News & Analysis as of

Life Sciences International Trade Commission (ITC)

Proskauer - The Patent Playbook

Litigating Patents in the ITC: When and Why Companies Take the Section 337 Route

Formerly a niche venue for trade-related matters, the International Trade Commission (“ITC”) has emerged as a battleground for many high stakes intellectual property disputes, particularly in the technology, life sciences,...more

BakerHostetler

Life Sciences Newsletter - March 2025

BakerHostetler on

Welcome to the first issue of the BakerHostetler Life Sciences Newsletter! Within it you will find an overview of noteworthy developments in the life sciences space and at BakerHostetler. ...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Federal Circuit Affirms Small U.S. Investments Can Satisfy Domestic Industry Requirement

A domestic industry may never be too small so long as the commercial product is 100% American-made according to the latest Federal Circuit opinion. In Wuhan Healthgen Biotech v. ITC, the Federal Circuit affirmed the...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Topics in 2024

What should in-house counsel be on the lookout for in 2024? As we begin a new year, our attorneys look ahead at intellectual property topics they expect will be trending in 2024. They cover areas including life sciences,...more

American Conference Institute (ACI)

[Event] 13th Summit on Biosimilars & Innovator Biologics - June 28th - 29th, Boston, MA

This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Rothwell, Figg, Ernst & Manbeck, P.C.

PTAB Agrees to Review Novartis’ Patent for an Ophthalmic Injection Syringe

On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled...more

Proskauer - The Patent Playbook

A Reminder of Doctrine of Equivalents in Biotechnology: Jennewein Biotechnologie GmbH v. International Trade Commission

Doctrine of equivalents (DOE) can be applied as a mechanism to hold a party liable for patent infringement even if the product or process does not literally infringe a patent claim, if the difference is “insubstantial”....more

Morgan Lewis

Life Science International Review Q3 - Nov. 2019

Morgan Lewis on

Welcome to the Q3 2019 issue of our Life Sciences International Review. This issue covers new developments within Europe, Asia, and the United States in intellectual property, regulatory, pricing, and international trade,...more

Mintz - Intellectual Property Viewpoints

Patent Prosecution and FDA Compliance Expenses May Help Satisfy the ITC’s Domestic Industry Requirement

In a recent initial determination, Administrative Law Judge (“ALJ”) Cheney of the U.S. International Trade Commission (“ITC”) provided useful guidance for patentees by reaffirming that there is no categorical rule that patent...more

Mintz - Intellectual Property Viewpoints

ITC Domestic Industry Products Do Not Need to Be Commercially Available

In a recent initial determination, Administrative Law Judge (“ALJ”) Cheney of the U.S. International Trade Commission (“ITC”) held that domestic industry products do not need to be commercially available to satisfy section...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

American Conference Institute (ACI)

[Event] Biosimilars Summit – Legal, Regulatory, and Commercial Strategies – June 24th-25th, New York City, NY

2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more

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