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FDA Publishes Draft Medical Device Cybersecurity Guidance Amidst Continued Cybersecurity Concerns

On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality...

Feed tagged as "sovereign immunity":
Gensetix, Inc. v. Baylor College of Medicine Before Newman, O’Malley, and Taranto. Appeal from the U.S. District Court for the Southern District of Texas. ... Read More »
GENETIC VETERINARY SCIENCES v. LABOKLIN GMBH & CO. KG Before Wallach, Hughes, and Stoll.  Appeal from the Eastern District of Virginia... Read More »
REGENTS OF THE UNIV. OF MINN. v. LSI CORPORATION Before Dyk, Wallach, and Hughes.  Appeal from the Patent Trial and Appeal Board. Summary: State... Read More »
  Federal Circuit Summary   Before Prost, Moore, and Wallach.  Appeal from the Northern District of Florida. Summary: When a... Read More »
The University of Minnesota (UMinn) and Toyota Motor Corp. (Toyota) co-own U.S. Patent 8,394,618 (the ’618 patent).  After Reactive Surfaces Ltd. filed a... Read More »
Preserving Access to Cost Effective Drugs (PACED) Act Senator Tom Cotton (R-Arkansas) and Senator Claire McCaskill (D-Missouri) along with Senators Pat Toomey... Read More »
Federal Statutes Applicable to Tribes Absent Expression to the Contrary In addition to the state sovereign immunity dispute now headed to the Federal Circuit, you ... Read More »
Federal Circuit to Consider PTAB Sovereign Immunity Defense State-affiliated entities enjoy immunity from suit in federal courts under the 11th amendment. To... Read More »
Jayendra DabhiThe PTAB find that the tribe doesn’t have sovereign immunity in this case. The PTAB said “In view of the recognized differences between the state sovereign immunity and tribal immunity doctrines, and the lack of statutory authority or controlling precedent for the specific issue before us, we decline the tribe’s invitation to hold for the first time that the doctrine of tribal immunity should be applied in IPR proceedings”The PTAB determined that the proceedings could continue without the tribe’s participation in view of “Allergan’s retained ownership interests in the challenged patents”. Based on the terms of the license between Allergan and the tribe, the licensee transferred “all substantial rights” in the challenged patents back to Allergan, so the proceedings can continue with Allergan as the patent owner. According to the PTAB, based on the record before it, the tribe has not retained anything more than an “illusory or superficial right” to sue for infringement of the challenged patents.The Patent Trial and Appeal Board PTAB determined that the Saint Regis Mohawk Tribe failed to establish the doctrine of tribal sovereign immunity.
Mar 1, 2018
Infringement Action Waives PTAB Immunity State-affiliated entities enjoy immunity from suit in federal courts under the 11th amendment. To date, a handful of such ... Read More »
Tribal Immunity Considered by PTAB Previously I explained that the 7th amendment argument in Oil States and the 11th amendment argument for sovereign immunity... Read More »
EXECUTIVE SUMMARY: When the America Invents Act was passed in 2011, most of us saw the inter partes review process as a streamlined, relatively inexpensive procedure... Read More »
Written by Peter Law and Kerry Taylor, Ph.D. The PTAB has again addressed sovereign immunity in the context of an IPR.  Reactive Surfaces, LTD. petitioned... Read More »
Written by Peter Law and Kerry S. Taylor, Ph.D. On May 23, 2017, the PTAB granted the University of Maryland’s (UM) motion to terminate inter partes review... Read More »
Written by Peter Law and Kerry S. Taylor, Ph.D. On January 25, 2017, a panel of the Patent Trial and Appeal Board (PTAB) held that “Eleventh Amendment... Read More »