Author Info for MoFo Life Sciences

Joe Adamczyk

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…more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Excise Tax, Food and Drug Administration (FDA), Inflation Reduction Act (IRA)

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Celeste Alvarez

Bill Proposes 10 Additional Years for COVID-19 Inventions

A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily curtail…more

Coronavirus/COVID-19, Infectious Diseases, Innovative Technology, Life Sciences, Medical Devices

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Stacy Cline Amin

Golden State Crackdown—Unpacking California’s Landmark Food Safety Act

This month, California Governor Gavin Newsom signed into law the California Food Safety Act—a bill targeted at enhancing food safety within California. The law bans the manufacture, sale, and distribution of four food additives…more

Additive Manufacturing, California, Food & Drug Regulations, Food and Drug Administration (FDA), Food Manufacturers

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Mehran Arjomand

Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Algorithms, Artificial Intelligence, Intellectual Property Protection, Life Sciences, Machine Learning

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Simon Arlington

FDA Clears The Path To Lab-Grown Meat

On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken…more

Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS), Food Supply, USDA

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Will Baker

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s…more

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Drug Pricing, Excise Tax, Fifth Amendment

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Claire Bendix

U.S. Plant Variety Protection Office Invited Comments On UPOV Test Guidelines And Is Aligning Exhibit C Forms With UPOV

On April 3, 2023, the U.S. Plant Variety Protection Office (PVPO) held a preparatory session for the International Union for the Protection of New Varieties of Plants (UPOV) Technical Working Party for Vegetables (TWV) and…more

Agricultural Sector, Plant Protection Act, Plant Variety Protection Office (PVPO), USDA

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Benjamin Mark-Alexander Beswick

UK’S New Emissions Trading Scheme Hosts First Auctions

On January 1, 2021, the UK launched its very own emissions trading scheme (the “UK ETS”) exercising its autonomy since departing the EU. Under this scheme, companies operating in certain sectors can trade emission allowances…more

Autonomy, Carbon Offset and Reduction Scheme for International Aviation (CORSIA), Carbon Pricing, Carbon Taxes, CCA

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Jonathan Bockman

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Algorithms, Artificial Intelligence, Intellectual Property Protection, Life Sciences, Machine Learning

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Brigid DeCoursey Bondoc

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To…more

AI Act, Algorithms, Artificial Intelligence, EU, Final Rules

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Erin Bosman

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Artificial Intelligence, Cybersecurity, Draft Guidance, Emerging Technologies, Food and Drug Administration (FDA)

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Michelle Celine Bradley

A Glimmer Of Hope For Simplified Patenting Of Medical Diagnostics In The United States

Should the recent bill entitled the Patent Eligibility Restoration Act of 2023 (PERA) become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101. By…more

CLS Bank v Alice Corp, Innovation, Inventions, Medical Devices, Patent-Eligible Subject Matter

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Adam Braverman

Supreme Court Denies Review Of Cost Sharing Assistance Program

The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible…more

Anti-Kickback Statute, Cost-Sharing, Department of Health and Human Services (HHS), Drug Pricing, Medicare

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Abby Burrus

An Insecure Future: Court Ruling Guts USDA Regs On Genetically Engineered Plants

In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2, 2024,…more

Agricultural Sector, APHIS, Appeals, Bioengineering, Crops

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Paige Chandler

Senate Unanimously Passes Bill To Limit Patent Infringement Challenges By Drug Manufacturers

The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of…more

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John Chapman

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal…more

Abbreviated New Drug Application (ANDA), Appeals, CAFC, Claim Construction, Generic Drugs

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Yuxiang Chen

The PTAB Axes Skin Treatment Patent Under Amgen

The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v…more

Amgen, Genus, Life Sciences, Method Claims, Patent Trial and Appeal Board

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Matthew Chivvis

Senate Unanimously Passes Bill To Limit Patent Infringement Challenges By Drug Manufacturers

The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of…more

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Alayna Choo

Patent Term Extension For Medical Devices

Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could not…more

Biologics, Eligibility, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), Medical Devices

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Wendy Chow

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s…more

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Drug Pricing, Excise Tax, Fifth Amendment

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Fitz Collings

Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

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…more

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Joshua Crawford

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Algorithms, Artificial Intelligence, Intellectual Property Protection, Life Sciences, Machine Learning

See all updates »

Melissa Crespo

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must also…more

Artificial Intelligence, California, Colorado, Data Privacy, Health Insurance Portability and Accountability Act (HIPAA)

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Can Cui

China Technology Export Update: Amendment Of The Export Technology Catalog

On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s Catalog of Technologies the Export of Which is Prohibited or…more

China, Exports, Life Sciences, Pharmaceutical Industry, Popular

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Krista deBoer

An Insecure Future: Court Ruling Guts USDA Regs On Genetically Engineered Plants

In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2, 2024,…more

Agricultural Sector, APHIS, Appeals, Bioengineering, Crops

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Keunbong Do

FDA Issues Final Transition Guidances For COVID-19 Devices

This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or…more

Coronavirus/COVID-19, Emergency Use Authorization (EUA), Food and Drug Administration (FDA), Medical Devices, Public Health Emergency

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Kate Driscoll

Prevent A Clinical Trial From Turning Into A Criminal Trial

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and…more

Biotechnology, Clinical Trials, Criminal Investigations, Cybersecurity, Department of Health and Human Services (HHS)

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Matthew Dunlap

UK’S New Emissions Trading Scheme Hosts First Auctions

On January 1, 2021, the UK launched its very own emissions trading scheme (the “UK ETS”) exercising its autonomy since departing the EU. Under this scheme, companies operating in certain sectors can trade emission allowances…more

Autonomy, Carbon Offset and Reduction Scheme for International Aviation (CORSIA), Carbon Pricing, Carbon Taxes, CCA

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Cory Ellison

UPOV Updates Explanatory Note On Essentially Derived Varieties (EDVS)

In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). The UPOV Convention outlines a popular sui…more

Biotechnology, Infringement, Intellectual Property Protection, Plant Variety Protection Act, Plant Variety Protection Office (PVPO)

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Joshua Fattal

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must also…more

Artificial Intelligence, California, Colorado, Data Privacy, Health Insurance Portability and Accountability Act (HIPAA)

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Jacqueline Madeleine Feigl

A Long Courtship For Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About A Unitary Supplementary Protection Certificate Gain Momentum

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…more

Court of Justice of the European Union (CJEU), EU, European Commission, Intellectual Property Protection, Provisional Applications

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Matthew Ferry

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks, AI…more

Artificial Intelligence, Data Privacy, Health Insurance Portability and Accountability Act (HIPAA), Healthcare, Intellectual Property Protection

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Zachary Fuchs

Senators Call For Report On State Of Psychedelic Research

Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) urging both agencies to advance research on the…more

Clinical Trials, Controlled Substances Act, DEA, Food and Drug Administration (FDA), Life Sciences

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Jenny Galloway

Life Sciences Regulatory Framework Becomes Law Post-Brexit

Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021…more

Clinical Trials, Criminal Sanctions, EU, Life Sciences, Medical Devices

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Lena Gankin

Golden State Crackdown—Unpacking California’s Landmark Food Safety Act

This month, California Governor Gavin Newsom signed into law the California Food Safety Act—a bill targeted at enhancing food safety within California. The law bans the manufacture, sale, and distribution of four food additives…more

Additive Manufacturing, California, Food & Drug Regulations, Food and Drug Administration (FDA), Food Manufacturers

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Josephine Garban

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

In ChromaDex Inc. v. Elysium Health Inc., 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…more

Dietary Supplements, Life Sciences, Patent Infringement, Patent Litigation, Patent-Eligible Subject Matter

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Corey Garyn

USPTO Fee Changes for 2025

In the November 20, 2024 Federal Register Notice, the United States Patent and Trademark Office (USPTO or the “Office”) released its final rule on patent fee adjustments (“Final Rule”). These fee adjustments, set to take effect…more

Federal Register, Final Rules, Information Disclosure Statement, Patent Applications, Patent Examinations

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Christopher Gloria

Subject Matter Eligibility of AI Medical Treatments

Artificial intelligence (AI) has quickly become a springboard for breakthroughs in personalized medicine, enhanced medical imaging, and predictive modeling for drug development. And given the role it played in two recent Nobel…more

AI Act, Algorithms, Artificial Intelligence, Healthcare, Life Sciences

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Grace Gong

Under Lock And Key – Private Sales May Not Qualify As Public Disclosure

Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product. The Leahy-Smith America Invents Act provides exceptions for…more

Inter Partes Review (IPR) Proceeding, Inventions, Patent Trial and Appeal Board, Patents, Prior Art

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Marcus Grimes

Golden State Crackdown—Unpacking California’s Landmark Food Safety Act

This month, California Governor Gavin Newsom signed into law the California Food Safety Act—a bill targeted at enhancing food safety within California. The law bans the manufacture, sale, and distribution of four food additives…more

Additive Manufacturing, California, Food & Drug Regulations, Food and Drug Administration (FDA), Food Manufacturers

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Robert Grohmann

Digitalization Of German Healthcare System To Receive Legislative Boost In 2024

It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At the…more

Digital Health, Germany, Healthcare, Medical Devices, Ministry of Health

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Andreas Grünwald

Pay-For-Delay Has A Tough (Antitrust) Time At EU Top Court

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. In two recent rulings – “Lundbeck and “Paroxetine” –…more

Anti-Competitive, Corporate Counsel, EU, European Commission, Generic Drugs

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Brandy Guarda

What is “Healthy?” Are Fats In?

Yesterday, FDA released the final rule that updates the definition for “healthy” nutrient content claims. In an update that may be long overdue, manufacturers who use the term “healthy” (or derivative terms: “health,”…more

Dietary Guidelines, Final Rules, Food and Drug Administration (FDA), Food Manufacturers, Health Claims

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Jens Hackl

Pay-For-Delay Has A Tough (Antitrust) Time At EU Top Court

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. In two recent rulings – “Lundbeck and “Paroxetine” –…more

Anti-Competitive, Corporate Counsel, EU, European Commission, Generic Drugs

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Joshua Hill Jr.

EHR Vendor Settles Kickback Allegations To The Tune Of $18.25 Million

On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying…more

Anti-Kickback Statute, Department of Justice (DOJ), Electronic Medical Records, False Claims Act (FCA), Marketing

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Bethany Hills

FDA Issues Draft Guidance On Human Gene Therapy Products Incorporating Human Genome Editing

On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product…more

Center for Biologics Evaluation and Research (CBER), Draft Guidance, Food and Drug Administration (FDA), Human Genes, Human Genome Project

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Hilary Hoffman

FDA Issues Draft Guidance On Human Gene Therapy Products Incorporating Human Genome Editing

On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product…more

Center for Biologics Evaluation and Research (CBER), Draft Guidance, Food and Drug Administration (FDA), Human Genes, Human Genome Project

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Owen Grayson Hosseinzadeh

FDA Clears The Path To Lab-Grown Meat

On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken…more

Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS), Food Supply, USDA

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Marta Hovanesian

Key Considerations For Sponsors Of Clinical Trials Under The EU Clinical Trial Regulation

Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a…more

Applications, Clinical Trials, Consent, EU, EU Clinical Trials Regulation (CTR)

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Muzamil Huq

It Takes Two To Taco: Taco John’s Abandons “Taco Tuesday” Trademark Registration

On July 18, 2023, the phrase “Taco Tuesday” was returned to the public after Taco John’s submitted a notice of abandonment for its TACO TUESDAY trademark registration before the United States Patent & Trademark Office’s…more

Abandonment, Intellectual Property Protection, Taco Bell, Trademark Infringement, Trademark Litigation

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Edith Pierre-Jerome

UPOV Updates Explanatory Note On Essentially Derived Varieties (EDVS)

In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). The UPOV Convention outlines a popular sui…more

Biotechnology, Infringement, Intellectual Property Protection, Plant Variety Protection Act, Plant Variety Protection Office (PVPO)

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Dan Kagan

New Jersey Court Affirms Prohibition Of Physician Practice From Opening And Operating In-Office Pharmacy

At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to…more

New Jersey, Pharmacies, Physicians, Prescription Drugs, Stark Law

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Matthew Karlyn

Non-Lab Diagnostics: FDA Regulatory Considerations

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases,…more

Coronavirus/COVID-19, Diagnostic Tests, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), Laboratory Developed Tests

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David Kaufman

UK’S New Emissions Trading Scheme Hosts First Auctions

On January 1, 2021, the UK launched its very own emissions trading scheme (the “UK ETS”) exercising its autonomy since departing the EU. Under this scheme, companies operating in certain sectors can trade emission allowances…more

Autonomy, Carbon Offset and Reduction Scheme for International Aviation (CORSIA), Carbon Pricing, Carbon Taxes, CCA

See all updates »

Brian Kidd

Prevent A Clinical Trial From Turning Into A Criminal Trial

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and…more

Biotechnology, Clinical Trials, Criminal Investigations, Cybersecurity, Department of Health and Human Services (HHS)

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Elena Catherine Klonoski

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To…more

AI Act, Algorithms, Artificial Intelligence, EU, Final Rules

See all updates »

Hannah Koo

Non-Lab Diagnostics: FDA Regulatory Considerations

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases,…more

Coronavirus/COVID-19, Diagnostic Tests, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), Laboratory Developed Tests

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Stephan Kreß

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 6 Of 6)

In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the…more

EU, Licenses, Medical Device Reports (MDRs), Medical Devices, Medical Software

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Paresh Kumar

Pediatric Exclusivity For Biologics

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for…more

Biologics, Exclusivity, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), License Applications

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Kenneth Kuwayti

Subject Matter Eligibility of AI Medical Treatments

Artificial intelligence (AI) has quickly become a springboard for breakthroughs in personalized medicine, enhanced medical imaging, and predictive modeling for drug development. And given the role it played in two recent Nobel…more

AI Act, Algorithms, Artificial Intelligence, Healthcare, Life Sciences

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Jack Lane

Subject Matter Eligibility of AI Medical Treatments

Artificial intelligence (AI) has quickly become a springboard for breakthroughs in personalized medicine, enhanced medical imaging, and predictive modeling for drug development. And given the role it played in two recent Nobel…more

AI Act, Algorithms, Artificial Intelligence, Healthcare, Life Sciences

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Christopher Lew

USDA’S PVP System Embraces Transgenic And Gene Edited Plants

Plant Variety Protection (PVP) is a form of intellectual property protection administered through the United States Department of Agriculture (USDA) for new varieties of plants…more

Biotechnology, DNA, Intellectual Property Protection, Plant Variety Protection Act, Plant Variety Protection Office (PVPO)

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Joyce Liou

It Takes Two To Taco: Taco John’s Abandons “Taco Tuesday” Trademark Registration

On July 18, 2023, the phrase “Taco Tuesday” was returned to the public after Taco John’s submitted a notice of abandonment for its TACO TUESDAY trademark registration before the United States Patent & Trademark Office’s…more

Abandonment, Intellectual Property Protection, Taco Bell, Trademark Infringement, Trademark Litigation

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Seth Lloyd

Supreme Court Denies Review Of Cost Sharing Assistance Program

The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible…more

Anti-Kickback Statute, Cost-Sharing, Department of Health and Human Services (HHS), Drug Pricing, Medicare

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Lauren Margolies

Front-of-pack, Front-of-mind

On Tuesday, FDA proposed a rule that would require a front-of-pack mini nutrition label on most packaged foods by 2028. This is yet another effort by FDA to make it easier for consumers to determine which foods are “healthy” at…more

Consumer Protection Laws, Food and Drug Administration (FDA), Food Labeling, Labeling, Nutrition Facts Labels

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Tricia Matibag

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks, AI…more

Artificial Intelligence, Data Privacy, Health Insurance Portability and Accountability Act (HIPAA), Healthcare, Intellectual Property Protection

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Mark McBriar

Under Lock And Key – Private Sales May Not Qualify As Public Disclosure

Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product. The Leahy-Smith America Invents Act provides exceptions for…more

Inter Partes Review (IPR) Proceeding, Inventions, Patent Trial and Appeal Board, Patents, Prior Art

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Garreth McCrudden

COVID-19 Vaccines: And Then There Were Three (Again)

On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others…more

ACIP, Biden Administration, Centers for Disease Control and Prevention (CDC), Contamination, Coronavirus/COVID-19

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Shawn Meade

Obviousness In Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms Of Action

Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. The Supreme Court emphasized “the need for…more

Obviousness, Patent Applications, Patent Infringement, Patent Trial and Appeal Board, Patents

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Brian Michael

Prevent A Clinical Trial From Turning Into A Criminal Trial

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and…more

Biotechnology, Clinical Trials, Criminal Investigations, Cybersecurity, Department of Health and Human Services (HHS)

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Morgan O'Neill Mitruka

It Takes Two To Taco: Taco John’s Abandons “Taco Tuesday” Trademark Registration

On July 18, 2023, the phrase “Taco Tuesday” was returned to the public after Taco John’s submitted a notice of abandonment for its TACO TUESDAY trademark registration before the United States Patent & Trademark Office’s…more

Abandonment, Intellectual Property Protection, Taco Bell, Trademark Infringement, Trademark Litigation

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Briana Erin Mittleman

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Algorithms, Artificial Intelligence, Intellectual Property Protection, Life Sciences, Machine Learning

See all updates »

Alyssa Monsen

Patent Vs. Trade Secret Considerations For Cell And Gene Therapies

Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are…more

Biologics, Business Model, Damages, Discovery, Food and Drug Administration (FDA)

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James Mullen III

Bill Proposes 10 Additional Years for COVID-19 Inventions

A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily curtail…more

Coronavirus/COVID-19, Infectious Diseases, Innovative Technology, Life Sciences, Medical Devices

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Andrew Murtha

Patent Vs. Trade Secret Considerations For Cell And Gene Therapies

Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are…more

Biologics, Business Model, Damages, Discovery, Food and Drug Administration (FDA)

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Alexander Najarian

New Face Mask Performance Standard Has Consumers Covered

ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain…more

ASTM, Coronavirus/COVID-19, Emergency Use Authorization (EUA), Food and Drug Administration (FDA), Masks

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Liz Newman

Recent Updates On Use Of Post-Filing Data As Evidence To Support Patentability

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…more

CNIPA, European Patent Office, First-to-File, Patent Applications, Patents

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Jean Nguyen

The USPTO And The FDA Join Hands To Promote Competition

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…more

Competition, Executive Orders, Food and Drug Administration (FDA), Patent Trial and Appeal Board, Popular

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Zachary Nora

Patent Term Adjustment Takes A Hit In Cellect Decision

Recently, the Federal Circuit addressed a significant issue of first impression with respect to obviousness-type double patenting (ODP), holding that ODP applies to patent claims that claim priority to the same application and…more

Obviousness, Obviousness-Type Double Patenting (ODP), Patent Litigation, Patent Term Adjustment, Patent Term Extensions

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Desmond O'Sullivan

Bill Proposes 10 Additional Years for COVID-19 Inventions

A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily curtail…more

Coronavirus/COVID-19, Infectious Diseases, Innovative Technology, Life Sciences, Medical Devices

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Nicole Victoria Ozeran

Rulings, FDA Guidance May Help Food Cos. In Protein Suits

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…more

Federal Food Drug and Cosmetic Act (FFDCA), Food & Drug Regulations, Food and Drug Administration (FDA), Food Labeling, Food Manufacturers

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Joseph Palmore

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s…more

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Drug Pricing, Excise Tax, Fifth Amendment

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Julie Park

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Artificial Intelligence, Cybersecurity, Draft Guidance, Emerging Technologies, Food and Drug Administration (FDA)

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Rachel Park

New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways

On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and…more

Health Care Providers, Hospitals, Mergers, New York, Notice Requirements

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Deborah Pohlmann

New Regulations Rooted In Evidence: Looking Back On How EPA And USDA Updated Engineered Plant Regulations And Labeling In 2023

Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year…more

APHIS, Biotechnology, Environmental Protection Agency (EPA), FIFRA, Final Rules

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Catherine Polizzi

Rare Disease: Sustained Progress In Development Regardless Of The Pandemic

Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In…more

Applicants, Coronavirus/COVID-19, Food and Drug Administration (FDA), Life Sciences, Orphan Drugs

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Meghan McLean Poon

Navigating Inventorship in the Era of AI-Assisted Drug Discovery

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Artificial Intelligence, Intellectual Property Protection, Inventions, Life Sciences, Machine Learning

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Karen Potter

USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

On June 10, 2025, the United States Patent and Trademark Office (USPTO) announced that, after nearly 20 years, it will be discontinuing its Accelerated Examination Program for utility applications on July 10, 2025. The USPTO’s…more

Accelerated Examination Program, Design Patent, Filing Requirements, Government Agencies, Patent Applications

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Ashley Quinn

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Artificial Intelligence, Cybersecurity, Draft Guidance, Emerging Technologies, Food and Drug Administration (FDA)

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Philip Radlanski

Digitalization Of German Healthcare System To Receive Legislative Boost In 2024

It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At the…more

Digital Health, Germany, Healthcare, Medical Devices, Ministry of Health

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Gareth Rees QC

Life Sciences Regulatory Framework Becomes Law Post-Brexit

Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021…more

Clinical Trials, Criminal Sanctions, EU, Life Sciences, Medical Devices

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Tina Reynolds

IP Implications Of USDA Research Collaborations

Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on their…more

Agricultural Sector, Collaboration, Health Technology, Intellectual Property Protection, Inventions

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Emily Jane Roberts, Ph.D.

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue patents…more

Appeals, Food and Drug Administration (FDA), Intellectual Property Protection, Life Sciences, Patent Litigation

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Kelsey Roberts Kingman

USPTO Enablement Guidelines After Amgen V. Sanofi

On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. The guidelines clarify that the…more

Amgen v Sanofi, Genus, Life Sciences, Popular, SCOTUS

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Matt Robinson

FTC Issues Updated Health Products Claims Guidance

On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for…more

Advertising, Dietary Supplements, Federal Trade Commission (FTC), Food and Drug Administration (FDA), Health Claims

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Liz Freeman Rosenzweig

An Insecure Future: Court Ruling Guts USDA Regs On Genetically Engineered Plants

In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2, 2024,…more

Agricultural Sector, APHIS, Appeals, Bioengineering, Crops

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Jeffrey Schmidt

USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

On June 10, 2025, the United States Patent and Trademark Office (USPTO) announced that, after nearly 20 years, it will be discontinuing its Accelerated Examination Program for utility applications on July 10, 2025. The USPTO’s…more

Accelerated Examination Program, Design Patent, Filing Requirements, Government Agencies, Patent Applications

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Wolfgang Schönig

Update February 2024 On Commission Plans Liberalization Of New Genomic Techniques (NGTS) In The EU

On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into…more

CRISPR, EU, European Parliament, European Patent Convention, European Patent Office

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Alex Schroth

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F…more

Department of Health and Human Services (HHS), Disclosure Requirements, Final Rules, Food and Drug Administration (FDA), Manufacturers

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Lisa Silverman

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue patents…more

Appeals, Food and Drug Administration (FDA), Intellectual Property Protection, Life Sciences, Patent Litigation

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Ashley Sperbeck

Under Lock And Key – Private Sales May Not Qualify As Public Disclosure

Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product. The Leahy-Smith America Invents Act provides exceptions for…more

Inter Partes Review (IPR) Proceeding, Inventions, Patent Trial and Appeal Board, Patents, Prior Art

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Marijn Storm

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must also…more

Artificial Intelligence, California, Colorado, Data Privacy, Health Insurance Portability and Accountability Act (HIPAA)

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Steve Sundberg, Ph.D.

Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Algorithms, Artificial Intelligence, Intellectual Property Protection, Life Sciences, Machine Learning

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William Tarantino

An Insecure Future: Court Ruling Guts USDA Regs On Genetically Engineered Plants

In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2, 2024,…more

Agricultural Sector, APHIS, Appeals, Bioengineering, Crops

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Caressa Tsai

Navigating Inventorship in the Era of AI-Assisted Drug Discovery

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Artificial Intelligence, Intellectual Property Protection, Inventions, Life Sciences, Machine Learning

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Alex van der Wolk

Key Considerations For Sponsors Of Clinical Trials Under The EU Clinical Trial Regulation

Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a…more

Applications, Clinical Trials, Consent, EU, EU Clinical Trials Regulation (CTR)

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Claudia Vetesi

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F…more

Department of Health and Human Services (HHS), Disclosure Requirements, Final Rules, Food and Drug Administration (FDA), Manufacturers

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Nicholas Vincent

Patent Term Extension For Biologics

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S…more

Biologics, Food and Drug Administration (FDA), Patent Term Extensions, Patents, Pharmaceutical Industry

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Marian Waldmann Agarwal

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must also…more

Artificial Intelligence, California, Colorado, Data Privacy, Health Insurance Portability and Accountability Act (HIPAA)

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Katherine Wang

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must also…more

Artificial Intelligence, California, Colorado, Data Privacy, Health Insurance Portability and Accountability Act (HIPAA)

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Michael Ward

An Insecure Future: Court Ruling Guts USDA Regs On Genetically Engineered Plants

In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2, 2024,…more

Agricultural Sector, APHIS, Appeals, Bioengineering, Crops

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Rebecca Weires

Federal Circuit addresses subject matter eligibility for compositions of matter in US Synthetic v. ITC

Earlier this month, the Federal Circuit decided a subject matter eligibility case closely watched in the pharmaceutical industry. The case involved composition-of-matter claims reciting measured results. Reversing the decision…more

Biotechnology, Intellectual Property Protection, Life Sciences, Patent Litigation, Patent-Eligible Subject Matter

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Hannah Alexandra Bethany Whitmore

In Vineis Veritas: No Sour Grapes As Egyptian Court Orders Removal Of Illegal Vines

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…more

Egypt, EU, Licenses, Ministry of Agriculture, Patent Infringement

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Janet Xiao

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal…more

Abbreviated New Drug Application (ANDA), Appeals, CAFC, Claim Construction, Generic Drugs

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Bu Yin

USPTO Fee Changes for 2025

In the November 20, 2024 Federal Register Notice, the United States Patent and Trademark Office (USPTO or the “Office”) released its final rule on patent fee adjustments (“Final Rule”). These fee adjustments, set to take effect…more

Federal Register, Final Rules, Information Disclosure Statement, Patent Applications, Patent Examinations

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Yuying You

The USPTO Proposes To Establish Permanent Electronic Filing For Patent Term Extension Applications

On May 6, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice, proposing to amend the Rules of Practice in Patent Cases to allow electronic submissions of patent term extension (PTE) applications, interim…more

Electronic Filing, Federal Register, Patent Application Information Retrieval (PAIR), Patent Term Extensions, Patents

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Jeffrey Gerard Young

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Algorithms, Artificial Intelligence, Intellectual Property Protection, Life Sciences, Machine Learning

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Anna Yuan

Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay…more

Algorithms, Artificial Intelligence, Intellectual Property Protection, Life Sciences, Machine Learning

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Paige Zhang

Standards For Inventiveness And Disclosure For Antibody Claims Across Jurisdictions

Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents. Most recently, Singapore updated…more

EU, European Patent Office, Genus, Jurisdiction, Life Sciences

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Qiwen Zhong

Establishing Unexpected Results: PTAB Highlights Pitfalls For Rule 132 Declarations

A recent decision by the Patent Trial and Appeal Board (PTAB) sheds light on certain pitfalls patent applicants may encounter when submitting declarations under 37 C.F.R. § 1.132 (“Rule 132 Declarations”). Rule 132 Declarations…more

Declaration, Obviousness, Patent Examinations, Patent Trial and Appeal Board, Patents

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Mai Phan Zymaris

Top 10 Considerations When Drafting And Negotiating SRAs, With U.S. And EU Perspectives

Sponsored Research Agreements (SRA) are used by companies to contract a research organization, such as a university, to conduct research and development activities in exchange for fees and the university’s rights to use the…more

EU, Indemnity Agreements, Intellectual Property Protection, Joint Ownership, Life Sciences

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