Phil Hamzik

Phil Hamzik assists the Pharmaceutical Group in patent prosecution. He has extensive knowledge in the areas of organic and medicinal chemistry.

Recent Posts

Proving Them Wrong: FDA Skepticism Helps Save Patent Claims

Posted by Phil Hamzik on Jan 17, 2018

Phil Hamzik

Evidence of skepticism of others in an IPR can be used to support the patentability of claims in response to obviousness challenges—skepticism is a standard “objective indicia” or secondary consideration of nonobviousness. In a recent series of IPRs filed by several generic drug makers against Eli Lilly & Co. (IPR2016-00318, IPR2016-00237 and IPR2016-00240), Eli Lilly bolstered its case for nonobviousness by pointing to the skepticism of the U.S. Food & Drug Administration (FDA) concerning its patented method. The PTAB’s decision illustrates that while skepticism by some may be helpful to patent owners, skepticism by the right people may be critical.

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Topics: BioPharma, Obviousness

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