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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...

 

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...

 

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In a non-precedential decision issued February 6, 2014, the Federal Circuit affirmed a district court decision that upheld the four Orange Book listed patents for Pfizer’s Lyrica®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 According to the court’s rules, the non-precedential designation of Pfizer Inc. v. Teva...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...

 

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...

 

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...

 

HTMLD.C. Circuit Rules That FDA Can Regulate Autologous Stem Cells
William T. Koustas; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
February 10, 2014, previously published on February 5, 2014
The litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA may have come to an end on Tuesday, February 4th, when the United States Court of Appeals for the District of Columbia Circuit ruled against Regenerative, concluding that FDA has the authority to regulate certain...

 

HTMLBroken Economic Incentives Require New Business Models for Antibiotics, Says CDC Antimicrobial Resistance Working Group Member
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
February 10, 2014, previously published on February 3, 2014
In a new paper published by The Petrie-Flom Center for Health Law Policy, BioTechnology, and BioEthics at Harvard Law School, and presented at a February 3, 2014 Health Law Workshop, Kevin Outterson, a Professor of Law at Boston University and member of the U.S. Centers for Disease Control and...

 

HTMLALJ Pender Denies Motion To Amend The Priority Date In Certain Sleep-Disordered Breathing Treatment Systems (337-TA-890)
Eric W. Schweibenz, Thomas C. Yebernetsky; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
February 7, 2014, previously published on February 5, 2014
On February 4, 2014, ALJ Thomas B. Pender issued the public version of Order No. 10 (dated January 24, 2014) in Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof (Inv. No. 337-TA-890).

 

Adobe PDFFDA Publishes New Guidance on Letters from Manufacturers to Health Care Providers
Igor Gorlach, Paul T. Kim; Foley Hoag LLP;
Legal Alert/Article
February 7, 2014, previously published on January 29, 2014
The Food and Drug Administration (FDA) issued a new guidance document on Dear Health Care Provider (DHCP) letters, titled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” DHCP letters are correspondence from a manufacturer or distributor to...

 


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