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On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet... Read More »
Federal Circuit Summary On September 10, 2018, the Federal Circuit decided Regents of the University of California v. Broad Institute, Inc., affirming the Patent... Read More »
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... Read More »
On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, affirming the Patent Trial and Appeal Board (PTAB)’s... Read More »
On July 18, 2018, the FDA released a Biosimilar Action Plan[1]  that is aimed at promoting competition and affordability across the market for biologics and... Read More »
Federal Circuit Summary En Banc (excl. Chen), Opinion for the court filed by Stoll, joined by Newman, Lourie, Moore, O’Malley, Wallach, and Taranto. ... Read More »
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA).  Sen. Hatch suggests that the HWIA will ... Read More »
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... Read More »
Until the cloning of Dolly the sheep in 1996 by scientists at the Roslin Institute, the idea of cloning a mammal, let alone a human being, was an idea relegated to... Read More »
In Ex parte Galloway, Appeal No. 2017-004696 (PTAB, May 24, 2018), the Board reversed the examiner’s rejections of claims to a method of diagnosing bladder... Read More »
On May 14, 2018, several important revisions to regulations of the Bayh-Dole Act (University and Small Business Patent Procedure Act of 1980, codified as 35 U.S.C... Read More »
In vitro gametogenesis (IVG) is a recent development in reproductive technology, and has been used for creating mouse embryos in vitro. IVG includes obtaining cells... Read More »
A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when... Read More »
Lundbeck Pharmaceutical Company, headquartered in Denmark, recently announced the acquisition of Prexton Therapeutics B.V. for $1.1 billion (U.S.)(1).  Lundbeck... Read More »
On March 6, 2018, 23andMe, Inc. received the first-ever FDA authorization for a direct-to-consumer genetic test that analyzes gene mutations to help predict a... Read More »
The PTAB held that all of Genentech’s challenged antibody purification claims were unpatentable as being anticipated, obvious, or both, in an IPR filed by... Read More »
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the... Read More »
Federal Circuit Summary Before Moore, Schall, and O’Malley.  Appeal from the Northern District of Illinois. Summary: A plaintiff need not prove its ... Read More »
Throughout the past year, substantial investment continued to pour into digital health and personalized medicine.  Personalized medicine involves the discovery... Read More »
On December 19, 2017, a seven-judge expanded PTAB panel ruled that the University of Minnesota (UM) waived its Eleventh Amendment immunity defense when it filed a... Read More »
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