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Biosimilars: draft guidance documents issued by FDA

USA - February 14 2012 The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 as part of the Patient Protection and Affordable Care Act of 2010....

Jeffrey A. Wolfson.

Accelerated patent examination plan extended

USA - June 28 2010 Most patent applicants can now accelerate the examination of a select number of patent applications in exchange for abandoning an equal number of unexamined, pending applications, according to an announcement issued by the US Patent and Trademark Office ("PTO") on June 24, 2010....

PTO seeking rulemaking authority despite rescinding proposed claims and continuation rules

USA - October 12 2009 The U.S. Patent and Trademark Office (“PTO”) has announced that the director has signed a Final Rule, which has not yet been published, that rescinds the hotly contested proposed claims and continuation rules....

Jeffrey A. Wolfson.