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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...

 

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...

 

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...

 

HTMLU.S. Government and USPTO Urges Federal Circuit to Dismiss Stem Cell Appeal
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
February 5, 2014, previously published on February 3, 2014
On January 17, 2014, the United States government and the United States Patent and Trademark Office (collectively “the government”) responded to the Federal Circuit’s December 4, 2013 order inviting them to address whether Consumer Watchdog (“CW”) has Article III...

 

HTMLUSPTO Proposes Real Party in Interest Patent Rules
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
February 3, 2014, previously published on January 27, 2014
A year after its “Roundtable on Proposed Requirements for Recordation of Real Party-in-Interest Information Throughout Application Pendency and Patent Term,” and six months after the White House Task Force on High-Tech Patent Issues made requiring patent applicants and owners to...

 

HTMLFDA Issues New Draft Guidance for Custom Devices; Some Points Worth Highlighting
Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
January 31, 2014, previously published on January 27, 2014
FDA has issued a new draft guidance on the custom device exemption. Comments are due by March 17, 2014. This schedule puts FDA on track to finalize the guidance by July 9, 2014, as required under section 617 of the Food and Drug Administration Safety and Innovation Act (“FDASIA”) (Pub....

 

HTMLSupreme Court Lays Burden of Proof on Patentee, Even in Declaratory Judgment Action
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
January 29, 2014, previously published on January 22, 2014
In Medtronic, Inc. v. Mirowski Family Ventures, LLC, a unanimous Supreme Court held that the patent holder bears the burden of proving infringement, even in a declaratory judgment action brought by a licensee. In reaching its decision, the Court dismissed concerns that it would skew the balance of...

 

HTMLPatent Owners’ Heavy Burdens: Proof of Infringement
Elizabeth Ann Lester, William L. Warren; Sutherland Asbill & Brennan LLP;
Legal Alert/Article
January 29, 2014, previously published on January 24, 2014
The U.S. Supreme Court reversed the U.S. Court of Appeals for the Federal Circuit in a unanimous opinion in Medtronic, Inc. v. Mirowski Family Ventures, LLC, No. 12-1128, on January 22, 2014, holding that patent owners bear the burden of proving infringement when a licensee seeks a declaratory...

 

HTMLSupreme Court Grants Certiorari in Nautilus v. Biosig Instruments
Michael G. Raucci; Sughrue Mion, PLLC;
Legal Alert/Article
January 23, 2014, previously published on January 15, 2014
On January 10, 2014, the Supreme Court granted certiorari in Nautilus v. Biosig Instruments (13-369) to decide the proper standard for finding patented claims indefinite under 35 U.S.C. § 112. At issue is whether the Federal Circuit’s construction of § 112, ¶ 2 conflicts with...

 


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