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Patent Considerations in View of the Nearshoring Trends to the Americas
Welcome to the Intellectual Property Litigation Newsletter, our review of decisions and trends in the intellectual property arena. In this edition, we learn that the Federal Circuit always says never, patent publications...more
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...more
In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more
In Wisconsin Alumni Research Foundation v. Apple, the Federal Circuit expanded the preclusive effect of non-infringement rulings. It ruled that prior judgments of non-infringement can prevent follow-on lawsuits involving...more
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
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
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
Since their introduction in California in 1993, the sales and use taxation of technology transfer agreements has been the subject of significant litigation and a seemingly endless regulation project. In the past few...more
As I have written about previously, the IP and competitive landscape for mRNA and lipid nanoparticles is complex. Pioneers, mid-stage, and new market entrants must take careful consideration of this landscape and develop a...more
Online shopping has become increasingly popular in recent years. E-commerce sales surpassed $6.5 trillion in 2023 and are expected to total over $8.1 trillion by 2026. Convenience of product variety and online competition...more
The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more
This CLE webinar will guide patent counsel on obviousness-type double patenting (ODP), including the recent decisions that have relied on Cellect. The panel will also discuss the USPTO's proposed terminal disclaimer rule and...more
A split Federal Circuit panel recently held that the safe harbor provision of 35 U.S.C. §271(e)(1) providing a defense to infringement applies if the allegedly infringing activity is “reasonably related to submitting...more
The Federal Circuit considered the relevance of an alleged infringer’s intent in a safe harbor analysis in Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. The District Court had previously granted summary judgment that...more
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...more
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
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
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
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
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
In view of the unprecedented uncertainty in patent law generated by counter-doctrinal Supreme Court decisions over the past decade or so and a cowed Federal Circuit relegated to complaining that their hands are tied on most...more
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
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
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
Congress’s protection from patent infringement for drug developers created under the Hatch-Waxman Act of 1984 (Act) has been extensively litigated over the past three+ decades, but the scope of the so-called “safe harbor...more