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WannaCry Ransomware Alert

This is not a drill. Companies and law enforcement agencies around the world have been left scrambling after the world’s most prolific ransomware attack hit over 500,000 computers in 150 countries over a span of only 4 days. The ransomware – called WannaCry, WCry, WannaCrypt, or WannaDecryptor – infects vulnerable computers and encrypts all of … Continue Reading

PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative:… Continue Reading

Mandatory Debarment for FCPA Violations? A Bad Idea Whose Time Should Never Come

By Mike Emmick In the fervor of the U.S.’s current anti-foreign-corruption efforts, a particularly misguided proposal has occasionally reared its ugly head: Requiring “mandatory debarment” for any company that violates the Foreign Corrupt Practices Act (“FCPA”). On the merits, such a proposal is completely wrong-headed. Debarment is a severe, forward-looking administrative remedy – the corporate … Continue Reading

The Uncomfortable Resurgence of the Responsible Corporate Officer Doctrine

By Mike Emmick and Joseph Barton Corporate executives in the health care and environmental industries are rapidly coming to appreciate the implications of the responsible corporate officer doctrine, a recently-revitalized weapon in U.S. Department of Justice’s battle against corporate crime. This doctrine is a peculiar exception to the usual requirements for a criminal prosecution. Ordinarily, … Continue Reading

The FCPA in 2011: Five Answers and a Looming Question

The Department of Justice has been warning the Life Sciences industries – pharmaceutical and medical device companies – of its intent to focus "on the application of the Foreign Corrupt Practices Act" ("FCPA") on the pharmaceutical and related industries. (Lanny Breuer, Assistant U.S. Attorney for the Criminal Division, November 12, 2009). The FCPA prohibits, among … Continue Reading

Safe-Harbor Provision of Hatch-Waxman Act Does Not Protect Post-Approval Research Activities

By Gray Buccigross The Federal Circuit issued its opinion in Classen Immunotherapies, Inc. v. Biogen Idec, 2011 U.S. App. Lexis 18126, on August 31, 2011. As part of that decision it held that the safe-harbor provision of the Hatch-Waxman Act is limited to activities reasonably related to obtaining pre-marketing FDA approval of generic counterparts, and … Continue Reading
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