Stem cells

News & Analysis as of

Bipartisan Health Policy Bills Advance

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

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

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

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

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

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

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

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

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"

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

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

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

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

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?

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

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

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

South Carolina Legislative Update - January 27, 2014

S. 22 – The South Carolina Government Restructuring Act of 2013 was approved by the conference committee and will be taken up by both chambers as soon as possible. The bill will eliminate the Budget and Control Board and...more

Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical Affairs Law

On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to...more

News from Abroad: EPO Clarifies Extent to which Methods Involving Use of Human Embryos Are Excluded from Patentability

Generally, the European Patent Office does not allow claims to methods involving the use of human embryos for industrial or commercial purposes. It was therefore perhaps not surprising that the Examiner objected to the...more

University of Pittsburgh v. Cellerix (PTAB 2013)

The Patent Trial and Appeals Board (PTAB), a creation of the Leahy-Smith America Invents Act that replaced the Board of Patent Appeals and Interferences (BPAI) overruled the Reexamination Unit's decision that the claims of...more

Update on WARF Stem Cell Patent Challenge

As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in...more

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