Section 271(e)(1) Safe Harbor Applies to Importation Regardless of Intent or Actual Use

April 18, 2024

Reading Time : 3 min

A divided panel of the Federal Circuit affirmed a district court’s grant of summary judgment of noninfringement, holding that importation of two product samples into the U.S. was reasonably related to obtaining FDA approval based on the particular facts of this case. In dissent, Judge Lourie disagreed, suggesting that summary judgment was not appropriate where factual disputes existed as to whether the importation was “solely” for purposes related to FDA approval.

At issue in this case was the importation of two sample heart valve systems. The accused infringer brought the samples into the U.S. in connection with a medical trade show. It was undisputed, however, that the samples were never shown at the trade show. It was also undisputed that the accused infringer never offered for sale or sold the samples. And in advance of the trade show, the accused infringer instructed its employees that they could not make offers for sale in the U.S. But the employees were permitted to make offers for other countries where the systems were already approved for human use. According to the accused infringer, it brought the samples to the U.S. trade show to identify potential clinicians for its premarket approval application who were known to attend the trade show. In support of this assertion, the accused infringer presented evidence that it started work on a premarket approval submission, began planning a “Landmark Trial” to include in future submissions to the FDA, contacted the FDA about the requirements for a premarket submission and retained a medical device consulting company to assist with its premarket submission.

Based on these facts, the district court found the accused infringer’s activities were protected by the Safe Harbor provision, and granted summary judgment of non-infringement. 

On appeal, the patentee argued the district court failed to apply an objective standard to the Safe Harbor and instead improperly relied on the accused infringer’s intent. The Federal Circuit rejected this argument, explaining that “the relevant inquiry is not why” the accused infringer imported the samples “or how” it used the samples, “but whether the act of importation was for a use reasonably related to submitting information to the FDA.” In view of the undisputed evidence that no offers for sale were made, the court held that no reasonably minded juror could have concluded the importation was “solely to support commercial sales, rather than to recruit clinical investigators.” According to the majority, “solely” as used in the Safe Harbor modifies uses and means, for each act of infringement, the safe harbor is available where the acts or uses that constitute infringement bear a reasonable relation to the development and submission of information to the FDA.

On this point, Judge Lourie dissented. In Judge Lourie’s view, the majority opinion and the Federal Circuit precedence on which it relies read the word “solely” out of the Safe Harbor. Judge Lourie believes that solely limits the application of the Safe Harbor to acts that have no purpose other than the development of information for the FDA. In other words, the Safe Harbor does not exist to protect acts that have a dual purpose, one of which is commercial. And here, factual disputes existed at least as to whether the accused infringer’s importation served a dual purpose—FDA approval and sales. Judge Lourie urged that consideration by the Federal Circuit en banc is warranted to consider the proper construction of the Safe Harbor provision.

Practice Tip: Parties who are actively developing products for which FDA approvals are required prior to commercial use should take care to ensure that any potential act of infringement preceding FDA approval is tied to the development of information that will be submitted to the FDA. Such activity is protected if it is reasonably related to an FDA submission; whereas activity that is solely commercial in nature is exempt from the Safe Harbor.  

Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd., No. 2022-1877, 2024 WL 1243032 (Fed. Cir. Mar. 25, 2024)

Share This Insight

Previous Entries

IP Newsflash

March 24, 2025

The Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) final written decision holding that the prior art exception of AIA Section 102(b)(2)(B) does not apply to a prior sale by an inventor when the sale is conducted in private. According to the Federal Circuit, a sale must disclose the relevant aspects of the invention to the public to qualify for the prior art exception of Section 102(b)(2)(B).

...

Read More

IP Newsflash

March 21, 2025

Under the Lanham Act, a plaintiff who prevails on a trademark infringement claim may be entitled to recover the “defendant’s profits” as damages. The Supreme Court in Dewberry Group, Inc. v. Dewberry Engineers Inc. unanimously construed “defendant’s profits” in 35 USC § 1117(a) to mean that only the named defendant’s profits can be awarded, not the profits of other related corporate entities. The Court, however, left open the possibility that other language in § 1117(a) may allow for damages linked to the profits of related entities, if properly raised and supported.

...

Read More

IP Newsflash

March 13, 2025

In a series of rulings on a motion in limine, the District of Delaware recently distinguished between what qualifies as being incorporated by reference and what does not for the purposes of an anticipation defense. In short, a parenthetical citation was held to be insufficient, while three passages discussing a cited reference met the test.

...

Read More

IP Newsflash

March 4, 2025

On February 28, 2025, the USPTO announced that it was rescinding former Director Vidal’s 2022 memorandum on discretionary denials by the Patent Trial and Appeal Board. The 2022 memorandum effectively narrowed the application of discretionary denials in cases with parallel district court litigation by specifying instances where discretionary denial could not be issued. With the withdrawal of the memorandum, individual PTAB panels will regain flexibility in weighing discretionary denials. While the long-term effect of that increased flexibility is not yet known, the immediate effect is likely to be a shift towards the discretionary analysis applied by PTAB panels before the issuance of the memorandum.

...

Read More

IP Newsflash

March 3, 2025

A District of Delaware judge recently granted a defendant’s motion to include a patent prosecution bar in its proposed protective order after determining that litigation counsel’s ability to practice before the Patent Office—without ever having represented the plaintiffs at the Patent Office in the past—weighed heavily in favor of the bar.

...

Read More

IP Newsflash

February 12, 2025

The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit explained that written description and enablement are evaluated based on the subject matter that is claimed, not the products that practice those claims. As a result, the patentee was not required to describe unclaimed, later-discovered features of the accused products despite the broad language in the claims that undisputedly covered the products.

...

Read More

IP Newsflash

January 24, 2025

The District of Delaware recently rejected a patentee’s argument that non-production of an opinion letter from counsel, combined with knowledge of the patent, warranted a finding that defendant induced infringement.

...

Read More

IP Newsflash

January 17, 2025

The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the court found the patentee’s complaint sufficiently alleged at least some uses of the claimed technology that, when taken as true, were not solely uses of a “patented invention” that were “reasonably related” to an FDA submission.

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.