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Pharmaceutical Industry Defense Strategies

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

DRI

[Event] Drug and Medical Device Seminar - May 20th - 22nd, Washington, DC

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Join us in Washington D.C. for the Drug and Medical Device industry’s premier event for learning, networking, and advancing the defense of life sciences clients! You’ll hear from heads of litigation from the world’s foremost...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

DRI

[Event] Medical Liability and Health Care Law Seminar - February 28th - March 1st, Miami, FL

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Join us in Miami, Florida, for an engaging and exciting seminar that will address some of medicine’s most relevant and controversial issues. Topics include: a maternal fetal medicine and pediatric neurology “blockbuster”...more

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...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

Nelson Mullins Riley & Scarborough LLP

PLAC MDL Task Force Comment Letter to MDL Subcommittee of the Advisory Committee on Civil Rules

As an organization representing many target defendants in mass tort MDLs, including some of the largest MDLs on the federal docket, the Product Liability Advisory Council is uniquely positioned to serve as a voice for the...more

Oberheiden P.C.

12 Keys to Surviving a Board of Pharmacy Investigation

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As a pharmacist, facing a board of pharmacy investigation can have a multitude of adverse consequences. While losing your license might seem like the greatest risk, this isn’t necessarily the case. Increasingly, boards of...more

Oberheiden P.C.

10 Keys to a Successful Pharmacy Audit Appeal

Oberheiden P.C. on

Medicare, Medicaid, and pharmacy benefit manager (PBM) audits can result in substantial losses for pharmacies. If auditors uncover evidence—or apparent evidence—of overpayments, not only can they initiate recoupments, but...more

Oberheiden P.C.

PBM Audit Defense: Key Strategies for Pharmacies in 2023

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Pharmacy benefit manager (PBM) audits are becoming increasingly dangerous for pharmacies. While the role of the PBM was initially to reduce costs for all parties involved, abusive PBM practices have led to the opposite in...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Maynard Nexsen

[Webinar] Offensive and Defensive Strategies for Protecting Your Company's Trade Secrets - May 27th, 12:00 pm - 1:00 pm EDT

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2021 Webinar Series: Life Sciences with Nexsen Pruet - Nexsen Pruet's newest webinar series is focusing on Life Sciences companies in the Carolinas. These webinars will focus on various legal and regulatory issues that...more

American Conference Institute (ACI)

[Virtual Event] 8th Annual Advanced Forum on False Claims and Qui Tam Enforcement - March 24th - 25th, 8:15 am - 4:45 pm...

THE ONLY EVENT WHERE YOU'LL HEAR FROM Government, In-house Counsel, The Judiciary, the Defense & Relator’s Bar - ACI’s 8th Annual Advanced Forum on False Claims and Qui Tam Enforcement will address the underlying...more

Haug Partners LLP

INSIGHT: Abbvie Defeats Novel Antitrust Claims Against Humira Patent Estate—Lessons Learned

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A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more

Haug Partners LLP

Defendants Successfully Disqualify Bankrupt Wholesaler Rochester Drug Co-Operative From Representing Class of Purchasers in...

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On July 8, 2020, Judge Alison Burroughs granted-in-part Defendants Shire and Actavis’s motion to decertify a direct purchaser plaintiff class in an alleged reverse payment antitrust case pending in the Federal District Court...more

Holland & Hart - Your Trial Message

Consider COVID Attitude Changes, Part 7: When it Comes to Distrust of Big Pharma, the Disease Might Be the Cure

Less than a year ago, in late 2019, the pharmaceutical industry came in dead last in a favorability contest with twenty-five other industries. According to that Gallup Poll, only a little more than a quarter of the population...more

Jones Day

Tenth Circuit Rejects False Claims Act Theory About Falsified Records on Materiality Grounds

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The Situation: The Supreme Court's ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016), opened the door to more materiality defenses under the False Claims Act ("FCA"), but without making...more

American Conference Institute (ACI)

[Virtual Event] 11th Annual Advanced Forum on Managed Care Disputes and Litigation - July 22nd-23rd

ACI’s 11th Annual Advanced Forum on Managed Care Disputes and Litigation will be offered in a virtual format this year to help you make sense of these developments, and their profound impact for managed care....more

Goodwin

Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

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On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more

American Conference Institute (ACI)

[Event] False Claims and Qui Tam Enforcement Forum – Strategies to Respond to the Rapidly Changing Landscape of False Claims Act...

With more than 34.8 billion recovered by the government since 2010 under the federal False Claims Act, it has never been more crucial for private practitioners and corporate in-house counsel to keep abreast of the changes and...more

American Conference Institute (ACI)

[Event] Drug and Medical Device Litigation – the Must-Attend Event for the Life Sciences Products Liability Community - December...

Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more

Skadden, Arps, Slate, Meagher & Flom LLP

Life Sciences Companies May Face More Scrutiny in Using FDA Documents to Dismiss Securities Cases

Following a recent decision from the U.S. Court of Appeals for the Ninth Circuit in Khoja v. Orexigen Therapeutics, Inc., plaintiffs alleging securities fraud against companies in the pharmaceutical and life sciences sector...more

Miles & Stockbridge P.C.

U.S. Supreme Court Clarifies Constitutional Limits on Specific Jurisdiction Over Foreign Defendants…Again

Since 2011, the U.S. Supreme Court has continued to roll back the expansion of personal jurisdiction by lower courts and has set more limitations on where a plaintiff can sue corporate defendants. We have watched this unfold...more

Katten Muchin Rosenman LLP

The Sixth Circuit Reins in the Government's Measure of False Claims Act Damages

Pharmaceutical and device companies, financial institutions, government contractors, oil and gas conglomerates, and other public and private entities continue to be in the crosshairs of aggressive federal government...more

Faegre Drinker Biddle & Reath LLP

The Double-Edged Sword: Genomic Profiling in Drug and Chemical Litigation

Since completion of the Human Genome Project, genomic profiling and the related advent of personalized medicine have become a hot topic. Many predicted this new genomic information would lead to targeted drug treatments that...more

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