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Microbiome Regulation Emerges From the Shadows: FDA to Co-Host Workshop on Live Cell Therapeutics

Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate. While the wave of new health technologies emerging from this research rises, companies working in the...more

TF3 Limited v. TRE Milano, LLC

Federal Circuit Summary - Before Newman, Lourie, and Hughes. Appeal from the Patent Trial and Appeal Board. Summary: Claim construction was not reasonable where it extended the breadth of the claims beyond what was...more

FDA Announces Public Meeting on Regulation of Cultured Meat Products

In recent years, market interest in meat substitutes has aligned with advances in cell culture techniques to support the emergence of lab-grown meat or ”cultured meat” as an alternative to farm-grown meat products. A product...more

The Druggable Microbiome

Discoveries regarding the role of the microbiome in human health and disease have been emerging with stunning frequency. While each new discovery builds upon the last, occasionally a point is reached at which, in the...more

Simpleair, Inc. v. Google, LLC.

Federal Circuit Summaries - Before Lourie, Reyna, and Chen. Appeal from the U.S. District Court for the Eastern District of Texas, Judge J. Rodney Gilstrap. Summary: Filing a terminal disclaimer to overcome an...more

Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more

Nonprofit Group Files IPR Petition Seeking to Invalidate Hepatitis C Drug Patent

In an effort to lay the groundwork for generic entry and reduced drug prices, the non-profit group Initiative for Medicines, Access and Knowledge, Inc. (I-MAK), with the support of the Laura and John Arnold foundation, has...more

FDA Offers Guidance on Streamlined Development of Treatments for Rare Bacterial Infections

On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, detailing proposals...more

PTAB Grants-in-Part Rare Motion to Amend Based on Unexpected Results

The PTAB granted-in-part a patent owner’s motion to substitute claims based on evidence of secondary considerations of nonobviousness in Valeo North America, Inc. v. Schaeffler Technologies, AG & CO. KG, IPR2016-00502, Paper...more

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

PTAB Institutes Two IPRs in Hospira v. Genentech Avastin Dispute

Bevacizumab (Avastin®) is the subject of the widely watched “patent dance” dispute between Genentech and Amgen regarding Amgen’s proposed biosimilar. Hospira, however, (now owned by Pfizer) has chosen a different path in...more

Probiotics: IP Perspectives on the Microbiome

Once considered parasites, free riders, or “opportunistic pathogens,” in recent years the roughly 100 trillion symbiotic bacteria that inhabit the various tissues of the human body have been increasingly recognized for their...more

IPR Denied after Board Finds Asserted PCT Publication Not Entitled to Priority Application’s Filing Date under Pre-AIA 35 U.S.C. §...

The PTAB denied institution of an IPR based on patent owner’s challenge to the prior art status of a PCT publication that was asserted by the petitioner as pre-AIA 35 U.S.C. § 102(e) prior art in Forty Seven, Inc. v....more

The USPTO “Patents 4 Patients” Program: What, How, and Why

On January 12, 2016, President Barack Obama announced his goal of a nationwide “Cancer Moonshot,” with the ultimate goal of accelerating cancer research “to end cancer as we know it” during his State of the Union Address As...more

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