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Senate Seeks to Reduce Biosimilar Prices by “Pruning” “Patent Thickets”

On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more

USPTO Says Wands Still Controls Enablement Analysis Post-Amgen

On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et...more

Recent Update on Patent Trial Practice Guide

The United States Patent and Trademark Office (USPTO) published an update to the AIA Trial Practice Guide (‘‘Trial Practice Guide’’) in August 2018 to revise guidance on practices before the Patent Trial and Appeal Board...more

Bayh-Dole Act Revisions

On May 14, 2018, several important revisions to regulations of the Bayh-Dole Act (University and Small Business Patent Procedure Act of 1980, codified as 35 U.S.C. § 200) went into effect. The final revisions were published...more

Cannabis Considerations: Protecting your Cannabis Innovation

Introduction – Is Patenting Cannabis Legal? Early protection of intellectual property is a critical component in any business’s efforts to secure a competitive advantage in the marketplace. In the cannabis space, efforts...more

Sovereign Immunity and Inter Partes Review

Sovereign immunity refers to the doctrine that the government cannot be sued without its consent. Specifically, the 11th Amendment precludes federal courts from exercising jurisdiction over states in suits brought by private...more

Doctrine of Equivalents under Enzo Biochem Inc. v. Applera Corp.

Before Prost, O’Malley, and Wallach. Appeal from the District of Connecticut (nonprecedential). On August 2, 2017, the Federal Circuit affirmed a decision by the U.S. District Court for the District of Connecticut granting...more

In Helsinn Healthcare, the Federal Circuit Offers Guidance on the On-Sale Bar under the AIA

The sale of a product prior to filing a patent application, or “on-sale bar,” has long been a potential barrier to obtaining a patent in the United States. Especially in the biotechnology space, which can involve a long...more

Biotechnology Considerations for the Unitary Patent System in Light of Brexit and Other Current Developments

Written by Daniel A. Kamkar and Eric Furman, Ph.D. After the United Kingdom voted to leave the European Union, dubbed “Brexit” by the press, many have called into question whether the UK would ratify the Unitary Patent...more

Continental patents a la carte or prix fixe? Biotechnology considerations for the unitary patent in Europe

Unitary patents in Europe - The European unitary patent and Unitary Patent Court (UPC) are slated to go into effect in early 2017. These monumental changes will have a significant impact on the ways patent rights are...more

Federal Circuit Finds Life Sciences Subject Matter Patent Eligible

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion vacating the summary judgment of invalidity of U.S. Patent No. 7,604,929 (“the ’929 Patent”) and sent the case back to the District Court...more

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