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HTMLFDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act
Carolyn A. Alenci, Frederick R. Ball; Duane Morris LLP;
Legal Alert/Article
December 10, 2014, previously published on November 17, 2014
Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution...

 

HTMLVanessa’s Law: What It Means for the Canadian Drug and Medical Device Industries
Sara Zborovski; Davis LLP;
Legal Alert/Article
December 3, 2014, previously published on November 13, 2014
Shhh, can you hear that? That’s the stamp of approval on a new era in Canadian drug and device regulation.

 

HTMLMobile Health Apps are in a Boom Phase - Why is it so Hard for Pharmaceutical Companies to Find Users?
Vinay Bhupathy; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
December 1, 2014, previously published on November 5, 2014
Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma) companies. A recent report published by Research2Guidance, indicates that...

 

Adobe PDFThe Battle of Pharmaceutical Patents in Brazil
Igor Simões; Simões Intellectual Property - Brazil;
Legal Alert/Article
November 27, 2014, previously published by Valor Economico Newspaper on December 15, 2004
This article is one of the most cited in the field of industrial property in Brazil until the present day, with over 25 citations in master’s theses, doctoral and legal and scientific articles. It has replicated in over 50 web pages. On August 19, 2014 reached 2360 hits on the search for the...

 

HTMLALJ Bullock Denies Motion to Compel in Certain Hemostatic Products (337-TA-913)
Katherine Cappaert, Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
November 27, 2014, previously published on November 17, 2014
On October 27, 2014, Chief ALJ Charles E. Bullock issued the public version of Order No. 20 (dated October 7, 2014) in Certain Hemostatic Products and Components Thereof (Inv. No. 337-TA-913).

 

Adobe PDFWhat is the Relation Between Registration of Pharmaceuticals and Patents?
Igor Simões; Simões Intellectual Property - Brazil;
Legal Alert/Article
November 27, 2014, previously published by Grupemef
The concern of the government when it comes to the pharmaceutical industry is obvious, both on the registration of medicinal drugs as on patents. Frequently, we face with threats from the Government to compulsorily license patents of certain drugs, measure known in Brazil as “breach of...

 

Adobe PDFOpportunities for the Launch of Generic and Similar Drugs in Brazil
Deborah Portilho, Igor Simões; Simoes Intellectual Property - Brazil;
Legal Alert/Article
November 27, 2014, previously published by UPpharma
Every pharmaceutical company must bear in mind the fact that the launch of new products invariably requires a careful research concerning the industrial property rights of third parties, particularly those relating to trademarks and patents. It turns out that some national companies only began to...

 

HTMLALJ Bullock Grants Joint Motion To Terminate Investigation In Certain Antivenom Compositions (337-TA-903)
Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
November 27, 2014, previously published on November 20, 2014
On November 13, 2014, Chief ALJ Charles E. Bullock issued Order No. 62 in Certain Antivenom Compositions and Products Containing the Same (Inv. No. 337-TA-903).

 

HTMLDistrict Court Finds Genetic Technologies Patent Invalid Under 101 on Motion to Dismiss
Courtenay C. Brinckerhoff; Foley Lardner LLP;
Legal Alert/Article
November 14, 2014, previously published on November 6, 2014
Judge Stark of the U.S. District Court for the District of Delaware granted defendants’ motion to dismiss Genetic Technologies, Ltd.’s patent infringement suit with regard to claim 1 of U.S. Patent 5,612,179 on the basis that the claimed sequence analysis method is invalid under 35 USC...

 

HTMLA Peek at the 60 Minutes GenePeeks Patents
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
November 12, 2014, previously published on October 29, 2014
On October 26, 2014, 60 Minutes aired a story called “Breeding Out Disease” that included a segment about GenePeeks, a company that uses genetic information from prospective parents to make thousands of “digital babies” and ”calculate the risk of two people conceiving...

 


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