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Firm Profile: Morrison & Foerster LLP
425 Market Street
San Francisco, CA 94105-2482, United States
Phone: (415) 268-7000
Fax: (415) 268-7522
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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)

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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 »

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

See all updates »

First Decisions Limit Prep Act Immunity In Coronavirus Context

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical…more

Coronavirus/COVID-19, Corporate Counsel, Countermeasures, Healthcare Facilities, Negligence

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

Is DOE Now In Vogue?

On March 27, 2023, the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi, a closely watched case on the issue of enablement under 35 U.S.C. § 112(a). Though not the main point of contention, the doctrine of…more

Doctrine of Equivalents, Infringement, Inventions, Patent Ownership, Patents

See all updates »

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

See all updates »

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

Biosimilars, Competition, Department of Health and Human Services (HHS), Drug Pricing, Food and Drug Administration (FDA)

See all updates »

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

See all updates »

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

See all updates »

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)

See all updates »

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 »

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)

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

The Importance Of Patents For ML-Based Medical Device Inventions

The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies…more

Advertising, Innovation, Inventions, Life Sciences, Machine Learning

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions

On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”…more

Algorithms, Artificial Intelligence, Food and Drug Administration (FDA), Machine Learning, Medical Devices

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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)

See all updates »

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

See all updates »

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)

See all updates »

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

See all updates »

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

See all updates »

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 »

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)

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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)

See all updates »

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

See all updates »

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

See all updates »

Patent Prosecution Strategies To Avoid Pitfalls In Post-Grant Proceedings

On October 26, 2023, the U.S. Court of Appeals for the Federal Circuit in Monterey Research, LLC v. STMicroelectronics, Inc. affirmed a pair of final written decisions at the Patent Trial and Appeal Board (PTAB) that invalidated…more

Claim Construction, Inter Partes Review (IPR) Proceeding, Patent Infringement, Patent Litigation, Patent Ownership

See all updates »

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

See all updates »

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

See all updates »

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)

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

USPTO Issues Reminder To Examiners On Proper “Means-Plus-Function” Analysis

On March 18, 2024, the USPTO issued a memorandum to its Examiners reminding them of the resources and proper analysis for interpreting limitations under 35 U.S.C. § 112(f), which are commonly referred to as “means-plus-function”…more

Claim Limitations, Examiners, Life Sciences, Means-Plus-Function, Patents

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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

See all updates »

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)

See all updates »

USPTO Issues Reminder To Examiners On Proper “Means-Plus-Function” Analysis

On March 18, 2024, the USPTO issued a memorandum to its Examiners reminding them of the resources and proper analysis for interpreting limitations under 35 U.S.C. § 112(f), which are commonly referred to as “means-plus-function”…more

Claim Limitations, Examiners, Life Sciences, Means-Plus-Function, Patents

See all updates »

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

See all updates »

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

See all updates »

Patent Prosecution Strategies To Avoid Pitfalls In Post-Grant Proceedings

On October 26, 2023, the U.S. Court of Appeals for the Federal Circuit in Monterey Research, LLC v. STMicroelectronics, Inc. affirmed a pair of final written decisions at the Patent Trial and Appeal Board (PTAB) that invalidated…more

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Patent Term Extension For Biologics

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JD Supra Privacy Policy

Updated: Dec 28, 2021:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and companies and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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