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Update on Qualified Small Business Stock: New Federal Legislation and Status of California Rules
Peter J. Elias,Babak Emil Nikravesh,Roburt J. Waldow, March 14, 2013
Eligible investors in qualified small businesses are entitled to certain tax benefits that, with recent federal legislative changes, have become more attractive. Under a special provision of the Internal Revenue Code, certain holders of "qualified small business stock" ("QSBS")...

European Medicines Agency Jeopardizes Investments in Drug Development
Jonathan Berman,Brian J. Forsatz Ph.D.,Christian B. Fulda,Mark D. Kafka,Yasunobu Takatama, December 28, 2012
The heart of a marketing authorization application ("MAA") is the pre-clinical and clinical data that proves the drug's safety and efficacy. This data is collected through substantial investments in time and money. The current and proposed policies of the European Medicines Agency...

The Safe Harbor for FDA Submissions Expands: Did the Federal Circuit Reverse Course?
Jonathan Berman,Anthony M. Insogna, September 3, 2012
Section 271(e)(1) of the patent code, known as the “safe harbor” provision, immunizes from infringement suits various acts that are undertaken in order to submit information to the Food and Drug Administration (“FDA”). The scope of these various acts and thus of the safe...

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