FDA Airs ‘Concerns’ Over IP Barriers
US Agency’s Patent Concerns Include Thickets, Product Hopping And Evergreening
Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’
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A “lack of co-ordination” between the US FDA and PTO has allowed patent thickets to grow via the granting of flawed patents that do not meet legal requirements, senators Maggie Hassan and Bill Cassidy have complained.
Amgen’s recent study on biosimilars trends has outlined the importance of US policy in the success of the biosimilars marketplace, insisting on the importance of increased competition and effective reimbursement and education policies. But with interests in innovative biologics as well as biosimilars, the company has also emphasized that pro-biosimilars policies must not stifle innovation and compromise free competition.
Samsung Bioepis recently broke new ground with the first US approval for a biosimilar with ophthalmic indications. But, senior vice-president and development division leader Kyung-Ah Kim tells Generics Bulletin, there remains work to be done to ensure that ophthalmic biosimilars can meet their full potential.