Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged biotechnology · clear
A new bill introduced in Congress last week may limit the ability of branded pharmaceutical companies to extend the period of exclusivity products beyond the term of a single patent. The bill, titled “Terminating the Extension of Rights…
On April 1, 2019, the Federal Circuit issued a non-precedential decision in Cleveland Clinic Foundation, Cleveland HeartLab, Inc. v. True Health Diagnostics LLC (“ Cleveland Clinic II ”), affirming the district court’s holding that claim…
In Natural Alternatives International, Inc. v. Creative Compounds, LLC . , Appeal No. 2018-1295, a divided panel of the Federal Circuit reversed and remanded a decision by the District Court for the Southern District of California that granted a judgment…
On February 6, 2019, the Federal Circuit decided Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC , affirming a District Court for the District of Massachusetts decision that the claims at issue were patent ineligible for being directed to a…
Federal Circuit Summary On September 10, 2018, the Federal Circuit decided Regents of the University of California v. Broad Institute, Inc. , affirming the Patent Trial and Appeal Board (PTAB)’s determination of no interference-in-fact between the…
On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC , affirming the Patent Trial and Appeal Board (PTAB)’s finding of invalidity of certain claims of seven Orange Book-listed patents for Xyrem®.…
Federal Circuit Summary En Banc (excl. Chen), Opinion for the court filed by Stoll , joined by Newman, Lourie, Moore, O’Malley, Wallach, and Taranto. Appeal from the United States District Court for the Eastern District of Virginia. Summary: 35…
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 (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize generic…
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 cancer. The method comprised isolating cells from the urine of a subject, dispersing at least…
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…
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…
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),…
