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D. Del. Says ANDA Specification Trumps All Else in Infringement Analysis

On February 8, 2022, U.S. District Court Judge Maryellen Noreika of the United States District Court for the District of Delaware granted the plaintiff’s motion to exclude defendant’s expert testimony for being “based on an erroneous legal theory” in a suit alleging defendants’ proposed generic Abbreviated New Drug Application (“ANDA”) product would infringe Exela’s patents under the Hatch-Waxman Act. Exela Pharma Sciences v. Eton Pharms., No. 20-cv-00365 (D. Del. Feb. 8, 2022). In so doing, Judge Noreika held that where the ANDA specification speaks to the claim limitation at issue, the ANDA specification, not other materials submitted to FDA describing the proposed ANDA product, controls the infringement analysis. Only where the ANDA specification itself does not speak to a claim limitation should the court consider other materials describing the ANDA product, such as biobatch data and actual samples, in order to assess infringement.

In early 2020, Eton submitted an ANDA seeking approval to market a generic version of Exela’s drug, Elcys®. Exela sued, alleging infringement of six patents, including ones with asserted claims directed to a specific maximum level of aluminum and specific quantity ranges of lead and mercury in the drug product. Eton’s ANDA specification, if approved, would allow Eton to market the proposed ANDA product with aluminum, lead, and mercury levels falling within Exela’s claimed ranges. However, Eton’s expert opined that the ANDA product biobatch data and sample exhibit batches submitted in the ANDA demonstrate that the proposed ANDA product will not actually contain aluminum, lead, or mercury levels within the claimed ranges, despite infringing amounts being permitted by the ANDA specification. Eton thus argued that the court should look beyond the ANDA specification and consider additional ANDA information when determining whether the ANDA product will infringe Exela’s patents. Exela disagreed, arguing that the expert’s approach is unreliably based on an erroneous legal premise, and moved to strike those portions of the expert testimony under Rule 702 of the Federal Rules of Evidence.

Judge Noreika agreed with Exela, applying the Federal Circuit’s decision in Sunovion Pharms. v. Teva Pharms. USA, which held, “[w]hat a generic applicant asks for and receives approval to market, if within the scope of a valid claim, is an infringement.” The court further explained that “the court should examine other materials [beyond the ANDA specification] to look at the product that the generic company is likely to sell when the ANDA specification is silent on that limitation.” Judge Noreika distinguished the case at hand from prior suits where courts examined ANDA materials other than the specification because those courts looked beyond the ANDA product specification when those specifications did not speak to the claim limitations at issue and thus did not “directly resolve the infringement question.” As noted by the Federal Circuit in Sunovion, courts should evaluate ANDA product infringement under the Hatch-Waxman Act via the ANDA specification, rather than evidence that the ANDA product may not embody the full scope of that specification, because of the possibility that the applicant could later market an approved and potentially infringing product within that broader disclosure. Doing otherwise tends to “unnecessarily defer[] resolution of the infringement issue” until such future ANDA product release, undermining the Hatch-Waxman framework’s goal of evaluating infringement early on.

Judge Noreika’s decision in this case reinforces the Federal Circuit’s holding in Sunovion and serves as a reminder that ANDA product infringement is primarily assessed by comparing the asserted claims with the ANDA specification, rather than other ANDA submission materials further describing the ANDA product. 

©1994-2023 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XII, Number 48
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About this Author

Peter J. Cuomo, Mintz Levin, Patent Litigation Lawyer, Expert Discovery Attorney,Patent Litigation IPRs & Other Post-Grant Proceedings Federal Circuit Appeals Hatch-Waxman ,ANDA Litigation Federal District Court
Of Counsel

Peter’s practice involves intellectual property enforcement and defense, and client counseling on issues related to IP rights. Peter's primary focus is in patent litigation where he has experience in every phase from pre-suit investigations through appeal, including, initial evaluation and case initiation, fact and expert discovery, pre-and post-trial motion practice, and trials and appeals. In addition to suits centered on the assertion and defense of infringement claims, Peter has experience with the successful resolution of multiple inventorship disputes and related misappropriation...

617-348-1854
Adam Samansky IP Attorney Mintz Law Firm
Member

Adam is an experienced IP litigator who primarily serves pharmaceutical, medical, high tech, and defense industry clients. He handles patent, trademark, and trade secret matters for innovators and investors. Adam has a strong record of success in multiparty, highly contested Hatch-Waxman litigation, in addition to other litigations involving advanced biochemistry, polymers, optics, manufacturing processes, and electronics. He has tried cases before multiple US district courts, briefed and argued cases before the US Court of Appeals for the Federal Circuit, and briefed bet-the-company...

617-348-1819
Joseph Rutowski IP Attorney Mintz
Associate

Joseph’s practice focuses on intellectual property litigation and counseling on issues related to intellectual property rights. Joseph’s primary focus is in patent litigation, including the intricacies of Hatch-Waxman pharmaceutical litigation. He has extensive experience in every stage of litigation, from pre-suit investigations through appeal – including case initiation, fact and expert discovery, motion practice, and successful preparation for and participation in trials involving patent infringement allegations.

Joseph has represented...

617.348.1873
Associate

Tianyi is an intellectual property litigator whose practice emphasizes patent matters in federal district courts and at the International Trade Commission. As a member of litigation teams, she researches prior art, drafts discovery requests, conducts document review, drafts deposition inquiries, and helps at all stages of cases, from complaint drafting through appeal.

Tianyi was a Summer Associate at Mintz in 2020, during which time she researched patent issues and prepared memoranda on topics including patent enforcement, prior art, and...

617-239-8422
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