News & Analysis as of

Confidential Information Pharmaceutical Industry

Hogan Lovells

New transparency rules for EMA’s Clinical Trials Information System (CTIS) - Clinical trial data disclosure in the EU

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As of 18 June 2024, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency (EMA) apply, and will impact patients, health care professionals and sponsors. Also as of 18 June, a revised version of the...more

Fox Rothschild LLP

Court Looks Closely, but Sees no Whistleblower Story to Support Fired Employee’s Download of Key Documents

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More than 500 sequentially accessed files downloaded to a personal thumb drive, and a description in a verified complaint of the purported confidential information and trade secrets implicated, were the key components of the...more

Wiley Rein LLP

Panuwat Insider Trading Verdict Foreshadows More Civil and Criminal Enforcement

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On April 5, 2024, a federal jury in California found Matthew Panuwat liable of insider trading in a closely followed case that may serve as the harbinger for expanded insider trading enforcement. In SEC v. Panuwat (N.D....more

BakerHostetler

The SEC Secures Major Trial Victory in Its First ‘Shadow Trading’ Insider Trading Enforcement Action – Securities and Exchange...

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On Friday, April 5, a California federal jury found a former Medivation executive liable for insider trading under the novel liability theory of “shadow trading,” following an eight-day trial and less than three hours of...more

Husch Blackwell LLP

California Enacts First-in-Nation Pharmacy Medication Error Reporting Law

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On October 8, 2023, Governor Gavin Newsom signed Assembly Bill 1286 (AB 1286), a sweeping pharmacy measure with several components aimed at promoting patient safety. Chief among AB 1286’s mandates is a new law requiring that...more

Seyfarth Shaw LLP

Medical Device Companies Settle Trade Secrets Dispute for $8,000,000

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Aegis Spine Inc. has agreed to pay $8,000,000 to fellow spinal implant manufacturer Life Spine Inc., following Life Spine’s suit in the Northern District of Illinois alleging Aegis had misappropriated Life Spine’s trade...more

Nelson Mullins Riley & Scarborough LLP

EMA Releases Official Guidance for Protecting PPD and CCI in Clinical Trial Filings within the European Economic Area (EEA)

Version 1.1 of the European Medicines Agency's (EMA) “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical Trials...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

McDermott Will & Emery

And the Band Played On: Reviewing Rule 54(b) Partial Summary Judgment Based on Who Did What to Whom and When

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In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit...more

PilieroMazza PLLC

Weekly Update for Government Contractors and Commercial Businesses – February 2022

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DOJ Recovers Over $5.6 Billion From Fraud and False Claims Act Matters in FY 2021: 6 Key Takeaways - On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it had recovered more than $5.6 billion in Fiscal...more

A&O Shearman

California District Court Allows Novel SEC Insider Trading Theory To Proceed

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On January 14, 2022, Judge William Orrick of the United States District Court for the Northern District of California issued an order denying a former biopharmaceutical company executive’s motion to dismiss and allowing the...more

Proskauer - Life Sciences

When Nondisclosure Agreements and Pharmaceutical Trade Secrets Intersect

In the United States, the scale of trade secret theft is estimated to be between $180 billion and $450 billion annually. Among the targets of this theft are pharmaceutical companies, which are some of the most...more

Goodwin

JHL Biotech Co-Founders Convicted in Genentech Trade Secret Theft

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Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and...more

Fisher Phillips

Protecting Against the Risk of Trade Secret Exposure Arising from Biotech Industry Collaboration

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Biotechnology companies in the healthcare/pharmaceutical realm are in an exceptionally competitive field, with many companies competing against each other for a chance to market similar innovative therapeutics. These...more

BCLP

SEC Brings First Case Charging Shadow Insider Trading

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The SEC’s filing of its first shadow trading case earlier this month signals the agency’s willingness to pursue actions based on expanded theories of insider trading liability. In a federal court complaint, the SEC on...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

Goodwin

Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court...

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On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent...more

K&L Gates LLP

K&L Gates Triage: Modernizing Confidentiality Rules for Substance Use Disorder Records (Again): 2019 Proposed Changes to 42 CFR...

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This week’s episode is the second in an ongoing series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic & the Confidentiality of Substance Use Disorder Records: an Update on 42 CFR Part 2 - Part 1...

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This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more

McDermott Will & Emery

SAMHSA Proposed Rule Would Reduce Barriers to Care Coordination

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SAMHSA has released a long-awaited proposed rule that would modify the federal regulations at 42 CFR Part 2 (Part 2) governing the confidentiality of substance use disorder (SUD) patient records created by federally assisted...more

Proskauer Rose LLP

HHS and SAMHSA Issue a Proposed Rule to Ease Coordination of Care for Patients with Substance Use Disorders

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On August 26, 2019, the U.S. Department of Health and Human Services ("HHS") and the Substance Abuse and Mental Health Services Administration ("SAMHSA") issued a proposed rule amending the regulations governing the...more

Mintz - Health Care Viewpoints

Part 2 Proposed Rule Brings Clarity and Reduces Regulatory Burdens for Substance Use Disorder Providers, but Challenges Remain

On August 22, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) announced a new proposed rule (the “Proposed Rule”) amending 42 CFR part 2 (“Part 2”), which is aimed at protecting patient records...more

Bass, Berry & Sims PLC

Proposed Changes Affect Privacy Protections of Patients Seeking Substance Use Disorder Treatment

On August 22, 2019, providers and other health industry participants involved in the provision of substance use disorder (SUD) services got some welcome news in the form of proposed regulatory changes. The U.S. Department of...more

McDermott Will & Emery

Annual EU Competition Review 2018

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CARTELS & RESTRICTIVE AGREEMENTS - CJEU’S EYE-OPENING RULING ON ANTITRUST COMPLIANCE AND OFF-LABEL MISINFORMATION – C 179/16, HOFFMAN-LA ROCHE AND OTHERS V AGCM, 23 JANUARY 2018 – On 23 January 2018, the CJEU...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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All of that SuperBowling seems to have put activist investor Starboard in the mood for some pizza—specifically, former NFL-partner Papa John’s, which has struggled in the wake of the removal of its founder and namesake John...more

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