MoFo Life Sciences

March 28, 2023 - United States, Asia, European Union, Litigation, Intellectual Property
Recent Updates on Use of Post-filing Data as Evidence to Support Patentability
By: Liz Newman Ph.D. and Karen G Potter Ph.D.
In a “first to file” patent system as exists in the United States and in most countries throughout the world, timing of when to file a patent application is critically important but must be balanced by patentability requirements such as nonobviousness and enablement. This
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March 27, 2023 - FDA, Regulatory, Litigation, Product Liability + Class Action, United States
FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives
By: Brigid DeCoursey Bondoc, William F. Tarantino and Claudia M. Vetesi
Update 5/1/2023 : FDA is reopening the comment period on the draft guidance published February 23, 2023 (88 FR 11449); the new deadline for comments is July 31, 2023. In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,”
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March 13, 2023 - Healthcare, Litigation, Intellectual Property, United States
Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid
By: Meghan McLean Poon Ph.D.
In ChromaDex Inc. v. Elysium Health Inc. ,[1] the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter eligibility under 35 U.S.C. § 101. ChromaDex, a
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March 01, 2023 - Healthcare, Pharma, Regulatory, Litigation, United States
States Extend Scope of Regulatory Oversight of Health Care Entities
The proliferation of private investor-backed management of health care practices continues to draw scrutiny from regulators into the impact on patient care, health care costs, and access to services. State regulators play a key role in monitoring and challenging anticompetitive behavior at the local
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February 28, 2023 - Healthcare, Pharma, Litigation, Regulatory, United States
CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program
The Inflation Reduction Act of 2022 (IRA) was signed into law on August 16, 2022 and includes several provisions to lower prescription drug costs for Medicare beneficiaries and reduce drug spending by the federal government. One provision of the IRA requires drug manufacturers to
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February 06, 2023 - Healthcare, Litigation, Antitrust, United States
DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing
By: Alexander Okuliar, Lisa M. Phelan, Joseph Charles Folio III and Margaret A. Webb
On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements outlining safe harbors for information sharing in the healthcare industry, and suggested that DOJ’s
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January 20, 2023 - Healthcare, United States, Pharma, Litigation, Regulatory
CMS Reveals New Details on Medicare Drug Price Negotiation Program
For the first time in history, the Centers for Medicare and Medicaid Services (CMS) will engage in price negotiations with drug manufacturers for a subset of high-cost, name-brand drugs covered by Medicare. Pursuant to the Inflation Reduction Act (IRA), CMS took its first steps
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January 17, 2023 - Bioinformatics, Litigation, United States, Data Analytics
Privacy Litigation 2022 Year in Review: Biometric Information Privacy Act (BIPA)
By: Tiffany Cheung
In 2022, Illinois’s Biometric Information Privacy Act (BIPA) litigation was bustling. Defendants in BIPA cases ranged from pharmacies, insurance companies, and social media platforms to software companies, schools, and airlines. Even with the steady stream of opinions in 2022, key questions about BIPA’s scope
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December 02, 2022 - Healthcare, FDA, Regulatory, Litigation, United States
The USPTO and the FDA Join Hands to Promote Competition
By: Mehran Arjomand and Jean Nguyen Ph.D.
On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). The webinar, entitled “The USPTO‑FDA Collaboration: A Discussion of
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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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Topic Archives: Litigation

Recent Updates on Use of Post-filing Data as Evidence to Support Patentability

By: Liz Newman Ph.D. and Karen G Potter Ph.D.

FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives

By: Brigid DeCoursey Bondoc, William F. Tarantino and Claudia M. Vetesi

Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid

By: Meghan McLean Poon Ph.D.

States Extend Scope of Regulatory Oversight of Health Care Entities

CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program

DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing

By: Alexander Okuliar, Lisa M. Phelan, Joseph Charles Folio III and Margaret A. Webb

CMS Reveals New Details on Medicare Drug Price Negotiation Program

Privacy Litigation 2022 Year in Review: Biometric Information Privacy Act (BIPA)

By: Tiffany Cheung

The USPTO and the FDA Join Hands to Promote Competition

By: Mehran Arjomand and Jean Nguyen Ph.D.

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.