News & Analysis as of

Innovation Draft Guidance

Polsinelli

Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

Polsinelli on

On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more

BakerHostetler

State Attorneys General Take a Strong Pro-Enforcement Stance in Comments to Draft Merger Guidelines

BakerHostetler on

On Sept. 18, 2023, 19 Democratic state attorneys general (AGs) filed public comments to the Draft Merger Guidelines (Draft Guidelines) proposed by the U.S. Department of Justice and the Federal Trade Commission (the Agencies)...more

White & Case LLP

JFTC and METI issued Guidelines for Business Collaboration with Startups

White & Case LLP on

On March 29, 2021, the Japan Fair Trade Commission ("JFTC") and Ministry of Economy, Trade and Industry ("METI") issued Guidelines for Business Collaboration with Startups ("Guidelines") for the purpose of promoting open...more

White & Case LLP

JFTC and METI Proposed Guidelines for Business Collaboration with Startups

White & Case LLP on

On December 23, 2020, the Japan Fair Trade Commission ("JFTC") and Ministry of Economy, Trade and Industry ("METI") proposed a draft of Guidelines for Business Collaboration with Startups ("Guidelines") for the purpose of...more

Stinson LLP

FDA Introduces Safer Technologies Program for Medical Devices

Stinson LLP on

On September 19, FDA issued a draft guidance that continues its trend to incentivize innovation and increase collaboration with industries in order to expedite the premarket review process, the “Safer Technologies Program for...more

Smart & Biggar

Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology

Smart & Biggar on

Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more

Knobbe Martens

The FDA's Medical Device Innovation Challenge: A New Approach to Combat the Opioid Epidemic

Knobbe Martens on

On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including...more

Snell & Wilmer

Protecting food industry innovations as the scope of patentable subject matter narrows

Snell & Wilmer on

Strong intellectual property increases the value of a company. Copyrights, trademarks, patents, and trade secrets are some avenues to protect intellectual property, but understanding when they’re available and understanding...more

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