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Archive for the ‘Pharmaceuticals’ Category

Federal Circuit Holds That Later-Developed Alternative Manufacturing Processes May Be “Patentably Distinct” from Their Related Products By Tyler Lacey – Edited by Evan Kubota Takeda Pharmaceutical Co. v. Doll, April 10, 2009, No. 2008-1131 Opinion On April 10th, the United States Court of Appeals for the Federal Circuit vacated and remanded the decision of the United States District Court for the District of Columbia, holding that manufacturing processes developed after a product is patented may be “patentably distinct” from their ... Read More...
Posted On Apr - 18 - 2009 Comments Off READ FULL POST
Federal Circuit Grants U.S. Patent and Trademarks Office Power to Limit Patent Applications By Sharona Hakimi – Edited by Caitlyn Ross Tafas v. Doll Federal Circuit, March 20, 2009, No. 2008-1352 Opinion On March 20th, the Federal Circuit affirmed in part and vacated in part a decision by the United States District Court for the Eastern District of Virginia in a suit that challenged rules proposed by the U.S. Patent and Trademarks Office (USPTO). Tafas, the plaintiff, contested the USPTO’s ... Read More...
Posted On Apr - 3 - 2009 Comments Off READ FULL POST
By Sarah Sorscher*, JD/MPH Candidate, Harvard Law School & Sara Crager, MD/PhD Candidate, Yale Editorial Policy Text of H.R. 1427 Summary Last week, Rep. Henry Waxman and several other representatives unveiled the latest version of a bill designed to lower the price of drugs by encouraging generic competition in biological products (“biologics”). Biologics are products derived from living processes and used to prevent, treat, or cure human illness. Most drugs, in contrast, are synthesized using chemical reactions.  Biologics include products such as vaccines, blood-derived products, antibodies, ... Read More...
Posted On Mar - 19 - 2009 Comments Off READ FULL POST
Supreme Court Holds that FDA Regulation Does Not Preempt State Tort Claim By Caitlyn Ross – Edited by Miriam Weiler Wyeth v. Levine Supreme Court of the United States, March 4, 2009, No. 06-1249 Slip Opinion On March 4th, the Supreme Court of the United States affirmed the judgment of the Vermont Supreme Court, holding that federal drug labeling regulations do not preempt state failure-to-warn lawsuits.  The Supreme Court held that compliance with FDA labeling requirements did not preempt Levine’s ... Read More...
Posted On Mar - 9 - 2009 Comments Off READ FULL POST
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