Stem cells

News & Analysis as of

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

Clinical Progress in Regenerative Medicine

Two separate clinical initiatives were recently announced that support the therapeutic use of regenerative medicine. The first utilzing induced pluripotent stem cells and the second, a state-wide network in support of...more

Consumer Watchdog Argues That WARF Stem Cell Patent Is Invalid under § 101

Last month, Consumer Watchdog filed its opening brief in an appeal of a Board decision affirming the patentability of U.S. Patent No. 7,029,913, arguing that the claims of the '913 patent are invalid because they cover...more

Patent-Eligibility of hESC Challenged

Now that the U.S. Supreme Court has determined that isolated, naturally-occurring genes are not patent-eligible (see, Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013))(“Myriad”), Consumer Watchdog...more

News from Abroad: UK Court Seek Clarification of the Term "Human Embryo"

In Oliver Brüstle v Greenpeace (Case 34/10) the Court of Justice of the European Union (CJEU) ruled that any non-fertilised but parthenogenically stimulated human ovum constitutes a "human embryo" within the meaning of...more

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...more

Supreme Court Will Not Hear Stem Cell Funding Petition

..The on again, off again nature of federal funding for human embryonic stem cell (hESC) research has created a great deal of uncertainty for academic scientists, major research medical centers, venture capital investors,...more

Supreme Court Denies Certiorari in Stem Cell Funding Case

In an order issued earlier today, the Supreme Court denied certiorari in Sherley v. Sebelius, ending the efforts by two adult stem cell researchers to prevent the National Institutes of Health (NIH) from funding research...more

How Can FDA More Reasonably Regulate Autologous Stem Cell Procedures?

In the December 26, 2012 edition of the Food & Drug Law Institutes (FDLI) Policy Forum, Andrew Ittleman of Fuerst Ittleman David & Joseph took on the question of how FDA may more reasonably regulate autologous stem cell...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

News from Abroad: UK IPO Stem Cell Decisions Raise Questions Concerning the Brüstle Decision

Originally published in the Forresters on December 02, 2012. Two UK applications were rejected by a UK examiner on the ground that they constituted the 'use of human embryos for industrial or commercial purposes',...more

News from Abroad: Emerging Practice of the European Patent Office on Stem Cell Inventions

Originally published in Forresters on November 25, 2012. Is There Light at the End of the Tunnel? - It is clear from an emerging practice of the European Patent Office (EPO) that they were not widely impressed...more

U.S. Supreme Court Asked to Review Federal Funding of Human Embryonic Stem Cell Research

On October 10, 2012, two pro-life groups petitioned the U.S. Supreme Court to review and reverse the U.S. Court of Appeals for the District of Columbia Circuit Court’s decision allowing the continued federal funding of...more

U.S. Supreme Court Agrees to Review Case That May Impact Patented Stem Cell Technologies

On October 5, 2012, the U.S. Supreme Court agreed to review the issue of whether the Federal Circuit erred by (1) refusing to find patent exhaustion that eliminates the right to control or prohibit the use of an invention...more

News from Abroad: EPO Codifies CJEU's Decision on Human Embryonic Stem Cells

On 8 October 2011, the Court of Justice of the European Union's (CJEU) handed down a landmark judgment on the correct interpretation of Article 6(2)(c) of the Biotechnology Directive (98/44/EC) relating to the patentability...more

Federal Stem Cell Funding Approved by Appellate Court

Good news for patients and stem cell researchers alike. On August 24th, the United States Courts of Appeals for the District of Columbia Circuit affirmed the District of Columbia court decision granting the government’s...more

Cultured Stem Cells — Court Rules on the Regenexx Case

As discussed in our prior K&L Gates Alert, “Cultured Stem Cells for Autologous Use: Practice of Medicine or FDA Regulated Drug and Biological Product?”, in 2010 the Food and Drug Administration (“FDA”) brought an action...more

IP Provisions and ROI for State-Funded Stem Cell-Based Products and Technologies in California

The California Institute of Regenerative Medicine (CIRM) reaches the end of its initial charter in 2017 and recently published its Transition Plan. The plan is a roadmap to sustained development of stem cell-based...more

Navigating the Evolving Regulation and Commercialization of Stem Cell Research

Interested parties that can successfully navigate the evolving regulation of stem cell research stand to gain significant scientific and commercial advantage. Given that in the fall of 2011 the Court of Justice of the...more

Alabama student optimistic about post-crash stem cell treatment

Those behind the use of embryonic stem cell treatment call the option a "hopeful experiment." It's not being widely used yet; in fact, only one Alabama patient has gone through the controversial treatment. Last year, a...more

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