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HTMLUnited States and PTO Invited to Stem Cell Party
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
December 12, 2013, previously published on December 8, 2013
Last week Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) squared off at the Federal Circuit over CW’s appeal of the inter partes reexamination of WARF’s U.S. Patent No. 7,029,913 (the ’913 Patent, entitled “Primate...

 

HTMLFDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants
Duane Morris LLP;
Legal Alert/Article
December 11, 2013, previously published on December 6, 2013
On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, the new...

 

HTMLThe Eighth Circuit Paves the Way for More Removals under CAFA's "Mass Action" Provision
Laura J. Bettenhausen; Baker Sterchi Cowden & Rice, L.L.C.;
Legal Alert/Article
December 10, 2013, previously published on December 4, 2013
The Eighth Circuit’s recent opinion in Atwell v. Boston Scientific Corporation is bound to have an impact on mass action litigation nationwide. Atwell involves the interpretation of the Class Action Fairness Act of 2005 (“CAFA”), which provides for the removal from state to...

 

HTMLCDRH Issues Final Guidance on Research Use Only and Investigational Use Only In Vitro Diagnostics Products
Jeffrey N. Gibbs, Allyson B. Mullen; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
December 5, 2013, previously published on December 3, 2013
On November 25, 2013, CDRH issued the Final Guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions” (the “RUO Guidance”). The draft guidance significantly limited the sale and distribution...

 

HTMLITC Institutes Investigation (337-TA-903) Regarding Certain Antivenom Compositions
Eric W. Schweibenz, Thomas C. Yebernetsky; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
December 5, 2013, previously published on December 2, 2013
On November 29, 2013, the U.S. International Trade Commission issued a press release announcing their vote to institute an investigation of Certain Antivenom Compositions and Products Containing the Same (Inv. No. 337-TA-903).

 

HTMLWARF Could Avoid Federal Circuit Review
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
December 4, 2013, previously published on December 1, 2013
On November 25, 2013, Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) responded to the Federal Circuit’s Order directing each party to brief whether CW, as a third party requester, has standing to appeal the U.S. Patent and Trademark...

 

HTMLNanotech Roundup: Latest National Nanotechnology Initiative Strategic Plan Released for Comment; NYAS Nanomedicine Conference Summary
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
December 3, 2013, previously published on December 2, 2013
The National Nanotechnology Initiative ("NNI") released its draft 2014 Strategic Plan for comment. The draft plan lays out the NNI’s goals and objectives, which remain largely unchanged from 2011. As with the 2011 Plan, the draft 2014 Plan includes a description of FDA’s...

 

HTMLFDA’s Message to Medical Device Company: Stop
Ralph S. Tyler; Venable LLP;
Legal Alert/Article
December 2, 2013, previously published on November 27, 2013
The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious diseases,” including diabetes, coronary heart disease,...

 

HTMLUnreported Injuries Caused by Robotic Surgery Complications
James P. Nevin; Brayton Purcell, LLP;
Legal Alert/Article
November 28, 2013, previously published on November 22, 2013
Robot-assisted surgery may surprisingly be more dangerous than traditional surgery techniques. The problem is that the FDA does not know absolutely either way because injuries and deaths from using the da Vinci Robotic System are going underreported while patients continue to file...

 

HTMLALJ Essex Grants-In-Part Motion to Compel In Certain Omega-3 Extracts From Marine or Aquatic Biomass (337-TA-877)
Eric W. Schweibenz, Thomas C. Yebernetsky; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
November 28, 2013, previously published on November 26, 2013
On November 22, 2013, ALJ Theodore R. Essex issued the public version of Order No. 32 (dated November 13, 2013) in Certain Omega-3 Extracts from Marine or Aquatic Biomass and Products Containing the Same (Inv. No. 337-TA-877).

 


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