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Pfizer Accuses J&J of Anticompetitive Business Practices over Remicade Biosimilar

In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, Celltrion’s partner Pfizer has filed a suit against...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

FDA re-approves Mylotarg® antibody-drug conjugate seven years after it had been withdrawn from the market

Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more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 Appeal from the District of Connecticut (nonprecedential).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

Ranbaxy and AstraZeneca Prevail in Nexium® Pay-For-Delay Case

On November 21, 2016, the U.S. Court of Appeals for the First Circuit upheld a 2014 jury verdict for AstraZeneca (AZ) and Ranbaxy regarding a 2012 payment of $700 million from AstraZeneca for Ranbaxy to abandon its challenge...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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