Safe Harbor Archives

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

by Christopher M. Bruno | May 15, 2025 | Patents

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running clinical trial and new clinical trials and remanded for further consideration of whether prohibiting a request for an additional indication was appropriate. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals LLC, Case No. 24-2274 (Fed. Cir. May 6, 2025) (Lourie, Reyna, Taranto, JJ.)

This appeal is one of several disputes between Jazz and Avadel regarding their competing sodium oxybate products. Jazz markets two such products: Xyrem, approved for treating excessive daytime sleepiness and certain cataplexy, and Xywav, which, in addition to Xyrem’s indications, also may be used for treating idiopathic hypersomnia. Avadel filed a § 505(b)(2) new drug application (NDA) to market its own product, Lumryz. During the pendency of the Lumryz application, Jazz obtained a patent and asserted that Avadel infringed it under 35 U.S.C. § 271(e)(2), part of the Hatch-Waxman Act, based on its filing of the Lumryz NDA. The patent was never Orange Book listed, so Avadel did not need to submit any patent certification.

The US Food & Drug Administration (FDA) approved Lumryz. Avadel launched the product, and Jazz amended its complaint to assert traditional § 271(a) – (c) infringement. Ultimately, Avadel and Jazz stipulated infringement, the patent was determined not invalid, and the jury awarded damages based on the post-launch infringement. After further proceedings, the district court permanently enjoined Avadel from seeking an idiopathic hypersomnia indication for Lumryz, offering an OLE phase of its then-running Lumryz idiopathic hypersomnia clinical trial, and against initiating new clinical trials. Avadel appealed, arguing that each of these restrictions was improper.

The Federal Circuit largely agreed with Avadel, reversing the first two prohibitions, and remanded the case back to the district court for further consideration of the prohibition against any new clinical trials. Turning first to the prohibition on new clinical trials, the Court held that initiating new trials for the purposes of submission to the FDA fell squarely within the Hatch-Waxman Safe Harbor for experimentation (under § 271(e)(1)) and thus could not be enjoined (per §271(e)(3)). Jazz unsuccessfully argued that Avadel had waived its Safe Harbor position, which required factual development.

Next, the Federal Circuit rejected the district court’s injunction against an OLE, concluding that the district court had not applied the Supreme Court’s four-factor eBay (2006) test for injunctions when deciding the appropriateness of such extraordinary relief. Refusing to determine whether an OLE extension qualified as safe-harbored activity in the first instance, the Court explained that only if such activity were deemed to be infringing on an appropriate record could it be enjoined.

Finally, with respect to prohibiting Avadel from seeking an idiopathic hypersomnia indication for Lumryz, the Federal Circuit concluded that the propriety of that restriction may turn on whether the infringement qualified under the Hatch-Waxman Act, reasoning that an injunction might run afoul of the § 271(e)(4) limitation on the scope of injunctive relief. [...]

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Vimeo’s Fleeting Interaction With Videos Doesn’t Negate Safe Harbor Protections

by Taylor MacDonald | Jan 23, 2025 | Copyrights

The US Court of Appeals for the Second Circuit affirmed a district court’s decision, granting Vimeo qualified protection under the Digital Millennium Copyright Act (DMCA) safe harbor provision. Capitol Records, LLC v. Vimeo, Inc., Case Nos. 21-2949(L); -2974(Con) (2d Cir. Jan. 13, 2025) (Leval, Parker, Merriam, JJ.) This case addresses, for the second time, whether Vimeo had “red flag knowledge” of the defendant’s copyrighted works under the DMCA.

DMCA Section 512(c) provides a safe harbor that shelters online service providers from liability for indirect copyright infringement on their platforms under certain conditions. Congress provided two exceptions that would remove the safe harbor protection:

Actual or red flag knowledge of infringing content
The ability to control content while receiving a financial benefit directly attributable to the accused infringement activity.

EMI, an affiliate of Capitol Records, vehemently opposed Vimeo’s inclusion of videos containing EMI’s music on its site and initiated the present suit in 2009. The district court granted summary judgment in favor of Vimeo, dismissing the plaintiffs’ claims on the ground that Vimeo was entitled to the safe harbor protection provided by Section 512(c). EMI appealed.

In a 2016 appeal (Vimeo I ), the Second Circuit considered Vimeo’s activities under the DMCA. In Vimeo I, the Court (in the context of an interlocutory appeal) ruled that the copyright holder must establish that the service provider (e.g., Vimeo) had “knowledge or awareness of infringing content,” and that the service provider bore the initial burden to prove it qualified for the DMCA safe harbor, whereupon the burden shifted to the copyright holder to prove a disqualifying exception.

Knowledge of Infringement

In Vimeo I, the Second Circuit cited its 2012 decision in Viacom Int’l v. You Tube and explained that red flag knowledge incorporates an objective standard. The facts actually known to the service provider must be sufficient such that a reasonable person would have understood there to be infringement that was not offset by fair use or a license. Vimeo I clarified that service provider employees who are not experts in copyright law cannot be expected to know more than any reasonable person without specialized understanding.

The Second Circuit explained that this knowledge analysis is a fact-intensive one, and that copyright owners cannot rely on service provider employees’ generalized understanding to prove red flag knowledge for any video (or other work). The Vimeo I court also noted that the DMCA did not place a burden on service providers to investigate whether users had acquired licenses. In Vimeo I, the Second Circuit further instructed that because the legal community cannot agree on a universal understanding of fair use, it would be unfair to expect “untutored” service provider employees to determine whether a given video is not fair use on its face.

Right and Ability to Control

In analyzing what constitutes the right and ability to control, the Second Circuit emphasized that Congress’ purpose behind the DMCA was to effect a compromise between rightsholders and safe harbor claimants: “Congress recognized that the [...]

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PTO Proposes Standardization of the Patent Term Adjustment Statement Regarding Information Disclosure Statements

by Amol Parikh | Jul 21, 2022 | Patents

The US Patent & Trademark Office (PTO) announced on July 12, 2022, that it intends to revise the rules pertaining to patent term adjustment to require that the patent term adjustment statement regarding information disclosure statements (IDS) be submitted on a PTO form. The PTO believes that the use of the form will streamline prosecution and be more accurate and efficient by eliminating the need for a manual review of the patent term adjustment statement.

The regulations in 37 CFR 1.704(c)(1) through (14) establish the circumstances that constitute an applicant’s failure to engage in reasonable efforts to conclude processing or examination of an application and the resulting reduction of any patent term adjustment. 37 CFR 1.704(d)(1) also provides a safe harbor for filing IDS. Filing only an IDS in compliance with §§ 1.97 and 1.98 or a request for continued examination with only a compliant IDS is not considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(6), (8), (9) or (10) if it is accompanied by the required statement. The statement required to accompany the paper or request for continued examination must affirm that each item of information contained in the IDS meets one of the following requirements:

It was first cited in any communication from a patent office in a counterpart foreign or international application or from the PTO, and this communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS.
It is a communication that was issued by a patent office in a counterpart foreign or international application or by the PTO, and this communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS.

The PTO proposes adding new paragraph (d)(3) to 37 CFR 1.704(d), which requires filers to submit the patent term adjustment statement under 37 CFR 1.704(d)(1) on a form PTO/SB/133 to derive the safe harbor benefit under 37 CFR 1.704(d). Form PTO/SB/133 includes the required statement described above. Filers who submit a 37 CFR 1.704(d)(1) patent term adjustment statement without using the form PTO/SB/133 and filers who submit the form PTO/SB/133 with any modification to the patent term adjustment statement will not receive the benefit of the safe harbor under 37 CFR 1.704(d). Under such circumstances, the IDS or the request for continued examination, with no submission other than an IDS, will be treated as unaccompanied by a patent term adjustment statement under 37 CFR 1.704(d)(1).

Comments on the proposed rule must be received by September 12, 2022, to ensure consideration.

Slipping Through the Cracks of the § 271(e)(1) Safe Harbor

by McDermott Will & Emery | Jan 8, 2020 | Life Sciences, Patents

The US Court of Appeals for the Federal Circuit affirmed that the majority of the batches of an accused biosimilar manufactured by Hospira were not protected by the Safe Harbor exemption of § 271(e)(1), and that patent infringement damages were not unreasonable, notwithstanding that none of the accused product had been sold. Amgen Inc. v. Hospira, Inc., Case Nos. 19-1067; -1102 (Fed. Cir., Dec. 16, 2019)(Moore, J.).

EPO is a glycoprotein that regulates red blood cell development. Recombinant versions of EPO are used to treat anemia. One example is Amgen’s product Epogen. In 2014, Hospira submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) requesting approval for its EPO biosimilar. Amgen then sued Hospira for infringement of its patent directed to methods of producing EPO isoforms and its patent directed to recombinant cells producing EPO at certain rates. Specifically, Amgen asserted that 21 pre-approval batches of EPO manufactured by Hospira infringed various claims of these patents.

Hospira appealed.

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