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Regulatory Due Diligence Becomes More Critical in a “Hot” Year for Deals in the FDA Space

FDA Law Blog

If this all holds true, it will follow the upward trend of the 2023 year in deals. In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity. Not every diligence issue is a dealbreaker.

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New issue alert: RabelsZ 87 (2023), Issue 3

Conflict of Laws

An Ontology of the In-Between [18th Ernst Rabel Lecture, 2022] [OPEN ACCESS], 433–464, DOI: 10.1628/rabelsz-2023-0063 The conflict of laws can serve heuristically to underscore two established but radically opposing models of modernist legal ordering: multilateralism and statutism.

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Giustizia consensuale No 2/2023: Abstracts

Conflict of Laws

The second issue of 2023 of Giustizia consensuale (published by Editoriale Scientifica) has just been released, and it features: Giuseppe Trisorio Liuzzi (Professor at the Università degli Studi di Bari “Aldo Moro”), La composizione negoziata. 222 of December 21, 2023, and No. Another book review is by Angela M.

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Patent Continuation Strategies Face Major Threat

Patently O

Google LLC , 20-06754 WHA, 2023 WL 6542320 (N.D. 6, 2023). In Sonos , Judge Alsup found Sonos’s patents unenforceable due to prosecution laches, despite Sonos diligently prosecuting related applications for 13 years; serially filing a continuation with each allowance. Google LLC , 20-06754 WHA, 2023 WL 6542320 (N.D.

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Skilled Searcher Test Allows Estoppel for Unknown References

Patently O

3, 2023) The recent decision in Ironburg Inventions Ltd. The court also addressed the burden of proof in estoppel cases, with the Federal Circuit holding that it lies with the party seeking the estoppel — a ruling that aligns with traditional practice and the best reading of the statute. by Dennis Crouch Ironburg Inventions Ltd.

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Timeliness in Supreme Court Practice

Patently O

It is not enough to simply assert that the issues at stake are important; even well known counsel must demonstrate that they have been diligent in their efforts to comply with the Court’s procedures. Ironically, the underlying Federal Circuit decision that Purdue sought to challenge, Purdue Pharma L.P. Collegium Pharmaceutical, Inc.,

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SCOTUS Issues First Opinion of the Term

Constitutional Law Reporter

Supreme Court issued its first opinion of the 2022-2023 Term. S. _ (2023), a unanimous Court held that the effective date of an award of service-related disability compensation to a veteran of the United States military determined pursuant to 38 U.S.C. §§ 5110(a)(1) and 5110(b)(1) is not subject to equitable tolling. In Arellano v.

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