Smeal Business Casual Post on Pay-for-Delay
I wrote a short post about the demise of the "pay-for-delay" prohibition in the final health care bill amendments that appeared in today's Business Casual Blog on the Smeal Website. Rather than repost it here, I thought it better to simply provide the link.
Speaking of the health care bill, one intellectual property part that did make it in is the new pathway for approving generic biologic drugs, or "biosimilars" (see report from Patent Docs). That's a pretty significant move, as there is currently no abbreviated mechanism for approving generic biologic treatments similar to the Hatch-Waxman Act for drugs. Notably, the term for relating the generic biologic compound to the innovator application is "biosimilar," which is different than the "bioequivalence" standard for drugs.
Speaking of the health care bill, one intellectual property part that did make it in is the new pathway for approving generic biologic drugs, or "biosimilars" (see report from Patent Docs). That's a pretty significant move, as there is currently no abbreviated mechanism for approving generic biologic treatments similar to the Hatch-Waxman Act for drugs. Notably, the term for relating the generic biologic compound to the innovator application is "biosimilar," which is different than the "bioequivalence" standard for drugs.
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About the Author
Dan Cahoy is Associate Professor of Business Law at Penn State's Smeal College of Business and Affiliate Professor of Law at the Dickinson School of Law . He is also a registered patent attorney. For more information, take a look at Dan's CV, Web bio or Research Page.
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