Knobbe/Martens: Intellectual Property Law


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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 of either bulk cell culture or 3D scaffolded cell culture, cultured meat is made by growing animal-derived cells in an artificial environment, and triggering their differentiation into muscle cells in order to produce artificial muscle tissue that can then be harvested and eaten.

Right to Try Act Gives Terminal Patients Opportunity to Try Early Therapies

Often those with terminal illnesses wish to try new experimental therapies.  Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act.[1]  The Act allows eligible patients to receive drugs that are not FDA-approved but have passed phase I clinical trials.  For a patient to be eligible, he or she must be diagnosed with a life-threatening disease or condition, exhausted all other treatment options including being unable to participate in a clinical trial, and give informed consent.

The Law and Human Cloning

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 science fiction[1].

FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain gene therapy products” will soon be able to qualify for fast track approval.[1]


Bayh-Dole Act Revisions

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. § 200) went into effect. The final revisions were published in the Federal Register of April 18, 2018.


China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from innovative drugs to also now cover innovative therapeutic biologics, orphan drugs, pediatric drugs, as well as drug products that have succeeded in a patent challenge (“first generics”).

Intellectual Property Impacts of In Vitro Gametogenesis

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 from a donor (such as skin cells), and differentiating the cells in a laboratory culture dish into gametes (eggs and sperm). Differentiated eggs can be inseminated with differentiated sperm in the laboratory culture dish to generate embryos for implantation into a womb.

Patenting and regulation of methods for creating three-parent babies

May 10, 2018 Jane Xia and Jason J. Jardine

A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when mothers carry genes for mitochondrial diseases. Similar to in vitro fertilization (IVF), MRT involves removing an egg from a woman (mother), removing sperm from a man (father), fertilizing the egg with the sperm, allowing the fertilized egg to form a blastocyst, and then implanting the blastocyst into the mother’s womb.

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 aggregate, researchers can begin to refocus their efforts, identifying distinct approaches to modulating and/or protecting our internal flora in order to preserve and enhance our own well-being. 

Bayer and Monsanto Deal Gets Blessed

April 23, 2018 Loni Morrow and Agnes Juang, Ph.D.

Since May of 2016, Bayer and Monsanto have been working on a deal to combine the two giants.  Based on a report released by the Wall Street Journal on Monday, April 9, 2018, the U.S. Department of Justice has just given its blessing to combine the companies.



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