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MDMA Submits Comments on FDA and Patent Issues

Thursday, April 24, 2014  
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MDMA submitted two sets of comments this week to the United States Patent and Trademark Office (USPTO) as well as the Office of Management and Budget (OMB). Our comments to James Engel, Senior Legal Advisor in the Office of Patent Legal Administration within the Deputy Commissioner for Patent Examination Policy's Office at USPTO were in regard to USPTO's Notice of Proposed Rulemaking, Proposing Changes to Require Identification of Attributable Ownership. Our comments to OMB were in regards to FDA's proposed revisions to regulations and other reclassification and classification provisions that FDA posted in a March 25, 2014 Federal Register announcement.

 

In our comments to USPTO, MDMA expressed concern over proposed changes that would require identification of attributable ownership, which would be extremely costly and burdensome for innovative and entrepreneurial medical technology companies. Our comments once again reaffirmed MDMA's position on patent reform, which is supportive of efforts to curb abusive practices of patent assertion entities (PAEs) or "patent trolls" but not while making it more costly and burdensome for innovators when defending or asserting their intellectual property rights.

 

In our comments to OMB, MDMA requested that OMB disapprove the proposed collection of information until FDA provides a fulsome review of all the information likely to be collected based upon the proposed rule. MDMA will be developing further comments to submit to FDA raising concerns about the proposed reclassification and classification changes. 

 

MDMA's comments to USPTO can be viewed by clicking here.  MDMA's comments to OMB can be viewed by clicking here.