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HTMLGPhA Calls for US-EU Convergence in Biosimilar and Generic Medicine Regulation
James C. Shehan; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 15, 2014, previously published on April 10, 2014
The Generic Pharmaceuticals Association (“GPhA”) opened a new front in its ongoing battle to shape the approval process for biosimilars, while also calling for more cooperation between the US and the EU in their oversight of traditional generic drugs. In a joint letter to the European...

 

HTMLLandmark Decision Confirms FTC Authority to Regulate Privacy and Data Security
Richard J. Johnson, Mark Mansour, Mauricio F. Paez, Katherine S. Ritchey, Gregory P. Silberman; Jones Day;
Legal Alert/Article
April 15, 2014, previously published on April 2014
In FTC v. Wyndham Worldwide Corp., No 13-1887, 2014 U.S. Dist. LEXIS 47622 (D.N.J. Apr. 7, 2014)—a case closely watched by privacy and data security professionals across the United States—a federal district court held that the Federal Trade Commission ("FTC") has authority...

 

HTMLDo the USPTO 101 Guidelines Violate International Trade Agreements?
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
April 11, 2014, previously published on April 9, 2014
One advantage of being a blogger in the relatively small world of patents is that I have gotten to know practitioners in other countries who also have a keen interest in patent law. One such person is Australian Registered Patent Attorney Mark Summerfield, who blogs at Patentology. I enjoyed his...

 

HTMLThe USPTO Does Not Need the Onerous Proposed Attributable Owner Rules
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
April 10, 2014, previously published on April 7, 2014
The Federal Register Notice promulgating the proposed Attributable Owner rules offers some lofty justifications for the rules. Because the rules have been promulgated pursuant to a White House initiative, they are likely to take effect in some form, but applicants and stakeholders should not miss...

 

HTMLA Second Lawsuit Tests the BPCIA Biosimilars “Patent Dance” Waters
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 4, 2014, previously published on April 1, 2014
Earlier this week, Celltrion Healthcare Co., Ltd. and Celltrion, Inc. (collectively “Celltrion”) filed a Complaint for Declaratory Judgment in the U.S. District Court for the District of Massachusetts seeking a judgment with respect to certain patents allegedly covering Janssen Biotech,...

 

HTMLThe State of Vaccines Under the USPTO 101 Guidelines
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
April 4, 2014, previously published on March 31, 2014
In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical fields.

 

HTMLITC Institutes Investigation (337-TA-911) Regarding Certain Lithium Silicate Materials
Alexander B. Englehart, Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
March 25, 2014, previously published on March 24, 2014
On March 21, 2014, the U.S. International Trade Commission issued a press release announcing their vote to institute an investigation of Certain Lithium Silicate Materials and Products Containing the Same (Inv. No. 337-TA-911).

 

HTMLDNA Samples
Tamara Bogosian, Paul A. Cappitelli, G. Ross Trindle; Best Best & Krieger LLP;
Legal Alert/Article
March 25, 2014, previously published on March 21, 2014
Overview: The Ninth Circuit Court of Appeals recently upheld a California law requiring that all persons arrested for, or charged with, a felony or attempted felony submit DNA samples for inclusion in law enforcement databases. The constitutional challenge was brought by a class of individuals that...

 

HTMLALJ Bullock Denies Summary Determination Of No Violation Based On Induced Infringement In Certain Antivenom Compositions (337-TA-903)
Alexander B. Englehart, Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
March 25, 2014, previously published on March 19, 2014
On March 14, 2014, Chief ALJ Charles E. Bullock issued Order No. 16 in Certain Antivenom Compositions and Products Containing the Same (Inv. No. 337-TA-903). In the Order, ALJ Bullock denied Respondents Laboratorios Silanes S.A. de C.V. and Instituto Bioclan S.A. de C.V.’s (collectively,...

 

HTMLALJ Bullock Denies Summary Determination Motion in Certain Antivenom Compositions (337-TA-903)
Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
March 20, 2014, previously published on March 18, 2014
On March 11, 2014, Chief ALJ Charles E. Bullock issued Order No. 12 in Certain Antivenom Compositions and Products Containing the Same (Inv. No. 337-TA-903).

 


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