PHARMACY

Court grants GSK’s motion against U.S. patent office

BY Drew Buono

WASHINGTON The U.S. District Court for the Eastern District of Virginia has granted GlaxoSmithKline’s motion for a preliminary injunction to stop the U.S. Patent and Trademark Office from enforcing a new final rule on patent claims.

The rule stated that if a patent application contains more than five independent claims or more than 25 total claims, the applicant must provide an examination-support document to the PTO. Also, the rule adjusts the number of continuing applications parties are allowed to file after submitting an initial application.

In the complaint filed By GlaxoSmithKline on Oct. 9, the company stated that the PTO doesn’t have the authority to change the rules because Congress still has not finished passing the Patent Reform Act, which would give the PTO the authority to do so.

GlaxoSmithKline is not the only one who is complaining; Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization also have expressed their objections to the rule by filing permissions to file amicus briefs.

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N.J. Rep. criticizes FDA over weaker antidepressant warnings for children

BY Drew Buono

WASHINGTON Rep. Mike Ferguson, R-N.J., is criticizing the Food and Drug Administration, for its revised antidepressant medication guides because the warnings for children take the medications have been weakened compared to the old guide.

Ferguson said the guides include more generalized information regarding the risks for children, teenagers and young adults taking antidepressants. He also stated that the new guides use a generic warning that combines all three age groups into one category and abbreviates safety information. 

In October 2003, the FDA issued an advisory warning of the increased risk of suicide in pediatric patients taking selective serotonin reuptake inhibitors for depression. After reviewing more data from pediatric studies, the agency told antidepressant manufacturers to revise their product labeling to include the risk of suicide in children and adolescents.

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Herbert Luther appointed Perrigo’s VP of global regulatory affairs

BY Drew Buono

ALLEGAN, Mich. Perrigo has announced that Herbert Luther will become the company’s vice president, global regulatory affairs.

In this role, Luther will be responsible for developing and executing regulatory-submission strategies, ensuring best practices, and implementing technologies to enhance efficiency.

Luther has over 20 years experience in the development of regulatory and clinical strategies. Before joining Perrigo, he worked at KV Pharmaceuticals, where he was vice president of regulatory/clinical affairs. Before that, he served as director of regulatory affairs at Barr Laboratories.

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