Stepping Stones to Success: Supporting Claims in the Life Sciences
- Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post. The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is... ›
RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS
By: Claudia M. Vetesi and Lena Gankin
Originally published by Law360 , Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount... ›A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum
By: Wolfgang Schönig
After a myriad of challenges , delays , and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction. On January 19, 2022, the UPC came into existence as an international organization. This date marks the... ›Possession of an "Effective" Dose
By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.
Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit denied Biogen International’s petition for panel rehearing and rehearing en banc , following a November split decision discussed below. Judges Lourie, Moore, and Newman dissented on the denial of en... ›Life Sciences Patent Trends in 2022 – Doctrine of Equivalents
By: Meghan McLean Poon Ph.D.
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims directed to specific sequences. At the same time, reliance on the... ›3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann Oxenham (CFSAN),... ›Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices
By: Fitz B. Collings
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a “Comprehensive Plan for Addressing High Drug Prices.” The HHS Report—issued... ›The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16
By: Wolfgang Schönig
Summary The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe. A study recently published by the European Commission (“Commission”)... ›- - FDA, Litigation
Ninth Circuit Weighs in on Fraud-on-the-FDA Theory, Marketing Devices for Off-Label Use, and Kickbacks
The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: (1) Engaged in “fraud-on-the-FDA” when obtaining clearance for several devices used in spinal fusion surgeries;... › Pay-for-Delay has a tough (antitrust) time at EU Top Court
By: Jens Hackl and Andreas Grünwald
In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts.[1] In two recent rulings – “Lundbeck”[2] and “Paroxetine”[3] – the European Court of Justice (ECJ) dealt with settlement agreements... ›