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HTMLFDA Memorandum Outlines Significant Overhaul of Inspection and Compliance Processes
Jonathan Berman, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
February 24, 2014, previously published on February 2014
In an internal memorandum to FDA leadership, Commissioner Margaret Hamburg "chart[s] the course for modifying Agency functions and processes to improve communication and collaboration and to clarify roles and responsibilities and decision rights across all Agency components."

 

HTMLFDA Issues Final Rule and Guidance on Electronic MDR Reporting
Allyson B. Mullen; Hyman Phelps McNamara P.C.;
Legal Alert/Article
February 24, 2014, previously published on February 19, 2014
On February 14, 2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). 79 Fed. Reg. 8832 (Feb. 14, 2014). The Final Rule does not materially...

 

HTMLConsiderations If Conceding Infringement Or Designing Around
Rebecca J. Pirozzolo-Mellowes; Foley & Lardner LLP;
Legal Alert/Article
February 19, 2014, previously published on February 18, 2014
A decision issued by the Federal Circuit earlier this year raises a few things to have in mind when considering whether to concede infringement and when planning to design around a patent.

 

HTMLStem Cells Grown in Lab Prior to Clinical Use as Transplantation Product Are Biological Drugs Subject to FDA Rules
Colleen K. O'Brien; Semmes, Bowen & Semmes A Professional Corporation;
Legal Alert/Article
February 18, 2014, previously published on February 2014
In this civil enforcement action, the U.S. Court of Appeals for the District of Columbia Circuit decided whether Defendants, Regenerative Sciences and three (3) individuals (collectively Regenerative Sciences), violated the Federal Food, Drug & Cosmetic Act (FDCA), 21 U.S.C. § 301, et...

 

HTMLFDA Releases Final eMDR Rule and Deadline for Compliance
Joseph Hammang, Daniel J. Herling; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
February 17, 2014, previously published on February 13, 2014
The Food and Drug Administration (FDA) announced and is promulgating today the Final Rule on Electronic Medical Device Reporting (eMDR). Originally proposed in 2009, the rule is now final and a deadline for compliance has been identified. The rule impacts device manufacturers and importers and...

 

HTMLW.Va. Doesn't Understand The Scientific Method: Part 1
David A. Oliver; Vorys, Sater, Seymour and Pease LLP;
Legal Alert/Article
February 17, 2014, previously published on February 13, 2014
Milward v. Acuity has spawned another troubling anti-science opinion: Harris v. CSX Transportation Inc.Whereas Milward held that credentialed wise men should be allowed to testify that an effect that has never been observed (indeed one that could not be detected by any analytical method known to...

 

HTMLFederal Circuit Upholds Lyrica Patents
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
February 12, 2014, previously published on February 11, 2014
In a non-precedential decision issued February 6, 2014, the Federal Circuit affirmed a district court decision that upheld the four Orange Book listed patents for Pfizer’s Lyrica® product. According to the court’s rules, the non-precedential designation of Pfizer Inc. v. Teva...

 

HTMLComputer-Aided Selection Method Fails Patent-Eligibility
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
February 11, 2014, previously published on February 10, 2014
In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and rule-application processes to select a treatment for a patient fails...

 

HTMLFederal Circuit Holds Computer-Implemented Method Claims Invalid Under Section 101
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
February 11, 2014, previously published on February 4, 2014
Although SmartGene, Inc. v. Advanced Biological Laboratories, SA is a non-precedential Federal Circuit decision, it could be interesting for that very reason, if it is a reflection of what the court sees as settled aspects of patent eligibility jurisprudence. Viewed in that light, this case could...

 

HTMLDo These Sequence Analysis Method Patents Satisfy Section 101?
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
February 11, 2014, previously published on February 7, 2014
According to an article on Law360, Bristol-Myers Squibb Co. is challenging the validity of two Genetic Technologies Ltd. patents on the basis that the claimed intron sequence analysis methods recite natural phenomena that do not satisfy the patent-eligibility requirements of 35 USC § 101. This...

 


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