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HTMLSplit Federal Circuit Decision Revives Antitrust Counterclaims in Patent Litigation
Michelle K. Fischer, Kevin D. McDonald, Geoffrey D. Oliver; Jones Day;
Legal Alert/Article
August 21, 2014, previously published on August 2014
The U.S. Court of Appeals for the Federal Circuit has remanded for further consideration antitrust claims accusing a patent holder of filing a sham infringement suit and a sham citizen petition with the Federal Drug Administration. The case is Tyco Healthcare Group LP v. Mutual Pharmaceutical Co....

 

HTMLFDA Issues Draft Guidance on Determination of Reference Product Exclusivity for Biologics
Colleen Heisey, Mark Mansour, Christopher M. Mikson; Jones Day;
Legal Alert/Article
August 12, 2014, previously published on August 2014
On August 4, the U.S. Food & Drug Administration ("FDA") issued a draft guidance titled "Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act." The draft guidance is intended to assist biological product sponsors and applicants in...

 

Adobe PDFAmending Claims During Inter Partes Review: Patent Practitioners Beware
Jaime D. Choi, David B. Cochran, John A. Marlott, Peter G. Thurlow; Jones Day;
Legal Alert/Article
August 11, 2014, previously published on August 2014
Although patent owners are theoretically allowed to amend patent claims during an inter partes review ("IPR") proceeding at the U.S. Patent and Trademark Ofiice ("USPTO"), in all of the proposed claim amendments submitted thus far, only one amendment has been allowed by the...

 

HTMLLegislators and Groups Urge FDA to Require Sex-Specific Data, Labeling in New Action Plan
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
Members of Congress and interest groups are pressuring FDA to promote sex-specific clinical research and product labeling, as the Agency develops an action plan to address deficiencies in the way industry collects, analyzes, and communicates demographic data.

 

HTMLFDA Accepts First Application for Biosimilar Product
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
In a significant step for generic biologic products, FDA accepted for review the first application for a biosimilar product. If approved, it could be the first biosimilar product to enter the U.S. market under the nearly five-year-old Biologics Price Competition and Innovation Act...

 

HTMLFDA Using Big Data Methods to Discover Drug Risks, Provide Access to Recall Information
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
Through recently deployed initiatives, FDA is taking advantage of new data systems to gather and assess drug risk data and promote easier public access to adverse event and recall information. The two projects, Mini-Sentinel and open FDA, offer greater efficiencies than existing methods, such as...

 

HTMLBackoff Point-of-Sale Malware: Here We Go Again
Richard J. Johnson, Mauricio F. Paez; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on August 2014
The Secret Service, the National Cybersecurity and Communications Integration Center, and others announced yesterday in a US-CERT Alert (available at www.us-cert.gov/ncas/alerts/TA14-212A) that recent investigations have revealed the use by malicious actors of malware—dubbed Backoff...

 

HTMLD.C. Circuit Holds that CFIUS Must Provide Due Process Before Prohibiting a Transaction
Giovanna M. Cinelli, Chad O. Dorr, Noel J. Francisco, Bevin M.B. Newman, Kenneth J. Nunnenkamp; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
The U.S. Court of Appeals for the D.C. Circuit has issued a landmark opinion granting due process rights to parties whose transactions have been blocked or suspended by the President of the United States following a national security review and investigation by the Committee on Foreign Investment...

 

HTMLClient Clearing: An ISDA/FBF Initiative for the French Market
Alban Caillemer du Ferrage, Karole-Anne Sauvet; Jones Day;
Legal Alert/Article
August 4, 2014, previously published on August 2014
The International Swaps and Derivatives Association ("ISDA") and the French Banking Federation ("FBF") just released the French Law Annex to the ISDA/FOA Client Cleared OTC Derivatives Addendum.

 

HTMLLaw Firm Investigative Reports No Longer Confidential?
Adam Salter; Jones Day;
Legal Alert/Article
August 1, 2014, previously published on July 2014
Justice Whelan of the Federal Court has held that an investigatory report into the conduct of an employee is not covered by client legal privilege. Accordingly, it may be disclosed to the subject of the report.

 


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