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USPTO Enablement Guidelines After Amgen V. Sanofi

On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. The guidelines clarify that the...more

Practical Strategies For Protecting Innovations Under The Doctrine Of Equivalents

Recent case law highlights enablement and written description challenges for genus claims. Given the challenges of enforcing genus claims, the doctrine of equivalents (DOE) may become a more important tool for patentees when...more

Five Questions After Amgen V. Sanofi

The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five...more

USPTO RELEASES 2022‒2026 STRATEGIC PLAN

Last week, the USPTO released its 2022‒2026 Strategic Plan. The Strategic Plan outlines the USPTO’s overarching goals for the coming years. How are these initiatives likely to affect patent applicants and owners?...more

Recent Biden Administration Efforts On Drug Pricing: USPTO Notice Focuses On Eliminating Inconsistencies In USPTO/FDA Statements

On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the...more

Possession Of An "Effective" Dose

When does an applicant have “enough” to file a patent application and be granted a patent? That question continues to dog applicants in the biopharmaceutical industry, particularly in view of recent Federal Circuit...more

Traversing Higher Hurdles For Functional Limitations Under Section 112

Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening...more

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