je.st

Home › petition

Tag: petition

Toward a Bullet-Proof Petition - Motivation to Combine

2015-04-14 21:57:01| Semiconductors - Topix.net

While 8 out of 10 Petitions seeking inter partes review are granted by the PTAB, there remain several key errors that unsuccessful Petitioners make. Among them is the failure to provide sufficient factual basis for a rationale to combine prior art references in an obviousness analysis.

Tags: to combine motivation petition

FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements

2015-04-03 07:01:53| Biotech - Topix.net

Late last week, the U.S. Food and Drug Agency dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their application and information on their manufacturing processes. At issue is the meaning of the term " shall " and whether the information-sharing and advance-notice provisions of the Biologics Price Competition and Innovation Act that a biosimilar applicant "shall providea copy of the application submitted [to FDA]and such other information that describes process or processes used to manufacture the biological product" is a mandatory requirement or an optional action for the biosimilar applicant.

Tags: requirements citizen applicant petition

Petition: Weekend L Train Shutdowns Will Be Detrimental To Brooklyn Businesses

2015-03-25 04:37:12| Railroads - Topix.net

Commuters at the Bedford Avenue subway station onboard a crowded L Train December 22, 2014. NEW YORK - Some Brooklyn residents have launched a petition calling on the Metropolitan Transportation Authority to cancel plans to shut down the L Train for five weekends in April and May. The MTA plans to shut down the L Train between the terminal at Eighth Avenue and 14th Street in Manhattan, and the Lorimer Street stop in Williamsburg, Brooklyn, for five straight weekends between April 11 and May 18, according to the MTA and published reports.

Tags: businesses weekend train brooklyn

Four indicted in petition fraud

2015-03-23 21:15:41| Grocery - Topix.net

Four Columbus residents were indicted Friday, March 20, in Union County on voter fraud charges stemming from a proposed Kroger liquor option on the November ballot. Charged with election falsification and forgery are: Christiana N. Holloway, of Miller Avenue; Michael H. Johnson, of Kilbourne Run Place; Champayne L. Thompson, of Howey Road; and David H. Winecoff, of West Long Street.

Tags: fraud petition indicted