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On June 12, 2018, Johnson & Johnson announced acceptance of an offer from Platinum Equity, a private investment firm, to acquire its diabetic monitoring unit, LifeScan, for approximately $2.1 billion. In response to the acquisition, Platinum Equity Chairman and CEO Tom Gores said

The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA expects to roll out a finalized version of the program by December 2018 and to have a pilot test available in 2019.

Before Lourie, Dyk, and Taranto. Appeal from the  District Court for the District of Delaware.

Summary:  A passing reference in the prior art to a formulation containing the claimed active ingredient and the claimed administration route may not be sufficient to invalidate a claim.

 

Before the Supreme Court. Thomas delivered opinion, joined by Roberts, Kennedy, Ginsburg, Alito, Sotomayor, and Kagan.  Gorsuch dissenting, joined by Breyer.

Summary: Patentee may recover foreign lost profits, where infringer violated § 271(f)(2) by exporting from the United States a component of a patented invention.

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.

Moldex-Metric, Inc. filed a trademark infringement lawsuit against McKeon Products.  Moldex-Metric asserted that McKeon infringed its unregistered trade dress consisting of a bright green color for foam ear plugs by using a similar green color for ear plugs.

Before Prost, Moore, and Stoll.  Appeal from the Patent Trial and Appeal Board.

Summary: An IPR petitioner bears the burden of persuasion concerning the patentability of proposed substitute claims. 

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 ITC has issued a series of new rules applying to all Section 337 investigations instituted after June 7, 2018.  Although the overall impact of these new rules is not yet known, attorneys will find the following four changes of particular interest.

 

On June 1, 2018 the U.S. Patent and Trademark Office designated a Board order in Western Digital Corporation v. SPEX Technologies, Inc. as informative on the issue of Motions to Amend during an IPR.  At the same time, the USPTO de-designated two previously designated orders concerning Motions to Amend.  The Western Digital order provides eight separate areas of guidance for the parties in the event the patent owner elects to file a Motion to Amend.  Some of the information may be familiar to IPR practitioners because of overlap with the de-designated orders, but the Western Digital order importantly incorporates new guidance from recent cases and Board practice.  Thus, IPR litigants should be aware of several important practice changes reflected in the order.

 

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