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The Interplay between Regulatory Exclusivities and Patent Litigation under the Hatch-Waxman Act

The Hatch-Waxman Act, officially known as the Drug Price Competition and Patent Term Restoration Act, revolutionized the pharmaceutical industry by balancing the interests of...

Objective Evidence in Determining Obviousness

MEDTRONIC, INC. v. TELEFLEX INNOVATIONS Before Moore, Lourie, and Dyk.  Appeal from the Patent Trial and Appeal Board. Summary: A close prima facie case of obviousness can be...

FDA Updates Cybersecurity Guidance

Written by:Matthew Ruth & Philip M. Nelson Going forward, medical device approval will require the device maker to provide cybersecurity information to the...

Patexia Insight 179: Best Patent Litigators of 2023: A Fusion of Analytics and Peer Reviews

In January, we delved into the intricacies of patent litigation in our third annual Patent Litigation Intelligence Report. This comprehensive study spanned five years, from July 1...

Fresh From the Bench: Latest Precedential Patent Case

CASE OF THE WEEK Medtronic, Inc. et al. v. Teleflex Innovations S.A.R.L., Appeal Nos. 2021-2356, -2358, -2361, -2363, and -2365 (Fed. Cir. May 24, 2023) In this week’s Case of...

ANDA Litigation: Navigating the Complexities of Patents and Generic Drug Approvals

In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market entry of generic drugs. However, the intersection...

FDA Approves Qalsody™ for Treatment of ALS

Written by: Douglas W. Crandell, Ph.D. & Robert J. Hilton, Ph.D. On April 25th, 2023, the U.S. Food and Drug Administration (FDA) approved QalsodyTM (tofersen) for the...

Feed tagged as "fda":
Written by:Matthew Ruth & Philip M. Nelson Going forward, medical device approval will require the device maker to provide... Read More »
In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market... Read More »
Written by: Raina Patel The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled ... Read More »
Written by: Alistair J. McIntyre The FDA recently announced release of final transition guidance documents for... Read More »
Written by: Paige L. Cappelli The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of... Read More »
Comments
Allen EhrlichAs an expert in medical devices, the FDA needs additional funding to speed up the timeline for approval of new innovative products. Hoping that Congress will approve this budget.
Mar 21, 2023
Written by: Nima Zargari, Ph.D. On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of... Read More »
Written by: Albert J. Sueiras Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve... Read More »
EndoStim announced on October 25th that the FDA granted a breakthrough device designation for the company’s implantable... Read More »
In late August, we published our third annual ANDA Litigation Intelligence Report, covering important statistics and evaluating all stakeholders in ... Read More »
On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures ... Read More »
On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical... Read More »
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes ... Read More »
Less than two months ago, Curevac filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech over patent... Read More »
  Small molecule drugs have been the norm for much of medicine’s history. Only in the past decade has there been a rise ... Read More »
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s... Read More »
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices... Read More »
Medtronic recently announced that it received clearance from the FDA and CE Mark approval for its LINQ II insertable cardiac monitor (ICM). The announcement notes... Read More »
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special”... Read More »
Last year, in a lengthy split decision, a Fed. Cir. panel affirmed the district court’s ruling that four “add-on” patents that Acorda owned were... Read More »
On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Food Safety and Inspection Service (FSIS) announced a formal agreement, in the form of a... Read More »
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