News & Analysis as of

Stem cells

The (Nuts and Bolts) of Application Formalities in China

China is in the midst of a tremendous patent boom. Worldwide, total patent application filings were up 7.8% in 2015, with China accounting for 84% of the total growth[1]. In 2015, the State Intellectual Property Office of the...more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

by Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

2016 – a year at a glance

by FPA Patent Attorneys on

What is a human? When is your best method not good enough? When is an inventor not an inventor? What happens when your patent application fails to deliver on its promise? These are just a few of the questions that the...more

FDA Convenes Two-Day Public Hearing on Human Cell and Tissue Product Regulatory Paradigm

by Mintz Levin on

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

FDA Legal and Regulatory – 2015 Year In Review

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on...more

Bipartisan Health Policy Bills Advance

by Reed Smith on

On September 8, 2015, the House of Representatives approved the following bipartisan bills by voice vote: ..H.R. 1344, the Early Hearing Detection and Intervention Act of 2015 – to reauthorize a program for early...more

Energy & Commerce Committee Approves Bipartisan Health Bills

by Reed Smith on

On July 29, 2015, the House Energy & Commerce Committee approved the following bipartisan bills that aim to improve health care for newborns, infants, and children...more

Inventorship, Ownership Issues Cause Dismissal of Suit

by Foley & Lardner LLP on

On July 22, 2015, the U.S. District Court for the District of Maryland dismissed a long standing patent infringement suit brought by StemCells, Inc. against Neuralstem, Inc., on the ground that all those with an ownership...more

House Panel to Review Bipartisan Bills to Improve Health Care for Infants/Children

by Reed Smith on

On June 25, 2015, the Energy & Commerce Health Subcommittee will review three bipartisan bills that aim to improve health care for newborns, infants, and children. Specifically, members will discuss: H.R. 2820, the...more

Patenting Stem Cells in View of the USPTO’s New Interim Guidance

by Foley & Lardner LLP on

Late last year, the USPTO issued its modified and revised 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Guidance) to assist patent examiners and the public in determining if a claim presented for...more

Some Human Embryonic Stem Cells Are Once Again Patent-eligible in Europe

Last Thursday, the European Court of Justice rendered a decision in International Stem Cell (ISCO) Corporation v. Comptroller General of Patents, Designs and Trademarks (UK) that significantly modified the landscape for human...more

European Court of Justice: landmark decision on patentability of stem cells

by DLA Piper on

The European Court of Justice (CJEU) has handed down a landmark judgment concerning the patentability of stem cells in Europe. Stem cells have the potential to revolutionize the treatment of human disease because of their...more

Do-Gooders Won’t Take “No” For An Answer

by Pepper Hamilton LLP on

About a month ago we posted an article on the dismissal of Consumer Watchdog’s appeal at the Court of Appeals for the Federal Circuit following a loss at the USPTO in an inter partes reexamination. Consumer Watchdog, Inc. had...more

Supreme Court Asked to Review Standing in Stem Cell Challenge

by Foley & Lardner LLP on

The Public Patent Foundation and Consumer Watchdog (collectively “CW”) petitioned the U.S. Supreme Court on October 31, 2014, seeking reversal of the Federal Circuit’s dismissal of its appeal from a decision of the USPTO that...more

Stem cell patentability: European update following Opinion of Advocate-General in ISCC and the Australian position

by FPA Patent Attorneys on

The recent Opinion of the Advocate-General suggests that a clarification and moderation of the Court of Justice of the European Union’s (CJEU) approach to the patentability of stem cells may be on the horizon. If followed,...more

Dolly Was a "Natural Phenomenon"

by McDermott Will & Emery on

In re Roslin Institute (Edinburgh) - Addressing patent eligible subject matter under 35 U.S.C. § 101, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent and Trademark Office...more

Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance

At last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took...more

Myriad - One Year Later

by Pepper Hamilton LLP on

The Supreme Court decision last year on June 13, 2013 in Association of Molecular Pathology v. Myriad Genetics may have been a watershed moment for the biotechnology industry. So far the effects have been hard to detect, but...more

Federal Circuit Dismisses WARF Stem Cell Case – A Missed Opportunity

by Foley & Lardner LLP on

Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the...more

Federal Circuit Finds Consumer Watchdog Lacks Standing to Appeal Reexamination Decision Upholding WARF Stem Cell Patent

by Foley & Lardner LLP on

In Consumer Watchdog v. Wisconsin Alumni Research Foundation, the Federal Circuit held that an inter partes reexamination requester must establish an injury in fact sufficient to confer Article III standing in order to appeal...more

Guest Post: Myriad -- An Obvious and Patent-Friendly Interpretation

MyriadIs Myriad truly authority for the proposition that naturally occurring nucleic acid sequences and a host of other naturally occurring materials are no longer patent-eligible? Was it really the intention of the Supreme...more

“Natural” Clones Are Ineligible for Patent Protection

by Dorsey & Whitney LLP on

Last week, in In re Roslin Institute (Edinburgh), the Federal Circuit affirmed the rejection by the United States Patent and Trademark Office (USPTO) of product claims covering cloned mammals. This case relates to Dolly,...more

Clones Not Patent-Eligible?

by Robins Kaplan LLP on

Thanks to recent advances in cloning technology, treating degenerative diseases with replacement tissue that matches a patient’s genetic makeup exactly is no longer science fiction. Just last month, for example, two research...more

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

by Foley & Lardner LLP on

In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in...more

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