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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Specifically, the Court focused on the purpose: to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications. The question is important because the result of that determination could drastically reduce the amount of patent term to be restored.

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ACI’s 23rd Advanced Summit on Life Sciences Patents

FDA Law Blog: Biosimilars

Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institutes 23rd Advanced Summit on Life Sciences Patents , which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, NY. Hyman, Phelps & McNamara, P.C.s

Science 59
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ACI’s 21st Annual Paragraph IV Disputes

FDA Law Blog: Biosimilars

PTOs PTAB, the FTC, and the FDA, to tackle the critical legal, regulatory, and business issues shaping pharmaceutical patent litigation. Raimondo Exploring the On-Sale Bar and Applicability of Prior Art Orange Book Delisting Attempts Navigating ODP and Patent Family Dynamics Hyman, Phelps & McNamara, P.C.s

FDA 59
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Drug Patent Research: Expert Tips for Using the FDA Orange and Purple Books

Drug Patent Watch

"Unlocking the Secrets of the FDA's Orange and Purple Books: Insider Tips from a Drug Patent Research Expert As the pharmaceutical industry continues to evolve at breakneck speed, staying ahead of the curve requires more than just a keen eye for innovation it demands a deep understanding of the regulatory landscape.

FDA 80
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FTC Continues to Rage Against Device Patent Listings in the Orange Book

FDA Law Blog: Biosimilars

Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed. For the second time in recent years, the FTC has filed an Amicus Brief explaining exactly which patents should not be in the Orange Book.

FDA 59
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A New Book on Hatch-Waxman – Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer

FDA Law Blog: Biosimilars

Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “ Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? ” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released (..)

Drugs 59
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HP&M Seeks Attorney with Significant Experience in Government Discount Programs and Price Reporting

FDA Law Blog: Biosimilars

The ideal candidate will have a book of business. Our firm culture is collaborative, and the subject matter is intellectually stimulating. Strong verbal and writing skills are required. Partner/director, counsel and senior associate level attorneys with the requisite substantive experience are encouraged to apply.