On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the settlement are confidential. According to the press
Intellectual Property
FDA Approves First Gene Therapy to Treat Children with Metachromatic Leukodystrophy
On March 18, 2024, the FDA approved Orchard Therapeutics’ LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy (MLD). MLD is a rare, fatal genetic disease affecting approximately one in every 40,000 individuals in the…
Navigating Restrictive Covenants in 2024: Insights from Seyfarth’s Commercial Litigation Outlook
Seyfarth proudly announced the annual installment of our Commercial Litigation Outlook and Webinar Series, featuring insights about litigation issues and trends to expect in 2024 from our nationally recognized team. The Trade Secrets practice group is pleased to present its…
Unraveling the Statute of Limitations in Copyright Infringement Cases
In the realm of copyright law, determining the scope of damages and the applicability of the statute of limitations remains a contentious issue. The Supreme Court case of Nealy v. Warner Chappell Music (argued before the Court in February of…
Biden Administration Proposes Biosimilar Substitution Without Interchangeability
The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. Specifically, the U.S. Department of Health & Human Services (HHS)’s 2025 proposed budget includes a…
A Port in the Infringement Storm: When 35 U.S.C. § 271(e)(1)’s Safe Harbor Applies
Earlier this week, the Federal Circuit granted Meril Life Sciences safe passage out of the infringement storm — otherwise known as Edwards Lifesciences — continuing to chase it (at least for now). More specifically, a divided panel of the Federal…
Comma, Comma, Comma, Comma, Comma Chameleon: How Punctuation Can Color IP & Other Legal Rights
“[T]he comma…this capricious bit of punctuation…”
United States v. Ron Pair Enterprises, Inc., 489 US 235, 249 (1989) (O’Connor, J, dissenting)
For want of a comma, we have this case.”
O’Connor et al. v. Oakhurst Dairy et al.,851…
Medicare Conversion Factor Increased to $33.2875
The 2024 Consolidated Appropriations Act passed and signed on Saturday, March 23, 2024, increased of Medicare Conversion Factor from $32.7442 to $33.2875, an increase of slightly over $0.54.
Unfair contract terms and the penalty doctrine – ACCC v Employsure Pty Ltd [2020] FCA 1409 (1 October 2020)
When deciding whether a contractual term is unfair, a Court will likely consider if the term would cause a significant unbalance, if it is not reasonably necessary to protect legitimate interests, or if it would cause detriment. Careful consideration should…
New USPTO guidelines on AI assisted inventions
In response to the Biden administrations Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence on 30 October 2023, which outlined policies and principles to promote responsible Artificial Intelligence innovation and competition, the United States…