News & Analysis as of

Patent Litigation Safe Harbors

Fish & Richardson

The Final Word on an Alleged Infringer’s Intent in a Hatch-Waxman Safe Harbor Analysis

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We have been monitoring the dispute between Edwards Lifesciences Corp. (“Edwards”) and Meril Life Sciences Pvt., Ltd. (“Meril”) before and after the initial Federal Circuit decision. The dispute focused on whether Meril’s...more

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

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In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

BakerHostetler

IP Litigation Newsletter - April 2024

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The safe harbor exception in 35 U.S.C. § 271(e)(1) applies “solely for uses reasonably related to the development and submission of information” to the Food and Drug Administration (FDA). The Federal Circuit interpreted the...more

McDermott Will & Emery

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...more

Bradley Arant Boult Cummings LLP

A Port in the Infringement Storm: When 35 U.S.C. § 271(e)(1)’s Safe Harbor Applies

Earlier this week, the Federal Circuit granted Meril Life Sciences safe passage out of the infringement storm — otherwise known as Edwards Lifesciences — continuing to chase it (at least for now). More specifically, a divided...more

Foley & Lardner LLP

Federal Circuit Applies Safe Harbor to Imported Medical Device Samples

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The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...more

Goodwin

District Court Grants Summary Judgment and Invalidates Patent in REGENXBIO v. Sarepta Litigation

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On January 5, 2024, in litigation between REGENXBIO and Sarepta Therapeutics, Judge Richard Andrews of the U.S. District Court for the District of Delaware District Court granted summary judgment for Sarepta and ruled that...more

Akin Gump Strauss Hauer & Feld LLP

In Wake of In re Cellect, District Court Interprets Safe Harbor Statute and Finds Patent Not Invalid for Obviousness-Type Double...

The District Court for the District of Delaware recently held on summary judgment that a patent with 2,295 days of combined patent term adjustment (PTA) and patent term extension (PTE) was not invalid for obviousness-type...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Goodwin

Sarepta and Catalent File Answers in REGENXBIO v. Sarepta Litigation

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Sarepta and Catalent File Answers in REGENXBIO v. Sarepta Litigation - As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics,...more

American Conference Institute (ACI)

[Event] 21st Advanced Summit on Life Sciences Patents - May 18th - 19th, New York, NY

ACI’s 21st Advanced Summit on Life Sciences Patents returns to New York City, this May, to provide practical insights on how to maximize your patent term and develop strategies to enhance global protections for your patent...more

Morrison & Foerster LLP

The USPTO Reins In Fintiv

No recent Patent Trial and Appeal Board (PTAB) decision has been more impactful than Apple Inc. v. Fintiv, Inc., IPR2020-00019 (Mar. 20, 2020). It has led to about 200 discretionary denials of post grant proceedings, sparked...more

Linda Liu & Partners

How to win the war against infringement on China’s e-commerce platforms

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In the information age, with the rapid development of the Internet, mobile Internet, big data, and other technologies, products can be promoted to the whole world without leaving your house; foreign companies can also open...more

Fish & Richardson

REGENXBIO v. SAREPTA: Make Sure You’re Safely Within the Safe Harbor Before Using a “Research Tool”

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Are patented products that are not themselves subject to FDA approval, but used to develop products that are subject to FDA approval, protected under the Hatch-Waxman safe harbor? While courts have reached different...more

Proskauer - Life Sciences

A Guiding Light for the Research Safe Harbor and “Research Tools”?

Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more

Goodwin

Federal Circuit Denies Hospira’s Petition to Rehear Safe Harbor Ruling in Epoetin Biosimilar Dispute

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The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute.  As we have previously reported, that ruling upheld a jury verdict...more

Goodwin

Hospira Asks Federal Circuit to Take Fresh Look at Safe Harbor Ruling in Epoetin Biosimilar Dispute

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Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2019 #3

PATENT CASE OF THE WEEK - Blackbird Tech LLC v. Health in Motion LLC, Appeal No. 2018-2393 (Fed. Cir. Dec. 16, 2019) - In this week’s Case of the Week, the Federal Circuit affirmed a fee award against prevailing...more

Mintz - Intellectual Property Viewpoints

Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.

On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more

Faegre Drinker Biddle & Reath LLP

After Supernus: It’s Up to You to Keep Your Patent Alive All Its Days

Patentees may obtain additional PTA if the USPTO’s calculation of “applicant delay” includes a period of time during which the patentee could have taken “no identifiable effort” to avoid. However, the onus is entirely on the...more

Wilson Sonsini Goodrich & Rosati

District Court Case Highlights Nuances Associated with Determining If a Generic or Biosimilar Applicant Is Entitled to Protection...

A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more

Kilpatrick

Safe Harbor Provision of 35 U.S.C. § 271(e)(1) – Implications of Intent and Continued Use

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The safe harbor defense has been of issue in two recent cases in which the bounds of the protection has been analyzed. Section 271(e)(1) carves out an exception to patent infringement liability when otherwise-infringing...more

Benesch

Federal Circuit Confirms That Continuation Patent Type May Not Be Retroactively Altered to Invoke Safe Harbor Provision

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In In re: Janssen Biotech, Inc., the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“Board”) holding that, for the purposes of the safe harbor provision of 35 U.S.C. § 121, a patent owner of a...more

Morrison & Foerster LLP - Social Media

2018: Predictions From Socially Aware’s Editors and Contributors

Happy 2018 to our readers! It has become a Socially Aware tradition to start the New Year with some predictions from our editors and contributors. With smart contracts on the horizon, the Internet of Things and...more

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