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The (Re-) Emergence of the Age of Enablement: Amgen v. Sanofi On May 18, 2023, biotech innovation suffered at least a temporary setback in Amgen v Sanofi in which a unanimous Supreme Court affirmed the rulings of the district court and the Court of Appeals for the Federal Circuit holding that Amgen’s challenged patent …
The (Re-) Emergence of the Age of Enablement: Amgen v. Sanofi Read More »
The (Re-) Emergence of the Age of Enablement: Amgen v. Sanofi On May 18, 2023, biotech innovation suffered at least a temporary setback in Amgen v Sanofi in which a unanimous Supreme Court affirmed the rulings of the district court and the Court of Appeals for the Federal Circuit holding that Amgen’s challenged patent …
The (Re-) Emergence of the Age of Enablement: Amgen v. Sanofi Read More »
Tackling Go-To-Market Challenges The medical device industry is amid an era of unprecedented regulatory complexity. Every 22 minutes, a new or updated regulatory requirement is issued somewhere in the world. All told, this amounts to 22,000 new or updated regulations every year, and it has led to a 150% increase in regulatory mandates over …
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