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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...

Written by: Brianne M. Kingery & Eric Furman, Ph.D. On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government... Read More »
Promosome LLC, a biotech firm represented by law firm Susman Godfrey, has just filed a patent infringement lawsuits against Moderna... Read More »
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS Before Moore, Lourie, and Dyk.  Appeal from the Patent Trial and Appeal Board... Read More »
The Hatch-Waxman Act, officially known as the Drug Price Competition and Patent Term Restoration Act, revolutionized the pharmaceutical... Read More »
Written by:Matthew Ruth & Philip M. Nelson Going forward, medical device approval will require the device maker to provide... Read More »
In January, we delved into the intricacies of patent litigation in our third annual Patent Litigation Intelligence Report. This comprehensive study ... Read More »
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... 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: Douglas W. Crandell, Ph.D. & Robert J. Hilton, Ph.D. On April 25th, 2023, the U.S. Food and Drug Administration (FDA)... Read More »
Written by:Tom Cowan Brain computer interface developer Paradromics on May 18, 2023, announced a $33 million Series A... Read More »
Written by: Matthew Pham & Daniel P. Hughes OneSubsea IP UK Limited v. FMC Technologies, Inc. Before Clevenger, Moore, and ... Read More »
Written by: Matthew Friedrichs & Daniel P. Hughes MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. Before Moore, Lourie... Read More »
In today's digital landscape, protecting your trademarks has become more challenging than ever before. With the rise of e-commerce... Read More »
In the realm of patent examination, the search for prior art plays a critical role in determining the novelty and inventiveness of an... Read More »
Written by: Sophia Petrichenko & Jason J. Jardine As predictions of an economic recession in the United States loom, 2023 has... Read More »
The recent judgment in Amgen v Sanofi by the United States Supreme Court has generated significant attention within the legal and patent... Read More »
Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning... Read More »
In the world of intellectual property, patents play a vital role in protecting inventions and encouraging innovation. However, disputes... Read More »
The Oncomouse patent stands as a remarkable milestone in the field of biotechnology patents, revolutionizing the way we approach... Read More »
CASE OF THE WEEK Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1981 (Fed. Cir. May 9, 2023)... Read More »
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