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Intellectual Property Protection Food and Drug Administration (FDA) Trade Secrets

Mintz - Intellectual Property Viewpoints

Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Foley & Lardner LLP

AI in Drug Discovery: 2025 Outlook

Foley & Lardner LLP on

Looking forward to the 2025 prediction season, a survey of the emerging AI-powered drug discovery landscape has been making the rounds—and with good reason. The survey, summarized by Stanford’s Chris Bradbury, is likely the...more

Fish & Richardson

Preparing Your Company for Hatch-Waxman

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The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more

Sheppard Mullin Richter & Hampton LLP

Trade Secret Protection & the COVID-19 Cure: Observations on Federal Policy-Making & Potential Impact on Biomedical Advances

As the COVID-19 pandemic spreads throughout the United States and Americans anxiously await the arrival of a vaccine, biotech companies are grappling with the uncertainty of patent protection for COVID related biomedical...more

Seyfarth Shaw LLP

The Week in Weed: February 2020 #2

Seyfarth Shaw LLP on

Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. It was a busy week for the states, as Virginia moved towards decriminalization.  The state House and Senate passed...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2018 #3

PATENT CASE OF THE WEEK - Polara Engineering Inc. v. Campbell Company, Appeal Nos. 2017-1974, -2033 (Fed. Cir. July 10, 2018) In this wide-ranging opinion, the Court provided a rare and lengthy opinion on the public use...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | March 2018 #2

US, EU Near Agreement on Shellfish Trade - The U.S. Food and Drug Administration (FDA) has proposed to allow the import of raw bivalve molluscan shellfish—including clams, mussels, oysters and scallops—harvested in the...more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Hogan Lovells on

Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | October 2017 #4

Furans in Baby Food May Pose Health Risk, EFSA Reports - The European Food Safety Authority (EFSA) has issued an assessment of the risks of furans and related compounds 2- and 3-methylfurans, concluding that they pose a...more

Foley & Lardner LLP

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

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As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Arnall Golden Gregory LLP

Der Markteintritt für deutsche IT Firmen aus dem Bereich des Gesundheitswesens

With expenditures of over $ 3 trillion of market in the field of health care in the United States is huge. Incentives of the Federal Government for the introduction of electronic medical records resulted increasingly in the...more

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