle course. But the solution fails to recognize plaintiffs' unique burden of proof in this Hatch-Waxman litigation. Under Glaxo, proving patent infringement requires determining what the applicant will "likely market if its application is approved." 110 F.3d at 1569. If the application is based on fraudulent specifications copied from a different formulation, the infringement analysis cannot proceed without first resolving whether those specifications actually define the drug product that EVER will market. When a Paper NDA is alleged to have been prepared using misappropriated specifications for the reference drug, the questions "does this product infringe?" and "was this approval fraudulently obtained?" are not separate inquiries—they are two sides of the same coin.The fraud case is prerequisite to the patent case.
The court's finding of "no factual overlap" inverts this reality. Bifurcation forces plaintiffs to prove the same facts twice, risks inconsistent findings, and may make proper resolution of either case impossible. And so the arithmetic of the ruling is flawed: diligent investigation + timely motion + prerequisite claims + common remedy = denied amendment, where, as here, speed trumps substance. The ruling may lie within the district court's discretion, but forcing bifurcation serves neither judicial economy nor Hatch-Waxman's purpose of complete pre-launch resolution of claims. In this rare interp of 505(b)(2) approval and alleged fraud, the fraud claims aren't peripheral—they're central. And central claims belong in a single proceeding, resolved before vulnerable patients begin treatment on a product whose approval may rest on a fraudulent foundation.
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