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Jurisdiction Pharmaceutical Industry

Marshall Dennehey

Commonwealth Court Rejects Insurer’s Reimbursement Claim Against Pharmacy in Billing Dispute

Marshall Dennehey on

Pioneer Construction Company, Inc., Eastern Alliance Insurance Company, and employers Alliance, Inc. v. Insight Pharmaceuticals, LLC d/b/a Insight Pharmacy; No. 867 C.D. 2022; filed May 12, 2025; Judge Covey - A workers’...more

Sheppard Mullin Richter & Hampton LLP

Biopharmaceutical Patent Litigation: Regeneron’s Defense Against Biosimilar Launches

This case involves an appeal from Regeneron Pharmaceuticals, Inc.’s (Regeneron) efforts to prevent defendants from marketing biosimilar versions of EYLEA®, a drug used to treat eye diseases, by asserting patent infringement....more

Carlton Fields

Fourth Circuit Applies Supreme Court’s Coinbase Decision Outside Context of Arbitration

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The Fourth Circuit Court of Appeals recently concluded that the U.S. Supreme Court’s decision in Coinbase Inc. v. Bielski is not limited to interlocutory appeals involving arbitration....more

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

Troutman Pepper Locke

California's Ban on Reverse Payment Settlements Partially Survives After a Five-Year Battle

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As state legislatures introduce legislation expanding the reach of their antitrust laws and state attorneys general ramp up their use of antitrust investigations and litigation, the legal landscape continues to become more...more

Goodwin

Federal Circuit Affirms Injunction Against Samsung and Formycon in Aflibercept BPCIA Litigation

Goodwin on

On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd....more

Array

eDiscovery and ANDA Litigation: Unique Timelines, Processes, and Workflows

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ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

Mintz - Intellectual Property Viewpoints

Can Enablement and Written Description Bars be Lower for Method-Of-Treatment Patent Claims?

Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more

Morgan Lewis

Cross-Border Collaborations: Key Pitfalls for Asian Life Sciences Companies and How to Avoid Them

Morgan Lewis on

Against the backdrop of a slower M&A market, collaborations between biotech companies and pharma companies have remained robust, particularly those focusing on innovation and collaboration for value creation. According to a...more

BCLP

Paris Litigation Gazette Issue 2 - March 2023

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Welcome to the Litigation Gazette. Each quarter, BCLP's Paris team will keep you informed of the main litigation news in competition law, commercial litigation, labor law, IP/IT/Data and compliance....more

Akin Gump Strauss Hauer & Feld LLP

Generic’s Conversion from Paragraph IV to Section viii Upends Subject Matter Jurisdiction on Declaratory Judgment Counterclaims

The District Court of Delaware dismissed a generic drug company’s declaratory judgment counterclaims of non-infringement and invalidity, finding that the court no longer had subject matter jurisdiction after the generic...more

WilmerHale

European Commission Blocks Illumina/GRAIL a week after FTC’s Administrative Law Judge Rejects FTC’s Challenge

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The last week has seen crucial developments at the European Commission (EC) and U.S. Federal Trade Commission (FTC) regarding the antitrust review of the $7.1 billion proposed acquisition by Illumina (the leading supplier of...more

King & Spalding

The EU General Court confirms the Commission's jurisdiction to review transactions that do not meet any national thresholds

King & Spalding on

In its judgment of 13 July 2022, the EU General Court confirmed that transactions that do not meet EU or Member State thresholds can be referred by national competition authorities to the European Commission (the...more

Bass, Berry & Sims PLC

The California Insurance Frauds Prevention Act: What to Know About California’s Powerful Commercial Health Insurance Fraud Statute

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Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention...more

Knobbe Martens

Federal Circuit Review - August 2021

Knobbe Martens on

It’s No Secret That a Related Company’s Physical Presence in a Jurisdiction May Not Be Enough For Proper Venue - In Andra Group, LP v. Victoria’s Secret Stores, LLC, Appeal No. 20-2009, The Federal Circuit held that an...more

Smart & Biggar

PMPRB Update: Jurisdiction extends to CSPs effective June 30; coming into force of Patented Medicines Regulations and Guidelines...

Smart & Biggar on

The coming into force of the amended Patented Medicines Regulations has been delayed a third time, now until January 1, 2022. The amendments, once in force, will add new price regulatory factors, revise the list of...more

Smart & Biggar

PMPRB update: Revised compliance timelines for grandfathered and gap medicines and proposed regulatory amendments directed to CSPs

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Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more

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

MarkIt to Market® - March 2021: GW Pharma Seeks Dismissal of Patent Suit Filed in Texas by Canopy Growth

We have been keeping a close eye on the patent suit filed by Canopy Growth against GW Pharma in the Western District of Texas’s Waco Division, a venue that has attained recent fame for its speed to trial in patent litigation....more

Smart & Biggar

2020 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

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In the first half of 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review the following top developments...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

Selling drugs to the Government just got a lot simpler. In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door to all drugs “manufactured”—that is, measured,...more

Sheppard Mullin Richter & Hampton LLP

What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020). In Acetris, the Federal Circuit was asked to...more

Akin Gump Strauss Hauer & Feld LLP

The Federal Circuit Finds Jurisdiction over the ITC’s Decision Not to Institute an Investigation Under Section 337 and Explains...

• The International Trade Commission (ITC) can decline to institute an investigation when a complaint fails to state a cognizable claim under Section 337 of the Tariff Act, 19 U.S.C. § 1337 (“Section 337”). • A decision...more

Sheppard Mullin Richter & Hampton LLP

Second Circuit Affirms “Snap” Removal Practice

Earlier last week, a Second Circuit panel resolved a sharp disagreement among district courts regarding the interpretation of the forum defendant rule in the context of a multi-district litigation (“MDL”) involving dozens of...more

Smart & Biggar

Amended PMNOC Regulations: First Anniversary Update

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As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more

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