FDA Law Blog

JANUARY 8, 2024

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.

Diligence 69

Diligence Calendaring Statute Government 69

Constitutional Law Reporter

JUNE 17, 2024

Nealy , 601 U.S. _ (2024), the U.S. The Court did not address when copyright infringement claims accrue with regard to the statute of limitations. Under the so-called discovery rule, a claim accrues when “the plaintiff discovers, or with due diligence should have discovered,” the infringing act. In Warner Chappell Music, Inc.

Diligence 52

Diligence Statute Court Constitutional Law 52

Patently O

FEBRUARY 20, 2024

” 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

Statute Diligence Court Laws 104

Patently O

JUNE 17, 2024

2024-1137 (Fed. June 17, 2024). The appellate court held that the district court’s analysis was deficient in several key respects, including not addressing the statute of limitations defense, defining trade secrets too broadly, and not sufficiently assessing irreparable harm and the public interest. .”

Statute 62

Statute Court Diligence Manufacturing 62

Patently O

DECEMBER 8, 2023

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.

Diligence 48

Diligence Statute Court Legal 48

Patently O

MAY 9, 2024

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). .”

Court 89

Court Diligence Statute Laws 89

FDA Law Blog

AUGUST 27, 2023

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.

Manufacturing 52

Manufacturing Diligence Statute 52