MoFo Life Sciences

August 29, 2022 - Intellectual Property, Litigation, FDA, Regulatory
Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements
By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings
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August 25, 2022 - Pharma, Intellectual Property, Litigation
Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation
By: Brian R. Matsui
Our Federal Circuitry blog recently discussed the Court's decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. , No. 21-2342. You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA says For our
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August 25, 2022 - Intellectual Property, Litigation, Medical Devices + Diagnostics
Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express
By: Brian R. Matsui
Our Federal Circuitry blog recently discussed the Court's decision in Hologic, Inc. v. Minerva Surgical, Inc. , No. 19-2054. You should read this case if: you want to know how the Federal Circuit will treat assignor estoppel post- Minerva You have to feel a little
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July 18, 2022 - Agtech, Asia, Global, Intellectual Property, Litigation
IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES
By: Liz Freeman Rosenzweig Ph.D.
The Beni Suef Economic Court in Egypt has recently ordered the removal of nearly five hectares of illegally grown Early Sweet™ grapevines, totaling 9000 vines and associated seedlings. The farm owner did not have a license to grow or commercialize the Early Sweet™ grapes
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April 15, 2022 - United States, Agtech, Litigation, Intellectual Property
Stepping Stones to Success: Supporting Claims in the Life Sciences
By: Meghan McLean Poon Ph.D. and Owen Grayson Hosseinzadeh
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
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April 13, 2022 - FDA, Product Liability + Class Action, Litigation, Regulatory
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
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April 08, 2022 - Litigation, European Union, Intellectual Property
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
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March 15, 2022 - United States, Litigation, Biotech, Healthcare, Pharma, Intellectual Property
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
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January 05, 2022 - Litigation, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
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
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December 23, 2021 - FDA, Medical Devices + Diagnostics, Litigation, Healthcare
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),
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Topic Archives: Litigation

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.

Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation

By: Brian R. Matsui

Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

By: Brian R. Matsui

IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES

By: Liz Freeman Rosenzweig Ph.D.

Stepping Stones to Success: Supporting Claims in the Life Sciences

By: Meghan McLean Poon Ph.D. and Owen Grayson Hosseinzadeh

RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

By: Claudia M. Vetesi and Lena Gankin

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

Possession of an "Effective" Dose

By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.

Life Sciences Patent Trends in 2022 – Doctrine of Equivalents

By: Meghan McLean Poon Ph.D.

3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session