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What Use Does § 271(e)(1) Safe Harbor “Solely” Protect?

The US Court of Appeals for the Federal Circuit affirmed that the 35 U.S.C. § 271(e)(1) safe harbor protecting certain infringing acts undertaken for regulatory approval applied to an alleged infringer’s importation of transcatheter heart systems while attending a trade conference, finding the importation reasonably related to submitting information to the US Food & Drug Administration (FDA) for medical device approval. Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., Case No. 22-1877 (Fed. Cir. Mar. 25, 2024) (Stoll, Cunningham, JJ.) (Lourie, J., dissenting).

The fact pattern in this case is unusual. Meril, a manufacturer of a transcatheter heart system approved for sale in Europe but not in the United States, brought two demonstration samples to San Francisco with lawyer-generated instructions that the samples could not be used, sold or offered for sale in the US. Meril presented at a trade booth during a cardiovascular medical device conference. It was undisputed that the samples never left a bag that was first kept at a hotel and later brought to the conference and placed in a storage room.

Edwards Lifesciences nevertheless sued for infringement based on importation. The district court found that Meril’s importation was reasonably related to its attempts to secure regulatory approval because they were for the purposes of recruiting investigators for a clinical trial Meril had made initial efforts to commence (as required to market this type of device in the US). Accordingly, the district court granted summary judgment of noninfringement on grounds that the safe harbor under § 271(e)(1) applied. Edwards appealed.

Edwards argued that the district court erred by not finding a genuine material dispute of fact relating to Meril’s subjective intent (i.e., whether, notwithstanding some evidence, Meril actually intended the importation to relate to FDA approval). Edwards also challenged whether the importation was solely related to FDA approval and argued that the non-use of the devices to recruit investigators rendered the safe harbor inapplicable.

The Federal Circuit rejected all three challenges. Canvassing the Federal Circuit’s decades of prior case law, the Court concluded that a putative infringer’s intent is irrelevant when determining whether the safe harbor applies. Thus, even if Edwards were correct in challenging Meril’s intent, there would still be no material factual dispute. On the issue of whether the importation activity was solely related to FDA approval, the Court, discussing the use of “solely” in terms of the safe harbor provision, reiterated prior cases’ determination that the uses need not be solely related to FDA approval, but rather, that the only uses that would be protected were those within the safe harbor. Finally, the Court again deemed the non-use of the devices irrelevant, as nothing in the statute required actual use.

Judge Lourie dissented, not because he necessarily viewed the district court’s or the majority’s application as squarely incorrect under existing precedent, but because he believed that existing precedent did not expressly give proper weight to the statute’s use of the word “solely.” Applying a plain text analysis, Judge Lourie argued that the safe harbor [...]

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After Supreme Court Remand, Copyright Infringement Claims Upheld in View of Registrant’s Unknown Inaccuracies

In February 2022, the Supreme Court of the United States held in Unicolors, Inc. v. H&M Hennes & Mauritz, L.P., that lack of either factual or legal knowledge on the part of a copyright holder can excuse an inaccuracy in the holder’s registration under the Copyright Act’s safe-harbor provision, 17 U.S.C. §411(b)(1), which governs the effect of inaccurate information in a copyright application. In light of this decision, the Supreme Court remanded the copyright dispute between textile design company Unicolors and global fast-fashion retail giant H&M Hennes & Mauritz to the US Court of Appeals for the Ninth Circuit for further proceedings on the issue of whether Unicolors held a valid copyright in a 2011 textile design asserted in its copyright infringement claim against H&M. On remand, the Ninth Circuit concluded that under the correct standard confirmed by the Supreme Court, Unicolors held a valid copyright registration because the factual inaccuracies in its application were excused by the safe-harbor provision. The Ninth Circuit affirmed the prior jury verdict against H&M for copyright infringement and remanded with respect to the issue of damages only. Unicolors, Inc. v. H&M Hennes & Mauritz, L.P., Case Nos. 18-56253; -56548 (9th Cir. Nov. 10, 2022) (Bea, Bade, McCalla, JJ.)

The Copyright Act safe-harbor provision saves a copyright registration from invalidity when the application contains errors, except when the copyright registrant knowingly transmitted inaccurate material facts to the US Copyright Office. After the Supreme Court made it clear that “[l]ack of knowledge of either fact or law can excuse an inaccuracy in a copyright registration,” the Ninth Circuit was charged with determining whether Unicolors submitted its copyright application with knowledge that the information therein was factually inaccurate and with knowledge that the application failed to comply with the specific governing legal requirements. The Court first analyzed the validity of Unicolors’s asserted copyright registration, then addressed the remaining issues raised by H&M on appeal.

The Ninth Circuit’s first step in the validity assessment was to determine whether Unicolors’s application did, in fact, contain an inaccuracy. As in its prior decision, the Court concluded that the application was inaccurate because Unicolors registered a collection of 31 separate fabric designs as a single-unit publication when those 31 works were not initially published as a singular bundled collection, as required under the Copyright Act.

The second step of the Ninth Circuit’s inquiry looked at whether Unicolors submitted its copyright application knowing that it contained errors. This is where the Court departed from its prior decision and affirmed the district court’s decision regarding the validity of the registration. Specifically, the Court found that the single-unit registration issue was an unsettled question of law at the time of Unicolors’s application, such that Unicolors did not know that it submitted an application containing false information because it lacked the requisite knowledge of inaccuracy and lacked an intent to defraud the Copyright Office. Finding Unicolors’s copyright registration valid, the Court determined that Unicolors could maintain its copyright infringement claim against H&M.


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