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Regulatory Due Diligence Becomes More Critical in a “Hot” Year for Deals in the FDA Space

FDA Law Blog

Claud — As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity. By John W.M.

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Beyond the Limit: The Battle Over Copyright Back-Damages in Warner Chappell Music v. Nealy

Patently O

” Copyright’s statute of limitations bars claims not “commenced within three years after the claim accrued.” MGM and SCA Hygiene Products stating that the statute of limitations “ordinarily” begins with the wrongful act. 51 ABA Preview of US Supreme Court Cases February 2024, at 12. ” 17 U.S.C. §

Statute 104
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Supreme Court Affirms Availability of Back-Damages Under Copyright Discovery Rule

Patently O

By Dennis Crouch and Timothy Knight On May 9, 2024, the Supreme Court issued its opinion in Warner Chappell Music v. 2024) , resolving a circuit split over the availability of back-damages in copyright infringement cases. 20, 2024). 20, 2024). Nealy , No. 22-1078, 601 U.S. ” See 17 U.S.C. § 504(a)-(c). .”

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Sonos v. Google: Late Claiming Estoppel

Patently O

Prosecution Laches: While agreeing Sonos diligently prosecuted its patents over 13 years, Judge Alsup still found unreasonable delay and prejudice to Google. Sonos will contend that prosecution laches should not apply given its diligence and the lack of improper motive or negligence.

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Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

FDA Law Blog

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. FDA states this will “facilitate the use and exhaustion of product supply already in the supply chain prior to November 27, 2024.” Guidance at 5. Guidance at 5.

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Will AI Replace Lawyers? 4 Expert Opinions

MyCase

In fact, according to the MyCase 2024 Legal Industry Report , 81% of respondents who leverage generative artificial intelligence (GAI) tools use it to increase productivity and efficiency. Due Diligence AI can aid due diligence processes in complex transactions such as mergers and acquisitions by analyzing large volumes of documents and data.

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Customs and Trade News Weekly Snapshot

Customs & International Trade Law

1 to April 1, 2024, for use of the Document Imaging System (DIS) as a method to submit the CBP Form 1302A Cargo Declaration – Outward with Commercial Forms. The urgency for businesses to undertake appropriate human rights due diligence measures. Census Bureau The Census Bureau on Sept.