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Genetic Materials

Locke Lord LLP

Trends in State and Federal Regulation of Consumer Genetic Testing

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Direct-to-consumer (“DTC”) genetic testing companies are faced with more scrutiny than ever over their privacy practices, security practices, and data use policies. In December 2023, 23andMe experienced a data breach...more

Carr Maloney P.C.

23andMe Reaches Proposed Settlement in Data Breach Class Action

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In November 2023, a class action lawsuit was filed against the genetic testing company, 23andMe. The plaintiffs alleged that a data breach resulted in the unauthorized disclosure of 6.9 million users’ personal and genetic...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

WilmerHale

World Intellectual Property Organization Adopts Treaty on Intellectual Property, Genetic Resources and Associated Traditional...

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Following nearly twenty-five years of negotiations, members of the World Intellectual Property Organization (WIPO) recently adopted a treaty implementing the new requirement for international patent applicants to disclose in...more

Constangy, Brooks, Smith & Prophete, LLP

Can GIPA be the new BIPA?

There’s a new wave of class action lawsuits hitting Illinois employers, based on a law that has been under the radar for more than 25 years: The Genetic Information Privacy Act, also known as GIPA. Passed in 1998, GIPA...more

Blank Rome LLP

Northern District of Illinois Weighs in on Employment-Related Examinations under Illinois’ GIPA

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In an important privacy law development, United States District Court for the Northern District of Illinois, Judge Sharon Coleman, has issued two of the first federal decisions applying a substantive analysis to provisions of...more

WilmerHale

Federal Circuit Patent Watch: Federal Circuit Affirms Preliminary Injunction Related to Tumor-Informed Testing

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Precedential and Key Federal Circuit Opinions - 1.  NATERA, INC. v. NEOGENOMICS LABORATORIES, INC. [OPINION] (2024-1324, 2024-1409, 7/12/2024) - Moore, Taranto, and Chen Moore, C.J. The Court affirmed the district...more

Womble Bond Dickinson

Codifying the Experimental Use Exception? USPTO Seeks Public Input

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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

Womble Bond Dickinson

FDA Updates Guidance on Intentional Genomic Alterations in Animals

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Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more

Bennett Jones LLP

A New International Treaty on Intellectual Property and Indigenous Knowledge and its Potential Impact on Canadian Agricultural...

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On May 24, 2024, after nearly 25 years of negotiations, the World Intellectual Property Office (WIPO) announced that member states, including Canada, had agreed to a new Treaty on Intellectual Property, Genetic Resources and...more

International Lawyers Network

Seedlings of Ideas For Artificial Intelligence: Learning From A Genetic Resources/Traditional Knowledge Treaty, The Plant Patent...

The World Intellectual Property Organization announced on May 24, 2024, a treaty on intellectual property, genetic resources, and associated traditional knowledge that was twenty-five years in the making. As WIPO’s press...more

Epstein Becker & Green

Texas Supreme Court Declines Opportunity to Hear Personhood Case

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On Friday, June 14, the Texas Supreme Court declined to consider a case that asked the Court to determine whether frozen embryos are persons or property under Texas law....more

U.S. Equal Employment Opportunity Commission...

Factor One Source Pharmacy to Pay $515,000 to Settle EEOC Disability and Genetic Information Discrimination Suit

Federal Agency Charged Pharmacy Pressured Employees and Applicants to Fill Expensive Hemophilia Prescriptions with the Company - DENVER – Factor One Source Pharmacy, LLC, a pharmacy providing specialized pharmacy services to...more

Womble Bond Dickinson

WIPO Adopts New IP Treaty on Genetic Resources & Traditional Knowledge

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After nearly a quarter of a century, the World Intellectual Property Organization (WIPO) has approved the passage of a new IP treaty: the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional...more

Hogan Lovells

U.S. BIOSECURE Act: Key considerations for global cell, tissue, and gene therapy stakeholders

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Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more

Hogan Lovells

China update: Human Genetic Resources Administration Rules support HGR Implementing Rules

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After years of waiting, China’s Ministry of Science and Technology (MOST) finally released the final version of the Implementing Rules on the Human Genetic Resources Administration Rules (Implementing Rules) on 1 June 2023,...more

Fox Rothschild LLP

Some Resources & Updates Relating to Genetic Testing for Paternity

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We have written a couple of times about the 23&Me phenomenon and the chance that those who enter this unknown world come back not just surprised but possibly creeped out by their quest for ancestral knowledge. USA Today...more

Amundsen Davis LLC

Illinois’ Genetic Information Privacy Act Litigation Trends and Why Employers Need to Pay Attention

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The Illinois’ Genetic Information Privacy Act (“GIPA”) has been Illinois law for over twenty years. Yet, only in the last year or two has there been an explosion of lawsuits being filed against companies in various...more

Epstein Becker & Green

Update: Alabama Legislature Moves to Shield IVF from “Personhood” Ruling

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In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine...more

Perkins Coie

The Next Wave of Privacy Litigation: The Illinois Genetic Information Privacy Act

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Enacted in 1998, Illinois’ Genetic Information Privacy Act (GIPA) governs the confidentiality and use of genetic testing and genetic information by employers and insurers. The statute was designed to prevent employers and...more

Womble Bond Dickinson

FDA Issues Guidance for Foods Made from Genome-Edited Plants

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The practice of altering plant genetics to better suit human needs, dates back thousands of years. What was once done through selective plant breeding – as well as alterations beyond what is possible with selective breeding –...more

Amundsen Davis LLC

Illinois’ Genetic Information Privacy Act: Litigation Trends in 2024 and Beyond

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The Illinois’ Genetic Information Privacy Act (“GIPA”) has been Illinois law for over twenty years. Yet, only in the last year or two has there been an explosion of lawsuits being filed against companies in various...more

Estlund Law, P.A.

Estlund Law Obtains A Dismissal Of All Charges For Client Charged With Violating Iranian Sanctions Regulations Under The...

Estlund Law, P.A. on

Miami, Florida, U.S.A.- Estlund Law client Dr. Faezeh Faghihi has spent her life in the service of others as a physician in her native Iran and in the United States, her adopted home country. Trained as a gynecologist, she...more

Fox Rothschild LLP

A 23&ME Update

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Valentine’s Day seemed an odd time to report the subject but CNN posted a five minute story provocatively titled as “I Slept with My Half Sibling.” This recounts the story of a Connecticut social worker who had symptoms of a...more

Troutman Pepper

The Murky World of IP Protection for Gene-Edited Plants

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Agribusiness is currently experiencing both a technological revolution and a corresponding increase in intellectual property uncertainty and disputes. Originally published in Law360 - October 26, 2023....more

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